FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report

Selection Criteria:

Active Ingredient: Product Name: FDA Received Date: MedDRA Version* : Total Cases**: Number of Pages:

. .;NUVARING From: 01-JAN-2009 To: 15.1 3,632 1,498 04-FEB-2013

Disclaimer: Submission of a safety report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer or product caused or contributed to the event. The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events. *. MedDRA Version refers to the name and version of the dictionary in use at the time the cases were retrieved from the FDA Adverse Event Reporting System (FAERS). MedDRA Medical Dictionary for Regulatory Activities (MedDRA) is a medical terminology developed under the support of the International Conference on Harmonization (ICH) and is a registered trademark of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). MedDRA is used by FDA, other regulatory agencies, and pharmaceutical manufacturers to code adverse events, medication errors and other information associated with the use of medical products. A MedDRA Preferred Term (PT) is used to standardize a medical concept in a report. For example, a report of heart attack or myocardial infarct are standardized to the same Preferred Term, Myocardial Infarction. MedDRA is updated twice a year. **. Total Cases reflects the number of individual patient case reports associated with the product of interest that were submitted to FDA within the specified time period. A case consists of an initial report and any follow-up reports submitted to FDA. Because FDA may receive reports on the same patient from more than one source, some of these cases may be duplicate patient reports.

Date - Time: 02-04-2013 9:43:10 AM EST

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FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report
The information in this report is generated from the FDA Adverse Event Reporting System (FAERS) by using a report query where suspect product(s) or active ingredients are selected from a standardized dictionary and a date range is specified as search criteria. The table below provides the definitions for field headings that are listed on the report.

FAERS data have limitations, including the following. There is no certainty that the reported event was actually due to the product. Reports are often incomplete - a blank field means that no data were provided. FDA does not receive reports on all adverse events that occur with a product. Many factors can influence whether or not an event will be reported, therefore, FAERS data cannot be used to compare products or calculate how frequently an event occurs in the U.S. population.

Field Heading Definition FDA Received Date The date that FDA received the most recent information regarding a case, either as an initial report or follow-up report. The FDA Received Date may not be the same as the date that the event occurred. The event may have occurred days or even months (or years) before the report was sent to (and received by) FDA. Note the displayed date on the report may be later than the query date range if FDA received follow-up information for a case. FDA provides the most current case information available. Case # A unique number assigned by FDA that identifies a FAERS case. A case includes the information received in the initial report plus any additional information received in follow-up reports. Case Type There are three case types in FAERS: Expedited (15-Day): submitted to FDA by manufacturers; these are reports containing serious, unexpected adverse events Nonexpedited: submitted periodically to FDA by manufacturers; these are reports containing adverse events other than those qualifying for expedited (15-day) reporting Direct: submitted directly to FDA by healthcare professionals, patients and other consumers Indicates whether the initial source who provided information about the event is a health professional (HP). Possible values are; Y - Yes, N No or the field is blank if it was not reported Based on FDA regulations, the reported outcome(s) determines whether a case is serious. The outcome categories include congenital anomaly/birth defect (CA), death (DE), disability (DS), hospitalization (HO), life-threatening (LT), other serious important medical event (OT), and required intervention to prevent permanent impairment/damage (RI). A case can have more than one outcome. The Manufacturer Control Number is the manufacturers unique identifier associated with the case. Also referred to as the Company Report Number. The patient's age, with age unit, based on information provided in the report. Patient sex (Male, Female, Unknown). The country where the event occurred. If not reported, then the country of the reporter. The International Organization for Standardization (ISO) 3166-1 alpha-3 country code is used as an abbreviation for the country.

Health Professional Outcomes

Manufacturer Control # Age Sex Country

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

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FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report
Field Heading Preferred Term Definition A Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term (PT) is used to standardize a medical concept in a report. For example, a report of heart attack or myocardial infarct are standardized to the same Preferred Term, Myocardial Infarction. MedDRA is a medical terminology developed under the support of the International Conference on Harmonization (ICH) and is a registered trademark of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). MedDRA is used by FDA, other regulatory agencies, and pharmaceutical manufacturers to code adverse events, medication errors and other information associated with the use of medical products Name of a drug or therapeutic biologic in the case report. A product name can appear as either a brand name (trade name) or an active ingredient name, depending on what was reported. There are two roles for products listed on the cases. Suspect (S) identifies the product(s) that the initial reporter deemed most likely to be associated with the event. Concomitant (C) identifies products taken at the same time as the suspect product, but not deemed by the initial reporter as being associated with the event. Reported route of product administration (e.g., oral, topical, injection, sublingual, inhalation). Refers to the amount of the product that was taken or given to a patient, and the frequency of administration. For example, 20 mg twice daily. The length of time the product was used. For example, if someone reported taking Drug A from January 1 to January 30, the duration would be 30 days. The manufacturer of the product, as indicated in the report.

Product Role

Route Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

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FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6874622 Date FDA Received
02-Jan-2009 Preferred Term MALAISE LOSS OF CONSCIOUSNESS PRODUCT QUALITY ISSUE Case # 6874622 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional N Outcomes DE,HO Role Route S Manufacturer Control # 2008-188604-NL Dosage Text Duration Age Sex Female Country USA

Manufacturer

6744151 Date FDA Received

05-Jan-2009 Preferred Term

Case # 6744151

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional

Outcomes HO Role Route S

Manufacturer Control # 2008-181833-NL Dosage Text DF

Age 23 YR Duration 5 YEAR

Sex Female

Country DEU

Manufacturer

PULMONARY EMBOLISM CHLAMYDIAL INFECTION DECREASED APPETITE MALAISE NIGHT SWEATS PERIPHERAL VASCULAR DISORDER PNEUMONIA

6878670 Date FDA Received

06-Jan-2009 Preferred Term

Case # 6878670

Case Type DIRECT Product NUVARING

Health Professional N

Outcomes HO,LT Role Route S VAGINAL

Manufacturer Control #

Age 45 YR

Sex Female

Country USA

Dosage Text 1 RING Q 28 DAYS VAG Manufacturer Control # 2008-185167-NL Dosage Text DF

Duration

Manufacturer SCHERING

PULMONARY EMBOLISM

6802880 Date FDA Received

09-Jan-2009 Preferred Term

Case # 6802880

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional

Outcomes HO Role Route S

Age

Sex Female

Country CAN

Duration

Manufacturer

STREPTOCOCCAL SEPSIS

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

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FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6889028 Date FDA Received
13-Jan-2009 Preferred Term DRUG HYPERSENSITIVITY BLISTER Case # 6889028 Case Type DIRECT Product NUVARING Health Professional N Outcomes OT Role Route S VAGINAL Dosage Text 1 RING EVERY 28 DAYS VAG Manufacturer Control # Age 35 YR Duration Sex Female Country USA

Manufacturer ORGANON

6890768 Date FDA Received

14-Jan-2009 Preferred Term

Case # 6890768

Case Type DIRECT Product NUVARING Case Type DIRECT Product NUVARING

Health Professional Y

Outcomes HO,LT Role Route S

Manufacturer Control #

Age 19 YR

Sex Female

Country USA

Dosage Text

Duration

Manufacturer

PULMONARY EMBOLISM

6891230 Date FDA Received

15-Jan-2009 Preferred Term CHEST PAIN

Case # 6891230

Health Professional N

Outcomes HO,LT Role Route S VAGINAL

Manufacturer Control #

Age 36 YR

Sex Female

Country USA

Dosage Text 0.120MG/0.015 MG DELIVERED PER DAY VAG

Duration 9 MTH

Manufacturer ORGANON

DYSPNOEA PAIN PLEURAL EFFUSION PULMONARY EMBOLISM

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

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FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6893675 Date FDA Received
21-Jan-2009 Preferred Term IMPAIRED WORK ABILITY ACTIVITIES OF DAILY LIVING IMPAIRED BREAST PAIN CRYING DECREASED APPETITE DIARRHOEA ECONOMIC PROBLEM FEAR FEELING ABNORMAL HEADACHE MALAISE MEDICAL DEVICE COMPLICATION NAUSEA PROGESTERONE INCREASED WEIGHT DECREASED Case # 6893675 Case Type DIRECT Product NUVARING Health Professional N Outcomes HO,OT Role Route S VAGINAL Dosage Text 0.03 MG EVERY 3 WKS VAG Manufacturer Control # Age 21 YR Duration Sex Female Country USA

Manufacturer ORGANON

6894638 Date FDA Received

21-Jan-2009 Preferred Term BREAST TENDERNESS

Case # 6894638

Case Type DIRECT Product NUVARING

Health Professional N

Outcomes OT Role Route S INTRA-CERVICAL

Manufacturer Control #

Age 36 YR

Sex Female

Country USA

Dosage Text ONE RING FOR 3WKS/ MONTH INTRACERVICAL

Duration

Manufacturer

DYSPAREUNIA HYPOTHYROIDISM INSOMNIA RASH PRURITIC VULVOVAGINAL SWELLING WEIGHT INCREASED

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

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FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6896433 Date FDA Received
21-Jan-2009 Preferred Term ABDOMINAL PAIN Case # 6896433 Case Type DIRECT Product NUVARING Health Professional N Outcomes OT Role Route S VAGINAL Dosage Text 0.120MG/0.015 MG PER DAY MONTLY VAG Manufacturer Control # 2009-189332-NL Dosage Text 3 WEEKS IN/ 1 WEEK OUT Age 20 YR Duration Sex Female Country USA Manufacturer Control # Age 42 YR Duration Sex Female Country USA

Manufacturer

6898361 Date FDA Received

21-Jan-2009 Preferred Term OFF LABEL USE BRONCHITIS PNEUMONIA

Case # 6898361

Case Type EXPEDITED (15-DAY) Product NUVARING TOPAMAX TRILEPTAL

Health Professional N

Outcomes OT Role Route S C C C C Outcomes HO Role Route S

Manufacturer

MEDICAL DEVICE COMPLICATION VAGINAL HAEMORRHAGE

CLINDAMYCIN PHOSPHATE ALBUTEROL ORAL INHALER Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional

6905291 Date FDA Received

28-Jan-2009 Preferred Term UTERINE LEIOMYOMA

Case # 6905291

Manufacturer Control # 2009-189883-NL Dosage Text DF

Age

Sex Female

Country CAN

Duration

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

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FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6905671 Date FDA Received
29-Jan-2009 Preferred Term ACNE CYSTIC DEPRESSION FAMILY STRESS HEADACHE IRRITABILITY LOSS OF LIBIDO MUSCLE SPASMS NO THERAPEUTIC RESPONSE PAIN WEIGHT INCREASED Case # 6905671 Case Type DIRECT Product NUVARING Health Professional N Outcomes RI Role Route S VAGINAL Dosage Text 1 RING 1 X MONTH VAG Manufacturer Control # Age 32 YR Duration Sex Female Country USA

Manufacturer

6904588 Date FDA Received

30-Jan-2009 Preferred Term DISCOMFORT

Case # 6904588

Case Type DIRECT Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control #

Age 20 YR

Sex Female

Country USA

Dosage Text 0.120MG/0.015MG 3WEEKS AT A TIME VAGENAL

Duration

Manufacturer

HAEMORRHAGE INJURY LACERATION MEDICAL DEVICE COMPLICATION PAIN

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

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FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6905674 Date FDA Received
02-Feb-2009 Preferred Term PULMONARY EMBOLISM COMPLICATION OF DEVICE INSERTION Case # 6905674 Case Type EXPEDITED (15-DAY) Product NUVARING KLONOPIN LAMICTAL "BURROUGHS WELLCOME" LUNESTA PROTONIX VITAMINS NOS CARAFATE Health Professional Y Outcomes DE Role Route S C C C C C C Health Professional N Outcomes OT Role Route S Manufacturer Control # 2009-189955-NL Dosage Text 3 WEEKS IN, 1 WEEK OUT Manufacturer Control # Age 28 YR Dosage Text Duration Sex Female Country USA Age 30 YR Duration Sex Female Country USA Manufacturer Control # 2009-190160-NL Dosage Text Age 38 YR Duration Sex Female Country USA

Manufacturer

6908699 Date FDA Received

02-Feb-2009 Preferred Term

Case # 6908699

Case Type EXPEDITED (15-DAY) Product NUVARING

Manufacturer

STAPHYLOCOCCAL INFECTION

6908076 Date FDA Received

03-Feb-2009 Preferred Term

Case # 6908076

Case Type DIRECT Product NUVARING

Health Professional Y

Outcomes HO,LT Role Route S

Manufacturer

SUPERIOR SAGITTAL SINUS THROMBOSIS TRANSVERSE SINUS THROMBOSIS

6912028 Date FDA Received

03-Feb-2009 Preferred Term

Case # 6912028

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes RI Role Route S

Manufacturer Control # 2009-189959-NL Dosage Text 3 WEEKS IN, 1 WEEK OUT

Age 20 YR Duration

Sex Female

Country USA

Manufacturer

URINARY TRACT INFECTION URETHRAL DISORDER

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

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FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6912873 Date FDA Received
05-Feb-2009 Preferred Term MUSCLE CONTRACTIONS INVOLUNTARY VAGINAL DISORDER Case # 6912873 Case Type DIRECT Product NUVARING Health Professional N Role Route S INTRAUTERINE Dosage Text 0.120 MG DAY INTRAUTERINE Outcomes Manufacturer Control # Age 26 YR Duration Sex Female Country USA

Manufacturer ORGANON

6912877 Date FDA Received

05-Feb-2009 Preferred Term HEADACHE

Case # 6912877

Case Type DIRECT Product NUVARING

Health Professional N

Outcomes

Manufacturer Control #

Age 24 YR

Sex Female

Country USA

Role Route S VAGINAL

Dosage Text 1 RING FOR 3 WEEKS VAG 3 WEEKS IN, 1 WEEK OUT

Duration

Manufacturer

DEPRESSION SUICIDAL IDEATION

6912619 Date FDA Received

06-Feb-2009 Preferred Term

Case # 6912619

Case Type DIRECT Product NUVARING Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes LT Role Route S VAGINAL

Manufacturer Control #

Age 37 YR

Sex Female

Country USA

Dosage Text 1 RING MONTHLY VAG Manufacturer Control # 2009-190353-NL Dosage Text 3 WEEKS IN/ 1 WEEK OUT

Duration

Manufacturer

PULMONARY EMBOLISM

6913422 Date FDA Received

06-Feb-2009 Preferred Term CONVULSION FALL

Case # 6913422

Health Professional N

Outcomes HO Role Route S

Age 22 YR Duration

Sex Female

Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

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FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6914333 Date FDA Received
09-Feb-2009 Preferred Term MIGRAINE ACTIVITIES OF DAILY LIVING IMPAIRED IMPAIRED DRIVING ABILITY PRESYNCOPE Case # 6914333 Case Type DIRECT Product NUVARING Health Professional N Role Route S VAGINAL Dosage Text 1 RING EVERY 4 WEEKS VAG Outcomes Manufacturer Control # Age 31 YR Duration Sex Female Country USA

Manufacturer

6915763 Date FDA Received

11-Feb-2009 Preferred Term

Case # 6915763

Case Type DIRECT Product

Health Professional Y

Outcomes HO,LT Role Route S S INTRAVENOUS DRIP VAGINAL

Manufacturer Control #

Age 45 YR

Sex Female

Country USA

Dosage Text 50 GMS/MONTH MONTHLY IV DRIP CONTINUOUSLY VAG Manufacturer Control # 2009-190506-NL Dosage Text 3 WEEKS IN, 1 WEEK OUT

Duration 2 YEAR 2 YEAR Age 20 YR Duration Sex

Manufacturer

PULMONARY EMBOLISM

GAMUNEX-C NUVARING

6913423 Date FDA Received

12-Feb-2009 Preferred Term

Case # 6913423

Case Type EXPEDITED (15-DAY) Product NUVARING ZYRTEC ZANTAC

Health Professional N

Outcomes DS,OT Role Route S C C C C C C

Country USA

Female

Manufacturer

ANAPHYLACTIC REACTION DRUG INEFFECTIVE BLINDNESS UNILATERAL VISUAL IMPAIRMENT

PROBIOTICA BENADRYL 'WARNERLAMBERT" /USA/ ALBUTEROL EPINEPHRINE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

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FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6915383 Date FDA Received
12-Feb-2009 Preferred Term PULMONARY EMBOLISM Case # 6915383 Case Type EXPEDITED (15-DAY) Product NUVARING Case Type EXPEDITED (15-DAY) Product NUVARING K-DUR MERCAPTOPURINE ALDACTONE SYNTHROID CYMBALTA WELCHOL Health Professional Y Health Professional Y Outcomes DE Role Route S Outcomes HO Role Route S C C C C C C Health Professional Y Product NUVARING Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes DE Role Route S Outcomes HO Role Route S Manufacturer Control # 2009-190963-NL Dosage Text Duration Age Sex Female Country USA Dosage Text Manufacturer Control # Age 39 YR Duration Sex Female Country USA Manufacturer Control # 2009-190771-NL Dosage Text 3 WEEKS IN, 1 WEEK OUT Manufacturer Control # 2009-190675-NL Dosage Text 3 WEEKS IN/ 1 WEEK OUT Age 44 YR Duration Sex Female Country USA Age 28 YR Duration Sex Female Country USA

Manufacturer

6917128 Date FDA Received

12-Feb-2009 Preferred Term

Case # 6917128

Manufacturer

LOWER LIMB FRACTURE FALL DEEP VEIN THROMBOSIS PULMONARY EMBOLISM

6920895 Date FDA Received

17-Feb-2009 Preferred Term

Case # 6920895

Case Type DIRECT

Manufacturer

CEREBRAL HAEMORRHAGE

6924443 Date FDA Received

17-Feb-2009 Preferred Term BLOOD DISORDER

Case # 6924443

Manufacturer

CEREBRAL THROMBOSIS

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

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FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6924459 Date FDA Received
20-Feb-2009 Preferred Term DEVICE EXPULSION Case # 6924459 Case Type DIRECT Product NUVARING Case # 6926516 Case Type DIRECT Product NUVARING Case # 6929435 Case Type EXPEDITED (15-DAY) Product NUVARING Case # 6930693 Case Type EXPEDITED (15-DAY) Product NUVARING Case # 6930765 Case Type DIRECT Product NUVARING Health Professional Y Health Professional Y Role Route S Outcomes HO Role Route S VAGINAL Dosage Text 1 MONTHLY VAG Health Professional Y Role Route S Outcomes Health Professional N Health Professional Y Role Route S Outcomes LT Role Route S VAGINAL Dosage Text 1 RING MONTHLY VAG Manufacturer Control # 2009-191320-NL Dosage Text DF Manufacturer Control # 2009-191319-NL Dosage Text DF Manufacturer Control # Age 53 YR Duration 5 YEAR Sex Female Country USA Duration Age Sex Female Country ITA Duration Age Sex Female Country ITA Manufacturer Control # Age 40 YR Duration Sex Female Country USA Dosage Text Outcomes Manufacturer Control # Age 20 YR Duration Sex Female Country USA

Manufacturer

6926516 Date FDA Received

23-Feb-2009 Preferred Term THROMBOSIS

Manufacturer

6929435 Date FDA Received

23-Feb-2009 Preferred Term PELVIC CONGESTION

Outcomes

Manufacturer

6930693 Date FDA Received

23-Feb-2009 Preferred Term PELVIC CONGESTION

Manufacturer

6930765 Date FDA Received

24-Feb-2009 Preferred Term

Manufacturer ORGANON

PULMONARY EMBOLISM

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

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FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6930952 Date FDA Received
24-Feb-2009 Preferred Term ALOPECIA FATIGUE WEIGHT INCREASED Case # 6930952 Case Type DIRECT Product NUVARING Health Professional N Outcomes OT Role Route S VAGINAL Dosage Text 1 RING 221 DAYS VAG Manufacturer Control # Age 45 YR Duration 221 DAY Sex Female Country USA

Manufacturer ORGANON

6932350 Date FDA Received

25-Feb-2009 Preferred Term PAIN UNEVALUABLE EVENT

Case # 6932350

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2009-191945-NL Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

6922446 Date FDA Received

27-Feb-2009 Preferred Term DEPRESSION DRUG INTERACTION

Case # 6922446

Case Type NON-EXPEDITED Product LAMICTAL NUVARING DEPAKOTE ZOLOFT

Health Professional N

Outcomes DS Role Route S S C C ORAL VAGINAL

Manufacturer Control # A0733694A Dosage Text 150MG per day 1UNIT Cyclic

Age 27 YR Duration 106 DAY

Sex Female

Country USA

Manufacturer GLAXOSMITHKLINE

6922740 Date FDA Received

27-Feb-2009 Preferred Term METRORRHAGIA DRUG INTERACTION

Case # 6922740

Case Type NON-EXPEDITED Product LAMICTAL NUVARING

Health Professional N

Outcomes

Manufacturer Control # A0745529A

Age

Sex Female

Country USA

Role Route S S ORAL

Dosage Text

Duration

Manufacturer GLAXOSMITHKLINE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

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FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6936155 Date FDA Received
02-Mar-2009 Preferred Term BLISTER HYPERSENSITIVITY Case # 6936155 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Role Route S VAGINAL Outcomes Manufacturer Control # 2009-191950-NL Dosage Text DF VAGINAL Duration Age Sex Female Country ESP

Manufacturer

6936810 Date FDA Received

02-Mar-2009 Preferred Term

Case # 6936810

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional

Outcomes

Manufacturer Control # 2009-191939-NL

Age

Sex Female

Country RUS

Role Route S

Dosage Text DF

Duration

Manufacturer

RESPIRATORY DISORDER ANGINA PECTORIS ASTHENIA BLOOD PRESSURE FLUCTUATION FATIGUE HAEMOGLOBIN DECREASED MENORRHAGIA ORAL HERPES PALPITATIONS TINNITUS VULVOVAGINAL DISCOMFORT

6942181 Date FDA Received

02-Mar-2009 Preferred Term JAUNDICE

Case # 6942181

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO Role Route S C

Manufacturer Control # 2009-191984-NL Dosage Text

Age 34 YR Duration 11 MTH

Sex Female

Country USA

Manufacturer

ALANINE AMINOTRANSFERASE INCREASED ASPARTATE AMINOTRANSFERASE INCREASED DEPRESSION

WELLBUTRIN NI

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 15 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6942713 Date FDA Received
04-Mar-2009 Preferred Term BREAST MASS BREAST DISCHARGE BREAST PAIN Case # 6942713 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Role Route S VAGINAL Outcomes Manufacturer Control # 2009-191948-NL Dosage Text DF VAGINAL Duration Age Sex Female Country POL

Manufacturer

6943508 Date FDA Received

06-Mar-2009 Preferred Term

Case # 6943508

Case Type DIRECT Product NUVARING

Health Professional N

Outcomes HO,LT Role Route S

Manufacturer Control #

Age 53 YR

Sex Female

Country USA

Dosage Text

Duration

Manufacturer ORGANON

PULMONARY EMBOLISM PULMONARY INFARCTION

6945085 Date FDA Received

06-Mar-2009 Preferred Term NECK PAIN

Case # 6945085

Case Type DIRECT Product NUVARING

Health Professional N

Outcomes HO Role Route S VAGINAL

Manufacturer Control #

Age 24 YR

Sex Female

Country USA

Dosage Text ONE VAGINAL RING ONCE A MONTH VAG

Duration

Manufacturer

ILL-DEFINED DISORDER PYREXIA RASH

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 16 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6689414 Date FDA Received
09-Mar-2009 Preferred Term SUICIDAL IDEATION ANXIETY PANIC REACTION AGGRESSION CARDIAC DISORDER DECREASED APPETITE DIZZINESS FLUSHING HYPERHIDROSIS IMPAIRED WORK ABILITY INSOMNIA PALPITATIONS PANIC ATTACK SMEAR CERVIX ABNORMAL TREMOR Case # 6689414 Case Type EXPEDITED (15-DAY) Product NUVARING SALBUTAMOL SULFATE FLUTICASONE PROPIONATE Health Professional Outcomes DS,LT Role Route S C C VAGINAL Manufacturer Control # 2008-178834-NL Dosage Text VAGINA Age 26 YR Duration 107 DAY Sex Female Country CAN

Manufacturer

6943068 Date FDA Received

09-Mar-2009 Preferred Term

Case # 6943068

Case Type DIRECT Product NUVARING Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes HO,LT Role Route S VAGINAL

Manufacturer Control #

Age 17 YR

Sex Female

Country USA

Dosage Text ONE RING FOR THREE WEEKS VAG Manufacturer Control # 2009-192143-NL Dosage Text 3 WEEKS IN, 1 WEEK OUT

Duration

Manufacturer ORGANON

DEEP VEIN THROMBOSIS

6943963 Date FDA Received

09-Mar-2009 Preferred Term DEPRESSION SUICIDAL IDEATION

Case # 6943963

Health Professional N

Outcomes HO Role Route S

Age 27 YR Duration

Sex Female

Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 17 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6948652 Date FDA Received
09-Mar-2009 Preferred Term CHOLELITHIASIS CHOLESTASIS DEVICE FAILURE Case # 6948652 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO Role Route S Manufacturer Control # 2009-192206-NL Dosage Text Age 24 YR Duration 1 MTH Sex Female Country USA

Manufacturer

6946233 Date FDA Received

10-Mar-2009 Preferred Term ANKLE FRACTURE INFECTION

Case # 6946233

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2009-192579-NL Dosage Text VAGINAL

Age

Sex Female

Country USA

Duration

Manufacturer

6802882 Date FDA Received

11-Mar-2009 Preferred Term

Case # 6802882

Case Type EXPEDITED (15-DAY) Product NUVARING IBUPROFEN

Health Professional

Outcomes HO Role Route S C C VAGINAL

Manufacturer Control # 2008-185298-NL Dosage Text 1 DF VAGINAL

Age 21 YR Duration 188 DAY

Sex Female

Country CAN

Manufacturer

RENAL FAILURE ACUTE RENAL TUBULAR NECROSIS MESANGIOPROLIFERATIVE GLOMERULONEPHRITIS DRUG EFFECT DELAYED

SALBUTAMOL

6946848 Date FDA Received

13-Mar-2009 Preferred Term MUSCLE SPASMS CHEST PAIN

Case # 6946848

Case Type DIRECT Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control #

Age 23 YR

Sex Female

Country USA

Dosage Text ONE RING EVERY 3 WEEKS VAG

Duration 1 DAY

Manufacturer ORGANON

INADEQUATE ANALGESIA MUSCLE CONTRACTIONS INVOLUNTARY PAIN

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 18 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6952469 Date FDA Received
17-Mar-2009 Preferred Term VOMITING HYPOGLYCAEMIA MALAISE MIGRAINE Case # 6952469 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Outcomes HO Role Route S Manufacturer Control # 2009-192542-NL Dosage Text DF Duration Age Sex Female Country FRA

Manufacturer

6950613 Date FDA Received

18-Mar-2009 Preferred Term

Case # 6950613

Case Type DIRECT Product NUVARING

Health Professional Y

Outcomes HO,LT Role Route S VAGINAL

Manufacturer Control #

Age 57 YR

Sex Female

Country USA

Dosage Text 0.12/0.015/DAY MONTHLY VAGINAL Manufacturer Control #

Duration 3 YEAR

Manufacturer ORGANON

DEEP VEIN THROMBOSIS

6953869 Date FDA Received

19-Mar-2009 Preferred Term BREAST TENDERNESS ABDOMINAL PAIN DYSMENORRHOEA MENORRHAGIA

Case # 6953869

Case Type DIRECT Product NUVARING

Health Professional N

Outcomes OT Role Route S

Age 24 YR

Sex Female

Country USA

Dosage Text

Duration

Manufacturer

MENSTRUAL DISORDER MOOD SWINGS

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 19 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6958658 Date FDA Received
19-Mar-2009 Preferred Term ROAD TRAFFIC ACCIDENT EXCORIATION INJURY OEDEMA PERIPHERAL PULMONARY EMBOLISM TACHYCARDIA Case # 6958658 Case Type DIRECT Product NUVARING Health Professional Y Outcomes HO,LT Role Route S VAGINAL Dosage Text ONE PER MONTH VAGINA Manufacturer Control # Age 42 YR Duration Sex Female Country USA

Manufacturer

6955586 Date FDA Received

20-Mar-2009 Preferred Term

Case # 6955586

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO,OT Role Route S

Manufacturer Control # 2009-192893-NL Dosage Text

Age 22 YR Duration

Sex Female

Country USA

Manufacturer

CERVIX ENLARGEMENT CERVIX CANCER METASTATIC COMPLICATION OF DEVICE REMOVAL

6926565 Date FDA Received

24-Mar-2009 Preferred Term CERVICAL DYSPLASIA

Case # 6926565

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes

Manufacturer Control # 2009-191276-NL

Age 23 YR Duration

Sex Female

Country DEU

Role Route S Health Professional Y Outcomes HO,LT Role Route S

Dosage Text DF Manufacturer Control # 2009-193179-NL Dosage Text 3 WEEKS IN, 1 WEEK OUT

Manufacturer

6955021 Date FDA Received

24-Mar-2009 Preferred Term CHEST PAIN HAEMOPTYSIS THROMBOSIS

Case # 6955021

Case Type EXPEDITED (15-DAY) Product NUVARING

Age 31 YR Duration

Sex Female

Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 20 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6957689 Date FDA Received
24-Mar-2009 Preferred Term HAEMORRHOIDS Case # 6957689 Case Type EXPEDITED (15-DAY) Product NUVARING Case # 6958100 Case Type DIRECT Product NUVARING Health Professional Y Health Professional Y Role Route S Outcomes HO,OT Role Route S VAGINAL Dosage Text ONE RING PER MONTH VAG INSERTED DAY 1-28 Outcomes Manufacturer Control # 2009-193201-NL Dosage Text DF Manufacturer Control # Age 47 YR Duration Sex Female Country USA Duration Age Sex Female Country ESP

Manufacturer

6958100 Date FDA Received

24-Mar-2009 Preferred Term PAIN IN EXTREMITY

Manufacturer ORGANON

GAIT DISTURBANCE IMPAIRED WORK ABILITY

6958068 Date FDA Received

25-Mar-2009 Preferred Term

Case # 6958068

Case Type DIRECT Product NUVARING

Health Professional Y

Outcomes DE Role Route S VAGINAL

Manufacturer Control #

Age 18 YR

Sex Female

Country USA

Dosage Text 3 WEEK PERIOD VAG 3 WEEK PERIOD

Duration

Manufacturer ORGANON

PULMONARY EMBOLISM MUSCLE STRAIN

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 21 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6967782 Date FDA Received
27-Mar-2009 Preferred Term BLOOD PRESSURE INCREASED CERVIX DISORDER INSOMNIA MENORRHAGIA RASH GENERALISED TREATMENT NONCOMPLIANCE URTICARIA UTERINE DISORDER WEIGHT INCREASED Case # 6967782 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Role Route S Outcomes Manufacturer Control # 2009-191630-NL Dosage Text DF Age 41 YR Duration Sex Female Country FIN

Manufacturer

6964335 Date FDA Received

31-Mar-2009 Preferred Term HYPERTENSION ASTHENIA HEADACHE

Case # 6964335

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional

Outcomes

Manufacturer Control # 2009-193322-NL

Age 37 YR Duration

Sex Female

Country ISR

Role Route S

Dosage Text DF

Manufacturer

6964340 Date FDA Received

31-Mar-2009 Preferred Term

Case # 6964340

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional

Outcomes HO Role Route S

Manufacturer Control # 2009-193472-NL Dosage Text DF

Age

Sex Female

Country DEU

Duration

Manufacturer

INTERVERTEBRAL DISC OPERATION NEUROMYOPATHY

6969401 Date FDA Received

31-Mar-2009 Preferred Term KIDNEY INFECTION

Case # 6969401

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2009-193408-NL Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 22 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6965960 Date FDA Received
01-Apr-2009 Preferred Term DIZZINESS SENSATION OF HEAVINESS PHOTOPSIA DYSARTHRIA DYSMENORRHOEA GENITAL HAEMORRHAGE Case # 6965960 Case Type EXPEDITED (15-DAY) Product NUVARING VIVELLE DOT CARBIDOPA LEVODOPA Health Professional Y Outcomes OT Role Route S C C C VAGINAL Manufacturer Control # 2009-193536-NL Dosage Text VAGINAL Age 36 YR Duration Sex Female Country USA

Manufacturer

6967842 Date FDA Received

03-Apr-2009 Preferred Term INJURY

Case # 6967842

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2009-193757-NL Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

MEDICAL DEVICE COMPLICATION

6967845 Date FDA Received

03-Apr-2009 Preferred Term HELLP SYNDROME CAESAREAN SECTION

Case # 6967845

Case Type EXPEDITED (15-DAY) Product NUVARING TOPAMAX CLARITIN ALLEGRA

Health Professional N

Outcomes OT Role Route S C C C

Manufacturer Control # 2009-193823-NL Dosage Text 3 WEEKS IN 1 WEEK OUT

Age 27 YR Duration 3 YEAR

Sex Female

Country USA

Manufacturer

RESPIRATORY DISORDER NEONATAL CARDIAC MURMUR MATERNAL EXPOSURE DURING PREGNANCY PREGNANCY WITH CONTRACEPTIVE DEVICE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 23 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6967889 Date FDA Received
06-Apr-2009 Preferred Term THROMBOSIS PULMONARY EMBOLISM Case # 6967889 Case Type DIRECT Product NUVARING Health Professional Y Outcomes HO Role Route S Dosage Text Manufacturer Control # Age 29 YR Duration Sex Female Country USA

Manufacturer

6971080 Date FDA Received

06-Apr-2009 Preferred Term

Case # 6971080

Case Type DIRECT Product NUVARING

Health Professional N

Outcomes HO Role Route S VAGINAL

Manufacturer Control #

Age 18 YR

Sex Female

Country USA

Dosage Text .120 MG MONTHLY VAG

Duration

Manufacturer

PULMONARY THROMBOSIS PAIN IN EXTREMITY

6971038 Date FDA Received

07-Apr-2009 Preferred Term

Case # 6971038

Case Type DIRECT Product NUVARING

Health Professional Y

Outcomes OT Role Route S VAGINAL

Manufacturer Control #

Age 25 YR

Sex Female

Country USA

Dosage Text 1 RING MONTHLY VAG

Duration 6 MTH

Manufacturer ORGANON

PREGNANCY WITH CONTRACEPTIVE DEVICE MATERNAL EXPOSURE DURING PREGNANCY

6972204 Date FDA Received

09-Apr-2009 Preferred Term LUNG INFECTION

Case # 6972204

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2009-194177-NL Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

6973202 Date FDA Received

10-Apr-2009 Preferred Term

Case # 6973202

Case Type EXPEDITED (15-DAY) Product NUVARING NASONEX VENTOLIN FLOVENT

Health Professional Y

Outcomes DE Role Route S C C C VAGINAL

Manufacturer Control # 2009-194279-NL Dosage Text VAGINAL

Age 42 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM LIMB INJURY

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 24 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6974732 Date FDA Received
13-Apr-2009 Preferred Term ABDOMINAL PAIN Atypical pneumonia MENORRHAGIA Case # 6974732 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional N Outcomes HO Role Route S Manufacturer Control # 2009-194097-NL Dosage Text Age 22 YR Duration Sex Female Country USA

Manufacturer

6975071 Date FDA Received

14-Apr-2009 Preferred Term

Case # 6975071

Case Type DIRECT Product NUVARING

Health Professional Y

Outcomes HO,LT Role Route S VAGINAL

Manufacturer Control #

Age 25 YR

Sex Female

Country USA

Dosage Text 1 RING MONTHLY X 3 WEEKS VAG

Duration

Manufacturer

PULMONARY EMBOLISM CHILLS COUGH HAEMOPTYSIS INJURY PYREXIA SYNCOPE

6975773 Date FDA Received

15-Apr-2009 Preferred Term VULVOVAGINAL PAIN

Case # 6975773

Case Type DIRECT Product NUVARING

Health Professional N

Outcomes DS,OT Role Route S VAGINAL

Manufacturer Control #

Age 41 YR

Sex Female

Country USA

Dosage Text 0.120MG/0.015 MG 1 EVERY 3 WEEKS VAG

Duration

Manufacturer

ACTIVITIES OF DAILY LIVING IMPAIRED FRUSTRATION MOVEMENT DISORDER PAIN TENDERNESS VULVOVAGINAL BURNING SENSATION VULVOVAGINAL DISCOMFORT

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 25 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6976079 Date FDA Received
15-Apr-2009 Preferred Term HYPERTENSION ARTHRALGIA COUGH GAIT DISTURBANCE JOINT SWELLING Case # 6976079 Case Type DIRECT Product NUVARING Health Professional N Outcomes OT Role Route S VAGINAL Dosage Text 1 RING 3 WEEKS VAG Manufacturer Control # Age 35 YR Duration Sex Female Country USA

Manufacturer ORGANON

6976504 Date FDA Received

16-Apr-2009 Preferred Term OVARIAN DISORDER THROMBOSIS

Case # 6976504

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO Role Route S

Manufacturer Control # 2009-194504-NL Dosage Text , 3 WEEKS IN 1 WEEK OUT

Age

Sex Female

Country USA

Duration

Manufacturer

6978269 Date FDA Received

17-Apr-2009 Preferred Term

Case # 6978269

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO Role Route S

Manufacturer Control # 2009-194515-NL Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

VAGINAL HAEMORRHAGE BREAST CANCER FEMALE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 26 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6979738 Date FDA Received
21-Apr-2009 Preferred Term AMENORRHOEA ACNE ANXIETY IMPAIRED WORK ABILITY INFERTILITY FEMALE PANIC ATTACK WEIGHT INCREASED Case # 6979738 Case Type DIRECT Product NUVARING Health Professional N Outcomes DS,OT,RI Role Route S Dosage Text Manufacturer Control # Age 25 YR Duration Sex Female Country USA

Manufacturer

6985272 Date FDA Received

23-Apr-2009 Preferred Term

Case # 6985272

Case Type DIRECT Product NUVARING

Health Professional Y

Outcomes HO Role Route S VAGINAL

Manufacturer Control #

Age 30 YR

Sex Female

Country USA

Dosage Text 1 RING EVERY THREE WEEKS VAG

Duration

Manufacturer

PULMONARY EMBOLISM DEEP VEIN THROMBOSIS

6934716 Date FDA Received

27-Apr-2009 Preferred Term PELVIC PAIN VENOUS THROMBOSIS HAEMORRHAGE OVARIAN MASS

Case # 6934716

Case Type EXPEDITED (15-DAY) Product NUVARING CELEXA

Health Professional Y

Outcomes OT Role Route S C

Manufacturer Control # 2009-191623-NL Dosage Text

Age 19 YR Duration 2 MTH

Sex Female

Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 27 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6987662 Date FDA Received
28-Apr-2009 Preferred Term THROMBOSIS EMOTIONAL DISTRESS FEAR OF DEATH THROMBOPHLEBITIS Case # 6987662 Case Type EXPEDITED (15-DAY) Product NUVARING Role Route S Health Professional Outcomes Manufacturer Control # 2009-195094-NL Dosage Text DF Age 36 YR Duration Sex Female Country SWE

Manufacturer

6898091 Date FDA Received

04-May-2009 Preferred Term HAEMOPTYSIS

Case # 6898091

Case Type EXPEDITED (15-DAY) Product NUVARING ALBUTEROL

Health Professional N

Outcomes HO Role Route S C

Manufacturer Control # 2008-177919-NL Dosage Text

Age 26 YR Duration 8 MTH

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM ASTHMA BLOOD OSMOLARITY DECREASED BLOOD PRESSURE DIASTOLIC DECREASED BODY TEMPERATURE DECREASED CAESAREAN SECTION ELECTROCARDIOGRAM ST-T CHANGE HEART RATE INCREASED HYPOKALAEMIA HYPONATRAEMIA NAUSEA PAIN PNEUMONIA PREGNANCY RESPIRATORY RATE INCREASED VOMITING

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 28 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6965573 Date FDA Received
06-May-2009 Preferred Term FLANK PAIN NAUSEA VOMITING DEEP VEIN THROMBOSIS ENDOMETRIOSIS MEAN CELL VOLUME DECREASED MICROCYTOSIS Peripheral artery stenosis PHLEBITIS SUPERFICIAL PYREXIA Case # 6965573 Case Type EXPEDITED (15-DAY) Product NUVARING IBUPROFEN CLARITIN Health Professional N Outcomes HO Role Route S C C Manufacturer Control # 2009-193822-NL Dosage Text 3 WEEKS IN, 1 WEEK OUT Age 29 YR Duration 1.42 YEAR Sex Female Country USA

Manufacturer

6994732 Date FDA Received

07-May-2009 Preferred Term THROMBOSIS FLANK PAIN

Case # 6994732

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2009-195685-NL Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

6994910 Date FDA Received

07-May-2009 Preferred Term URTICARIA

Case # 6994910

Case Type DIRECT Product NUVARING

Health Professional Y

Outcomes OT Role Route S VAGINAL

Manufacturer Control #

Age 23 YR

Sex Female

Country USA

Dosage Text 0.120 MG/0.015 MG PER DAY ONCE A MONTH VAG

Duration

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 29 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6999083 Date FDA Received
08-May-2009 Preferred Term CERVIX CARCINOMA STAGE 0 Case # 6999083 Case Type EXPEDITED (15-DAY) Product NUVARING Case Type DIRECT Product NUVARING Case # 6997865 Case Type DIRECT Product NUVARING Health Professional N Role Route S INTRAUTERINE Dosage Text 1 ONCE A MONTH INTRA-UTERI Health Professional N Health Professional Y Role Route S Outcomes HO,LT,OT Role Route S VAGINAL Dosage Text 1 EVERY 30 DAYS VAG Manufacturer Control # Age 18 YR Duration Sex Female Country USA Outcomes Manufacturer Control # 2009-195709-NL Dosage Text DF Manufacturer Control # Age 35 YR Duration 1 YEAR Age 18 YR Duration Sex Female Country USA Sex Female Country FIN

Manufacturer

6998208 Date FDA Received

12-May-2009 Preferred Term HEPATIC FAILURE

Case # 6998208

Manufacturer

6997865 Date FDA Received

13-May-2009 Preferred Term FATIGUE DIZZINESS NAUSEA

Outcomes

Manufacturer

6999290 Date FDA Received

13-May-2009 Preferred Term

Case # 6999290

Case Type DIRECT Product NUVARING

Health Professional N

Outcomes HO,LT Role Route S VAGINAL

Manufacturer Control #

Age 34 YR

Sex Female

Country USA

Dosage Text ONE RING 3-WEEK PERIOD VAG Manufacturer Control # 2009-194583-NL

Duration

Manufacturer ORGANON

DEEP VEIN THROMBOSIS

6980226 Date FDA Received

15-May-2009 Preferred Term CERVICAL DYSPLASIA

Case # 6980226

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional

Outcomes

Age 42 YR Duration

Sex Female

Country DEU

Role Route S

Dosage Text DF

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 30 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7002534 Date FDA Received
15-May-2009 Preferred Term WITHDRAWAL SYNDROME Case # 7002534 Case Type DIRECT Product NUVARING Health Professional N Outcomes OT Role Route S VAGINAL Dosage Text ETONOGESTREL 0.120MG/DAY THREE WEEKS/MONTH VAG Manufacturer Control # Age 25 YR Duration Sex Female Country USA

Manufacturer ORGANON

ACNE HYPERACUSIS MIGRAINE MOOD SWINGS NAUSEA PHOTOPHOBIA VOMITING WEIGHT INCREASED

7003428 Date FDA Received

15-May-2009 Preferred Term ABORTION COMPLETE

Case # 7003428

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO Role Route S

Manufacturer Control # 2008-184177-NL Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

MATERNAL EXPOSURE DURING PREGNANCY PREGNANCY WITH CONTRACEPTIVE DEVICE TWIN PREGNANCY

6990047 Date FDA Received

19-May-2009 Preferred Term

Case # 6990047

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes LT Role Route S VAGINAL

Manufacturer Control # 2009-195560-NL Dosage Text DF VAGINAL

Age 33 YR Duration

Sex Female

Country CHL

Manufacturer

CEREBROVASCULAR ACCIDENT METRORRHAGIA

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 31 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7007356 Date FDA Received
20-May-2009 Preferred Term VENA CAVA THROMBOSIS BLOOD HOMOCYSTEINE INCREASED IRON DEFICIENCY ANAEMIA Case # 7007356 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes OT Role Route S Manufacturer Control # 2008-184637-NL Dosage Text Age 23 YR Duration 2 YEAR Sex Female Country USA

Manufacturer

6961271 Date FDA Received

21-May-2009 Preferred Term

Case # 6961271

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes

Manufacturer Control # 2009-193192-NL

Age 24 YR Duration 164 DAY

Sex Female

Country CAN

Role Route S C Outcomes DE Role Route S Health Professional N Outcomes OT,RI Role Route S

Dosage Text DF

Manufacturer

BLINDNESS TRANSIENT BLINDNESS UNILATERAL

PAROXETINE HYDROCHLORIDE Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y

7009611 Date FDA Received

22-May-2009 Preferred Term DEATH

Case # 7009611

Manufacturer Control # 2009-196346-NL Dosage Text

Age 30 YR Duration

Sex Female

Country USA

Manufacturer

7009738 Date FDA Received

28-May-2009 Preferred Term FUNGAL INFECTION

Case # 7009738

Case Type DIRECT Product NUVARING

Manufacturer Control #

Age 30 YR

Sex Female

Country USA

Dosage Text DAILY VAG FOR A FEW MONTHS IN 2007

Duration

Manufacturer ORGANON

FEMALE SEXUAL DYSFUNCTION LICHEN SCLEROSUS

7010544 Date FDA Received

28-May-2009 Preferred Term

Case # 7010544

Case Type DIRECT Product NUVARING

Health Professional Y

Outcomes LT Role Route S VAGINAL

Manufacturer Control #

Age 30 YR

Sex Female

Country USA

Dosage Text 1 RING EVERY MONTH VAG

Duration

Manufacturer ORGANON

CEREBROVASCULAR ACCIDENT

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 32 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7015220 Date FDA Received
29-May-2009 Preferred Term VULVOVAGINAL MYCOTIC INFECTION Case # 7015220 Case Type EXPEDITED (15-DAY) Product NUVARING Case Type DIRECT Product NUVARING Health Professional N Health Professional Y Outcomes OT Role Route S Outcomes HO Role Route S VAGINAL Dosage Text 1 RING ONCE / MONTH VAG Manufacturer Control # Age 31 YR Duration Sex Female Country USA Manufacturer Control # 2009-196423-NL Dosage Text Age 29 YR Duration Sex Female Country CHE

Manufacturer

7014725 Date FDA Received

01-Jun-2009 Preferred Term TREMOR CHEST DISCOMFORT CONFUSIONAL STATE DIARRHOEA DIZZINESS DIZZINESS POSTURAL DYSPNOEA FATIGUE

Case # 7014725

Manufacturer ORGANON

HEART RATE INCREASED LOSS OF CONSCIOUSNESS NAUSEA PERIPHERAL COLDNESS THINKING ABNORMAL

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 33 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7023122 Date FDA Received
05-Jun-2009 Preferred Term MATERNAL DRUGS AFFECTING FOETUS CAESAREAN SECTION FOETAL DISORDER PREMATURE BABY VOLVULUS Case # 7023122 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Role Route S TRANSPLACENTAL Outcomes Manufacturer Control # 2009-197398-NL Dosage Text TRANSPLACENTAL 1 WEEK 6 DAYS Duration Age Sex Unknown Country FIN

Manufacturer

7023702 Date FDA Received

05-Jun-2009 Preferred Term PREGNANCY CAESAREAN SECTION

Case # 7023702

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2008-181703-NL Dosage Text

Age 29 YR Duration

Sex Female

Country FIN

Manufacturer

1.58 YEAR

MATERNAL EXPOSURE DURING PREGNANCY PREMATURE BABY

7025657 Date FDA Received

09-Jun-2009 Preferred Term ERYTHEMA NODOSUM

Case # 7025657

Case Type DIRECT Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control #

Age 42 YR

Sex Female

Country USA

Dosage Text 3 WEEKS USE VAG

Duration

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 34 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6865895 Date FDA Received
10-Jun-2009 Preferred Term NECK PAIN CEREBROVASCULAR ACCIDENT CAROTID ARTERY OCCLUSION ANTIPHOSPHOLIPID ANTIBODIES POSITIVE ARTHRALGIA BRADYCARDIA BRAIN HERNIATION INTRACRANIAL PRESSURE INCREASED MITRAL VALVE INCOMPETENCE PULMONARY VALVE INCOMPETENCE TIBIA FRACTURE Case # 6865895 Case Type EXPEDITED (15-DAY) Product NUVARING IMITREX "CERENEX" TOPAMAX Health Professional N Outcomes HO,DS Role Route S C C Manufacturer Control # 2008-187773-NL Dosage Text Age 46 YR Duration 194 DAY Sex Female Country USA

Manufacturer

6989555 Date FDA Received

11-Jun-2009 Preferred Term

Case # 6989555

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional

Outcomes

Manufacturer Control # 2008-189081-NL

Age 42 YR Duration 2 MTH

Sex Female

Country DEU

Role Route S C C C C C C

Dosage Text DF

Manufacturer

BLOOD PRESSURE INCREASED HEADACHE DIZZINESS

CANDESARTAN CILEXETIL CYCLOSPORINE MYCOPHENOLATE SODIUM CALCITRIOL CIPROFLOXACIN TORASEMIDE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 35 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7030120 Date FDA Received
11-Jun-2009 Preferred Term PULMONARY EMBOLISM PLEURISY PNEUMOTHORAX Case # 7030120 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional N Outcomes HO Role Route S Manufacturer Control # 2008-182107-NL Dosage Text 3 WEEKS IN, 1 WEEK OUT Age 26 YR Duration Sex Female Country USA

Manufacturer

6877909 Date FDA Received

12-Jun-2009 Preferred Term

Case # 6877909

Case Type EXPEDITED (15-DAY) Product NUVARING ADVAIR HFA ALBUTEROL ALLEGRA

Health Professional N

Outcomes HO,OT Role Route S C C C C C C C

Manufacturer Control # 2008-178516-NL Dosage Text

Age 26 YR Duration 86 DAY

Sex Female

Country USA

Manufacturer

MUSCULOSKELETAL CHEST PAIN PNEUMONIA CHEST PAIN PULMONARY EMBOLISM

OMEPRAZOLE ARTHROTEC SKELAXIN IBUPROFEN

7026708 Date FDA Received

12-Jun-2009 Preferred Term BREAST PAIN AMENORRHOEA BACK PAIN HEADACHE MEDICATION ERROR NAUSEA

Case # 7026708

Case Type DIRECT Product NUVARING

Health Professional N

Outcomes

Manufacturer Control #

Age 26 YR

Sex Female

Country USA

Role Route S VAGINAL

Dosage Text 1 PER MONTH VAG

Duration

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 36 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7038672 Date FDA Received
12-Jun-2009 Preferred Term CYSTIC FIBROSIS ABORTION INDUCED MATERNAL DRUGS AFFECTING FOETUS Case # 7038672 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes CA Role Route S TRANSPLACENTAL Manufacturer Control # 2009-197907-NL Dosage Text DF, TRANSPLACENTAL Duration Age Sex Unknown Country FRA

Manufacturer

7030062 Date FDA Received

16-Jun-2009 Preferred Term

Case # 7030062

Case Type DIRECT Product NUVARING Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes HO,DS Role Route S VAGINAL

Manufacturer Control #

Age 46 YR

Sex Female

Country USA

Dosage Text MONTHLY VAG Manufacturer Control # 2009-198053-NL Dosage Text

Duration

Manufacturer

DEEP VEIN THROMBOSIS

7032835 Date FDA Received

16-Jun-2009 Preferred Term

Case # 7032835

Health Professional Y

Outcomes OT Role Route S

Age

Sex Female

Country USA

Duration

Manufacturer

DEEP VEIN THROMBOSIS FALL

7035296 Date FDA Received

17-Jun-2009 Preferred Term CROHN'S DISEASE

Case # 7035296

Case Type EXPEDITED (15-DAY) Product NUVARING ASACOL

Health Professional N

Outcomes OT Role Route S C

Manufacturer Control # 2009-198132-NL Dosage Text

Age 32 YR Duration

Sex Female

Country USA

Manufacturer

DISEASE RECURRENCE INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION MEMORY IMPAIRMENT

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 37 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7033804 Date FDA Received
18-Jun-2009 Preferred Term PREGNANCY WITH CONTRACEPTIVE DEVICE MATERNAL EXPOSURE DURING PREGNANCY Case # 7033804 Case Type DIRECT Product NUVARING Health Professional N Outcomes OT Role Route S Dosage Text Manufacturer Control # Age 20 YR Duration Sex Female Country USA

Manufacturer

7035166 Date FDA Received

18-Jun-2009 Preferred Term

Case # 7035166

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO Role Route S

Manufacturer Control # 2009-189978-NL Dosage Text

Age 20 YR Duration 48 WEEK

Sex Female

Country USA

Manufacturer

INTRACRANIAL VENOUS SINUS THROMBOSIS DIPLOPIA EYE PAIN

7042383 Date FDA Received

23-Jun-2009 Preferred Term

Case # 7042383

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO,OT Role Route S

Manufacturer Control # 2009-104451-NL Dosage Text

Age 47 YR Duration

Sex Female

Country USA

Manufacturer

ABDOMINAL PAIN LOWER PULMONARY EMBOLISM THROMBOSIS

7040561 Date FDA Received

24-Jun-2009 Preferred Term

Case # 7040561

Case Type DIRECT Product NUVARING

Health Professional N

Outcomes DE Role Route S ENDOCERVICAL

Manufacturer Control #

Age 23 YR

Sex Female

Country USA

Dosage Text ONE MONTHLY ENDOCERVICAL

Duration

Manufacturer

INFLUENZA LIKE ILLNESS CONVULSION DIZZINESS LOSS OF CONSCIOUSNESS PULMONARY EMBOLISM RESPIRATORY ARREST

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 38 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7043117 Date FDA Received
24-Jun-2009 Preferred Term ABORTION SPONTANEOUS MATERNAL EXPOSURE DURING PREGNANCY PREGNANCY WITH CONTRACEPTIVE DEVICE Case # 7043117 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO Role Route S VAGINAL Manufacturer Control # 2009-198746-NL Dosage Text DF, VAGINAL Age 40 YR Duration 1 MTH Sex Female Country VEN

Manufacturer

7042784 Date FDA Received

25-Jun-2009 Preferred Term PAIN IN EXTREMITY

Case # 7042784

Case Type EXPEDITED (15-DAY) Product NUVARING SYNTHROID LISINOPRIL

Health Professional Y

Outcomes OT Role Route S C C

Manufacturer Control # 2009-197308-NL Dosage Text

Age 42 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS OEDEMA PERIPHERAL MUSCLE SWELLING MYALGIA

7036466 Date FDA Received

26-Jun-2009 Preferred Term

Case # 7036466

Case Type EXPEDITED (15-DAY) Product NUVARING Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes

Manufacturer Control # 2009-198080-NL

Age 31 YR Duration

Sex Female

Country PRT

Role Route S Health Professional Y Outcomes HO Role Route S Health Professional N Outcomes OT Role Route S

Dosage Text DF Manufacturer Control # 2009-198836-NL Dosage Text DF Manufacturer Control # 2009-199068-NL Dosage Text

Manufacturer

CUTANEOUS LUPUS ERYTHEMATOSUS

1.5 YEAR Age 33 YR Duration Sex Female Country DEU

7043683 Date FDA Received

26-Jun-2009 Preferred Term COLITIS ULCERATIVE

Case # 7043683

Manufacturer

7047347 Date FDA Received

29-Jun-2009 Preferred Term KIDNEY INFECTION

Case # 7047347

Case Type EXPEDITED (15-DAY) Product NUVARING

Age

Sex Female

Country USA

Duration

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 39 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7047486 Date FDA Received
30-Jun-2009 Preferred Term DRUG PRESCRIBING ERROR Case # 7047486 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional N Outcomes HO Role Route S Manufacturer Control # 2009-198956-NL Dosage Text 1 NEW RING EVERY WEEK, 3 WEEKS LONG, WITH 1 RINGFREE WEEK Age 24 YR Duration Sex Female Country USA

Manufacturer

CONVULSION OVERDOSE

7047726 Date FDA Received

30-Jun-2009 Preferred Term OSTEOPENIA

Case # 7047726

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes

Manufacturer Control # 2009-199019-NL

Age 31 YR Duration

Sex Female

Country DEU

Role Route S Health Professional Y Outcomes HO Role Route S

Dosage Text DF, Manufacturer Control # 2009-198520-NL Dosage Text

Manufacturer

7050391 Date FDA Received

02-Jul-2009 Preferred Term FEELING ABNORMAL

Case # 7050391

Case Type EXPEDITED (15-DAY) Product NUVARING

Age 28 YR Duration

Sex Female

Country USA

Manufacturer

PREGNANCY WITH CONTRACEPTIVE DEVICE

7055685 Date FDA Received

13-Jul-2009 Preferred Term

Case # 7055685

Case Type DIRECT Product NUVARING

Health Professional Y

Outcomes HO,LT,RI Role Route S VAGINAL

Manufacturer Control #

Age 18 YR

Sex Female

Country USA

Dosage Text 1 3WKS IN 1WK OUT VAG

Duration

Manufacturer ORGANON

ACUTE HEPATIC FAILURE LIVER INJURY

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 40 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7058865 Date FDA Received
14-Jul-2009 Preferred Term RASH LIP SWELLING Case # 7058865 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional N Outcomes OT Role Route S Manufacturer Control # 2009-200066-NL Dosage Text Age 37 YR Duration Sex Female Country USA

Manufacturer

7056504 Date FDA Received

16-Jul-2009 Preferred Term MOOD SWINGS

Case # 7056504

Case Type DIRECT Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control #

Age 30 YR

Sex Female

Country USA

Dosage Text ETONOGESTREL/ ERTHINYL ESTRADIOL 1 PER MONTH VAGINAL 066

Duration

Manufacturer

CRYING HEADACHE SOCIAL AVOIDANT BEHAVIOUR

7060453 Date FDA Received

16-Jul-2009 Preferred Term ARTERIAL DISORDER

Case # 7060453

Case Type EXPEDITED (15-DAY) Product NUVARING FLONASE ALLEGRA

Health Professional Y

Outcomes HO Role Route S C C

Manufacturer Control # 2009-199954-NL Dosage Text

Age 27 YR Duration

Sex Female

Country USA

Manufacturer

CAROTID ARTERY DISSECTION

7054879 Date FDA Received

20-Jul-2009

Case # 7054879

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # USBAYER-200919084NA

Age 21 YR

Sex Female

Country USA

Preferred Term OVARIAN CYST DYSPNOEA CHEST PAIN PAIN IN EXTREMITY

Product YAZ NUVARING

Role Route S S ORAL

Dosage Text

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 41 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7065525 Date FDA Received
21-Jul-2009 Preferred Term PULMONARY EMBOLISM Case # 7065525 Case Type DIRECT Product NUVARING Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional N Health Professional Y Outcomes HO,LT,RI Role Route S VAGINAL Dosage Text 1 RING 3 WEEKS VAG Manufacturer Control # 2009-200472-NL Dosage Text DF VAGINAL Age 35 YR Duration Sex Female Country BRA Manufacturer Control # Age 30 YR Duration Sex Female Country USA

Manufacturer

7066603 Date FDA Received

21-Jul-2009 Preferred Term FOOT FRACTURE HYPOTHYROIDISM WEIGHT INCREASED

Case # 7066603

Outcomes HO Role Route S VAGINAL

Manufacturer

7068389 Date FDA Received

24-Jul-2009 Preferred Term HEADACHE CHEST PAIN MOOD SWINGS PARAESTHESIA

Case # 7068389

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes LT Role Route S

Manufacturer Control # 2009-201033-NL Dosage Text NI, 4 WEEKS

Age 46 YR Duration

Sex Female

Country USA

Manufacturer

7074602 Date FDA Received

27-Jul-2009 Preferred Term

Case # 7074602

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional

Outcomes HO Role Route S

Manufacturer Control # 2009198941-NL Dosage Text DF;

Age 24 YR Duration

Sex Female

Country RUS

Manufacturer

ABDOMINAL PAIN LOWER BODY TEMPERATURE INCREASED DIZZINESS FUNGAL INFECTION GASTRITIS NAUSEA VAGINAL HAEMORRHAGE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 42 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7038264 Date FDA Received
29-Jul-2009 Preferred Term MATERNAL DRUGS AFFECTING FOETUS BREECH PRESENTATION CAESAREAN SECTION KIDNEY MALFORMATION OLIGOHYDRAMNIOS RENAL HYPOPLASIA SINGLE FUNCTIONAL KIDNEY Case # 7038264 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes CA Role Route S TRANSPLACENTAL Manufacturer Control # 2009-198638-NL Dosage Text DF, TRANSPLACENTAL Duration Age Sex Female Country POL

Manufacturer

7062580 Date FDA Received

29-Jul-2009 Preferred Term DYSPNOEA ANXIETY CHEST DISCOMFORT CHEST PAIN FALL SLEEP DISORDER STRESS WHEEZING

Case # 7062580

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes HO Role Route S

Manufacturer Control # 2009-200160-NL Dosage Text

Age 23 YR Duration

Sex Female

Country USA

Manufacturer

2.75 YEAR

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 43 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7073979 Date FDA Received
29-Jul-2009 Preferred Term EYE PAIN HYPOAESTHESIA ATRIAL SEPTAL DEFECT CENTRAL NERVOUS SYSTEM LESION CEREBROVASCULAR ACCIDENT HYPERCOAGULATION MIGRAINE MULTIPLE SCLEROSIS NAUSEA VOMITING Case # 7073979 Case Type DIRECT Product NUVARING ZOLOFT Health Professional Y Outcomes HO,DS Role Route S C VAGINAL Dosage Text ONE RING, PER 3 WEEKS, VAG Manufacturer Control # Age 25 YR Duration 3 WEEK Sex Female Country USA

Manufacturer SCHERING

7074000 Date FDA Received

29-Jul-2009 Preferred Term HEADACHE

Case # 7074000

Case Type DIRECT Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control #

Age 37 YR

Sex Female

Country USA

Dosage Text ONCE EVERY 4 WEEKS VAG

Duration

Manufacturer ORGANON

ABNORMAL SENSATION IN EYE ALOPECIA DIZZINESS LOSS OF LIBIDO SENSORY DISTURBANCE VISION BLURRED

7076970 Date FDA Received

31-Jul-2009 Preferred Term URTICARIA

Case # 7076970

Case Type DIRECT Product NUVARING

Health Professional

Outcomes OT Role Route S

Manufacturer Control #

Age 28 YR

Sex Female

Country USA

Dosage Text 1ST TIME USE

Duration

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 44 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7077837 Date FDA Received
31-Jul-2009 Preferred Term MENSTRUATION IRREGULAR HAEMANGIOMA CONGENITAL PREGNANCY WITH IMPLANT CONTRACEPTIVE Case # 7077837 Case Type DIRECT Product NUVARING Health Professional Y Outcomes CA Role Route S VAGINAL Dosage Text 1 VAGINAL RING, ONCE MONTHLY, VAG Manufacturer Control # Age Sex Country USA 182 DAY Female Duration

Manufacturer SCHERING PLOUGH

7077850 Date FDA Received

31-Jul-2009 Preferred Term

Case # 7077850

Case Type DIRECT Product NUVARING

Health Professional

Outcomes OT Role Route S

Manufacturer Control #

Age 24 YR

Sex Female

Country USA

Dosage Text ONCE MONTHLY

Duration

Manufacturer

BLOOD PRESSURE INCREASED DIZZINESS DYSPNOEA MOOD ALTERED WEIGHT INCREASED

7079773 Date FDA Received

04-Aug-2009 Preferred Term

Case # 7079773

Case Type DIRECT Product NUVARING

Health Professional N

Outcomes HO,LT,RI Role Route S VAGINAL

Manufacturer Control #

Age 19 YR

Sex Female

Country USA

Dosage Text 1 RING MONTHLY VAG

Duration

Manufacturer

PULMONARY EMBOLISM CARDIAC DISORDER HEPATIC CYST

7080158 Date FDA Received

05-Aug-2009 Preferred Term

Case # 7080158

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes DE Role Route S

Manufacturer Control # 2009SP017116 Dosage Text

Age 20 YR Duration

Sex Female

Country USA

Manufacturer

INTRACRANIAL ANEURYSM

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 45 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7080465 Date FDA Received
05-Aug-2009 Preferred Term DYSPNOEA DECREASED APPETITE DEPRESSION DYSPAREUNIA DYSURIA EYE PRURITUS NAUSEA VULVOVAGINAL PRURITUS Case # 7080465 Case Type DIRECT Product NUVARING Health Professional N Outcomes LT Role Route S VAGINAL Dosage Text .120MG/.015 3 WEEKS VAG Manufacturer Control # Age 23 YR Duration 3 WEEK Sex Female Country USA

Manufacturer ORGANON

7080007 Date FDA Received

06-Aug-2009 Preferred Term

Case # 7080007

Case Type EXPEDITED (15-DAY) Product NUVARING Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes DE Role Route S

Manufacturer Control # 2009SP017103 Dosage Text

Age 20 YR Duration

Sex Female

Country USA

Manufacturer

INTRACRANIAL ANEURYSM

7081503 Date FDA Received

07-Aug-2009 Preferred Term

Case # 7081503

Health Professional Y

Outcomes HO Role Route S VAGINAL

Manufacturer Control # 2009SP016961 Dosage Text 1 DF; ;VAG Manufacturer Control #

Age

Sex Female

Country USA

Duration

Manufacturer

INTRACRANIAL VENOUS SINUS THROMBOSIS

7081531 Date FDA Received

10-Aug-2009 Preferred Term HEPATIC NEOPLASM PAIN

Case # 7081531

Case Type DIRECT Product NUVARING

Health Professional N

Outcomes OT Role Route S

Age 33 YR

Sex Female

Country USA

Dosage Text 1X MONTHLY

Duration

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 46 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7085671 Date FDA Received
10-Aug-2009 Preferred Term DEEP VEIN THROMBOSIS Case # 7085671 Case Type DIRECT Product NUVARING Health Professional N Outcomes HO,LT Role Route S VAGINAL Dosage Text 1 RING 3WKS IN 1 OUT VAG Manufacturer Control # Age 29 YR Dosage Text .120 MG DAILY LEFT IN FOR 3WEEKS VAG Manufacturer Control # Duration 6 MTH Age 34 YR Dosage Text Duration Sex Female Sex Female Manufacturer Control # Age 20 YR Duration Sex Female Country USA

Manufacturer ORGANON

7087093 Date FDA Received

13-Aug-2009 Preferred Term LOSS OF LIBIDO

Case # 7087093

Case Type DIRECT Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Country USA

Manufacturer ORGANON Country USA

7087158 Date FDA Received

13-Aug-2009 Preferred Term THROMBOSIS

Case # 7087158

Case Type DIRECT Product NUVARING

Health Professional N

Outcomes HO Role Route S

Manufacturer

7087163 Date FDA Received

13-Aug-2009 Preferred Term

Case # 7087163

Case Type DIRECT Product NUVARING

Health Professional N

Outcomes HO,LT Role Route S VAGINAL

Manufacturer Control #

Age 47 YR

Sex Female

Country USA

Dosage Text 1 RING EVERY 3 WEEKS VAG

Duration

Manufacturer ORGANON

DEEP VEIN THROMBOSIS PULMONARY EMBOLISM

7088066 Date FDA Received

13-Aug-2009 Preferred Term OPTIC NEURITIS STRABISMUS

Case # 7088066

Case Type EXPEDITED (15-DAY) Product NUVARING HAVRIX STAMARIL MALARONE

Health Professional Y

Outcomes OT Role Route S C C C VAGINAL

Manufacturer Control # 2009-198969-NL Dosage Text VAG

Age 26 YR Duration

Sex Female

Country CHE

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 47 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7064676 Date FDA Received
17-Aug-2009 Preferred Term MELKERSSON-ROSENTHAL SYNDROME Case # 7064676 Case Type EXPEDITED (15-DAY) Product NUVARING GLEEVEC Health Professional Y Outcomes OT Role Route S C Health Professional N Product NUVARING Outcomes HO,OT Role Route S VAGINAL Dosage Text 0.015 MG PER DAY VAG Manufacturer Control # Manufacturer Control # Age 21 YR Duration 6 YEAR Sex Female Country USA Manufacturer Control # 2009-200018-NL Dosage Text Age 37 YR Duration Sex Female Country DEU

Manufacturer

7090952 Date FDA Received

17-Aug-2009 Preferred Term MIGRAINE

Case # 7090952

Case Type DIRECT

Manufacturer ORGANON

7095139 Date FDA Received

18-Aug-2009 Preferred Term ALOPECIA

Case # 7095139

Case Type DIRECT Product NUVARING

Health Professional N

Outcomes DS,RI Role Route S VAGINAL

Age 23 YR

Sex Female

Country USA

Dosage Text MONTHLY VAG Manufacturer Control #

Duration

Manufacturer

7095242 Date FDA Received

18-Aug-2009 Preferred Term

Case # 7095242

Case Type DIRECT Product NUVARING Case Type DIRECT Product NUVARING

Health Professional Y

Outcomes HO,LT Role Route S

Age 41 YR

Sex Female

Country USA

Dosage Text WEEKLY P.V. Manufacturer Control #

Duration

Manufacturer SCHERING

MESENTERIC VEIN THROMBOSIS

7097757 Date FDA Received

20-Aug-2009 Preferred Term HYPOAESTHESIA

Case # 7097757

Health Professional N

Outcomes HO,DS Role Route S VAGINAL

Age 39 YR

Sex Female

Country USA

Dosage Text 1 RING EVERY 3 WEEKS VAG

Duration

Manufacturer SCHERING PLOUGH

COMPLICATION OF DEVICE REMOVAL DEEP VEIN THROMBOSIS

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 48 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7101432 Date FDA Received
20-Aug-2009 Preferred Term DEHYDRATION FOOD POISONING IATROGENIC INJURY LOSS OF CONSCIOUSNESS PHLEBITIS VENOUS THROMBOSIS Case # 7101432 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional N Outcomes HO,OT Role Route S Manufacturer Control # 2009SP018289 Dosage Text Age 34 YR Duration Sex Female Country CHL

Manufacturer

7101689 Date FDA Received

20-Aug-2009 Preferred Term CONVULSION

Case # 7101689

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes HO Role Route S VAGINAL

Manufacturer Control # 2009SP017423 Dosage Text VAG Manufacturer Control # 2008-186321-NL Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

7072443 Date FDA Received

21-Aug-2009 Preferred Term

Case # 7072443

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO,OT Role Route S

Age 30 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS CELLULITIS

7101867 Date FDA Received

21-Aug-2009 Preferred Term CONVULSION

Case # 7101867

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes HO Role Route S

Manufacturer Control # 2009SP019546 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 49 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7102016 Date FDA Received
21-Aug-2009 Preferred Term HEPATITIS TOXIC HYPOTHERMIA STRESS Case # 7102016 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional N Outcomes OT Role Route S Manufacturer Control # 2009SP020170 Dosage Text Age 39 YR Duration Sex Female Country RUS

Manufacturer

7101964 Date FDA Received

24-Aug-2009 Preferred Term UTERINE POLYP

Case # 7101964

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2009SP020296 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

7101966 Date FDA Received

24-Aug-2009 Preferred Term OVARIAN INFECTION SALPINGITIS

Case # 7101966

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2009SP019834 Dosage Text 1 DF, VAG

Age

Sex Female

Country USA

Duration

Manufacturer

UTERINE HAEMORRHAGE

7103706 Date FDA Received

25-Aug-2009 Preferred Term ASTHMA

Case # 7103706

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2009SP018494 Dosage Text VAG

Age

Sex Female

Country SWE

Duration

Manufacturer

CONDITION AGGRAVATED

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 50 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7035191 Date FDA Received
26-Aug-2009 Preferred Term ACUTE SINUSITIS SEASONAL ALLERGY URINARY TRACT INFECTION CONSTIPATION DYSPNOEA EXERTIONAL CHRONIC OBSTRUCTIVE PULMONARY DISEASE ABDOMINAL PAIN MIGRAINE HEADACHE SWELLING DEEP VEIN THROMBOSIS PULMONARY EMBOLISM ATELECTASIS HYPERCOAGULATION OVARIAN CYST Case # 7035191 Case Type EXPEDITED (15-DAY) Product NUVARING EXCEDRIN ZELNORM CONCERTA TESTOSTERONE TOPAMAX FIORICET VERAPAMIL HYDROCHLORIDE SINGULAIR NASONEX ADVAIR HFA CLARITIN ZYRTEC ALLEGRA CLARINEX LORATADTNE ENTEX ER MAXAIR Health Professional Y Outcomes HO,OT Role Route S C C C C C C C C C C C C C C C C C Health Professional N Outcomes OT Role Route S Manufacturer Control # 2009-201114-NL Dosage Text Duration Age Sex Female Country USA VAGINAL Manufacturer Control # 2008-177920-NL Dosage Text 1 DF; VAG Age 39 YR Duration Sex Female Country USA

Manufacturer

7072104 Date FDA Received

26-Aug-2009 Preferred Term

Case # 7072104

Case Type EXPEDITED (15-DAY) Product NUVARING

Manufacturer

TRANSIENT ISCHAEMIC ATTACK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 51 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7107926 Date FDA Received
27-Aug-2009 Preferred Term CONVULSION MENSTRUATION IRREGULAR Case # 7107926 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional N Outcomes OT Role Route S VAGINAL Manufacturer Control # 2009SP020855 Dosage Text 1 DF, Q3W, VAG Age 24 YR Duration Sex Female Country USA

Manufacturer

7029762 Date FDA Received

28-Aug-2009 Preferred Term VARICOSE VEIN ABDOMINAL PAIN

Case # 7029762

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO Role Route S

Manufacturer Control # 2009-190760-NL Dosage Text

Age 30 YR Duration

Sex Female

Country USA

Manufacturer

ABORTION INCOMPLETE ABORTION SPONTANEOUS CHEST PAIN DYSPEPSIA FOETAL DEATH GASTROENTERITIS VIRAL MATERNAL EXPOSURE DURING PREGNANCY PELVIC PAIN PREGNANCY WITH CONTRACEPTIVE DEVICE THROMBOSIS TONGUE ULCERATION VAGINAL HAEMORRHAGE

7106126 Date FDA Received

31-Aug-2009 Preferred Term PLEURAL EFFUSION

Case # 7106126

Case Type DIRECT Product NUVARING

Health Professional Y

Outcomes HO,LT,OT Role Route S

Manufacturer Control #

Age 30 YR

Sex Female

Country USA

Dosage Text

Duration

Manufacturer

PULMONARY EMBOLISM

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 52 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7109346 Date FDA Received
31-Aug-2009 Preferred Term ABDOMINAL PAIN UPPER CHOLECYSTECTOMY DEPRESSION HEADACHE MOOD SWINGS NAUSEA VISUAL IMPAIRMENT WEIGHT INCREASED Case # 7109346 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional N Outcomes OT Role Route S Manufacturer Control # 2009SP021060 Dosage Text Duration 9 MTH Age Sex Female Country USA

Manufacturer

7109655 Date FDA Received

31-Aug-2009 Preferred Term DEAFNESS

Case # 7109655

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2009SP020725 Dosage Text 1 DF;

Age

Sex Female

Country DEU

Duration

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 53 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6224653 Date FDA Received
01-Sep-2009 Preferred Term ANXIETY AGITATION BLOOD GLUCOSE INCREASED BRADYCARDIA CARDIAC ARREST HYPERHIDROSIS MYOCARDITIS NEPHROSCLEROSIS PULMONARY EMBOLISM SPEECH DISORDER TACHYPNOEA WOUND Case # 6224653 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes DE Role Route S Manufacturer Control # 2007-152786-NL Dosage Text Age 37 YR Duration Sex Female Country USA

Manufacturer

7071184 Date FDA Received

01-Sep-2009 Preferred Term MENORRHAGIA DYSMENORRHOEA

Case # 7071184

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO Role Route S C C C C C C

Manufacturer Control # 2009-190849-NL Dosage Text

Age 34 YR Duration

Sex Female

Country USA

Manufacturer

HYDROCHLOROTHIAZIDE NORVASC PROCARDIA POTASSIUM CHLORIDE LEXAPRO MEDROXYPROGESTERONE

BLOOD THYROID STIMULATING HORMONE DECREASED DEEP VEIN THROMBOSIS DYSPNOEA PAIN IN EXTREMITY FURUNCLE HAEMATEMESIS PULMONARY EMBOLISM

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 54 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7108533 Date FDA Received
02-Sep-2009 Preferred Term PULMONARY EMBOLISM Case # 7108533 Case Type DIRECT Product NUVARING Health Professional N Outcomes HO Role Route S VAGINAL Dosage Text ONE RING FOR 3 WEEKS AND REMOV VAG Manufacturer Control # Age 45 YR Duration 2 YEAR Sex Female Country USA

Manufacturer

DEEP VEIN THROMBOSIS

7112498 Date FDA Received

03-Sep-2009 Preferred Term DEPRESSION DEHYDRATION DIZZINESS

Case # 7112498

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2009SP021723 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

LOSS OF CONSCIOUSNESS METRORRHAGIA MOOD SWINGS

7114021 Date FDA Received

03-Sep-2009 Preferred Term

Case # 7114021

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2009SP021705 Dosage Text

Age 25 YR Duration

Sex Female

Country DEU

Manufacturer

CONDITION AGGRAVATED CROHN'S DISEASE

7114055 Date FDA Received

03-Sep-2009 Preferred Term DRUG INTERACTION EPILEPSY

Case # 7114055

Case Type EXPEDITED (15-DAY) Product NUVARING LAMICTAL

Health Professional Y

Outcomes OT Role Route S S VAGINAL

Manufacturer Control # 2009SP020737 Dosage Text VAG

Age 23 YR Duration

Sex Female

Country CHE

Manufacturer

CONDITION AGGRAVATED NERVOUS SYSTEM DISORDER

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 55 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7114244 Date FDA Received
03-Sep-2009 Preferred Term ERYTHEMA FACE OEDEMA Case # 7114244 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional N Outcomes OT Role Route S VAGINAL Manufacturer Control # 2009SP018028 Dosage Text VAG Duration Age Sex Female Manufacturer Country

7114428 Date FDA Received

03-Sep-2009 Preferred Term

Case # 7114428

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2009-198086-NL Dosage Text

Age 29 YR Duration

Sex Female

Country USA

Manufacturer

ABORTION SPONTANEOUS GASTROENTERITIS VIRAL MATERNAL EXPOSURE DURING PREGNANCY PREGNANCY THROMBOSIS TONGUE ULCERATION VAGINAL DISCHARGE

7114641 Date FDA Received

03-Sep-2009 Preferred Term ABDOMINAL MASS DYSPEPSIA DYSPNOEA LIP SWELLING OEDEMA PERIPHERAL SWELLING FACE URTICARIA

Case # 7114641

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2009SP019667 Dosage Text ; VAG

Age

Sex Female

Country USA

Duration

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 56 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7115656 Date FDA Received
04-Sep-2009 Preferred Term BLINDNESS UNILATERAL FATIGUE Case # 7115656 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional N Outcomes OT Role Route S Manufacturer Control # 2009SP022940 Dosage Text Age 32 YR Duration Sex Female Country USA

Manufacturer

7113762 Date FDA Received

08-Sep-2009 Preferred Term DIZZINESS AMNESIA CONVULSION

Case # 7113762

Case Type DIRECT Product NUVARING

Health Professional N

Outcomes DS,OT Role Route S VAGINAL

Manufacturer Control #

Age 21 YR

Sex Female

Country USA

Dosage Text 1 RING MONTHLY -3 WEEKS- VAG

Duration 5 MIN

Manufacturer ORGANON

LOSS OF CONSCIOUSNESS MOTOR DYSFUNCTION NAUSEA PARAESTHESIA RETCHING VISION BLURRED VOMITING

7130899 Date FDA Received

14-Sep-2009 Preferred Term HYPOTHYROIDISM

Case # 7130899

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2009SP024322 Dosage Text

Age

Sex Female

Country DEU

Duration

Manufacturer

6773215 Date FDA Received

16-Sep-2009 Preferred Term BACK PAIN

Case # 6773215

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes DE,HO Role Route S

Manufacturer Control # 2008-183409-NL Dosage Text 1 DF; QM

Age 25 YR Duration

Sex Female

Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 57 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6773215
Preferred Term NAUSEA VOMITING APNOEIC ATTACK ARRHYTHMIA ASCITES ASPARTATE AMINOTRANSFERASE INCREASED ASPIRATION ATELECTASIS BLOOD ALKALINE PHOSPHATASE INCREASED BLOOD CALCIUM DECREASED BRAIN DEATH CARDIO-RESPIRATORY ARREST CYANOSIS DISSEMINATED INTRAVASCULAR COAGULATION HAEMORRHAGE HEPATIC FAILURE HEPATIC STEATOSIS HYPOXIC-ISCHAEMIC ENCEPHALOPATHY LUNG CONSOLIDATION LUNG INFILTRATION MALAISE METABOLIC ACIDOSIS MULTI-ORGAN FAILURE MUSCLE SPASMS OEDEMA PAIN IN EXTREMITY PULMONARY INFARCTION PULSE ABSENT REPERFUSION INJURY Product DOANS PILLS (MAGNESIUM SALICYLATE) MOTRIN Role Route C C Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 58 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6773215
Preferred Term SEPSIS SYNDROME SEPTIC SHOCK WHITE BLOOD CELL COUNT INCREASED Product Role Route Dosage Text Duration Manufacturer

7133363 Date FDA Received

16-Sep-2009 Preferred Term PREGNANCY

Case # 7133363

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2009SP023733 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

ABORTION SPONTANEOUS MATERNAL EXPOSURE DURING PREGNANCY

7133369 Date FDA Received

16-Sep-2009 Preferred Term PYELONEPHRITIS

Case # 7133369

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO Role Route S VAGINAL

Manufacturer Control # 2009SP023939 Dosage Text 1 DF; VAG

Age

Sex Female

Country USA

Duration

Manufacturer

INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION MEDICAL DEVICE COMPLICATION

7133380 Date FDA Received

17-Sep-2009 Preferred Term

Case # 7133380

Case Type DIRECT Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control #

Age 18 YR

Sex Female

Country USA

Dosage Text ONCE MONTHLY VAG

Duration

Manufacturer

CYSTITIS NONINFECTIVE BLADDER IRRITATION DYSPAREUNIA LOSS OF LIBIDO PAIN VULVOVAGINAL DRYNESS

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 59 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7114643 Date FDA Received
21-Sep-2009 Preferred Term THROMBOSIS CEREBROVASCULAR ACCIDENT AMNESIA HEADACHE HYPERTENSION BLOOD DISORDER CARDIOVASCULAR DISORDER HYPERCOAGULATION ARRHYTHMIA ANGINA PECTORIS CHEST PAIN DEEP VEIN THROMBOSIS EAR INFECTION EAR PAIN GENERAL PHYSICAL CONDITION ABNORMAL HYPOACUSIS MIGRAINE PERIPHERAL VASCULAR DISORDER SUBARACHNOID HAEMORRHAGE TRANSVERSE SINUS THROMBOSIS Case # 7114643 Case Type EXPEDITED (15-DAY) Product NUVARING NOREL SR AMOXICILLIN ACETAMINOPHEN AND CODEINE PHOSPHATE AZITHROMYCIN CIPRODEX PROPRANOLOL TYLENOL WITH CODEINE NEURONTIN Health Professional Y Outcomes HO Role Route S C C C C C C C C Manufacturer Control # 2009SP017784 Dosage Text 1 DF;QM Age 25 YR Duration Sex Female Country USA

Manufacturer

7139911 Date FDA Received

21-Sep-2009 Preferred Term ECTOPIC PREGNANCY

Case # 7139911

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO Role Route S

Manufacturer Control # 2009SP024225 Dosage Text

Age 33 YR Duration

Sex Female

Country FIN

Manufacturer

MATERNAL EXPOSURE DURING PREGNANCY PREGNANCY WITH CONTRACEPTIVE DEVICE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 60 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7140524 Date FDA Received
21-Sep-2009 Preferred Term EPILEPSY Case # 7140524 Case Type EXPEDITED (15-DAY) Product NUVARING Case # 7144654 Case Type EXPEDITED (15-DAY) Product NUVARING ATIVAN GOLDENSEAL Health Professional N Health Professional Y Outcomes OT Role Route S Outcomes OT Role Route S S S ; PRN; Manufacturer Control # 2009SP025234 Dosage Text Age 31 YR Duration Sex Female Country USA Manufacturer Control # 2009SP025302 Dosage Text Duration Age Sex Female Country DEU

Manufacturer

7144654 Date FDA Received

24-Sep-2009 Preferred Term ANXIETY TREMOR FUNGAL INFECTION ALOPECIA HYPERTHYROIDISM

Manufacturer

PATHOGEN RESISTANCE

6256941 Date FDA Received

28-Sep-2009 Preferred Term MENINGISM ABDOMINAL PAIN

Case # 6256941

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO,LT,OT Role Route S

Manufacturer Control # 2007-154406-NL Dosage Text

Age 16 YR Duration

Sex Female

Country AUT

Manufacturer

ACUTE RESPIRATORY DISTRESS SYNDROME ARTHRALGIA HEADACHE INFECTIOUS PERITONITIS OOPHORITIS PAIN PYREXIA SALPINGO-OOPHORITIS TOXIC SHOCK SYNDROME STREPTOCOCCAL

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 61 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7138792 Date FDA Received
28-Sep-2009 Preferred Term MESENTERIC VEIN THROMBOSIS GASTROINTESTINAL NECROSIS HEPATIC VEIN THROMBOSIS Case # 7138792 Case Type DIRECT Product NUVARING Health Professional N Outcomes LT Role Route S VAGINAL Dosage Text 36 1/MONTH (3 YEARS) VAGINAL Manufacturer Control # Age 29 YR Duration Sex Female Country AUT

Manufacturer

7143947 Date FDA Received

29-Sep-2009 Preferred Term AMENORRHOEA ANAEMIA ANOVULATORY CYCLE

Case # 7143947

Case Type DIRECT Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control #

Age 29 YR

Sex Female

Country USA

Dosage Text 1 RING PER MONTH VAG

Duration

Manufacturer ORGANON

BLOOD OESTROGEN DECREASED OSTEOPENIA

7149490 Date FDA Received

30-Sep-2009 Preferred Term HERNIA REPAIR METRORRHAGIA

Case # 7149490

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2009SP027155 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

7150562 Date FDA Received

30-Sep-2009 Preferred Term

Case # 7150562

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2009SP026633 Dosage Text

Age 28 YR Duration

Sex Female

Country CAN

Manufacturer

UTERINE HAEMORRHAGE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 62 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7147990 Date FDA Received
05-Oct-2009 Preferred Term VAGINAL DISCHARGE CERVICAL DYSPLASIA GENITAL HERPES SMEAR CERVIX ABNORMAL Case # 7147990 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO,OT Role Route S Manufacturer Control # 2009SP026466 Dosage Text QM Age 29 YR Duration Sex Female Country HUN

Manufacturer

7152528 Date FDA Received

05-Oct-2009 Preferred Term

Case # 7152528

Case Type EXPEDITED (15-DAY) Product NUVARING Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2009SP027555 Dosage Text

Age

Sex Female

Country DEU

Duration

Manufacturer

SMEAR CERVIX ABNORMAL

7153719 Date FDA Received

05-Oct-2009 Preferred Term

Case # 7153719

Health Professional Y

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2009SP027791 Dosage Text 1 DF; VAG

Age 38 YR Duration

Sex Female

Country FRA

Manufacturer

PREGNANCY WITH CONTRACEPTIVE DEVICE ABORTION SPONTANEOUS MATERNAL EXPOSURE DURING PREGNANCY

7153126 Date FDA Received

06-Oct-2009 Preferred Term

Case # 7153126

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2009SP026673 Dosage Text VAG

Age 25 YR Duration

Sex Female

Country

Manufacturer

URINARY INCONTINENCE PYELONEPHRITIS RENAL COLIC VAGINAL HAEMORRHAGE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 63 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7153751 Date FDA Received
06-Oct-2009 Preferred Term EPILEPSY Case # 7153751 Case Type EXPEDITED (15-DAY) Product NUVARING Case # 7124834 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Health Professional N Outcomes OT Role Route S Outcomes CA Role Route S TRANSPLACENTAL Manufacturer Control # 2009SP023614 Dosage Text TRPL Duration Age Sex Unknown Country FRA Manufacturer Control # 2009SP028183 Dosage Text Duration Age Sex Female Country USA

Manufacturer

7124834 Date FDA Received

07-Oct-2009 Preferred Term SPINA BIFIDA ABORTION INDUCED

Manufacturer

ARNOLD-CHIARI MALFORMATION CEREBRAL VENTRICLE DILATATION MATERNAL DRUGS AFFECTING FOETUS NEURAL TUBE DEFECT TALIPES

7142708 Date FDA Received

07-Oct-2009 Preferred Term VAGINAL DISCHARGE CERVICAL DYSPLASIA

Case # 7142708

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO,OT Role Route S

Manufacturer Control # 2009SP026474 Dosage Text 1 DF; QM;

Age 30 YR Duration

Sex Female

Country HUN

Manufacturer

PAPILLOMA VIRAL INFECTION

7142711 Date FDA Received

13-Oct-2009 Preferred Term VAGINAL DISCHARGE CERVICAL DYSPLASIA

Case # 7142711

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO,OT Role Route S

Manufacturer Control # 2009SP026471 Dosage Text 1 DF; QM;

Age 24 YR Duration

Sex Female

Country HUN

Manufacturer

PAPILLOMA VIRAL INFECTION

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 64 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7157897 Date FDA Received
13-Oct-2009 Preferred Term CERVIX CARCINOMA STAGE 0 Case # 7157897 Case Type EXPEDITED (15-DAY) Product NUVARING Case Type EXPEDITED (15-DAY) Product NUVARING Case # 7158561 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Health Professional Y Health Professional Y Outcomes OT Role Route S Outcomes OT Role Route S Outcomes OT Role Route S VAGINAL Manufacturer Control # 2009SP028958 Dosage Text 1 DF; VAG Age 39 YR Duration Sex Female Country FRA Manufacturer Control # 2009SP029222 Dosage Text Duration Age Sex Female Country DEU Manufacturer Control # 2009SP029226 Dosage Text Duration Age Sex Female Country DEU

Manufacturer

7158057 Date FDA Received

13-Oct-2009 Preferred Term CARCINOMA IN SITU

Case # 7158057

Manufacturer

7158561 Date FDA Received

13-Oct-2009 Preferred Term VAGINAL ULCERATION HYPERTROPHY METRORRHAGIA VAGINAL DISORDER

Manufacturer

7158571 Date FDA Received

13-Oct-2009 Preferred Term

Case # 7158571

Case Type EXPEDITED (15-DAY) Product NUVARING Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2009SP029060 Dosage Text

Age

Sex Female

Country DEU

Duration

Manufacturer

SMEAR CERVIX ABNORMAL

7161431 Date FDA Received

14-Oct-2009 Preferred Term THROMBOCYTOPENIA

Case # 7161431

Health Professional Y

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2009SP029290 Dosage Text VAG

Age 22 YR Duration

Sex Female

Country ESP

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 65 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7155463 Date FDA Received
16-Oct-2009 Preferred Term CEREBROVASCULAR ACCIDENT Case # 7155463 Case Type DIRECT Product NUVARING Health Professional Y Outcomes HO,LT Role Route S VAGINAL Dosage Text 1 RING EVERY 4 WEEKS VAG SINCC 19YRS OF AGE -2004Manufacturer Control # Age 24 YR Duration Sex Female Country USA

Manufacturer ORGANON

ANTINUCLEAR ANTIBODY POSITIVE APHASIA RED BLOOD CELL SEDIMENTATION RATE INCREASED SENSORY DISTURBANCE

7163463 Date FDA Received

16-Oct-2009 Preferred Term

Case # 7163463

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S TRANSPLACENTAL

Manufacturer Control # 2009SP029535 Dosage Text ;TRPL

Age

Sex Unknown

Country USA

Duration

Manufacturer

SMALL FOR DATES BABY MATERNAL DRUGS AFFECTING FOETUS

7163488 Date FDA Received

16-Oct-2009 Preferred Term IRRITABILITY DEPRESSION

Case # 7163488

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2009SP029613 Dosage Text

Age 30 YR Duration

Sex Female

Country USA

Manufacturer

LOSS OF EMPLOYMENT STRESS SUICIDAL IDEATION

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 66 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7157394 Date FDA Received
19-Oct-2009 Preferred Term PULMONARY EMBOLISM THROMBOSIS Case # 7157394 Case Type DIRECT Product NUVARING Health Professional N Outcomes HO,LT Role Route S VAGINAL Dosage Text ONE UNIT MONTHLY VAG Manufacturer Control # Age 34 YR Duration Sex Female Country USA

Manufacturer

7157547 Date FDA Received

20-Oct-2009 Preferred Term

Case # 7157547

Case Type DIRECT Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control #

Age 42 YR

Sex Female

Country USA

Dosage Text MONTHLY

Duration 1 YEAR

Manufacturer

MATERNAL EXPOSURE DURING PREGNANCY UNWANTED PREGNANCY

7165094 Date FDA Received

20-Oct-2009 Preferred Term

Case # 7165094

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2009SP029135 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

UNINTENDED PREGNANCY MATERNAL EXPOSURE DURING PREGNANCY

7165107 Date FDA Received

20-Oct-2009 Preferred Term

Case # 7165107

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2009SP029134 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

UNINTENDED PREGNANCY MATERNAL EXPOSURE DURING PREGNANCY

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 67 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7166428 Date FDA Received
22-Oct-2009 Preferred Term PALPITATIONS Case # 7166428 Case Type DIRECT Product NUVARING Health Professional N Outcomes OT Role Route S VAGINAL Dosage Text 1 RING CONTINUOUS USE CHANGE PER 4 WEEKS VAG Manufacturer Control # Age 21 YR Duration 122 DAY Sex Female Country USA

Manufacturer

MYOCARDIAL INFARCTION

7167769 Date FDA Received

22-Oct-2009 Preferred Term DYSPNOEA CHEST PAIN LARYNGEAL OEDEMA

Case # 7167769

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2009SP031450 Dosage Text ; VAG

Age 28 YR Duration

Sex Female

Country USA

Manufacturer

7169819 Date FDA Received

22-Oct-2009 Preferred Term AMBLYOPIA

Case # 7169819

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2009SP030447 Dosage Text

Age 27 YR Duration

Sex Female

Country DEU

Manufacturer

7160988 Date FDA Received

23-Oct-2009 Preferred Term THROMBOSIS

Case # 7160988

Case Type DIRECT Product NUVARING

Health Professional N

Outcomes HO,LT Role Route S

Manufacturer Control #

Age 25 YR

Sex Female

Country USA

Dosage Text

Duration

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 68 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7160995 Date FDA Received
23-Oct-2009 Preferred Term CHILLS Case # 7160995 Case Type DIRECT Product NUVARING Health Professional N Role Route S VAGINAL Dosage Text ONCE PER MONTH ONCE PER MONTH VAG Outcomes Manufacturer Control # Age 47 YR Duration Sex Female Country USA

Manufacturer ORGANON

DISCOMFORT MEDICAL DEVICE COMPLICATION METRORRHAGIA PRODUCT SIZE ISSUE

7165375 Date FDA Received

29-Oct-2009 Preferred Term

Case # 7165375

Case Type DIRECT Product NUVARING Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes LT,OT Role Route S VAGINAL

Manufacturer Control #

Age 31 YR

Sex Female

Country USA

Dosage Text MONTHLY VAG Manufacturer Control # 2009SP030586 Dosage Text 1 DF Manufacturer Control #

Duration

Manufacturer

PULMONARY EMBOLISM

7178205 Date FDA Received

29-Oct-2009 Preferred Term RENAL FAILURE

Case # 7178205

Health Professional Y

Outcomes OT Role Route S

Age

Sex Female

Country USA

Duration

Manufacturer

7167749 Date FDA Received

30-Oct-2009 Preferred Term

Case # 7167749

Case Type DIRECT Product NUVARING

Health Professional N

Outcomes HO Role Route S VAGINAL

Age 21 YR

Sex Female

Country USA

Dosage Text 0.015MG PER DAY DAILY VAG

Duration

Manufacturer

PULMONARY THROMBOSIS

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 69 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7176540 Date FDA Received
30-Oct-2009 Preferred Term HYPERTENSION SYNCOPE Case # 7176540 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes OT Role Route S Manufacturer Control # 2009SP032491 Dosage Text Duration Age Sex Unknown Country USA

Manufacturer

7178579 Date FDA Received

30-Oct-2009 Preferred Term

Case # 7178579

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes DE Role Route S

Manufacturer Control # 2009SP032771 Dosage Text

Age 16 YR Duration

Sex Female

Country DEU

Manufacturer

PULMONARY EMBOLISM THROMBOSIS

7178497 Date FDA Received

02-Nov-2009 Preferred Term

Case # 7178497

Case Type EXPEDITED (15-DAY) Product NUVARING ALBUTEROL ZOLOFT

Health Professional N

Outcomes OT Role Route S C C

Manufacturer Control # 2009SP032746 Dosage Text

Age 16 YR Duration

Sex Female

Country USA

Manufacturer

UNINTENDED PREGNANCY OVARIAN CYST HYPERTENSION DYSPNOEA MIGRAINE PREGNANCY WITH CONTRACEPTIVE DEVICE THROMBOSIS

7168420 Date FDA Received

03-Nov-2009 Preferred Term DEPRESSION APATHY CRYING FEELING OF DESPAIR SUICIDAL IDEATION

Case # 7168420

Case Type DIRECT Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control #

Age 37 YR

Sex Female

Country USA

Dosage Text

Duration

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 70 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7182350 Date FDA Received
05-Nov-2009 Preferred Term MATERNAL DRUGS AFFECTING FOETUS CATARACT CONGENITAL Case # 7182350 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes OT Role Route S TRANSPLACENTAL Manufacturer Control # 2009SP032547 Dosage Text TRPL Age Sex Country CHE < 1 DAY Unknown Duration

Manufacturer

7182375 Date FDA Received

05-Nov-2009 Preferred Term DEVICE BREAKAGE HYPERTHYROIDISM CANDIDIASIS

Case # 7182375

Case Type EXPEDITED (15-DAY) Product NUVARING PURAN T4

Health Professional N

Outcomes OT Role Route S C VAGINAL

Manufacturer Control # 2009SP033604 Dosage Text UNK; VAG

Age 31 YR Duration

Sex Female

Country

Manufacturer

COMPLICATION OF DEVICE INSERTION VULVOVAGINAL DISCOMFORT

7175023 Date FDA Received

06-Nov-2009 Preferred Term CROHN'S DISEASE

Case # 7175023

Case Type DIRECT Product NUVARING

Health Professional N

Outcomes HO,LT,OT Role Route S VAGINAL

Manufacturer Control #

Age 27 YR

Sex Female

Country USA

Dosage Text 1 STANDARD RING EVERY FOUR WEEKS VAG

Duration 5 MTH

Manufacturer SCHERING PLOUGH

CONDITION AGGRAVATED THROMBOSIS

CIMZIA PENTASA FLAGYL PREDNISONE

C C C C

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 71 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7177355 Date FDA Received
09-Nov-2009 Preferred Term HAEMORRHAGE DRUG HYPERSENSITIVITY HEADACHE NO THERAPEUTIC RESPONSE Case # 7177355 Case Type DIRECT Product NUVARING Health Professional N Outcomes LT Role Route S VAGINAL Dosage Text INSERT 1 RING FOR 3 WEEKS VAG Manufacturer Control # Age 42 YR Duration Sex Female Country USA

Manufacturer

7191023 Date FDA Received

12-Nov-2009 Preferred Term SYNDACTYLY

Case # 7191023

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes CA Role Route S TRANSPLACENTAL

Manufacturer Control # 2009SP035231 Dosage Text TRPL

Age

Sex

Country DEU

< 1 DAY Female Duration

Manufacturer

MATERNAL DRUGS AFFECTING FOETUS

7194397 Date FDA Received

12-Nov-2009 Preferred Term HAEMATOCHEZIA

Case # 7194397

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2009SP033026 Dosage Text 1 DF QM Manufacturer Control # 2009SP033300 Dosage Text VAG

Age 19 YR Duration

Sex Female

Country USA

Manufacturer

7194398 Date FDA Received

12-Nov-2009 Preferred Term

Case # 7194398

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Age 21 YR Duration

Sex Female

Country USA

Manufacturer

GALLBLADDER DISORDER

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 72 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7192824 Date FDA Received
13-Nov-2009 Preferred Term DIZZINESS CHEST PAIN FATIGUE SYNCOPE Case # 7192824 Case Type EXPEDITED (15-DAY) Product NUVARING LEVOTHYROXINE Health Professional N Outcomes OT Role Route S S VAGINAL Manufacturer Control # 2009SP034602 Dosage Text ; VAG Age 19 YR Duration Sex Female Country USA

Manufacturer

7159429 Date FDA Received

17-Nov-2009 Preferred Term

Case # 7159429

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO,OT Role Route S

Manufacturer Control # 2009SP029207 Dosage Text

Age 47 YR Duration

Sex Female

Country DEU

Manufacturer

SMEAR CERVIX ABNORMAL CERVICAL DYSPLASIA

7183891 Date FDA Received

18-Nov-2009 Preferred Term

Case # 7183891

Case Type DIRECT Product NUVARING

Health Professional N

Outcomes OT,RI Role Route S VAGINAL

Manufacturer Control #

Age 28 YR

Sex Female

Country USA

Dosage Text 1 MONTHLY VAG

Duration

Manufacturer SCHERING PLOUGH

IRRITABLE BOWEL SYNDROME ABDOMINAL DISTENSION GASTRIC ULCER GASTROOESOPHAGEAL REFLUX DISEASE MENTAL IMPAIRMENT

7157923 Date FDA Received

19-Nov-2009 Preferred Term

Case # 7157923

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2009SP029216 Dosage Text

Age 34 YR Duration

Sex Female

Country DEU

Manufacturer

CERVIX CARCINOMA STAGE 0

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 73 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7194884 Date FDA Received
19-Nov-2009 Preferred Term DEATH Case # 7194884 Case Type EXPEDITED (15-DAY) Product NUVARING Case # 7187020 Case Type DIRECT Product NUVARING Health Professional Y Health Professional Y Outcomes DE Role Route S Outcomes HO Role Route S VAGINAL Dosage Text 15 MCG ETHINYL ESTRADION EVERY 4 WEEKS VAGINAL; 120 MCG ETONOGESTREL EVERY 4 WEEKS VAGINAL Manufacturer Control # Age 44 YR Duration 2 YEAR Sex Female Country USA Manufacturer Control # 2009SP035144 Dosage Text Duration Age Sex Female Country USA

Manufacturer

7187020 Date FDA Received

20-Nov-2009 Preferred Term

Manufacturer ORGANON

PULMONARY EMBOLISM

DEEP VEIN THROMBOSIS

7202707 Date FDA Received

20-Nov-2009 Preferred Term PNEUMONIA OEDEMA PERIPHERAL WEIGHT INCREASED

Case # 7202707

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2009SP033865 Dosage Text

Age 24 YR Duration

Sex Female

Country RUS

Manufacturer

7207672 Date FDA Received

24-Nov-2009 Preferred Term ECTOPIC PREGNANCY

Case # 7207672

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2009SP037331 Dosage Text 1 DF; VAG

Age

Sex Female

Country USA

Duration

Manufacturer

MATERNAL EXPOSURE DURING PREGNANCY PREGNANCY WITH IMPLANT CONTRACEPTIVE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 74 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7212379 Date FDA Received
24-Nov-2009 Preferred Term CARDIAC MURMUR VENTRICULAR SEPTAL DEFECT MATERNAL DRUGS AFFECTING FOETUS Case # 7212379 Case Type EXPEDITED (15-DAY) Product NUVARING LEVOTHYROXINE SODIUM OXAZEPAM Health Professional Y Health Professional N Outcomes CA Role Route S S C Outcomes OT Role Route S C C Outcomes OT Role Route S Dosage Text Manufacturer Control # Age 36 YR Duration 3 WEEK Sex Female Country USA Manufacturer Control # 2009SP037398 Dosage Text Age 36 YR Duration Sex Female Country USA TRANSPLACENTAL TRANSPLACENTAL Manufacturer Control # 2009SP037110 Dosage Text ; TRPL ; TRPL Age 1 DAY Duration Sex Female Country NLD

Manufacturer

7213411 Date FDA Received

27-Nov-2009 Preferred Term CERVICAL DYSPLASIA

Case # 7213411

Case Type EXPEDITED (15-DAY) Product NUVARING

Manufacturer

FOLIC ACID (CON.) SPIRONOLACTONE (CON.)

7196187 Date FDA Received

30-Nov-2009 Preferred Term

Case # 7196187

Case Type DIRECT Product NUVARING

Health Professional N

Manufacturer

URINARY TRACT INFECTION BLADDER PAIN

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 75 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7114658 Date FDA Received
01-Dec-2009 Preferred Term MIGRAINE BODY TEMPERATURE INCREASED CAVERNOUS SINUS THROMBOSIS CEREBROVASCULAR ACCIDENT GRAND MAL CONVULSION HYPERTENSION INTRACRANIAL VENOUS SINUS THROMBOSIS JUGULAR VEIN THROMBOSIS SINUS TACHYCARDIA SUPERIOR SAGITTAL SINUS THROMBOSIS THROMBOPHLEBITIS TRANSVERSE SINUS THROMBOSIS URINARY TRACT INFECTION WHITE BLOOD CELL COUNT INCREASED Case # 7114658 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO,OT Role Route S VAGINAL Manufacturer Control # 2009-195823-NL Dosage Text 1 DF; ONCE; VAG Age 29 YR Duration Sex Female Country USA

Manufacturer

7192821 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7192821

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes DE Role Route S

Manufacturer Control # 2009SP035434 Dosage Text

Age 31 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS PULMONARY EMBOLISM

7271459 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7271459

Case Type NON-EXPEDITED Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2009SP023236 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

PULMONARY EMBOLISM DEEP VEIN THROMBOSIS

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 76 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7271474 Date FDA Received
01-Dec-2009 Preferred Term DEEP VEIN THROMBOSIS Case # 7271474 Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Health Professional N Role Route S Health Professional Y Health Professional Y Outcomes OT Role Route S VAGINAL Manufacturer Control # 2009SP021285 Dosage Text VAG Manufacturer Control # 2009SP021251 Dosage Text Duration Age Sex Female Country USA Age 24 YR Duration Sex Female Country USA

Manufacturer

7271475 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7271475

Outcomes OT Role Route S Outcomes

Manufacturer

PULMONARY EMBOLISM

7271479 Date FDA Received

01-Dec-2009 Preferred Term DEVICE EXPULSION

Case # 7271479

Manufacturer Control # 2009SP021067 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION

7271487 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7271487

Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2009SP024161 Dosage Text 1 DF Manufacturer Control # 2009SP026796 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

CEREBROVASCULAR ACCIDENT

7276498 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7276498

Health Professional Y

Outcomes OT Role Route S

Age

Sex Female

Country USA

Duration

Manufacturer

DEEP VEIN THROMBOSIS

7276506 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7276506

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2009SP026270 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

PULMONARY EMBOLISM

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 77 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7276508 Date FDA Received
01-Dec-2009 Preferred Term THROMBOSIS Case # 7276508 Case Type NON-EXPEDITED Product NUVARING Case # 7276513 Case Type NON-EXPEDITED Product ETHINYL ESTRADIOL \PROGESTERONE NUVARING Health Professional N Health Professional N Outcomes OT Role Route S Outcomes HO,OT Role Route S S Health Professional Y VAGINAL ; VAG Manufacturer Control # 2009SP024941 Dosage Text Age 23 YR Duration Sex Female Country USA Manufacturer Control # 2009SP025602 Dosage Text Age 27 YR Duration Sex Female Country FIN Manufacturer Control # 2009SP025677 Dosage Text Duration Age Sex Female Country USA

Manufacturer

7276513 Date FDA Received

01-Dec-2009 Preferred Term

Manufacturer

PULMONARY EMBOLISM

7276521 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7276521

Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING

Outcomes HO,OT Role Route S

Manufacturer

PULMONARY EMBOLISM

7277470 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7277470

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2009SP028383 Dosage Text

Age 40 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY THROMBOSIS

7277480 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7277480

Health Professional Y

Outcomes HO Role Route S VAGINAL

Manufacturer Control # 2009SP028401 Dosage Text 1 DF; VAG

Age 44 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS PULMONARY EMBOLISM

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 78 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7277708 Date FDA Received
01-Dec-2009 Preferred Term PULMONARY EMBOLISM Case # 7277708 Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING VITAMINS NOS Case # 7277775 Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING MAXALT ACTONEL CITRUCEL FORTAMET MIACALCIN Health Professional Y Health Professional Y Health Professional Y Health Professional Y Health Professional N Outcomes HO Role Route S Outcomes HO Role Route S Outcomes HO,LT Role Route S C Outcomes HO Role Route S Outcomes HO Role Route S C C C C C Manufacturer Control # 2009-198799-NL Dosage Text Age 50 YR Duration Sex Female Country USA Manufacturer Control # 2009-199394-NL Dosage Text Age 29 YR Duration Sex Female Country USA Manufacturer Control # 2009-199578-NL Dosage Text 1 DF ; Manufacturer Control # 2009-199354-NL Dosage Text Age 26 YR Duration Sex Female Country USA Age 32 YR Duration Sex Female Country USA Manufacturer Control # 2009SP023413 Dosage Text Age 38 YR Duration Sex Female Country USA

Manufacturer

7277763 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7277763

Manufacturer

CEREBROVASCULAR ACCIDENT

7277774 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7277774

Manufacturer

PULMONARY EMBOLISM MUSCLE SPASMS

7277775 Date FDA Received

01-Dec-2009 Preferred Term

Manufacturer

PULMONARY EMBOLISM

7277811 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7277811

Manufacturer

DEEP VEIN THROMBOSIS OFF LABEL USE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 79 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7277813 Date FDA Received
01-Dec-2009 Preferred Term PHLEBITIS SUPERFICIAL Case # 7277813 Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case # 7277817 Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Health Professional N Health Professional N Health Professional Y Health Professional Y Health Professional Y Outcomes OT Role Route S Outcomes OT Role Route S Outcomes HO Role Route S Outcomes OT Role Route S Outcomes OT Role Route S Manufacturer Control # 2009-198141-NL Dosage Text Duration Age Sex Female Country USA Manufacturer Control # 2009-198246-NL Dosage Text Duration Age Sex Female Country USA Manufacturer Control # 2009-198716-NL Dosage Text Age 22 YR Duration Sex Female Country USA Manufacturer Control # 2009-198711-NL Dosage Text Duration Age Sex Female Country USA Manufacturer Control # 2009-198980-NL Dosage Text Age 23 YR Duration Sex Female Country USA

Manufacturer

7277814 Date FDA Received

01-Dec-2009 Preferred Term THROMBOSIS

Case # 7277814

Manufacturer

7277817 Date FDA Received

01-Dec-2009 Preferred Term

Manufacturer

PULMONARY EMBOLISM

7278728 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7278728

Manufacturer

DEEP VEIN THROMBOSIS

7278733 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7278733

Manufacturer

RENAL VEIN THROMBOSIS DEEP VEIN THROMBOSIS

7278765 Date FDA Received

01-Dec-2009 Preferred Term THROMBOSIS

Case # 7278765

Case Type NON-EXPEDITED Product NUVARING

Health Professional N

Outcomes HO Role Route S

Manufacturer Control # 2009-197789-NL Dosage Text

Age 27 YR Duration

Sex Female

Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 80 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7278766 Date FDA Received
01-Dec-2009 Preferred Term PULMONARY EMBOLISM Case # 7278766 Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case # 7278797 Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Health Professional N Health Professional Y Health Professional N Health Professional Y Health Professional Y Health Professional Y Outcomes HO Role Route S Outcomes HO Role Route S Outcomes OT Role Route S Outcomes OT Role Route S Outcomes OT Role Route S Outcomes OT Role Route S Manufacturer Control # 2009-194499-NL Dosage Text Duration Age Sex Female Country USA Manufacturer Control # 2009-194670-NL Dosage Text Duration Age Sex Female Country USA Manufacturer Control # 2009-197440-NL Dosage Text Duration Age Sex Female Country USA Manufacturer Control # 2009-197546-NL Dosage Text Duration Age Sex Female Country USA Manufacturer Control # 2009-197751-NL Dosage Text Age 30 YR Duration Sex Female Country USA Manufacturer Control # 2009-197782-NL Dosage Text Duration Age Sex Female Country USA

Manufacturer

7278773 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7278773

Manufacturer

CEREBROVASCULAR ACCIDENT

7278777 Date FDA Received

01-Dec-2009 Preferred Term THROMBOSIS

Case # 7278777

Manufacturer

7278797 Date FDA Received

01-Dec-2009 Preferred Term

Manufacturer

DEEP VEIN THROMBOSIS

7278800 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7278800

Manufacturer

DEEP VEIN THROMBOSIS

7278808 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7278808

Manufacturer

DEEP VEIN THROMBOSIS

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 81 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7278866 Date FDA Received
01-Dec-2009 Preferred Term PULMONARY EMBOLISM Case # 7278866 Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Health Professional Y Health Professional Y Health Professional Y Outcomes HO Role Route S Outcomes HO Role Route S Outcomes HO,LT Role Route S Manufacturer Control # 2009-194363-NL Dosage Text Age 42 YR Duration Sex Female Country USA Manufacturer Control # 2009-194457-NL Dosage Text Duration Age Sex Female Country USA Manufacturer Control # 2009-194452-NL Dosage Text Age 48 YR Duration Sex Female Country USA

Manufacturer

7278867 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7278867

Manufacturer

PULMONARY EMBOLISM

7278876 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7278876

Manufacturer

CEREBROVASCULAR ACCIDENT PULMONARY EMBOLISM

7278881 Date FDA Received

01-Dec-2009 Preferred Term THROMBOSIS

Case # 7278881

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2009-194326-NL Dosage Text

Age 33 YR Duration

Sex Female

Country USA

Manufacturer

7278904 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7278904

Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2009-194264-NL Dosage Text

Age 51 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM

7278905 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7278905

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2009-194250-NL Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

DEEP VEIN THROMBOSIS

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 82 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7278961 Date FDA Received
01-Dec-2009 Preferred Term PULMONARY EMBOLISM Case # 7278961 Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Health Professional N Health Professional N Outcomes OT Role Route S Outcomes OT Role Route S Manufacturer Control # 2009-200051-NL Dosage Text Duration Age Sex Female Country USA Manufacturer Control # 2009-200049-NL Dosage Text Duration Age Sex Female Country USA

Manufacturer

7278964 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7278964

Manufacturer

PULMONARY EMBOLISM PELVIC VENOUS THROMBOSIS

7278967 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7278967

Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2009-200055-NL Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

PULMONARY EMBOLISM

7278969 Date FDA Received

01-Dec-2009 Preferred Term THROMBOSIS

Case # 7278969

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2009-199747-NL Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

7278980 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7278980

Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2009-199570-NL Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

DEEP VEIN THROMBOSIS

7279187 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7279187

Health Professional N

Outcomes HO Role Route S VAGINAL

Manufacturer Control # 2009SP021084 Dosage Text 1 DF; VAG

Age 45 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 83 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7279205 Date FDA Received
01-Dec-2009 Preferred Term PULMONARY THROMBOSIS Case # 7279205 Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING HUMIRA Case Type NON-EXPEDITED Product NUVARING METHOTREXATE HUMIRA LISINOPRIL Health Professional N Health Professional N Health Professional N Health Professional Y Outcomes HO Role Route S Outcomes HO Role Route S Outcomes HO Role Route S C Outcomes HO Role Route S C C C Health Professional Y Outcomes HO,LT Role Route S VAGINAL Manufacturer Control # 2009SP021899 Dosage Text VAG Age 33 YR Duration Sex Female Country USA Manufacturer Control # 2009SP022283 Dosage Text Age 37 YR Duration Sex Female Country USA Manufacturer Control # 2009SP022297 Dosage Text Age 37 YR Duration Sex Female Country USA Manufacturer Control # 2009SP023129 Dosage Text Age 24 YR Duration Sex Female Country USA Manufacturer Control # 2009SP020420 Dosage Text Duration Age Sex Female Country USA

Manufacturer

7279259 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7279259

Manufacturer

PULMONARY EMBOLISM

7279272 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7279272

Manufacturer

PULMONARY EMBOLISM DEEP VEIN THROMBOSIS

7279279 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7279279

Manufacturer

PULMONARY EMBOLISM DEEP VEIN THROMBOSIS

7279305 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7279305

Case Type NON-EXPEDITED Product NUVARING

Manufacturer

DEEP VEIN THROMBOSIS INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION PULMONARY EMBOLISM

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 84 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7279306 Date FDA Received
01-Dec-2009 Preferred Term PULMONARY EMBOLISM Case # 7279306 Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Health Professional N Health Professional Y Health Professional N Health Professional N Outcomes OT Role Route S Outcomes OT Role Route S Outcomes OT Role Route S VAGINAL Manufacturer Control # 2009SP021281 Dosage Text VAG Manufacturer Control # 2009SP019823 Dosage Text Duration 3 DAY Age Sex Female Country USA Age 23 YR Duration Sex Female Country USA Manufacturer Control # 2009SP021866 Dosage Text Duration Age Sex Female Country USA Manufacturer Control # 2009SP021863 Dosage Text Duration Age Sex Female Country USA

Manufacturer

7279316 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7279316

Manufacturer

DEEP VEIN THROMBOSIS

7279336 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7279336

Manufacturer

PULMONARY EMBOLISM

7280939 Date FDA Received

01-Dec-2009 Preferred Term THROMBOSIS DIZZINESS INSOMNIA MUSCLE TIGHTNESS

Case # 7280939

Outcomes OT Role Route S

Manufacturer

7280943 Date FDA Received

01-Dec-2009 Preferred Term THROMBOSIS

Case # 7280943

Case Type NON-EXPEDITED Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2009SP019200 Dosage Text VAG

Age 30 YR Duration

Sex Female

Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 85 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7280992 Date FDA Received
01-Dec-2009 Preferred Term PULMONARY EMBOLISM Case # 7280992 Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Health Professional N Health Professional N Outcomes HO,OT Role Route S VAGINAL Manufacturer Control # 2009SP019157 Dosage Text QM;VAG Manufacturer Control # 2009SP017664 Dosage Text 1 DF; VAG Age 36 YR Duration Sex Female Country USA Age 30 YR Duration Sex Female Country USA

Manufacturer

7281030 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7281030

Outcomes HO,LT Role Route S VAGINAL

Manufacturer

PULMONARY EMBOLISM DEEP VEIN THROMBOSIS

7281685 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7281685

Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2008-188708-NL Dosage Text

Age 29 YR Duration

Sex Unknown

Country USA

Manufacturer

CEREBRAL THROMBOSIS

7281724 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7281724

Health Professional

Outcomes OT Role Route S

Manufacturer Control # 2008-188411-NL Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

DEEP VEIN THROMBOSIS

7281729 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7281729

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2008-188326-NL Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

DEEP VEIN THROMBOSIS

7281730 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7281730

Health Professional Y

Outcomes HO Role Route S

Manufacturer Control # 2009-189457-NL Dosage Text

Age 50 YR Duration

Sex Female

Country USA

Manufacturer

CEREBROVASCULAR ACCIDENT

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 86 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7281735 Date FDA Received
01-Dec-2009 Preferred Term DEEP VEIN THROMBOSIS Case # 7281735 Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING CELEXA Health Professional Y Health Professional Y Outcomes HO Role Route S Outcomes HO Role Route S C Health Professional Y Outcomes HO Role Route S Health Professional Y Outcomes HO Role Route S Health Professional N Outcomes OT Role Route S Health Professional Y VAGINAL Manufacturer Control # 2009SP017346 Dosage Text 1 DF; VAG Manufacturer Control # 2009SP017362 Dosage Text ;VAG Age 40 YR Duration 2 MTH Age 49 YR Duration Sex Female Country USA Sex Female Country USA Manufacturer Control # 2008-188846-NL Dosage Text Age 21 YR Duration Sex Female Country USA Manufacturer Control # 2009-189265-NL Dosage Text Age 40 YR Duration Sex Female Country USA Manufacturer Control # 2009-189274-NL Dosage Text Age 22 YR Duration Sex Female Country USA Manufacturer Control # 2008-188359-NL Dosage Text Age 31 YR Duration Sex Female Country USA

Manufacturer

7281764 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7281764

Manufacturer

PULMONARY EMBOLISM

7281767 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7281767

Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING

Manufacturer

PULMONARY EMBOLISM

7281771 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7281771

Manufacturer

PULMONARY EMBOLISM

7281816 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7281816

Manufacturer

PULMONARY THROMBOSIS

7281872 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7281872

Outcomes OT Role Route S VAGINAL

Manufacturer

PULMONARY EMBOLISM

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 87 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7281930 Date FDA Received
01-Dec-2009 Preferred Term ISCHAEMIC STROKE Case # 7281930 Case Type NON-EXPEDITED Product NUVARING Case # 7282397 Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Health Professional N Health Professional Y Health Professional Y Health Professional N Health Professional Y Health Professional Y Outcomes HO,LT,OT Role Route S Outcomes HO,OT Role Route S VAGINAL Manufacturer Control # 2009-201082-NL Dosage Text 1 DF;QM;VAG Manufacturer Control # 2009-196783-NL Dosage Text Duration Age Sex Female Country USA Duration Age Sex Female Country USA Manufacturer Control # 2009SP017386 Dosage Text Age 30 YR Duration Sex Female Country USA

Manufacturer

7282397 Date FDA Received

01-Dec-2009 Preferred Term

Manufacturer

PULMONARY EMBOLISM

7283303 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7283303

Outcomes OT Role Route S Outcomes OT Role Route S Outcomes OT Role Route S Outcomes OT Role Route S

Manufacturer

PULMONARY EMBOLISM

7283320 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7283320

Manufacturer Control # 2009-196690-NL Dosage Text

Age 30 YR Duration

Sex Female

Country USA

Manufacturer

CEREBROVASCULAR ACCIDENT

7283321 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7283321

Manufacturer Control # 2009-196702-NL Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

PULMONARY EMBOLISM

7283324 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7283324

Manufacturer Control # 2009-196602-NL Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

PULMONARY EMBOLISM

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 88 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7283340 Date FDA Received
01-Dec-2009 Preferred Term CEREBROVASCULAR ACCIDENT Case # 7283340 Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Health Professional Health Professional Y Health Professional Y Health Professional N Health Professional Y Outcomes OT Role Route S Outcomes HO Role Route S Outcomes HO Role Route S Outcomes LT Role Route S Outcomes HO Role Route S Manufacturer Control # 2008-186083-NL Dosage Text Duration Age Sex Female Country USA Manufacturer Control # 2008-186863-NL Dosage Text Duration Age Sex Female Country USA Manufacturer Control # 2008-187488-NL Dosage Text Duration Age Sex Female Country USA Manufacturer Control # 2008-187506-NL Dosage Text Age 23 YR Duration Sex Female Country USA Manufacturer Control # 2009-196525-NL Dosage Text Age 30 YR Duration Sex Female Country USA

Manufacturer

7284148 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7284148

Manufacturer

PULMONARY EMBOLISM

7284153 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7284153

Manufacturer

MYOCARDIAL INFARCTION

7284166 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7284166

Manufacturer

PULMONARY EMBOLISM

7284237 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7284237

Manufacturer

DEEP VEIN THROMBOSIS PULMONARY EMBOLISM

7284307 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7284307

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes HO Role Route S

Manufacturer Control # 2008-185174-NL Dosage Text

Age 33 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 89 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7284334 Date FDA Received
01-Dec-2009 Preferred Term PULMONARY EMBOLISM Case # 7284334 Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING HYDROCORTISONE Health Professional Y Health Professional Y Health Professional Y Outcomes OT Role Route S Outcomes OT Role Route S Outcomes HO Role Route S C Outcomes HO Role Route S Health Professional Y Outcomes HO,LT Role Route S Manufacturer Control # 2009-194159-NL Dosage Text Age 25 YR Duration Sex Female Country USA Manufacturer Control # 2009-194154-NL Dosage Text Age 24 YR Duration Sex Female Country USA Manufacturer Control # 2008-185057-NL Dosage Text Age 16 YR Duration Sex Female Country USA Manufacturer Control # 2008-185008-NL Dosage Text Age 27 YR Duration Sex Female Country USA Manufacturer Control # 2008-185178-NL Dosage Text Duration Age Sex Female Country USA

Manufacturer

7284385 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7284385

Manufacturer

THROMBOPHLEBITIS SUPERFICIAL

7284392 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7284392

Manufacturer

DEEP VEIN THROMBOSIS

7284651 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7284651

Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Manufacturer

ERYTHEMA MULTIFORME

7284652 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7284652

Manufacturer

DEEP VEIN THROMBOSIS PULMONARY EMBOLISM

7284661 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7284661

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes LT,OT Role Route S VAGINAL

Manufacturer Control # 2009-193994-NL Dosage Text VAG

Age

Sex Female

Country USA

Duration

Manufacturer

ANAPHYLACTIC SHOCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 90 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7284669 Date FDA Received
01-Dec-2009 Preferred Term PULMONARY EMBOLISM THROMBOSIS Case # 7284669 Case Type NON-EXPEDITED Product NUVARING Health Professional Y Outcomes HO Role Route S Manufacturer Control # 2009-193802-NL Dosage Text Age 29 YR Duration Sex Female Country USA

Manufacturer

7284674 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7284674

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes HO Role Route S

Manufacturer Control # 2009-193755-NL Dosage Text

Age 47 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS PULMONARY EMBOLISM

7284676 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7284676

Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2009-193756-NL Dosage Text

Age 24 YR Duration

Sex Female

Country USA

Manufacturer

THROMBOPHLEBITIS SUPERFICIAL

7284681 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7284681

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2008-185884-NL Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

CEREBROVASCULAR ACCIDENT

7284686 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7284686

Health Professional Y

Outcomes HO Role Route S

Manufacturer Control # 2008-185723-NL Dosage Text

Age 30 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 91 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7284698 Date FDA Received
01-Dec-2009 Preferred Term PULMONARY EMBOLISM DEEP VEIN THROMBOSIS Case # 7284698 Case Type NON-EXPEDITED Product NUVARING Health Professional Y Outcomes HO Role Route S Manufacturer Control # 2008-185602-NL Dosage Text Age 27 YR Duration Sex Female Country USA

Manufacturer

7284700 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7284700

Case Type NON-EXPEDITED Product NUVARING BACTRIM

Health Professional Y

Outcomes OT Role Route S C VAGINAL

Manufacturer Control # 2008-185485-NL Dosage Text VAG

Age 29 YR Duration

Sex Female

Country USA

Manufacturer

TOXIC SHOCK SYNDROME ERYTHEMA

7284713 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7284713

Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2008-185399-NL Dosage Text VAG Manufacturer Control # 2008-185365-NL Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

DEEP VEIN THROMBOSIS

7284715 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7284715

Health Professional Y

Outcomes OT Role Route S

Age

Sex Female

Country USA

Duration

Manufacturer

PULMONARY EMBOLISM

7284716 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7284716

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2008-185366-NL Dosage Text

Age 40 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM

7284720 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7284720

Health Professional Y

Outcomes HO Role Route S

Manufacturer Control # 2009-201107-NL Dosage Text 1 DF; QM

Age

Sex Female

Country USA

Duration

Manufacturer

PULMONARY EMBOLISM

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 92 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7284723 Date FDA Received
01-Dec-2009 Preferred Term DEEP VEIN THROMBOSIS PULMONARY EMBOLISM Case # 7284723 Case Type NON-EXPEDITED Product NUVARING Health Professional Y Outcomes HO Role Route S Manufacturer Control # 2009-193680-NL Dosage Text Duration Age Sex Female Country USA

Manufacturer

7284733 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7284733

Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2009-193182-NL Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

PULMONARY EMBOLISM

7284735 Date FDA Received

01-Dec-2009 Preferred Term THROMBOSIS

Case # 7284735

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2009-193104-NL Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

7284739 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7284739

Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2009-192801-NL Dosage Text

Age 34 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM

7284741 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7284741

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2009-192350-NL Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

PULMONARY EMBOLISM

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 93 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7284743 Date FDA Received
01-Dec-2009 Preferred Term CEREBRAL THROMBOSIS CEREBRAL HAEMORRHAGE Case # 7284743 Case Type NON-EXPEDITED Product NUVARING AMITRIPTYLINE HYDROCHLORIDE MULTI-VITAMIN CLEOCIN Health Professional Y Outcomes HO,DS Role Route S C C C Health Professional Y Outcomes HO Role Route S C Manufacturer Control # 2009-200847-NL Dosage Text Age 17 YR Duration Sex Female Country USA Manufacturer Control # 2009-190134-NL Dosage Text Age 27 YR Duration Sex Female Country USA

Manufacturer

7284746 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7284746

Case Type NON-EXPEDITED Product NUVARING

Manufacturer

PULMONARY EMBOLISM DEEP VEIN THROMBOSIS NECK PAIN

WELLBUTRIN

7284752 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7284752

Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2009-189838-NL Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

PULMONARY EMBOLISM

7284753 Date FDA Received

01-Dec-2009 Preferred Term THROMBOSIS

Case # 7284753

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2009-200652-NL Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

7284758 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7284758

Case Type NON-EXPEDITED Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2009-189796-NL Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

DEEP VEIN THROMBOSIS

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 94 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7284759 Date FDA Received
01-Dec-2009 Preferred Term THROMBOPHLEBITIS SUPERFICIAL Case # 7284759 Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case # 7284765 Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING ALVEDON Health Professional Y Health Professional Y Health Professional Y Health Professional Y Outcomes OT Role Route S Outcomes HO,LT Role Route S Outcomes OT Role Route S Outcomes HO Role Route S C Health Professional N Outcomes HO Role Route S Health Professional N Outcomes OT Role Route S Manufacturer Control # 2009-198722-NL Dosage Text Duration Age Sex Female Country USA Manufacturer Control # 2009-189709-NL Dosage Text Duration Age Sex Female Country USA VAGINAL Manufacturer Control # 2009-200471-NL Dosage Text VAG Age 24 YR Duration Sex Female Country SWE Manufacturer Control # 2009-189740-NL Dosage Text Age 30 YR Duration Sex Female Country USA Manufacturer Control # 2009-200492-NL Dosage Text Duration Age Sex Female Country USA Manufacturer Control # 2009-189781-NL Dosage Text Age 47 YR Duration Sex Female Country USA

Manufacturer

7284760 Date FDA Received

01-Dec-2009 Preferred Term THROMBOSIS

Case # 7284760

Manufacturer

7284765 Date FDA Received

01-Dec-2009 Preferred Term

Manufacturer

PULMONARY EMBOLISM

7284768 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7284768

Manufacturer

PULMONARY THROMBOSIS

7284773 Date FDA Received

01-Dec-2009 Preferred Term THROMBOSIS

Case # 7284773

Case Type NON-EXPEDITED Product NUVARING

Manufacturer

7284774 Date FDA Received

01-Dec-2009 Preferred Term EMBOLISM VENOUS

Case # 7284774

Case Type NON-EXPEDITED Product NUVARING

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 95 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7284785 Date FDA Received
01-Dec-2009 Preferred Term PULMONARY EMBOLISM Case # 7284785 Case Type NON-EXPEDITED Product NUVARING LEVOTHYROXINE SODIUM Health Professional Y Outcomes HO Role Route S C Outcomes HO Role Route S Manufacturer Control # 2009-200455-NL Dosage Text 1 DF; Age 32 YR Duration Sex Female Country USA VAGINAL Manufacturer Control # 2009-192275-NL Dosage Text VAG Age 53 YR Duration Sex Female Country USA

Manufacturer

7284788 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7284788

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Manufacturer

PULMONARY EMBOLISM TINEA CRURIS

7284789 Date FDA Received

01-Dec-2009 Preferred Term THROMBOSIS

Case # 7284789

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2009-192069-NL Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

7284790 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7284790

Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2009-198269-NL Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

THROMBOPHLEBITIS SUPERFICIAL

7284792 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7284792

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2009-198242-NL Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

DEEP VEIN THROMBOSIS

7284796 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7284796

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2009-200459-NL Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

PULMONARY EMBOLISM

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 96 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7284806 Date FDA Received
01-Dec-2009 Preferred Term PULMONARY EMBOLISM THROMBOSIS Case # 7284806 Case Type NON-EXPEDITED Product NUVARING Health Professional Y Outcomes OT Role Route S Manufacturer Control # 2009-197011-NL Dosage Text Age 30 YR Duration Sex Female Country USA

Manufacturer

7284812 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7284812

Case Type NON-EXPEDITED Product NUVARING GEODON Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes HO Role Route S C

Manufacturer Control # 2009-197048-NL Dosage Text

Age 29 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM DEEP VEIN THROMBOSIS

7284815 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7284815

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2009-197049-NL Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

DEEP VEIN THROMBOSIS

7284817 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7284817

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2009-197054-NL Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

DEEP VEIN THROMBOSIS

7284818 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7284818

Health Professional Y

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2009-197083-NL Dosage Text VAG

Age 46 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 97 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7284822 Date FDA Received
01-Dec-2009 Preferred Term DEEP VEIN THROMBOSIS OFF LABEL USE Case # 7284822 Case Type NON-EXPEDITED Product NUVARING Health Professional Y Outcomes OT Role Route S Manufacturer Control # 2009-200373-NL Dosage Text Age 51 YR Duration Sex Female Country USA

Manufacturer

7284824 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7284824

Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2009-200156-NL Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

PULMONARY EMBOLISM

7284829 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7284829

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2009-200103-NL Dosage Text

Age 35 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS

7284859 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7284859

Health Professional Y

Outcomes HO Role Route S

Manufacturer Control # 2009-194844-NL Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

PULMONARY EMBOLISM

7284872 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7284872

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2009-194833-NL Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

PULMONARY EMBOLISM

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 98 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7284887 Date FDA Received
01-Dec-2009 Preferred Term DEEP VEIN THROMBOSIS Case # 7284887 Case Type NON-EXPEDITED Product NUVARING ULTRACET PREDNISONE HYDROCODONE BITARTRATE ETODOLAC Health Professional Outcomes HO,OT Role Route S C C C C Health Professional Y Outcomes HO,OT Role Route S C C C C C C C C C C C C Outcomes HO Role Route S Manufacturer Control # 2009-191026-NL Dosage Text Duration Age Sex Female Country USA Manufacturer Control # 2007-165246-NL Dosage Text 1 DF;QM Age 41 YR Duration Sex Female Country USA Manufacturer Control # 2008-178648-NL Dosage Text Age 23 YR Duration Sex Female Country USA

Manufacturer

7284892 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7284892

Case Type NON-EXPEDITED Product NUVARING TOPAMAX

Manufacturer

CEREBROVASCULAR ACCIDENT HEPATIC ENZYME INCREASED ATELECTASIS

AMITRIPTYLINE HYDROCHLORIDE TYLENOL NASACORT AQ ZITHROMAX TAMIFLU SKELAXIN NEURONTIN DICLOFENAC SODIUM VIOXX VALTREX MAXALT-MLT

7284919 Date FDA Received

01-Dec-2009 Preferred Term ABDOMINAL PAIN

Case # 7284919

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 99 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7284923 Date FDA Received
01-Dec-2009 Preferred Term THROMBOSIS Case # 7284923 Case Type NON-EXPEDITED Product NUVARING Case # 7284924 Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Health Professional Y Health Professional N Health Professional Y Health Professional Y Health Professional Y Health Professional Y Outcomes HO Role Route S Outcomes HO Role Route S Outcomes HO Role Route S Outcomes OT Role Route S Outcomes HO,OT Role Route S Outcomes HO Role Route S Manufacturer Control # 2009-190184-NL Dosage Text Age 24 YR Duration Sex Female Country USA Manufacturer Control # 2009-190526-NL Dosage Text Age 48 YR Duration Sex Female Country USA Manufacturer Control # 2009-190640-NL Dosage Text Duration Age Sex Female Country USA Manufacturer Control # 2009-190654-NL Dosage Text Age 21 YR Duration Sex Female Country USA Manufacturer Control # 2009-190687-NL Dosage Text Age 46 YR Duration Sex Female Country USA Manufacturer Control # 2009-190683-NL Dosage Text Duration Age Sex Female Country USA

Manufacturer

7284924 Date FDA Received

01-Dec-2009 Preferred Term

Manufacturer

DEEP VEIN THROMBOSIS

7284927 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7284927

Manufacturer

PULMONARY EMBOLISM

7284932 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7284932

Manufacturer

DEEP VEIN THROMBOSIS

7284939 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7284939

Manufacturer

CEREBROVASCULAR ACCIDENT

7284947 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7284947

Manufacturer

DEEP VEIN THROMBOSIS

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 100 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7284973 Date FDA Received
01-Dec-2009 Preferred Term DEEP VEIN THROMBOSIS Case # 7284973 Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Health Professional Y Health Professional Y Health Professional Y Health Professional Y Outcomes OT Role Route S Outcomes HO Role Route S Outcomes HO Role Route S Outcomes OT Role Route S Manufacturer Control # 2009-191442-NL Dosage Text Age 50 YR Duration Sex Female Country USA Manufacturer Control # 2009-191679-NL Dosage Text Age 35 YR Duration Sex Female Country USA Manufacturer Control # 2009-191856-NL Dosage Text Age 25 YR Duration Sex Female Country USA Manufacturer Control # 2009-191983-NL Dosage Text Age 43 YR Duration Sex Female Country USA

Manufacturer

7284975 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7284975

Manufacturer

PULMONARY EMBOLISM

7284977 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7284977

Manufacturer

CEREBROVASCULAR ACCIDENT

7284986 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7284986

Manufacturer

PULMONARY EMBOLISM DEEP VEIN THROMBOSIS

7284989 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7284989

Case Type NON-EXPEDITED Product NUVARING

Health Professional N

Outcomes OT Role Route S S

Manufacturer Control # 2009-191289-NL Dosage Text

Age 23 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM DEEP VEIN THROMBOSIS HEADACHE

UNSPECIFIED INGREDIENT

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 101 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7284990 Date FDA Received
01-Dec-2009 Preferred Term DEEP VEIN THROMBOSIS ANXIETY PULMONARY EMBOLISM Case # 7284990 Case Type NON-EXPEDITED Product NUVARING Health Professional N Outcomes HO Role Route S Manufacturer Control # 2009-191122-NL Dosage Text Age 37 YR Duration Sex Female Country USA

Manufacturer

7284991 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7284991

Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes HO Role Route S

Manufacturer Control # 2009-191063-NL Dosage Text

Age 32 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM

7284992 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7284992

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2009-191018-NL Dosage Text

Age 26 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM

7284998 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7284998

Health Professional Y

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2009-196463-NL Dosage Text VAG Manufacturer Control # 2009-196369-NL Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

PULMONARY THROMBOSIS

7285001 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7285001

Health Professional Y

Outcomes HO,LT Role Route S

Age 22 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM

7285015 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7285015

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2009-196067-NL Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

DEEP VEIN THROMBOSIS

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 102 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7285475 Date FDA Received
01-Dec-2009 Preferred Term CEREBROVASCULAR ACCIDENT Case # 7285475 Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING ZOLOFT WELLBUTRIN AVELOX COLD MEDICATION MUCINEX FLUTICASONE PROPIONATE ASPIRIN Health Professional N Health Professional N Outcomes OT Role Route S Outcomes HO Role Route S C C C C C C C Health Professional N Outcomes OT Role Route S Health Professional Y Outcomes HO Role Route S Health Professional Y Outcomes OT Role Route S Manufacturer Control # 2009-195601-NL Dosage Text Duration Age Sex Female Country USA Manufacturer Control # 2009-195616-NL Dosage Text Age 26 YR Duration Sex Female Country USA Manufacturer Control # 2009-195764-NL Dosage Text Duration Age Sex Female Country USA Manufacturer Control # 2009-196434-NL Dosage Text Age 44 YR Duration Sex Female Country USA Manufacturer Control # 2009-195782-NL Dosage Text Duration Age Sex Female Country USA

Manufacturer

7285510 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7285510

Manufacturer

CEREBROVASCULAR ACCIDENT

7285537 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7285537

Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING

Manufacturer

PULMONARY EMBOLISM

7285560 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7285560

Manufacturer

PULMONARY EMBOLISM

7285625 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7285625

Manufacturer

DEEP VEIN THROMBOSIS

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 103 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7286217 Date FDA Received
01-Dec-2009 Preferred Term PULMONARY EMBOLISM Case # 7286217 Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Health Professional Y Health Professional Y Outcomes HO Role Route S VAGINAL Manufacturer Control # 2009-195431-NL Dosage Text ;VAG Manufacturer Control # 2009-195382-NL Dosage Text Age 40 YR Duration Sex Female Country USA Age 26 YR Duration Sex Female Country USA

Manufacturer

7286290 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7286290

Outcomes OT Role Route S

Manufacturer

DEEP VEIN THROMBOSIS PULMONARY EMBOLISM

7286291 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7286291

Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2009-195203-NL Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

DEEP VEIN THROMBOSIS

7294607 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7294607

Health Professional

Outcomes HO Role Route S VAGINAL

Manufacturer Control # 2008-185072-NL Dosage Text ;VAG Manufacturer Control # 2008-183330-NL Dosage Text 1 DF;

Age

Sex Female

Country USA

Duration

Manufacturer

PULMONARY EMBOLISM

7294629 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7294629

Health Professional Y

Outcomes HO,OT Role Route S

Age 24 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS BACK PAIN PAIN

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 104 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7294711 Date FDA Received
01-Dec-2009 Preferred Term PULMONARY EMBOLISM Case # 7294711 Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Health Professional N Health Professional N Outcomes OT Role Route S Outcomes HO Role Route S VAGINAL Manufacturer Control # 2009SP017691 Dosage Text 1 DF; QM; VAG Age 30 YR Duration Sex Female Country USA Manufacturer Control # 2009-2011111-NL Dosage Text Duration Age Sex Female Country USA

Manufacturer

7294746 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7294746

Manufacturer

DEEP VEIN THROMBOSIS GALLBLADDER DISORDER THROMBOSIS

7300636 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7300636

Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes HO,OT Role Route S

Manufacturer Control # 2008-186049-NL Dosage Text

Age 30 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS

7301870 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7301870

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2009-198597-NL Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

PULMONARY EMBOLISM

7304900 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7304900

Health Professional Y

Outcomes HO Role Route S

Manufacturer Control # 2009-192986-NL Dosage Text

Age 47 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 105 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7305078 Date FDA Received
01-Dec-2009 Preferred Term PULMONARY EMBOLISM MIGRAINE Case # 7305078 Case Type NON-EXPEDITED Product NUVARING Health Professional N Outcomes HO Role Route S Manufacturer Control # 2009-194894-NL Dosage Text 1 DF Age 19 YR Duration Sex Female Country USA

Manufacturer

7305086 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7305086

Case Type NON-EXPEDITED Product NUVARING XANAX ZYRTEC

Health Professional Y

Outcomes HO Role Route S C C

Manufacturer Control # 2009-194160-NL Dosage Text

Age 33 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM

7305087 Date FDA Received

01-Dec-2009 Preferred Term

Case # 7305087

Case Type NON-EXPEDITED Product NUVARING TOPAMAX

Health Professional Y

Outcomes HO Role Route S C C C VAGINAL

Manufacturer Control # 2009-193989-NL Dosage Text VAG

Age 33 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS PULMONARY EMBOLISM

WELLBUTRIN ABILIFY

7222320 Date FDA Received

03-Dec-2009 Preferred Term METRORRHAGIA

Case # 7222320

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2009SP038619 Dosage Text

Age 30 YR Duration

Sex Female

Country USA

Manufacturer

ENDOMETRIAL CANCER

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 106 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7222322 Date FDA Received
03-Dec-2009 Preferred Term DYSPNOEA PULMONARY EMBOLISM Case # 7222322 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes DE Role Route S Manufacturer Control # 2009SP038761 Dosage Text Age 17 YR Duration Sex Female Country USA

Manufacturer

7225669 Date FDA Received

03-Dec-2009 Preferred Term DEVICE DISLOCATION

Case # 7225669

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO Role Route S

Manufacturer Control # 2009SP038441 Dosage Text

Age 33 YR Duration

Sex Female

Country DEU

Manufacturer

7169826 Date FDA Received

04-Dec-2009 Preferred Term PARALYSIS HYPOAESTHESIA

Case # 7169826

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2009SP030990 Dosage Text

Age 34 YR Duration

Sex Female

Country DEU

Manufacturer

7110449 Date FDA Received

07-Dec-2009 Preferred Term COAGULOPATHY THROMBOSIS

Case # 7110449

Case Type EXPEDITED (15-DAY) Product NUVARING ALEVE

Health Professional Y

Outcomes OT Role Route S C

Manufacturer Control # 2009-196374-NL Dosage Text 1DF;QM

Age 23 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS DEPRESSION EMBOLISM ARTERIAL HAEMORRHOIDS HOMANS' SIGN

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 107 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7228337 Date FDA Received
07-Dec-2009 Preferred Term CONVULSION Case # 7228337 Case Type EXPEDITED (15-DAY) Product NUVARING KEPPRA (CON.) Health Professional Y Outcomes OT Role Route S C Outcomes DE,OT Role Route S VAGINAL Manufacturer Control # 2009SP024406 Dosage Text VAG Age 42 YR Duration Sex Female Country USA Manufacturer Control # 2009SP039272 Dosage Text Age 23 YR Duration Sex Female Country USA

Manufacturer

7133888 Date FDA Received

08-Dec-2009 Preferred Term NAUSEA

Case # 7133888

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Manufacturer

ACUTE PULMONARY OEDEMA ARRHYTHMIA CARDIAC ARREST CIRCULATORY COLLAPSE DYSPNOEA FEELING HOT HEPATITIS OXYGEN SATURATION DECREASED PULMONARY CONGESTION PULSELESS ELECTRICAL ACTIVITY RESPIRATORY ARREST RESPIRATORY RATE INCREASED SINUS TACHYCARDIA UNRESPONSIVE TO STIMULI VOMITING

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 108 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7134802 Date FDA Received
08-Dec-2009 Preferred Term TACHYCARDIA METRORRHAGIA ALOPECIA Case # 7134802 Case Type EXPEDITED (15-DAY) Product NUVARING CALCIUM PANTOTHENATE \KERATIN\VITAMIN B LEVOTHYROXINE SODIUM Case # 7232236 Case Type EXPEDITED (15-DAY) Product NUVARING Case # 7227058 Case Type EXPEDITED (15-DAY) Product NUVARING Case # 7284197 Case Type NON-EXPEDITED Product NUVARING TYLENOL CLARITIN FLONASE Health Professional Y Health Professional N Health Professional Y Health Professional N Outcomes OT Role Route S S C Outcomes OT Role Route S VAGINAL Manufacturer Control # 2009SP038475 Dosage Text 1 DF; VAG Manufacturer Control # 2009SP038428 Dosage Text Duration Age Sex Female Country DNK Age 31 YR Duration Sex Female Country FRA VAGINAL Manufacturer Control # 2009SP024528 Dosage Text VAG Age 36 YR Duration Sex Female Country BRA

Manufacturer

7232236 Date FDA Received

08-Dec-2009 Preferred Term BILE DUCT STONE

Manufacturer

7227058 Date FDA Received

10-Dec-2009 Preferred Term CHOLELITHIASIS

Outcomes OT Role Route S Outcomes HO,LT Role Route S C C C

Manufacturer

7284197 Date FDA Received

10-Dec-2009 Preferred Term

Manufacturer Control # 2008-186433-NL Dosage Text

Age 21 YR Duration

Sex Female

Country USA

Manufacturer

SUPERIOR SAGITTAL SINUS THROMBOSIS

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 109 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7222537 Date FDA Received
14-Dec-2009 Preferred Term CHOLECYSTECTOMY BILE DUCT STONE BILIARY TRACT DISORDER ECONOMIC PROBLEM Case # 7222537 Case Type DIRECT Product NUVARING Health Professional N Outcomes HO,OT Role Route S VAGINAL Dosage Text ONE RING ONCE A MONTH VAG Manufacturer Control # Age 28 YR Duration Sex Female Country USA

Manufacturer

7222894 Date FDA Received

14-Dec-2009 Preferred Term PAIN IN EXTREMITY

Case # 7222894

Case Type DIRECT Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control #

Age 34 YR

Sex Female

Country USA

Dosage Text 1 RING MONTHLY VAG Manufacturer Control # 2009SP040135 Dosage Text NUVARING (ETONOGESTREL/ ETHINYLESTRADIOL)

Duration

Manufacturer SCHERING PLOUGH

7234141 Date FDA Received

14-Dec-2009 Preferred Term CONVULSION

Case # 7234141

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S

Age 43 YR Duration

Sex Female

Country USA

Manufacturer

INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 110 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7235938 Date FDA Received
15-Dec-2009 Preferred Term HYPERTENSION HEADACHE INTRACRANIAL VENOUS SINUS THROMBOSIS SUBARACHNOID HAEMORRHAGE SUBDURAL HAEMATOMA THROMBOPHLEBITIS TRANSVERSE SINUS THROMBOSIS Case # 7235938 Case Type EXPEDITED (15-DAY) Product NUVARING RESTORL TOPROL XL Health Professional Y Outcomes HO Role Route S C C Manufacturer Control # 2009AP017305 Dosage Text 1 DF Age 31 YR Duration Sex Female Country USA

Manufacturer

7223300 Date FDA Received

16-Dec-2009 Preferred Term ISCHAEMIC STROKE

Case # 7223300

Case Type DIRECT Product NUVARING

Health Professional N

Outcomes HO,LT,OT,RI Role Route S

Manufacturer Control #

Age 21 YR

Sex Female

Country USA

Dosage Text

Duration

Manufacturer

7015662 Date FDA Received

18-Dec-2009 Preferred Term

Case # 7015662

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes CA Role Route S TRANSPLACENTAL

Manufacturer Control # 2009-196969-NL Dosage Text TRPL

Age

Sex Unknown

Country FRA

Duration

Manufacturer

MATERNAL DRUGS AFFECTING FOETUS CAESAREAN SECTION GASTROSCHISIS INTESTINAL DILATATION VOLVULUS OF SMALL BOWEL

7234893 Date FDA Received

23-Dec-2009 Preferred Term DEVICE EXPULSION ECTOPIC PREGNANCY

Case # 7234893

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO,OT Role Route S

Manufacturer Control # 2009SP035626 Dosage Text

Age 22 YR Duration

Sex Female

Country DNK

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 111 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7245484 Date FDA Received
23-Dec-2009 Preferred Term BREAST CELLULITIS BURNING SENSATION PARAESTHESIA Case # 7245484 Case Type EXPEDITED (15-DAY) Product NUVARING NUVARING Health Professional N Outcomes HO Role Route S S Manufacturer Control # 2009SP042322 Dosage Text Age 27 YR Duration Sex Female Country USA

Manufacturer

7161361 Date FDA Received

29-Dec-2009 Preferred Term PREGNANCY BREAST PAIN CYSTITIS

Case # 7161361

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2009SP029081 Dosage Text VAG

Age 40 YR Duration

Sex Female

Country NLD

Manufacturer

MATERNAL EXPOSURE BEFORE PREGNANCY MENOPAUSAL SYMPTOMS METRORRHAGIA NEPHROLITHIASIS

7235529 Date FDA Received

29-Dec-2009 Preferred Term

Case # 7235529

Case Type DIRECT Product NUVARING

Health Professional

Outcomes HO,LT,RI Role Route S

Manufacturer Control #

Age 20 YR

Sex Female

Country USA

Dosage Text INSERT 1 Q 4 WKS HOME

Duration

Manufacturer

PULMONARY EMBOLISM DEEP VEIN THROMBOSIS

7238797 Date FDA Received

04-Jan-2010 Preferred Term

Case # 7238797

Case Type DIRECT Product NUVARING

Health Professional N

Outcomes DE Role Route S

Manufacturer Control #

Age 18 YR

Sex Female

Country USA

Dosage Text

Duration

Manufacturer

HEPATIC CANCER STAGE IV

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 112 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7238843 Date FDA Received
04-Jan-2010 Preferred Term DEPRESSION DISEASE RECURRENCE ABDOMINAL PAIN UPPER BREAST PAIN CONTACT LENS INTOLERANCE DYSPEPSIA HEADACHE IRRITABILITY MOOD SWINGS MUSCLE SPASMS NAUSEA SKIN DISCOLOURATION WEIGHT INCREASED Case # 7238843 Case Type DIRECT Product NUVARING PRISTIQ EXTENDED RELEASE Health Professional N Outcomes OT Role Route S C VAGINAL Dosage Text VAG Manufacturer Control # Age 32 YR Duration Sex Female Country BRA

Manufacturer ORGANON

7243509 Date FDA Received

07-Jan-2010 Preferred Term

Case # 7243509

Case Type DIRECT Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control #

Age 29 YR

Sex Female

Country USA

Dosage Text 0.120MG ETONOGESTREL PER DAY VAG 0.015MG ETHINYL ESTRADIOL PER DAY VAG

Duration

Manufacturer

VULVOVAGINAL DRYNESS

VULVOVAGINAL BURNING SENSATION DYSPAREUNIA DYSURIA HEADACHE MOOD ALTERED VULVOVAGINAL MYCOTIC INFECTION

MONISTAT

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 113 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7241597 Date FDA Received
11-Jan-2010 Case # 7241597 Case Type NON-EXPEDITED Health Professional Y Outcomes Manufacturer Control # USBAYER-200942819NA Role Route S S S Health Professional N Product NUVARING Outcomes HO Role Route S Dosage Text Manufacturer Control # Age 35 YR Duration Sex Female Country USA Dosage Text Duration Age Sex Female Country USA

Preferred Term METRORRHAGIA

Product CIPROFLOXACIN FLAGYL NUVARING

Manufacturer BAYER

7245479 Date FDA Received

11-Jan-2010 Preferred Term PANIC ATTACK DEPRESSION IRRITABILITY LIBIDO DECREASED

Case # 7245479

Case Type DIRECT

Manufacturer

VULVOVAGINAL PRURITUS

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 114 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7124765 Date FDA Received
12-Jan-2010 Preferred Term DEEP VEIN THROMBOSIS THROMBOSIS MENSTRUATION IRREGULAR VISION BLURRED ADJUSTMENT DISORDER ALCOHOL USE ANAEMIA ANAL FISSURE ANOGENITAL DYSPLASIA ANOGENITAL WARTS ANXIETY COLITIS ULCERATIVE COLPOSCOPY ABNORMAL EMOTIONAL DISORDER FATIGUE HAEMORRHOIDS HEADACHE LETHARGY PHARYNGITIS PULMONARY EMBOLISM TREATMENT NONCOMPLIANCE UPPER RESPIRATORY TRACT INFECTION WEIGHT DECREASED Case # 7124765 Case Type EXPEDITED (15-DAY) Product NUVARING ADVAIR PROVENTIL IBUPROFEN Health Professional Y Outcomes HO Role Route S C C C Manufacturer Control # 2009-195831-NL Dosage Text 1 DF; Age 22 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 115 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7255238 Date FDA Received
13-Jan-2010 Preferred Term NAUSEA VOMITING AMYLASE INCREASED PAIN IN EXTREMITY POLYMENORRHOEA Case # 7255238 Case Type EXPEDITED (15-DAY) Product NUVARING TYLENOL Health Professional N Outcomes OT Role Route S C Manufacturer Control # 2009SP042342 Dosage Text Age 39 YR Duration Sex Female Country USA

Manufacturer

7257050 Date FDA Received

14-Jan-2010 Preferred Term PNEUMONIA

Case # 7257050

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2010SP001812 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

7067876 Date FDA Received

15-Jan-2010 Preferred Term ISCHAEMIC STROKE

Case # 7067876

Case Type EXPEDITED (15-DAY) Product NUVARING IMITREX

Health Professional N

Outcomes HO,DS,OT Role Route S C VAGINAL

Manufacturer Control # 2009-200461-NL Dosage Text 1 DF; VAG

Age 40 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM DEEP VEIN THROMBOSIS

7258572 Date FDA Received

19-Jan-2010 Preferred Term OVARIAN CYST

Case # 7258572

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2010SP000913 Dosage Text

Age 24 YR Duration

Sex Female

Country USA

Manufacturer

PREGNANCY WITH CONTRACEPTIVE DEVICE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 116 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7208271 Date FDA Received
20-Jan-2010 Preferred Term PULMONARY EMBOLISM ACNE ACUTE SINUSITIS ATELECTASIS CHEST PAIN DEEP VEIN THROMBOSIS FALL INSOMNIA LIMB INJURY LUNG INFILTRATION OTITIS MEDIA PHARYNGITIS PLEURAL EFFUSION PNEUMONIA UPPER RESPIRATORY TRACT INFECTION VAGINAL DISCHARGE Case # 7208271 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO Role Route S Manufacturer Control # 2009SP036639 Dosage Text Age 30 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 117 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7239787 Date FDA Received
20-Jan-2010 Preferred Term ABDOMINAL PAIN DYSMENORRHOEA ANAL ABSCESS CONSTIPATION DIARRHOEA FOREIGN TRAVEL GALLBLADDER DISORDER MENORRHAGIA PELVIC FLUID COLLECTION RECTAL FISSURE STREPTOCOCCAL SEPSIS Case # 7239787 Case Type EXPEDITED (15-DAY) Product NUVARING PALAFER Health Professional Y Outcomes HO,OT Role Route S C VAGINAL Manufacturer Control # 2009SP042100 Dosage Text ;VAG Age 23 YR Duration Sex Female Country CAN

Manufacturer

7249925 Date FDA Received

20-Jan-2010

Case # 7249925

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes HO,OT

Manufacturer Control # US-PFIZER INC-2010005676 Dosage Text UNK

Age 35 YR

Sex Female

Country USA

Preferred Term ECLAMPSIA BLOOD PRESSURE INCREASED UTERINE INFECTION ABDOMINAL DISTENSION ABDOMINAL PAIN ACNE GALLBLADDER PAIN HORMONE LEVEL ABNORMAL KIDNEY INFECTION UTERINE NEOPLASM WEIGHT INCREASED

Product DEPO-PROVERA NUVARING NUVARING

Role Route S S S INTRAMUSCULAR VAGINAL

Duration

Manufacturer PFIZER

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 118 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7179494 Date FDA Received
21-Jan-2010 Preferred Term CEREBROVASCULAR ACCIDENT TRANSIENT ISCHAEMIC ATTACK ATRIAL FIBRILLATION BODY TEMPERATURE INCREASED JAUNDICE PAIN Case # 7179494 Case Type EXPEDITED (15-DAY) Product NUVARING TYLENOL Health Professional Y Outcomes HO Role Route S C VAGINAL Manufacturer Control # 2009SP032634 Dosage Text 1 DF;QM;VAG Age 38 YR Duration Sex Female Country USA

Manufacturer

7257189 Date FDA Received

22-Jan-2010 Preferred Term

Case # 7257189

Case Type DIRECT Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control #

Age 29 YR

Sex Female

Country USA

Dosage Text DELIVERS 0.120MG/ 0.015 MG DAY EVERY 3 WEEKS VAG

Duration

Manufacturer MERCK

PELVIC INFLAMMATORY DISEASE

MEDICAL DEVICE COMPLICATION

LEVAQUIN METRONIDAZOLE

C C

7271939 Date FDA Received

22-Jan-2010 Preferred Term HAEMOPTYSIS

Case # 7271939

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2010SP003417 Dosage Text

Age 24 YR Duration

Sex Female

Country USA

Manufacturer

7260183 Date FDA Received

25-Jan-2010 Preferred Term

Case # 7260183

Case Type DIRECT Product NUVARING

Health Professional N

Outcomes

Manufacturer Control #

Age 27 YR

Sex Female

Country USA

Role Route S

Dosage Text

Duration

Manufacturer

EXPOSURE DURING BREAST FEEDING SUPPRESSED LACTATION

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 119 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7279204 Date FDA Received
26-Jan-2010 Preferred Term INFERTILITY FEMALE Case # 7279204 Case Type EXPEDITED (15-DAY) Product NUVARING Case # 7235316 Case Type EXPEDITED (15-DAY) Product TRILEPTAL Health Professional Y Health Professional N Outcomes OT Role Route S VAGINAL Manufacturer Control # 2010SP003734 Dosage Text ; VAG Manufacturer Control # PHHY2009FI57074 Dosage Text One and a half tablet in the morning and 2 tablets in the evening Duration Age Sex Female Country FIN Duration Age Sex Female Country ESP

Manufacturer

7235316 Date FDA Received

27-Jan-2010 Preferred Term ABORTION INDUCED

Outcomes OT Role Route S

Manufacturer

DRUG INTERACTION Maternal exposure during pregnancy

NUVARING

7279833 Date FDA Received

27-Jan-2010 Preferred Term

Case # 7279833

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO,OT Role Route S

Manufacturer Control # 2010SP002780 Dosage Text

Age 22 YR Duration

Sex Female

Country SWE

Manufacturer

CORONARY ARTERY THROMBOSIS MYOCARDIAL INFARCTION

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 120 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7173678 Date FDA Received
01-Feb-2010 Preferred Term PULMONARY EMBOLISM PANIC ATTACK BACK PAIN DIZZINESS VISUAL IMPAIRMENT HEADACHE LARYNGITIS RHINITIS ALLERGIC OVARIAN CYST EPICONDYLITIS ABDOMINAL DISCOMFORT SLEEP APNOEA SYNDROME SUPRAVENTRICULAR TACHYCARDIA GASTROOESOPHAGEAL REFLUX DISEASE Case # 7173678 Case Type EXPEDITED (15-DAY) Product NUVARING EFFEXOR NADOLOL ALBUTEROL SINGULAIR ZOCOR CLARITIN GEODON IMITREX ZOLOFT CLONAZEPAM FLONASE TEMAZEPAM PREVACID Health Professional Y Outcomes HO,OT Role Route S S C C C C C C C C C C C C ORAL 150 MG; ; PO Manufacturer Control # 2009-200092-NL Dosage Text Age 47 YR Duration Sex Female Country USA

Manufacturer

7292052 Date FDA Received

03-Feb-2010 Preferred Term EMBOLISM VENOUS

Case # 7292052

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes DE,HO Role Route S

Manufacturer Control # 2010SP006293 Dosage Text

Age

Sex Unknown

Country USA

Duration

Manufacturer

7277521 Date FDA Received

04-Feb-2010 Preferred Term

Case # 7277521

Case Type DIRECT Product NUVARING

Health Professional

Outcomes HO Role Route S

Manufacturer Control #

Age 27 YR

Sex Female

Country USA

Dosage Text

Duration

Manufacturer

PULMONARY EMBOLISM

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 121 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7299327 Date FDA Received
04-Feb-2010 Preferred Term EMBOLISM VENOUS Case # 7299327 Case Type EXPEDITED (15-DAY) Product NUVARING Case # 7022557 Case Type EXPEDITED (15-DAY) Product NUVARING LECITHIN CIPROFLOXACIN Health Professional Y Health Professional Y Outcomes DE,HO Role Route S Outcomes HO Role Route S C C Manufacturer Control # 2009-197231-NL Dosage Text 1 DF Age 22 YR Duration Sex Female Country USA Manufacturer Control # 2010SP006294 Dosage Text Duration Age Sex Unknown Country USA

Manufacturer

7022557 Date FDA Received

12-Feb-2010 Preferred Term

Manufacturer

TRANSVERSE SINUS THROMBOSIS ABDOMINAL PAIN NAUSEA ACNE ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED APATHY ARTHRALGIA CELLULITIS CHLAMYDIA TEST POSITIVE DEPRESSION HERPES SIMPLEX HYPERSENSITIVITY HYPERSOMNIA MENSTRUATION IRREGULAR MOOD SWINGS MYOPIA PAIN PARTNER STRESS SMEAR CERVIX ABNORMAL SUBCUTANEOUS ABSCESS VOMITING WEIGHT INCREASED

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 122 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7201987 Date FDA Received
12-Feb-2010 Preferred Term ABDOMINAL PAIN DIARRHOEA DIVERTICULITIS VAGINAL DISCHARGE Case # 7201987 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO Role Route S Manufacturer Control # 2009SP029230 Dosage Text Duration Age Sex Female Country AUS

Manufacturer

7292612 Date FDA Received

12-Feb-2010 Preferred Term PYELONEPHRITIS CYSTITIS

Case # 7292612

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2010SP000784 Dosage Text VAG

Age 23 YR Duration

Sex Female

Country NLD

Manufacturer

URINARY TRACT INFECTION

7304720 Date FDA Received

12-Feb-2010 Preferred Term ABSCESS

Case # 7304720

Case Type EXPEDITED (15-DAY) Product NUVARING L-THYROXIN

Health Professional Y

Outcomes HO,OT Role Route S C

Manufacturer Control # 2010SP006808 Dosage Text

Age 27 YR Duration

Sex Female

Country DEU

Manufacturer

7304943 Date FDA Received

12-Feb-2010 Preferred Term AMNESIA

Case # 7304943

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2010SP006488 Dosage Text

Age 36 YR Duration

Sex Female

Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 123 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7307943 Date FDA Received
12-Feb-2010 Preferred Term ABORTION SPONTANEOUS MATERNAL EXPOSURE DURING PREGNANCY VAGINAL HAEMORRHAGE Case # 7307943 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes OT Role Route S Manufacturer Control # 2010SP007352 Dosage Text Age 22 YR Duration Sex Female Country USA

Manufacturer

7286357 Date FDA Received

13-Feb-2010 Preferred Term CARDIAC ARREST ANOXIA COMA HYPOXIA

Case # 7286357

Case Type DIRECT Product NUVARING

Health Professional N

Outcomes HO,LT,OT,RI Role Route S VAGINAL

Manufacturer Control #

Age 40 YR

Sex Female

Country USA

Dosage Text ONCE A MONTH VAG

Duration

Manufacturer

PULMONARY EMBOLISM

7297580 Date FDA Received

13-Feb-2010 Preferred Term

Case # 7297580

Case Type DIRECT Product NUVARING Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes HO,LT,RI Role Route S

Manufacturer Control #

Age 48 YR

Sex Female

Country USA

Dosage Text

Duration

Manufacturer

PULMONARY THROMBOSIS

7167532 Date FDA Received

16-Feb-2010 Preferred Term

Case # 7167532

Health Professional Y

Outcomes HO,OT Role Route S C VAGINAL

Manufacturer Control # 2009SP016944 Dosage Text QM;VAG

Age 50 YR Duration

Sex Female

Country USA

Manufacturer

SPINAL OSTEOARTHRITIS SCOLIOSIS ALOPECIA ARTHRALGIA ATROPHIC VULVOVAGINITIS BLOOD POTASSIUM DECREASED BLOOD SODIUM DECREASED

SPORANOX (CON.)

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 124 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7167532
Preferred Term CARDIOMEGALY CELLULITIS CULTURE URINE POSITIVE CYST CYSTITIS DEEP VEIN THROMBOSIS DEHYDRATION DIARRHOEA ESCHERICHIA INFECTION FUNGAL INFECTION HYPERSENSITIVITY HYPOAESTHESIA HYPOAESTHESIA ORAL HYPOTENSION INTERVERTEBRAL DISC DEGENERATION INTERVERTEBRAL DISC DISORDER LACUNAR INFARCTION PHLEBITIS PLEURAL EFFUSION PNEUMONIA PULMONARY EMBOLISM PULMONARY OEDEMA PYELONEPHRITIS RADICULOPATHY SPINAL COLUMN STENOSIS THYROID NEOPLASM VAGINAL HAEMORRHAGE WEIGHT INCREASED Product Role Route Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 125 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7312261 Date FDA Received
18-Feb-2010 Preferred Term ABORTION SPONTANEOUS MATERNAL EXPOSURE DURING PREGNANCY PREGNANCY VAGINITIS BACTERIAL Case # 7312261 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Role Route S VAGINAL Outcomes Manufacturer Control # 2010SP007063 Dosage Text ;VAG Duration Age Sex Female Country SWE

Manufacturer

7313564 Date FDA Received

18-Feb-2010 Preferred Term ANAEMIA

Case # 7313564

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2010SP008089 Dosage Text VAG

Age

Sex Female

Country BRA

Duration

Manufacturer

ABDOMINAL PAIN UPPER DRUG INTERACTION

7314508 Date FDA Received

18-Feb-2010 Preferred Term VISUAL IMPAIRMENT GLAUCOMA MIGRAINE

Case # 7314508

Case Type EXPEDITED (15-DAY) Product NUVARING TOPAMAX

Health Professional Y

Outcomes OT Role Route S S

Manufacturer Control # 2009SP042603 Dosage Text

Age 34 YR Duration

Sex Female

Country USA

Manufacturer

7320958 Date FDA Received

24-Feb-2010 Preferred Term

Case # 7320958

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2010SP010387 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

NEOPLASM MALIGNANT

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 126 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7281617 Date FDA Received
25-Feb-2010 Preferred Term COMPLICATION OF DEVICE INSERTION IATROGENIC INJURY Case # 7281617 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO Role Route S VAGINAL Manufacturer Control # 2010SP002087 Dosage Text 1 DF;VAG ; 1 DF;OTHER Age 38 YR Duration Sex Female Country AUS

Manufacturer

7322090 Date FDA Received

25-Feb-2010 Preferred Term CERVIX CARCINOMA

Case # 7322090

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2010SP010392 Dosage Text 1 DF; VAG Manufacturer Control # 2009-190782-NL Dosage Text

Age

Sex Female

Country FRA

Duration

Manufacturer

7186739 Date FDA Received

26-Feb-2010 Preferred Term

Case # 7186739

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO,OT Role Route S C C

Age 26 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM HYPOTHYROIDISM PREGNANCY BLOOD FIBRINOGEN INCREASED INITIAL INSOMNIA INTERNATIONAL NORMALISED RATIO DECREASED MATERNAL EXPOSURE DURING PREGNANCY MENORRHAGIA OEDEMA PERIPHERAL PERIODIC LIMB MOVEMENT DISORDER POOR QUALITY SLEEP PROTHROMBIN TIME PROLONGED SNORING SOMNOLENCE TACHYCARDIA

ACETAMINOPHEN (CON.) IBUPROFEN (CON.)

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 127 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7288574 Date FDA Received
26-Feb-2010 Preferred Term DEEP VEIN THROMBOSIS GROIN ABSCESS Case # 7288574 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO,OT Role Route S Manufacturer Control # 2010SP004745 Dosage Text Age 26 YR Duration Sex Female Country DEU

Manufacturer

7296936 Date FDA Received

26-Feb-2010 Preferred Term METRORRHAGIA

Case # 7296936

Case Type NON-EXPEDITED Product LAMICTAL NUVARING

Health Professional N

Outcomes

Manufacturer Control # A0814112A

Age

Sex Female

Country USA

Role Route S S Health Professional Y Outcomes OT Role Route S

Dosage Text

Duration

Manufacturer GLAXOSMITHKLINE

7323593 Date FDA Received

26-Feb-2010 Preferred Term

Case # 7323593

Case Type EXPEDITED (15-DAY) Product NUVARING

Manufacturer Control # 2010SP009878 Dosage Text 1 DF;QM

Age 39 YR Duration

Sex Female

Country IND

Manufacturer

VENOUS STASIS RETINOPATHY VAGINAL HAEMORRHAGE

7307142 Date FDA Received

02-Mar-2010 Preferred Term

Case # 7307142

Case Type DIRECT Product NUVARING

Health Professional Y

Outcomes HO,LT Role Route S VAGINAL

Manufacturer Control #

Age 48 YR

Sex Female

Country USA

Dosage Text EVERY 3 WEEKS VAG

Duration

Manufacturer

PULMONARY EMBOLISM

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 128 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7329166 Date FDA Received
05-Mar-2010 Preferred Term PULMONARY EMBOLISM PULMONARY HYPERTENSION MICTURITION URGENCY POLLAKIURIA DYSPLASIA MUSCLE SPASMS URINARY TRACT INFECTION ANXIETY DEPRESSION BRONCHITIS ATRIAL THROMBOSIS Case # 7329166 Case Type EXPEDITED (15-DAY) Product NUVARING PREDNISONE (CON.) IBUPROFEN (CON.) BENADRYL (CON.) ALLEGRA (CON.) SINGULAIR (CON.) ADVAIR (CON.) XOPENEX (CON.) PULMICORT RESPULES (CON.) DIFLUCAN (CON.) PROVENTIL HFA (CON.) IBUPROFEN (CON.) ZOMIG (CON.) Health Professional Y Outcomes HO,OT Role Route S C C C C C C C C C C C C Outcomes OT Role Route S Manufacturer Control # 2010SP013625 Dosage Text Duration Age Sex Female Country USA Manufacturer Control # 2009SP037342 Dosage Text Age 29 YR Duration Sex Female Country USA

Manufacturer

7331052 Date FDA Received

08-Mar-2010 Preferred Term

Case # 7331052

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Manufacturer

DEEP VEIN THROMBOSIS LEG AMPUTATION

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 129 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7331552 Date FDA Received
08-Mar-2010 Preferred Term VAGINAL HAEMORRHAGE MENORRHAGIA VAGINAL DISCHARGE HEART RATE INCREASED MIGRAINE BRONCHITIS COITAL BLEEDING COSTOCHONDRITIS EAR INFECTION FATIGUE GASTROENTERITIS HYPOALBUMINAEMIA POLYCYTHAEMIA VERA PULMONARY EMBOLISM RHINITIS TENSION HEADACHE Case # 7331552 Case Type EXPEDITED (15-DAY) Product NUVARING ONE-A-DAY NOS HYDRO DP FLUCONAZOLE METHYLPREDNISOLONE Health Professional Y Outcomes HO,OT Role Route S C C C C VAGINAL Manufacturer Control # 2007-155044-NL Dosage Text VAG Age 25 YR Duration Sex Female Country USA

Manufacturer

7332587 Date FDA Received

08-Mar-2010 Preferred Term DEATH

Case # 7332587

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes DE Role Route S

Manufacturer Control # 2010SP013617 Dosage Text

Age 14 YR Duration

Sex Female

Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 130 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6206529 Date FDA Received
09-Mar-2010 Preferred Term NAUSEA VOMITING GRAND MAL CONVULSION TRANSVERSE SINUS THROMBOSIS ANTINUCLEAR ANTIBODY POSITIVE FATIGUE AMNESIA IMPAIRED DRIVING ABILITY MENORRHAGIA ACUTE RESPIRATORY FAILURE ANAEMIA ANTITHROMBIN III INCREASED COAGULATION FACTOR VIII LEVEL INCREASED CONFUSIONAL STATE CRYING DEHYDRATION DEPRESSION DRUG SCREEN POSITIVE ENCEPHALOMALACIA FALSE POSITIVE INVESTIGATION RESULT HAEMORRHAGIC INFARCTION PROTEIN C INCREASED VASOGENIC CEREBRAL OEDEMA Case # 6206529 Case Type EXPEDITED (15-DAY) Product NUVARING ASACOL PURINETHOL PREDNISONE IMIPRAMINE EFFEXOR AMBIEN XANAX ASTELIN Health Professional Y Outcomes HO,DS Role Route S C C C C C C C C VAGINAL Manufacturer Control # 2006-151141-NL Dosage Text ; VAG Age 48 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 131 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6994872 Date FDA Received
09-Mar-2010 Preferred Term FALL UPPER LIMB FRACTURE DIZZINESS ATELECTASIS DEEP VEIN THROMBOSIS DYSPNOEA JOINT INJURY LEUKOCYTOSIS OEDEMA PERIPHERAL PULMONARY EMBOLISM PULMONARY INFARCTION SINUS TACHYCARDIA VOMITING Case # 6994872 Case Type EXPEDITED (15-DAY) Product NUVARING NORCO IBUPROFEN Health Professional Y Outcomes HO,OT Role Route S C C VAGINAL Manufacturer Control # 2008-179132-NL Dosage Text 1 DF; QM; VAG Age 39 YR Duration Sex Female Country USA

Manufacturer

7318886 Date FDA Received

09-Mar-2010 Preferred Term ANORGASMIA DIARRHOEA FATIGUE NAUSEA

Case # 7318886

Case Type DIRECT Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control #

Age 49 YR

Sex Female

Country USA

Dosage Text 1 RING 3 WEEKS

Duration

Manufacturer BAYER

7332803 Date FDA Received

09-Mar-2010 Preferred Term MENTAL DISORDER

Case # 7332803

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2010SP012822 Dosage Text VAG

Age

Sex Female

Country SWE

Duration

Manufacturer

PULMONARY EMBOLISM

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 132 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7334028 Date FDA Received
11-Mar-2010 Preferred Term MULTIPLE SCLEROSIS CONDITION AGGRAVATED Case # 7334028 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional N Outcomes OT Role Route S Manufacturer Control # 2010SP012495 Dosage Text Duration Age Sex Female Manufacturer Country

7335689 Date FDA Received

11-Mar-2010 Preferred Term

Case # 7335689

Case Type EXPEDITED (15-DAY) Product NUVARING DILANTIN

Health Professional Y

Outcomes OT Role Route S C

Manufacturer Control # 2010SP013936 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

GRAND MAL CONVULSION METRORRHAGIA

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 133 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7178139 Date FDA Received
12-Mar-2010 Preferred Term DEEP VEIN THROMBOSIS PULMONARY EMBOLISM HEADACHE PULMONARY THROMBOSIS ABDOMINAL PAIN UPPER CARDIAC DISORDER CHOLELITHIASIS CYST DILATATION VENTRICULAR FATIGUE LACRIMATION INCREASED LUNG NEOPLASM MULTIPLE ALLERGIES MUSCLE SPASMS PULMONARY INFARCTION ROAD TRAFFIC ACCIDENT SNEEZING SOFT TISSUE INFLAMMATION SPLENOMEGALY Case # 7178139 Case Type EXPEDITED (15-DAY) Product NUVARING SYNTHROID ADVIL ALEVE Health Professional Y Outcomes HO Role Route S C C C VAGINAL Manufacturer Control # 2009SP017405 Dosage Text 1 DF;QM;VAG Age 29 YR Duration Sex Female Country USA

Manufacturer

7322192 Date FDA Received

12-Mar-2010 Preferred Term

Case # 7322192

Case Type DIRECT Product NUVARING

Health Professional Y

Outcomes HO,LT Role Route S

Manufacturer Control #

Age 25 YR

Sex Female

Country USA

Dosage Text

Duration

Manufacturer

DEEP VEIN THROMBOSIS

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 134 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7336574 Date FDA Received
12-Mar-2010 Preferred Term CERVICAL DYSPLASIA Case # 7336574 Case Type EXPEDITED (15-DAY) Product NUVARING Case # 7278852 Case Type EXPEDITED (15-DAY) Product NUVARING ALEVE Health Professional Y Health Professional Y Outcomes OT Role Route S Outcomes HO Role Route S C Manufacturer Control # 2009-194500-NL Dosage Text Age 24 YR Duration Sex Female Country USA Manufacturer Control # 2010SP010765 Dosage Text Duration Age Sex Female Country USA

Manufacturer

7278852 Date FDA Received

15-Mar-2010 Preferred Term

Manufacturer

DEEP VEIN THROMBOSIS BACK PAIN ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED ASPARTATE AMINOTRANSFERASE INCREASED BLOOD CALCIUM DECREASED DRUG DOSE OMISSION DRUG INEFFECTIVE GAIT DISTURBANCE MUSCULOSKELETAL PAIN PROTHROMBIN TIME PROLONGED PYREXIA TENDONITIS THROMBOPHLEBITIS SEPTIC WEIGHT BEARING DIFFICULTY

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 135 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7284441 Date FDA Received
15-Mar-2010 Preferred Term PELVIC PAIN DYSPNOEA OVARIAN CYST RUPTURED DEEP VEIN THROMBOSIS MELANOCYTIC NAEVUS ABDOMINAL PAIN ACNE ANXIETY DISORDER CONJUNCTIVITIS CYSTITIS ECZEMA PANIC ATTACK TENDONITIS URINARY TRACT INFECTION URINE BILIRUBIN INCREASED URINE KETONE BODY PRESENT VIRAL INFECTION Case # 7284441 Case Type EXPEDITED (15-DAY) Product NUVARING CLARITHROMYCIN RETIN-A SULFAMETHOXAZOLE METRONIDAZOLE Health Professional Y Outcomes HO,OT Role Route S C C C C Manufacturer Control # 2008-183090-NL Dosage Text Age 20 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 136 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7230051 Date FDA Received
16-Mar-2010 Preferred Term PULMONARY EMBOLISM COAGULATION FACTOR VIII LEVEL INCREASED ABORTION MISSED ABORTION SPONTANEOUS BLOOD PRESSURE INCREASED BLOOD THYROID STIMULATING HORMONE DECREASED BODY TINEA CAESAREAN SECTION GOITRE HEPATOSPLENOMEGALY HUMAN PAPILLOMA VIRUS TEST POSITIVE MATERNAL EXPOSURE DURING PREGNANCY PELVIC INFLAMMATORY DISEASE POST PROCEDURAL CELLULITIS PROTEINURIA SMEAR CERVIX ABNORMAL THYROID CYST THYROID FIBROSIS THYROID HAEMORRHAGE TREATMENT NONCOMPLIANCE TRI-IODOTHYRONINE FREE INCREASED TWIN PREGNANCY WOUND DRAINAGE WOUND INFECTION Case # 7230051 Case Type EXPEDITED (15-DAY) Product NUVARING AUGMENTIN Health Professional Y Outcomes HO Role Route S C VAGINAL Manufacturer Control # 2009-196588-NL Dosage Text 1 DF;Q3W;VAG Age 19 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 137 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7324228 Date FDA Received
16-Mar-2010 Preferred Term DEEP VEIN THROMBOSIS Case # 7324228 Case Type DIRECT Product NUVARING Case Type EXPEDITED (15-DAY) Product NUVARING AMBIEN CELEXA XANAX VIOXX AMERGE EFFEXOR XR TOPAMAX RELPAX METRONIDAZOLE LEVAQUIN PREDNISONE ALBUTEROL DIFLUCAN LORAZEPAM SERZONE METHYLPHENIDATE AMOXICILLIN BETAMETHASONE W/ CLOTRIMAZOLE TERAZOL ORTHO TRI CYCLEN YASMIN NASONEX Health Professional Y Health Professional Y Outcomes HO,DS Role Route S Outcomes HO Role Route S C C C C C C C C C C C C C C C C C C C C C C VAGINAL Dosage Text SEVERAL MONTHS Manufacturer Control # 2009-189179-NL Dosage Text VAG Age 25 YR Duration Sex Female Country USA Manufacturer Control # Age 17 YR Duration Sex Female Country USA

Manufacturer

7072318 Date FDA Received

17-Mar-2010 Preferred Term NAUSEA RASH ALOPECIA ANXIETY DEPRESSION INSOMNIA EPISTAXIS MIGRAINE

Case # 7072318

Manufacturer

CEREBROVASCULAR ACCIDENT VENTRICULAR SEPTAL DEFECT URINARY TRACT INFECTION MENORRHAGIA BREAST PAIN HAEMOCHROMATOSIS DYSPNOEA SKIN DISCOLOURATION

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 138 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7072318
Preferred Term Product CLARINEX AMITRIPTYLINE ZOMIG ACETAMINOPHEN AND CODEINE ALLERX MYTUSSIN SINGULAIR METHYLPREDNISOLONE VICOPROFEN Role Route C C C C C C C C C Outcomes OT Product NUVARING Role Route S VAGINAL Dosage Text 1 3 WKS VAG Manufacturer Control # Age 28 YR Duration 3 MTH Sex Female Country USA Dosage Text Duration Manufacturer

7329731 Date FDA Received

18-Mar-2010 Preferred Term

Case # 7329731

Case Type DIRECT

Health Professional

Manufacturer ORGANON

BENIGN OVARIAN TUMOUR PAIN

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 139 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7284821 Date FDA Received
19-Mar-2010 Preferred Term PULMONARY EMBOLISM DILATATION VENTRICULAR ANAEMIA ATELECTASIS BLOOD ALBUMIN DECREASED BLOOD GLUCOSE INCREASED BLOOD PRESSURE SYSTOLIC DECREASED DEEP VEIN THROMBOSIS EPISTAXIS HEADACHE INTERNATIONAL NORMALISED RATIO DECREASED OXYGEN SATURATION DECREASED PULMONARY HYPERTENSION Case # 7284821 Case Type EXPEDITED (15-DAY) Product NUVARING VITAMINS NOS Health Professional Y Outcomes HO,OT Role Route S C VAGINAL Manufacturer Control # 2009-196751-NL Dosage Text 1 DF, QM; VAG Age 26 YR Duration Sex Female Country USA

Manufacturer

7347453 Date FDA Received

19-Mar-2010 Preferred Term

Case # 7347453

Case Type EXPEDITED (15-DAY) Product NUVARING Case Type DIRECT Product NUVARING

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2010SP015404 Dosage Text

Age 20 YR Duration

Sex Female

Country DEU

Manufacturer

HENOCH-SCHONLEIN PURPURA

7334565 Date FDA Received

22-Mar-2010 Preferred Term

Case # 7334565

Health Professional Y

Outcomes LT Role Route S

Manufacturer Control #

Age 23 YR

Sex Female

Country USA

Dosage Text

Duration

Manufacturer STANDARD

DEEP VEIN THROMBOSIS

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 140 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7333539 Date FDA Received
23-Mar-2010 Preferred Term SKIN DISCOLOURATION ALOPECIA BLISTER BREAST TENDERNESS DRY EYE DYSPNOEA JOINT SWELLING LIP DISCOLOURATION OEDEMA PERIPHERAL RASH SCLERAL DISORDER WEIGHT INCREASED Case # 7333539 Case Type DIRECT Product NUVARING Health Professional Y Outcomes OT Role Route S VAGINAL Dosage Text 1 RING 3 WEEKS VAGINAL Manufacturer Control # Age 31 YR Duration Sex Female Country USA

Manufacturer ORGANON

7339143 Date FDA Received

23-Mar-2010 Preferred Term PARAESTHESIA ASTHENIA FATIGUE HYPOAESTHESIA

Case # 7339143

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO Role Route S

Manufacturer Control # 2010SP008734 Dosage Text

Age 28 YR Duration

Sex Female

Country DEU

Manufacturer

HYPOAESTHESIA ORAL MIGRAINE WITH AURA MUSCULAR WEAKNESS PARAESTHESIA ORAL

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 141 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7338011 Date FDA Received
24-Mar-2010 Preferred Term OEDEMA PERIPHERAL Case # 7338011 Case Type DIRECT Product NUVARING Health Professional Outcomes HO Role Route S VAGINAL Dosage Text 1 RING X 3 WEEEKS; REMOVED X1 WEEK, INTRAVAGINALLY Manufacturer Control # Age 43 YR Duration Sex Female Country USA

Manufacturer

MUSCLE SPASMS PAIN IN EXTREMITY

7271483 Date FDA Received

29-Mar-2010 Preferred Term

Case # 7271483

Case Type EXPEDITED (15-DAY) Product NUVARING PROTONIX NEXIUM VALTREX

Health Professional Y

Outcomes HO,OT Role Route S C C C

Manufacturer Control # 2009SP021076 Dosage Text

Age 46 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM DEEP VEIN THROMBOSIS RESPIRATORY RATE INCREASED HEART RATE INCREASED ABORTION SPONTANEOUS ALCOHOL USE BREAST MASS CELLULITIS CHEST PAIN MATERNAL EXPOSURE DURING PREGNANCY PALPITATIONS PREGNANCY WITH CONTRACEPTIVE DEVICE STAPHYLOCOCCAL INFECTION

7339893 Date FDA Received

29-Mar-2010 Preferred Term VOMITING ABDOMINAL PAIN DEHYDRATION

Case # 7339893

Case Type DIRECT Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control #

Age 23 YR

Sex Female

Country USA

Dosage Text

Duration

Manufacturer ORGANON

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 142 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7341792 Date FDA Received
29-Mar-2010 Preferred Term RASH GENERALISED MEDICAL DEVICE COMPLICATION MEDICATION ERROR OEDEMA PERIPHERAL TOXIC SHOCK SYNDROME Case # 7341792 Case Type DIRECT Product NUVARING Health Professional N Outcomes LT,OT Role Route S VAGINAL Dosage Text VAG Manufacturer Control # Age 49 YR Duration Sex Female Country USA

Manufacturer

7109258 Date FDA Received

30-Mar-2010 Preferred Term

Case # 7109258

Case Type EXPEDITED (15-DAY) Product NUVARING ADVIL MORTRIN TYLENOL

Health Professional Y

Outcomes HO Role Route S C C C VAGINAL

Manufacturer Control # 2009-196599-NL Dosage Text QM; VAG

Age 44 YR Duration

Sex Female

Country USA

Manufacturer

ABDOMINAL PAIN UPPER INFLUENZA PULMONARY EMBOLISM PLEURITIC PAIN DRUG DOSE OMISSION PULMONARY INFARCTION THYROID NEOPLASM

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 143 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7196302 Date FDA Received
30-Mar-2010 Preferred Term PREGNANCY WITH CONTRACEPTIVE DEVICE MATERNAL DRUGS AFFECTING FOETUS CONGENITAL ANOMALY LARGE FOR DATES BABY LUNG DISORDER MEDICATION ERROR NEONATAL DISORDER NEONATAL RESPIRATORY DISTRESS SYNDROME PLAGIOCEPHALY PREMATURE BABY SKULL MALFORMATION UNINTENDED PREGNANCY Case # 7196302 Case Type EXPEDITED (15-DAY) Product NUVARING BETASERON Health Professional Y Outcomes HO,OT Role Route S S TRANSPLACENTAL TRANSPLACENTAL Manufacturer Control # 2009SP035418 Dosage Text TRPL TRPL Age Sex Country USA < 1 DAY Unknown Duration

Manufacturer

7249552 Date FDA Received

30-Mar-2010 Preferred Term

Case # 7249552

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S S C C SUBCUTANEOUS

Manufacturer Control # 2009SP033725 Dosage Text 8 MIU;QOD;SC ; 4 MIU;QOD;SC

Age 25 YR Duration

Sex Female

Country USA

Manufacturer

PREGNANCY WITH IMPLANT CONTRACEPTIVE CAESAREAN SECTION INJECTION SITE PAIN PREMATURE LABOUR MATERNAL EXPOSURE DURING PREGNANCY

BETASERON PRENATAL OR (VITAMINS) PERCOCET

7345577 Date FDA Received

31-Mar-2010 Preferred Term

Case # 7345577

Case Type DIRECT Product NUVARING

Health Professional

Outcomes HO Role Route S VAGINAL

Manufacturer Control #

Age 42 YR

Sex Female

Country USA

Dosage Text ONCE A MONTH VAG

Duration

Manufacturer ORGANON

PULMONARY EMBOLISM

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 144 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7358310 Date FDA Received
01-Apr-2010 Preferred Term PREGNANCY WITH CONTRACEPTIVE DEVICE ABORTION INCOMPLETE Case # 7358310 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes OT Role Route S Manufacturer Control # 2010SP018262 Dosage Text Duration Age Sex Female Country DEU

Manufacturer

7358311 Date FDA Received

01-Apr-2010 Preferred Term

Case # 7358311

Case Type EXPEDITED (15-DAY) Product NUVARING Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2010SP018370 Dosage Text VAG Manufacturer Control # 2010SP018093 Dosage Text

Age

Sex Female

Country NLD

Duration

Manufacturer

TRIGEMINAL NEURALGIA

7357890 Date FDA Received

02-Apr-2010 Preferred Term CERVICAL DYSPLASIA

Case # 7357890

Health Professional Y

Outcomes OT Role Route S

Age

Sex Female

Country USA

Duration

Manufacturer

POST PROCEDURAL HAEMORRHAGE PROCEDURAL HAEMORRHAGE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 145 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7247771 Date FDA Received
06-Apr-2010 Preferred Term OROPHARYNGEAL PAIN FLANK PAIN HAEMOPTYSIS PULMONARY EMBOLISM PLEURAL EFFUSION COLLAGEN DISORDER ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED ALOPECIA CALCINOSIS DERMATITIS ALLERGIC HEART RATE IRREGULAR HYPOTHYROIDISM INTERNATIONAL NORMALISED RATIO INCREASED LICHENOID KERATOSIS PULMONARY INFARCTION SKIN WRINKLING STRESS Case # 7247771 Case Type EXPEDITED (15-DAY) Product NUVARING ACYCLOVIR CLEOCIN CLINDAMYCIN ACIDOPHILIS VITAMINS NOS Health Professional Y Outcomes HO Role Route S C C C C C VAGINAL Manufacturer Control # 2009SP043366 Dosage Text VAG Age 46 YR Duration Sex Female Country USA

Manufacturer

7350094 Date FDA Received

06-Apr-2010 Preferred Term

Case # 7350094

Case Type DIRECT Product NUVARING

Health Professional Y

Outcomes LT Role Route S VAGINAL

Manufacturer Control #

Age 27 YR

Sex Female

Country USA

Dosage Text 1 RING FOR 3 WEEKS VAG

Duration

Manufacturer

PULMONARY EMBOLISM

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 146 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7361104 Date FDA Received
07-Apr-2010 Preferred Term TRISOMY 21 MATERNAL DRUGS AFFECTING FOETUS Case # 7361104 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes CA Role Route S Manufacturer Control # 2010SP018656 Dosage Text TRPL Age Sex Country USA 76 DAY Unknown Duration

Manufacturer

7361126 Date FDA Received

07-Apr-2010 Preferred Term

Case # 7361126

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO Role Route S VAGINAL

Manufacturer Control # 2010SP019035 Dosage Text VAG

Age 29 YR Duration

Sex Female

Country NLD

Manufacturer

ARTERIAL OCCLUSIVE DISEASE LEG AMPUTATION

7029740 Date FDA Received

08-Apr-2010 Preferred Term

Case # 7029740

Case Type EXPEDITED (15-DAY) Product NUVARING IMITREX

Health Professional Y

Outcomes DE,HO Role Route S C C

Manufacturer Control # 2009-197931-NL Dosage Text 1 DF

Age 35 YR Duration

Sex Female

Country USA

Manufacturer

VASCULITIS CEREBRAL CEREBROVASCULAR ACCIDENT COMA BLOOD GLUCOSE INCREASED BLOOD PRESSURE INCREASED CEREBRAL INFARCTION HAEMORRHAGIC STROKE INFLUENZA LIKE ILLNESS KETONURIA WHITE BLOOD CELL COUNT INCREASED

WELLBUTRIN

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 147 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7354312 Date FDA Received
08-Apr-2010 Preferred Term ABDOMINAL DISTENSION CONSTIPATION FLATULENCE Case # 7354312 Case Type DIRECT Product NUVARING Health Professional N Outcomes OT Role Route S Dosage Text 1 RING 3 WEEKS Manufacturer Control # Age 23 YR Duration Sex Female Country USA

Manufacturer

7355265 Date FDA Received

09-Apr-2010 Preferred Term PALPITATIONS CHRONIC SINUSITIS COUGH

Case # 7355265

Case Type DIRECT Product NUVARING

Health Professional N

Outcomes

Manufacturer Control #

Age 41 YR

Sex Female

Country USA

Role Route S

Dosage Text

Duration 3 MTH

Manufacturer ORGANON

PULMONARY CONGESTION

7367585 Date FDA Received

13-Apr-2010 Preferred Term TIBIA FRACTURE

Case # 7367585

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2010SP019938 Dosage Text ; VAG

Age 32 YR Duration

Sex Female

Country ESP

Manufacturer

MENSTRUAL DISORDER

7362117 Date FDA Received

14-Apr-2010 Preferred Term ANGINA PECTORIS DIZZINESS DYSPNOEA VOMITING

Case # 7362117

Case Type DIRECT Product NUVARING

Health Professional N

Outcomes HO,OT Role Route S VAGINAL

Manufacturer Control #

Age 25 YR

Sex Female

Country USA

Dosage Text AS DIRECTED 3-WEEK PERIOD USE VAG

Duration

Manufacturer ORGANON

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 148 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7372952 Date FDA Received
20-Apr-2010 Preferred Term PYREXIA VULVOVAGINAL SWELLING EYE SWELLING OEDEMA MOUTH ABDOMINAL DISTENSION ABDOMINAL PAIN BLISTER HEADACHE VOMITING Case # 7372952 Case Type EXPEDITED (15-DAY) Product NUVARING KLONOPIN OXYCODONE CELEBRATE MULTIVITAMIN Health Professional N Outcomes OT Role Route S C C C Manufacturer Control # 2010SP019854 Dosage Text Age 41 YR Duration Sex Female Country USA

Manufacturer

7371368 Date FDA Received

21-Apr-2010 Preferred Term

Case # 7371368

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2009-200354-NL Dosage Text 1 DF; ; VAG

Age 22 YR Duration

Sex Female

Country FRA

Manufacturer

PREGNANCY WITH CONTRACEPTIVE DEVICE ABORTION COMPLICATED ABORTION INDUCED MATERNAL EXPOSURE DURING PREGNANCY UTERINE HAEMORRHAGE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 149 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7377016 Date FDA Received
22-Apr-2010 Preferred Term PULMONARY EMBOLISM DEEP VEIN THROMBOSIS CARDIAC ARREST AGITATION APNOEA HYPOXIA LOSS OF CONSCIOUSNESS PULSE ABSENT PUPIL FIXED UNRESPONSIVE TO STIMULI Case # 7377016 Case Type EXPEDITED (15-DAY) Product NUVARING ZOLOFT RANITIDINE Health Professional Y Outcomes DE,OT Role Route S C C VAGINAL Manufacturer Control # 20089-170662-NL Dosage Text 1 DF, QM; VAG Age 32 YR Duration Sex Female Country USA

Manufacturer

7379054 Date FDA Received

22-Apr-2010 Preferred Term CERVICAL DYSPLASIA

Case # 7379054

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2010SP022109 Dosage Text QM;VAG Manufacturer Control # 2010SP014601 Dosage Text VAG

Age 38 YR Duration

Sex Female

Country CHL

Manufacturer

7335684 Date FDA Received

27-Apr-2010 Preferred Term

Case # 7335684

Case Type EXPEDITED (15-DAY) Product NUVARING CLARITIN IBUPROFEN TYLENOL BENADRYL

Health Professional Y

Outcomes DE,HO,OT Role Route S C C C C VAGINAL

Age 33 YR Duration

Sex Female

Country USA

Manufacturer

CEREBROVASCULAR ACCIDENT CONVULSION

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 150 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7355041 Date FDA Received
27-Apr-2010 Preferred Term PULMONARY EMBOLISM HYPOXIC-ISCHAEMIC ENCEPHALOPATHY RIGHT VENTRICULAR FAILURE Case # 7355041 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO,LT Role Route S VAGINAL Manufacturer Control # 2010SP018399 Dosage Text VAG Age 20 YR Duration Sex Female Country DEU

Manufacturer

7375929 Date FDA Received

27-Apr-2010 Preferred Term DEPRESSION ANXIETY INSOMNIA VISION BLURRED WEIGHT INCREASED

Case # 7375929

Case Type DIRECT Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control #

Age 39 YR

Sex Female

Country USA

Dosage Text 1 RING MONTHLY VAG

Duration 1 YEAR

Manufacturer

7377959 Date FDA Received

27-Apr-2010 Preferred Term ANXIETY

Case # 7377959

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2010SP022407 Dosage Text

Age 24 YR Duration

Sex Female

Country USA

Manufacturer

ABDOMINAL DISTENSION BOWEL MOVEMENT IRREGULARITY DIZZINESS LOSS OF CONSCIOUSNESS PALPITATIONS PARAESTHESIA URTICARIA VISION BLURRED

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 151 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7346360 Date FDA Received
04-May-2010 Preferred Term INFERTILITY Case # 7346360 Case Type EXPEDITED (15-DAY) Product NUVARING Case # 7338997 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Health Professional N Outcomes OT Role Route S Outcomes OT Role Route S Manufacturer Control # 2010SP014226 Dosage Text Duration Age Sex Female Country DEU Manufacturer Control # 2010SP015811 Dosage Text Duration Age Sex Female Country GBR

Manufacturer

7338997 Date FDA Received

05-May-2010 Preferred Term

Manufacturer

CIRCULATORY COLLAPSE VERTIGO

7388562 Date FDA Received

06-May-2010 Preferred Term ARTHROPATHY UTERINE LEIOMYOMA

Case # 7388562

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes HO Role Route S C VAGINAL

Manufacturer Control # 2010SP024241 Dosage Text QM;VAG

Age 40 YR Duration

Sex Female

Country CHL

Manufacturer

SERETIDE /01434201/ (CON.)

INCORRECT DRUG ADMINISTRATION DURATION METRORRHAGIA PROCEDURAL PAIN VULVOVAGINAL MYCOTIC INFECTION

7388598 Date FDA Received

06-May-2010 Preferred Term

Case # 7388598

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes HO Role Route S VAGINAL

Manufacturer Control # 2010SP024235 Dosage Text QM;VAG

Age 34 YR Duration

Sex Female

Country CHL

Manufacturer

ROAD TRAFFIC ACCIDENT DEPRESSION INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION JAW FRACTURE VAGINAL HAEMORRHAGE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 152 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7388625 Date FDA Received
06-May-2010 Preferred Term PREGNANCY WITH CONTRACEPTIVE DEVICE MATERNAL EXPOSURE DURING PREGNANCY DIZZINESS NAUSEA VOMITING ASTHMA DISCOMFORT HAEMORRHAGE IN PREGNANCY HYPERTENSION INCORRECT STORAGE OF DRUG NASOPHARYNGITIS SELF-MEDICATION UTERINE LEIOMYOMA VAGINAL HAEMORRHAGE Case # 7388625 Case Type EXPEDITED (15-DAY) Product NUVARING CINABEL /00212501/ (CON.) ZYRTEC /00884302/ (CON.) TRIOVAL (CON.) ACETAMINOPHEN (CON.) Health Professional Y Outcomes OT Role Route S C C C C VAGINAL Manufacturer Control # 2010SP020278 Dosage Text QM;VAG Age 34 YR Duration Sex Female Country CHL

Manufacturer

7389851 Date FDA Received

10-May-2010 Preferred Term

Case # 7389851

Case Type EXPEDITED (15-DAY) Product NUVARING TOPAMAX

Health Professional N

Outcomes OT Role Route S S VAGINAL

Manufacturer Control # 2010SP024634 Dosage Text VAG

Age 27 YR Duration

Sex Female

Country USA

Manufacturer

PREGNANCY WITH CONTRACEPTIVE DEVICE ABORTION SPONTANEOUS AMENORRHOEA MENSTRUATION DELAYED

7392225 Date FDA Received

10-May-2010 Preferred Term

Case # 7392225

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2010SP025256 Dosage Text 1 DF; ;VAG

Age 42 YR Duration

Sex Female

Country FRA

Manufacturer

MYOCARDIAL INFARCTION

7179816
Date - Time: 02-04-2013 9:43:10 AM EST Note: If the field is blank, there is no data Page: 153 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7179816
FDA Received Date 11-May-2010 Preferred Term DEPRESSION CONDITION AGGRAVATED INSOMNIA FEAR OF DEATH ANXIETY FEAR OF DISEASE THROMBOSIS ABDOMINOPLASTY LIPOSUCTION ELECTIVE SURGERY TOBACCO USER RASH MUSCULOSKELETAL PAIN BACK PAIN NECK PAIN HAEMATOMA ELECTROCARDIOGRAM T WAVE ABNORMAL BLOOD PRESSURE DECREASED ELECTROCARDIOGRAM QT PROLONGED HEART RATE INCREASED BREAST FIBROSIS CERVICAL CYST CONSTIPATION DYSFUNCTIONAL UTERINE BLEEDING HAEMATOCRIT DECREASED HAEMOGLOBIN DECREASED HYPERCOAGULATION HYPOAESTHESIA Case # 7179816 Case Type EXPEDITED (15-DAY) Product NUVARING NUVARING RITALIN ADDERALL WELLBUTRIN INDERAL XANAX CALCIUM CITRATE CELEXA VITAMIN B12 CLARITIN AMBIEN PRAVACHOL VICODIN FLEXERIL INDERAL ATENOLOL TYLENOL SUMATRIPTAN SUCCINATE NEXIUM Health Professional Y Outcomes HO,LT,OT Role Route S S C C C C C C C C C C C C C C C C C C Manufacturer Control # 2009-201153-NL Dosage Text 1 DF Age 42 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 154 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7179816
Preferred Term LABORATORY TEST ABNORMAL POST PROCEDURAL DRAINAGE POST PROCEDURAL HAEMORRHAGE PROTHROMBIN TIME PROLONGED PULMONARY EMBOLISM SKIN DISCOLOURATION THROMBOSIS IN DEVICE URINE OUTPUT DECREASED VAGINAL HAEMORRHAGE VASCULAR ANOMALY WHITE BLOOD CELL COUNT INCREASED Product Role Route Dosage Text Duration Manufacturer

7277491 Date FDA Received

11-May-2010 Preferred Term

Case # 7277491

Case Type EXPEDITED (15-DAY) Product NUVARING PREVACID

Health Professional Y

Outcomes HO Role Route S C VAGINAL

Manufacturer Control # 2009SP026861 Dosage Text QM;VAG

Age 24 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM DEEP VEIN THROMBOSIS CERVICAL DYSPLASIA EPISTAXIS HEADACHE PLATELET COUNT DECREASED UNEVALUABLE EVENT VAGINAL HAEMORRHAGE

7392229 Date FDA Received

11-May-2010 Preferred Term THYROID CANCER

Case # 7392229

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes HO Role Route S

Manufacturer Control # 2010SP025429 Dosage Text

Age

Sex Female

Country DEU

Duration

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 155 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7393698 Date FDA Received
12-May-2010 Preferred Term CEREBRAL INFARCTION HEMIPARESIS DISTURBANCE IN ATTENTION DRUG INTOLERANCE ERYTHEMA FATIGUE GENERAL PHYSICAL CONDITION ABNORMAL MEMORY IMPAIRMENT MENTAL DISORDER Case # 7393698 Case Type EXPEDITED (15-DAY) Product ETHINYL ESTRADIOL \NORGESTREL IMPLANON NUVARING Health Professional Y Outcomes HO Role Route S S S 1 DF Manufacturer Control # 2010SP021596 Dosage Text Age 29 YR Duration Sex Female Country DEU

Manufacturer

7395007 Date FDA Received

13-May-2010 Preferred Term

Case # 7395007

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2010SP022710 Dosage Text

Age 37 YR Duration

Sex Female

Country DEU

Manufacturer

DISEASE RECURRENCE CROHN'S DISEASE GASTROINTESTINAL INFECTION PROCTOCOLITIS SUDDEN HEARING LOSS

7397143 Date FDA Received

17-May-2010 Preferred Term TACHYCARDIA

Case # 7397143

Case Type DIRECT Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control #

Age 42 YR

Sex Female

Country USA

Dosage Text 0.120 MG/0.015 MG PER DAY VAG

Duration

Manufacturer ORGANON

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 156 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7397160 Date FDA Received
17-May-2010 Preferred Term FLUID RETENTION Case # 7397160 Case Type DIRECT Product NUVARING Health Professional N Outcomes OT Role Route S VAGINAL Dosage Text ONE NUVARING EVERY THREE WEEKS VAG Manufacturer Control # Age 26 YR Duration Sex Female Country USA

Manufacturer ORGANON

ARTHRALGIA DEPRESSION GAIT DISTURBANCE GASTRIC DILATATION NO THERAPEUTIC RESPONSE PAIN IN EXTREMITY VAGINAL HAEMORRHAGE WEIGHT INCREASED

7397852 Date FDA Received

18-May-2010 Preferred Term

Case # 7397852

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2010SP026404 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

SYSTEMIC LUPUS ERYTHEMATOSUS DIZZINESS

7398814 Date FDA Received

19-May-2010 Preferred Term

Case # 7398814

Case Type DIRECT Product NUVARING

Health Professional Y

Outcomes HO,DS,LT Role Route S VAGINAL

Manufacturer Control #

Age 32 YR

Sex Female

Country USA

Dosage Text ONE RING 3 WEEKS VAGINAL

Duration

Manufacturer

CEREBROVASCULAR ACCIDENT BRAIN INJURY EYE DISORDER HEMIPLEGIA THROMBOSIS

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 157 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7399659 Date FDA Received
19-May-2010 Preferred Term HYPERTENSION BLOOD CORTISOL INCREASED HYPERALDOSTERONISM ROAD TRAFFIC ACCIDENT Case # 7399659 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes OT Role Route S Manufacturer Control # 2010SP026593 Dosage Text Duration Age Sex Female Country DEU

Manufacturer

7400521 Date FDA Received

19-May-2010 Preferred Term NAUSEA HEADACHE OCULAR ICTERUS THROMBOSIS VOMITING

Case # 7400521

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2010SP026342 Dosage Text 1 DF;VAG

Age 17 YR Duration

Sex Female

Country USA

Manufacturer

7373011 Date FDA Received

20-May-2010 Preferred Term DEPRESSION FEELING ABNORMAL SUICIDAL IDEATION

Case # 7373011

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2010SP021184 Dosage Text 1 DF;QW

Age

Sex Female

Country USA

Duration

Manufacturer

7400350 Date FDA Received

20-May-2010 Preferred Term VAGINAL ODOUR

Case # 7400350

Case Type DIRECT Product NUVARING

Health Professional N

Outcomes

Manufacturer Control #

Age 25 YR

Sex Female

Country USA

Role Route S VAGINAL

Dosage Text 1 MONTHLY VAG

Duration

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 158 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7402368 Date FDA Received
21-May-2010 Preferred Term THROMBOSIS Case # 7402368 Case Type DIRECT Product NUVARING Case # 7222287 Case Type EXPEDITED (15-DAY) Health Professional Y Health Professional N Outcomes DE Role Route S Outcomes HO,OT Manufacturer Control # 2008-187499-NL Age 23 YR Sex Female Country USA Dosage Text Manufacturer Control # Age 22 YR Duration Sex Female Country USA

Manufacturer

7222287 Date FDA Received

24-May-2010

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 159 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7222287
Preferred Term IRRITABLE BOWEL SYNDROME DEEP VEIN THROMBOSIS INJURY ABDOMINAL PAIN ABORTION INDUCED ABORTION SPONTANEOUS ANKLE FRACTURE BREAST MASS CHEST PAIN DEPRESSION DYSMENORRHOEA DYSPNOEA FURUNCLE HYPEREMESIS GRAVIDARUM JOINT INJURY JOINT STIFFNESS JOINT SWELLING LOBAR PNEUMONIA MENORRHAGIA MOBILITY DECREASED NAUSEA OEDEMA PERIPHERAL OSTEOMALACIA PELVIC PAIN PREGNANCY SUICIDAL IDEATION THYROID MASS THYROID NEOPLASM VAGINAL HAEMORRHAGE VOMITING VULVOVAGINAL MYCOTIC INFECTION Product NUVARING PRILOSEC DOXYCYCLINE Role Route S C C Dosage Text 1 DF Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 160 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7407967 Date FDA Received
25-May-2010 Preferred Term DIZZINESS DYSPHAGIA DYSPNOEA HYPOKALAEMIA INSOMNIA LOSS OF CONSCIOUSNESS PALPITATIONS PANCREATITIS PANIC ATTACK VISION BLURRED Case # 7407967 Case Type DIRECT Product NUVARING Health Professional N Outcomes HO,OT Role Route S Dosage Text Manufacturer Control # Age 30 YR Duration Sex Female Country USA

Manufacturer ORGANON

7407219 Date FDA Received

26-May-2010 Preferred Term DISCOMFORT

Case # 7407219

Case Type EXPEDITED (15-DAY) Product NUVARING TOPAMAX NADOLOL

Health Professional N

Outcomes OT Role Route S C C VAGINAL

Manufacturer Control # 2010SP027281 Dosage Text 1 DF; VAG

Age 23 YR Duration

Sex Female

Country USA

Manufacturer

OVARIAN CYST RUPTURED DEVICE EXPULSION

7410355 Date FDA Received

27-May-2010 Preferred Term MIGRAINE CLUSTER HEADACHE

Case # 7410355

Case Type DIRECT Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control #

Age 47 YR

Sex Female

Country USA

Dosage Text AS DIRECTED

Duration

Manufacturer

LACRIMATION INCREASED MIDDLE INSOMNIA NAUSEA PHOTOPHOBIA

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 161 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7410502 Date FDA Received
28-May-2010 Preferred Term APPARENT DEATH GAIT DISTURBANCE INFERTILITY FEMALE INTRACARDIAC THROMBUS PULMONARY THROMBOSIS THROMBOSIS Case # 7410502 Case Type DIRECT Product NUVARING Health Professional N Outcomes LT Role Route S Dosage Text Manufacturer Control # Age 24 YR Duration Sex Female Country USA

Manufacturer

7412492 Date FDA Received

01-Jun-2010 Preferred Term VERTIGO DIZZINESS NAUSEA

Case # 7412492

Case Type DIRECT Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control #

Age 29 YR

Sex Female

Country USA

Dosage Text 1 RING CONSTANT VAG

Duration

Manufacturer

7414032 Date FDA Received

01-Jun-2010 Preferred Term HOT FLUSH MOOD SWINGS BREAST PAIN DRUG INTERACTION HEADACHE METRORRHAGIA

Case # 7414032

Case Type EXPEDITED (15-DAY) Product NUVARING LAMICTAL CELEXA

Health Professional N

Outcomes OT Role Route S C C

Manufacturer Control # 2010SP028707 Dosage Text 1 DF;

Age 33 YR Duration

Sex Female

Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 162 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7426112 Date FDA Received
03-Jun-2010 Preferred Term BLOOD CHOLESTEROL INCREASED LOW DENSITY LIPOPROTEIN INCREASED CHOLELITHIASIS Case # 7426112 Case Type EXPEDITED (15-DAY) Product DESOGESTREL NUVARING Health Professional Y Outcomes OT Role Route S S Manufacturer Control # 2010SP014540 Dosage Text Age 27 YR Duration Sex Female Country DEU

Manufacturer

7426039 Date FDA Received

04-Jun-2010 Preferred Term

Case # 7426039

Case Type EXPEDITED (15-DAY) Product NUVARING ZOLOFT XANAX CIMETIDINE

Health Professional N

Outcomes OT Role Route S C C C VAGINAL

Manufacturer Control # 2010SP028835 Dosage Text 1 DF;QM;VAG

Age 36 YR Duration

Sex Female

Country USA

Manufacturer

BONE DENSITY DECREASED OVARIAN CYST CHOLELITHIASIS NEPHROLITHIASIS BACK PAIN EPILEPSY MUSCLE SPASMS VOMITING

7426164 Date FDA Received

04-Jun-2010 Preferred Term

Case # 7426164

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2010SP029827 Dosage Text 1 DF

Age 46 YR Duration

Sex Female

Country USA

Manufacturer

UTERINE CERVICAL PAIN UTERINE LEIOMYOMA

7368095 Date FDA Received

07-Jun-2010 Preferred Term

Case # 7368095

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO Role Route S VAGINAL

Manufacturer Control # 2010SP020320 Dosage Text VAG

Age 26 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM DEEP VEIN THROMBOSIS INFARCTION

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 163 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7357891 Date FDA Received
08-Jun-2010 Preferred Term CONSTIPATION RETINAL HAEMORRHAGE RECTAL HAEMORRHAGE APHASIA ALANINE AMINOTRANSFERASE DECREASED ASPARTATE AMINOTRANSFERASE DECREASED BLOOD POTASSIUM DECREASED CAROTID ARTERY OCCLUSION CEREBRAL HAEMORRHAGE CEREBRAL ISCHAEMIA GASTROINTESTINAL HAEMORRHAGE HAEMOGLOBIN DECREASED HIGH DENSITY LIPOPROTEIN DECREASED LOW DENSITY LIPOPROTEIN INCREASED PROCTALGIA WEIGHT DECREASED Case # 7357891 Case Type EXPEDITED (15-DAY) Product NUVARING ALEVE LEVSIN CYMBALTA Health Professional Y Outcomes HO,OT Role Route S C C C Manufacturer Control # 2009SP030816 Dosage Text Age 29 YR Duration Sex Female Country USA

Manufacturer

7418397 Date FDA Received

08-Jun-2010 Preferred Term ACNE

Case # 7418397

Case Type DIRECT Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control #

Age 28 YR

Sex Female

Country USA

Dosage Text 1 MONTHLY VAG

Duration

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 164 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7426243 Date FDA Received
08-Jun-2010 Preferred Term ALOPECIA AGGRESSION HERPES VIRUS INFECTION NAUSEA PAIN IN EXTREMITY Case # 7426243 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional N Outcomes OT Role Route S VAGINAL Manufacturer Control # 2010SP030164 Dosage Text Duration Age Sex Female Country DEU

Manufacturer

7426525 Date FDA Received

08-Jun-2010 Preferred Term TONSILLITIS

Case # 7426525

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO Role Route S VAGINAL

Manufacturer Control # 2010SP028781 Dosage Text VAG Manufacturer Control # 2010SP030361 Dosage Text

Age 22 YR Duration

Sex Female

Country AUS

Manufacturer

7437605 Date FDA Received

08-Jun-2010 Preferred Term MALAISE

Case # 7437605

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S

Age 35 YR Duration

Sex Female

Country LTU

Manufacturer

ABORTION SPONTANEOUS MATERNAL EXPOSURE DURING PREGNANCY

7419198 Date FDA Received

09-Jun-2010 Preferred Term

Case # 7419198

Case Type DIRECT Product NUVARING

Health Professional Y

Outcomes HO,DS Role Route S ORAL

Manufacturer Control #

Age 29 YR

Sex Female

Country USA

Dosage Text 1 TABLET EVERY DAY PO

Duration

Manufacturer SCHERING PLOUGH

ABDOMINAL PAIN LOWER DEEP VEIN THROMBOSIS OEDEMA PERIPHERAL SKIN DISCOLOURATION

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 165 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7420420 Date FDA Received
10-Jun-2010 Preferred Term SWELLING FACE THROAT TIGHTNESS Case # 7420420 Case Type DIRECT Product NUVARING Health Professional N Outcomes OT Role Route S VAGINAL Dosage Text .120/.015 MG PER DAY VAG Manufacturer Control # Age 35 YR Duration Sex Female Country USA

Manufacturer ORGANON

7426306 Date FDA Received

10-Jun-2010 Preferred Term

Case # 7426306

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes DE Role Route S

Manufacturer Control # 2010SP031896 Dosage Text

Age 33 YR Duration

Sex Female

Country CAN

Manufacturer

GRAND MAL CONVULSION ABNORMAL BEHAVIOUR BRAIN HERNIATION BRAIN OEDEMA CEREBRAL INFARCTION FEELING ABNORMAL HAEMORRHAGIC INFARCTION TIC TRANSVERSE SINUS THROMBOSIS

1.5 YEAR

7426323 Date FDA Received

10-Jun-2010 Preferred Term HYPERPLASIA CERVICAL POLYP CERVIX DISORDER

Case # 7426323

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2010SP030054 Dosage Text QM;VAG

Age

Sex Female

Country MEX

Duration

Manufacturer

7426381 Date FDA Received

10-Jun-2010 Preferred Term CERVICAL POLYP

Case # 7426381

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2010SP030061 Dosage Text QM;VAG

Age

Sex Female

Country MEX

Duration

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 166 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7386196 Date FDA Received
15-Jun-2010 Preferred Term OSTEOPOROSIS MELAS SYNDROME MITOCHONDRIAL MYOPATHY ANAEMIA DEVICE EXPULSION VULVOVAGINAL DISCOMFORT MEDICAL DEVICE DISCOMFORT Case # 7386196 Case Type EXPEDITED (15-DAY) Product NUVARING COENZYME Q10 /00517201/ LEVOCARNITINE VITAMIN C /00008001/ ALENDRONATE SODIUM LEVOTHYROXINE SODIUM Health Professional Y Outcomes OT Role Route S C C C C C VAGINAL Manufacturer Control # 2010SP024293 Dosage Text VAG Age 39 YR Duration Sex Female Country BRA

Manufacturer

7451755 Date FDA Received

15-Jun-2010 Preferred Term

Case # 7451755

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2010SP032264 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

PREGNANCY WITH CONTRACEPTIVE DEVICE ABORTION SPONTANEOUS MATERNAL EXPOSURE DURING PREGNANCY

7426582 Date FDA Received

16-Jun-2010 Preferred Term

Case # 7426582

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2010SP031159 Dosage Text ; QM; VAG

Age 37 YR Duration

Sex Female

Country CHL

Manufacturer

VIITH NERVE PARALYSIS ABNORMAL DREAMS DISEASE RECURRENCE INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION MYALGIA

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 167 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7450462 Date FDA Received
16-Jun-2010 Preferred Term DEATH Case # 7450462 Case Type EXPEDITED (15-DAY) Product NUVARING Case # 7424971 Case Type EXPEDITED (15-DAY) Product NUVARING CETIRIZIN (CON.) Health Professional Y Role Route S C VAGINAL Health Professional Y Outcomes DE Role Route S VAGINAL Manufacturer Control # 2010SP033188 Dosage Text ;VAG Manufacturer Control # 2010SP029470 Dosage Text VAG Age 34 YR Duration Sex Female Country FRA Age 29 YR Duration Sex Female Country USA

Manufacturer

7424971 Date FDA Received

17-Jun-2010 Preferred Term

Outcomes

Manufacturer

URINARY TRACT INFECTION PYELONEPHRITIS ESCHERICHIA INFECTION PAIN

7426368 Date FDA Received

18-Jun-2010 Preferred Term APPENDIX DISORDER

Case # 7426368

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes HO,OT Role Route S VAGINAL

Manufacturer Control # 2010SP030469 Dosage Text QM; VAG

Age 17 YR Duration

Sex Female

Country CHL

Manufacturer

ABDOMINAL PAIN UPPER INCORRECT DRUG ADMINISTRATION DURATION

7440833 Date FDA Received

18-Jun-2010 Preferred Term ABORTION

Case # 7440833

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2010SP033773 Dosage Text 1 DF; Q3W; VAG

Age 28 YR Duration

Sex Female

Country USA

Manufacturer

MATERNAL EXPOSURE DURING PREGNANCY

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 168 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7449115 Date FDA Received
18-Jun-2010 Preferred Term FOETAL DEATH MATERNAL DRUGS AFFECTING FOETUS SMALL FOR DATES BABY Case # 7449115 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes DE Role Route S TRANSPLACENTAL Manufacturer Control # 2010SP033806 Dosage Text TRPL Duration Age Sex Unknown Country DEU

Manufacturer

7436159 Date FDA Received

21-Jun-2010 Preferred Term THROMBOSIS

Case # 7436159

Case Type DIRECT Product NUVARING

Health Professional Y

Outcomes OT Role Route S VAGINAL

Manufacturer Control #

Age 25 YR

Sex Female

Country USA

Dosage Text ETONEGESTRAL 0.120 ESTRIOL0.015 THREE WEEKS VAGINAL Manufacturer Control # 2010SP033385 Dosage Text

Duration

Manufacturer ORGANON

7440860 Date FDA Received

21-Jun-2010 Preferred Term

Case # 7440860

Case Type EXPEDITED (15-DAY) Product NUVARING Case Type EXPEDITED (15-DAY)

Health Professional Y

Outcomes OT Role Route S

Age 32 YR Duration

Sex Female

Country DEU

Manufacturer

CIRCULATORY COLLAPSE

7427296 Date FDA Received

24-Jun-2010

Case # 7427296

Health Professional N

Outcomes HO,LT,OT

Manufacturer Control # USBAYER-201025157NA Dosage Text FREQUENCY CONTINUOUS

Age 23 YR

Sex Female

Country USA

Preferred Term PULMONARY EMBOLISM CHEST PAIN

Product MIRENA NUVARING

Role Route S S INTRAUTERINE

Duration

Manufacturer BAYER

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 169 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7451830 Date FDA Received
24-Jun-2010 Preferred Term CHOLECYSTITIS ACUTE ABDOMINAL PAIN UPPER BILE DUCT STONE HYPERBILIRUBINAEMIA Case # 7451830 Case Type EXPEDITED (15-DAY) Product NUVARING ELAVIL PROZAC UNSPECIFIED INGREDIENT WELLBUTRIN Health Professional N Outcomes HO Role Route S S S S S Outcomes HO,OT Role Route S S Health Professional Y Product NUVARING Case Type DIRECT Product NUVARING Health Professional N Outcomes OT Role Route S Outcomes HO,DS,LT,RI Role Route S Dosage Text 3 WEEKS INSERTED 1 WEEK OUT Manufacturer Control # Age 36 YR Duration Sex Female Country CAN Dosage Text ORAL ORAL INTRAMUSCULAR 300 MG;QD;PO Manufacturer Control # SOLV00210001370 Dosage Text DAILY, DAILY DOSE DAILY, DAILY DOSE Manufacturer Control # Age 29 YR Duration Sex Female Country USA Age 47 YR Duration Sex Female Country USA 30 MG;QD;PO 40 MG;QD;PO Manufacturer Control # 2010SP032890 Dosage Text Age 24 YR Duration Sex Female Country CHE

Manufacturer

7524019 Date FDA Received

24-Jun-2010 Preferred Term

Case # 7524019

Case Type NON-EXPEDITED Product

Health Professional N

Manufacturer

DEEP VEIN THROMBOSIS OFF LABEL USE

PROMETRIUM NUVARING

7451553 Date FDA Received

28-Jun-2010 Preferred Term

Case # 7451553

Case Type DIRECT

Manufacturer

MEDICAL DEVICE COMPLICATION

7453366 Date FDA Received

29-Jun-2010 Preferred Term

Case # 7453366

Manufacturer MERCK

PULMONARY EMBOLISM

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 170 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7379850 Date FDA Received
01-Jul-2010 Preferred Term ABDOMINAL PAIN ASTHMA URINARY TRACT INFECTION AMENORRHOEA METRORRHAGIA Case # 7379850 Case Type EXPEDITED (15-DAY) Product NUVARING OMEPRAZOLE WELLBUTRIN SPIRONOLACTONE PROTONIX MENTAX VITAMINS Health Professional Y Outcomes OT Role Route S C C C C C C Health Professional Y Outcomes OT Role Route S C VAGINAL Manufacturer Control # 2010SP021902 Dosage Text 1 DF; QM; VAG Age 38 YR Duration Sex Female Country AUS Manufacturer Control # 2010SP023288 Dosage Text Age 34 YR Duration Sex Female Country USA

Manufacturer

7392266 Date FDA Received

01-Jul-2010 Preferred Term BURNING SENSATION PARAESTHESIA ORAL LIP PAIN

Case # 7392266

Case Type EXPEDITED (15-DAY) Product NUVARING

Manufacturer

FLUOXETINE HCL

7469005 Date FDA Received

01-Jul-2010 Preferred Term

Case # 7469005

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2010SP035943 Dosage Text ; VAG

Age

Sex Female

Country USA

Duration

Manufacturer

MATERNAL EXPOSURE DURING PREGNANCY ABORTION SPONTANEOUS PREGNANCY WITH CONTRACEPTIVE DEVICE

7472764 Date FDA Received

01-Jul-2010 Preferred Term CROHN'S DISEASE

Case # 7472764

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2010SP035656 Dosage Text

Age 25 YR Duration

Sex Female

Country DEU

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 171 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7472962 Date FDA Received
01-Jul-2010 Preferred Term ECTOPIC PREGNANCY LABORATORY TEST INTERFERENCE MATERNAL EXPOSURE DURING PREGNANCY PREGNANCY WITH CONTRACEPTIVE DEVICE Case # 7472962 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional N Outcomes HO Role Route S VAGINAL Manufacturer Control # 2010SP035416 Dosage Text I DF; VAG Age 35 YR Duration Sex Female Country FRA

Manufacturer

7478987 Date FDA Received

06-Jul-2010 Preferred Term

Case # 7478987

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2010SP036818 Dosage Text ; VAG

Age 25 YR Duration

Sex Female

Country USA

Manufacturer

PREGNANCY WITH CONTRACEPTIVE DEVICE ABORTION SPONTANEOUS MATERNAL EXPOSURE DURING PREGNANCY

7450397 Date FDA Received

07-Jul-2010 Preferred Term

Case # 7450397

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S S VAGINAL

Manufacturer Control # 2009SP024413 Dosage Text ; VAG

Age 19 YR Duration

Sex Female

Country DEU

Manufacturer

PREGNANCY WITH CONTRACEPTIVE DEVICE MATERNAL EXPOSURE DURING PREGNANCY FOETAL DEATH HELLP SYNDROME

CLARITHROMYCIN

7461496 Date FDA Received

07-Jul-2010 Preferred Term

Case # 7461496

Case Type DIRECT Product NUVARING

Health Professional N

Outcomes OT,RI Role Route S

Manufacturer Control #

Age 24 YR

Sex Female

Country USA

Dosage Text

Duration

Manufacturer

PULMONARY EMBOLISM

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 172 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7491369 Date FDA Received
07-Jul-2010 Preferred Term SUICIDE ATTEMPT HEADACHE IDIOPATHIC THROMBOCYTOPENIC PURPURA TREATMENT FAILURE Case # 7491369 Case Type EXPEDITED (15-DAY) Product NUVARING ATARAX FLUOXETINE ACETAMINOPHEN Case # 7449123 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Health Professional Y Outcomes HO,LT Role Route S S S S VAGINAL ORAL ORAL ORAL Manufacturer Control # 2010SP036983 Dosage Text 1 DF; VAG 12.25 MG; QD; PO 20 MG; QD; PO 1 GM; QD; PO Manufacturer Control # 2010SP033528 Dosage Text ; VAG Age 23 YR Duration Sex Female Country ESP Age 24 YR Duration Sex Female Country FRA

Manufacturer

7449123 Date FDA Received

09-Jul-2010 Preferred Term VULVAL OEDEMA FACE OEDEMA OEDEMA PERIPHERAL ORAL HERPES

Outcomes OT Role Route S VAGINAL

Manufacturer

7451456 Date FDA Received

12-Jul-2010 Preferred Term DEVICE EXPULSION DEVICE MISUSE

Case # 7451456

Case Type EXPEDITED (15-DAY) Product NUVARING GLAFORNIL

Health Professional N

Outcomes

Manufacturer Control # 2010SP032049

Age 24 YR Duration

Sex Female

Country CHL

Role Route S C Health Professional N Outcomes OT Role Route S VAGINAL VAGINAL

Dosage Text QM;VAG

Manufacturer

7473016 Date FDA Received

12-Jul-2010 Preferred Term PRODUCT SIZE ISSUE DISCOMFORT POLLAKIURIA

Case # 7473016

Case Type DIRECT Product NUVARING

Manufacturer Control #

Age 38 YR

Sex Female

Country USA

Dosage Text 1 MONTHLY VAG

Duration

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 173 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7488285 Date FDA Received
15-Jul-2010 Preferred Term PULMONARY EMBOLISM Case # 7488285 Case Type DIRECT Product NUVARING Case Type DIRECT Product NUVARING Health Professional N Health Professional N Outcomes HO,LT Role Route S VAGINAL Dosage Text .120MG/.015 MG PER DAY VAG Manufacturer Control # Age 21 YR Role Route S ENDOCERVICAL Dosage Text ENDOCERVICA Duration Sex Female Manufacturer Control # Age 31 YR Duration Sex Female Country USA

Manufacturer ORGANON Country USA

7488332 Date FDA Received

15-Jul-2010 Preferred Term HEADACHE DIZZINESS FATIGUE NAUSEA VISUAL IMPAIRMENT VITREOUS FLOATERS

Case # 7488332

Outcomes RI

Manufacturer ORGANON

7479343 Date FDA Received

16-Jul-2010

Case # 7479343

Case Type EXPEDITED (15-DAY)

Health Professional Y

Outcomes HO,LT

Manufacturer Control # FR-PFIZER INC-2010085933 Dosage Text 1 DF, alternate day 1 DF, alternate day 20 mg, UNK 1 g, UNK 1 DF, monthly

Age 24 YR

Sex Female

Country FRA

Preferred Term SUICIDE ATTEMPT IDIOPATHIC THROMBOCYTOPENIC PURPURA

Product ATARAX ATARAX FLUOXETINE ACETAMINOPHEN NUVARING

Role Route S S S S S ORAL ORAL VAGINAL ORAL

Duration 17 DAY 17 DAY 12 DAY 1 DAY

Manufacturer PFIZER PFIZER

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 174 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7480329 Date FDA Received
16-Jul-2010 Case # 7480329 Case Type NON-EXPEDITED Health Professional N Outcomes OT Manufacturer Control # US-PFIZER INC-2007081139 Dosage Text Age 25 YR Sex Female Country USA

Preferred Term GASTROINTESTINAL HAEMORRHAGE NAUSEA DIARRHOEA FAECES DISCOLOURED FLATULENCE

Product CHANTIX NUVARING

Role Route S S

Duration

Manufacturer PFIZER

7512306 Date FDA Received

19-Jul-2010 Preferred Term IRRITABILITY FEELING ABNORMAL

Case # 7512306

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2010SP038283 Dosage Text

Age 29 YR Duration

Sex Female

Country USA

Manufacturer

INCORRECT PRODUCT STORAGE POSTMENOPAUSAL HAEMORRHAGE

7415002 Date FDA Received

20-Jul-2010 Preferred Term OVARIAN CYST HEADACHE DEVICE EXPULSION DIZZINESS ECONOMIC PROBLEM MEDICAL DEVICE PAIN MOOD ALTERED

Case # 7415002

Case Type EXPEDITED (15-DAY) Product NUVARING ARMONYL

Health Professional N

Outcomes OT Role Route S C VAGINAL

Manufacturer Control # 2010SP029338 Dosage Text QM;VAG

Age 24 YR Duration

Sex Female

Country CHL

Manufacturer

VAGINAL INFLAMMATION

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 175 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7133770 Date FDA Received
23-Jul-2010 Preferred Term DEEP VEIN THROMBOSIS INTERNATIONAL NORMALISED RATIO INCREASED PROTHROMBIN TIME PROLONGED SWEAT GLAND TUMOUR SYNOVIAL CYST MAY-THURNER SYNDROME DEVICE OCCLUSION INSOMNIA Case # 7133770 Case Type EXPEDITED (15-DAY) Product NUVARING IMITREX OXYCODONE AND ACETAMINOPHEN TEMAZEPAM FIORICET XYLOCAINE EPINEPHRINE Health Professional Y Outcomes HO,OT Role Route S C C C C C C VAGINAL Manufacturer Control # 2008-178168-NL Dosage Text 1 DF;QM;VAG Age 41 YR Duration Sex Female Country USA

Manufacturer

7528656 Date FDA Received

23-Jul-2010 Preferred Term ECTOPIC PREGNANCY MENORRHAGIA

Case # 7528656

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2010SP039607 Dosage Text

Age

Sex Female

Country RUS

Duration

Manufacturer

7427427 Date FDA Received

27-Jul-2010 Preferred Term

Case # 7427427

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes HO Role Route S C C

Manufacturer Control # 2010SP031393 Dosage Text

Age 41 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS HYPOCOAGULABLE STATE

LEVOTHYROXINE ACETAMINOPHEN

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 176 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7522499 Date FDA Received
27-Jul-2010 Preferred Term MALAISE CRYING DEVICE ISSUE HALLUCINATION HYPERHIDROSIS NAUSEA SUICIDAL IDEATION TREMOR Case # 7522499 Case Type DIRECT Product NUVARING Health Professional Outcomes DS,OT Role Route S VAGINAL Dosage Text 1 ONCE A WEEK VAG Manufacturer Control # Age 48 YR Duration Sex Female Country USA

Manufacturer

7530384 Date FDA Received

27-Jul-2010 Preferred Term AMENORRHOEA INFERTILITY FEMALE

Case # 7530384

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes DS Role Route S

Manufacturer Control # 2010SP039715 Dosage Text

Age 25 YR Duration 10 MTH

Sex Female

Country USA

Manufacturer

7530461 Date FDA Received

27-Jul-2010 Preferred Term CERVIX CARCINOMA

Case # 7530461

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2010SP038374 Dosage Text

Age

Sex Female

Country DEU

Duration

Manufacturer

7533394 Date FDA Received

27-Jul-2010 Preferred Term

Case # 7533394

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2010SP040292 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

MYOCARDIAL INFARCTION

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 177 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7531183 Date FDA Received
02-Aug-2010 Preferred Term HEART RATE INCREASED DEEP VEIN THROMBOSIS DILATATION VENTRICULAR DYSPNOEA PULMONARY EMBOLISM Case # 7531183 Case Type DIRECT Product NUVARING Health Professional Y Outcomes HO,LT,RI Role Route S VAGINAL Dosage Text 1 RING ONCE A MONTH VAG Manufacturer Control # Age 32 YR Duration Sex Female Country USA

Manufacturer MERCK

7533142 Date FDA Received

02-Aug-2010 Preferred Term THROMBOSIS PAIN IN EXTREMITY

Case # 7533142

Case Type DIRECT Product NUVARING

Health Professional Y

Outcomes DS,LT Role Route S

Manufacturer Control #

Age 31 YR

Sex Female

Country USA

Dosage Text

Duration

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 178 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7114664 Date FDA Received
03-Aug-2010 Preferred Term PULMONARY EMBOLISM PAIN MICROCYTIC ANAEMIA LEUKOCYTOSIS PROTHROMBIN TIME PROLONGED INTERNATIONAL NORMALISED RATIO INCREASED MENORRHAGIA ATELECTASIS CONCUSSION CONTUSION DEEP VEIN THROMBOSIS DIABETES MELLITUS FALL FATIGUE HYPERTENSION LIP NEOPLASM MULTIPLE ALLERGIES MUSCLE STRAIN ORAL NEOPLASM PLEURAL EFFUSION PNEUMONIA TINNITUS Case # 7114664 Case Type EXPEDITED (15-DAY) Product NUVARING TYLENOL PM KEFLEX HYDROCHLOROTHIAZIDE PROMETHAZINE OXYCODONE AND ACETAMINOPHEN IBUPROFEN Health Professional Y Outcomes HO,DS,OT Role Route S C C C C C C Manufacturer Control # 2008-183374-NL Dosage Text 1 DF; QM; Age 33 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 179 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7493888 Date FDA Received
03-Aug-2010 Preferred Term CYSTITIS INFLAMMATION NEPHROLITHIASIS WITHDRAWAL BLEED Case # 7493888 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional N Outcomes OT Role Route S VAGINAL Manufacturer Control # 2010SP036510 Dosage Text VAG Age 22 YR Duration Sex Female Country NLD

Manufacturer

7541280 Date FDA Received

03-Aug-2010 Preferred Term INFLAMMATION RENAL DISORDER

Case # 7541280

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2010SP040927 Dosage Text

Age

Sex Female

Country DEU

Duration

Manufacturer

7544603 Date FDA Received

05-Aug-2010 Preferred Term INFECTION INJURY PRURITUS

Case # 7544603

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2010SP040910 Dosage Text VAG

Age

Sex Female

Country ESP

Duration

Manufacturer

7546136 Date FDA Received

09-Aug-2010 Preferred Term METRORRHAGIA SYNCOPE HYPOTENSION WITHDRAWAL BLEED

Case # 7546136

Case Type EXPEDITED (15-DAY) Product NUVARING ARADIX

Health Professional N

Outcomes OT Role Route S C VAGINAL

Manufacturer Control # 2010SP041881 Dosage Text QM;VAG

Age 16 YR Duration

Sex Female

Country CHL

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 180 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7546306 Date FDA Received
09-Aug-2010 Preferred Term DYSMENORRHOEA ARTHRALGIA BASEDOW'S DISEASE BREAST DISORDER FEMALE CONTUSION DEEP VEIN THROMBOSIS FAECES DISCOLOURED FATIGUE FEELING HOT HERPES ZOSTER HYPOAESTHESIA LIMB INJURY LIVER FUNCTION TEST ABNORMAL MUSCULOSKELETAL CHEST PAIN OVARIAN CYST THROMBOSIS UTERINE LEIOMYOMA UTERINE POLYP Case # 7546306 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes OT Role Route S Manufacturer Control # 2010SP041751 Dosage Text Age 36 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 181 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7546434 Date FDA Received
09-Aug-2010 Preferred Term DEEP VEIN THROMBOSIS PULMONARY EMBOLISM MULTIPLE INJURIES ANIMAL BITE ANTIPHOSPHOLIPID SYNDROME ARTHRALGIA ATRIAL FIBRILLATION AUTOIMMUNE DISORDER BACK PAIN BRADYCARDIA BREAST PAIN DERMATITIS ALLERGIC DIZZINESS HYPERCOAGULATION HYPERHIDROSIS HYPOAESTHESIA INFLAMMATION PALPITATIONS PNEUMONIA RESUSCITATION RETINAL DISORDER SARCOIDOSIS SYNOVIAL CYST SYSTEMIC LUPUS ERYTHEMATOSUS Case # 7546434 Case Type EXPEDITED (15-DAY) Product NUVARING CENTRUM VITAMINS ASPIRIN Health Professional Y Outcomes HO,DS,OT Role Route S C C Manufacturer Control # 2009SP037080 Dosage Text Age 43 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 182 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7546466 Date FDA Received
09-Aug-2010 Preferred Term INFERTILITY FEMALE Case # 7546466 Case Type EXPEDITED (15-DAY) Product NUVARING PROMETRIUM Health Professional N Outcomes OT Role Route S C Outcomes HO Role Route S S C Manufacturer Control # 2009-193332-NL Dosage Text Age 27 YR Duration Sex Female Country USA VAGINAL Manufacturer Control # 2010SP041581 Dosage Text ; VAG Age 22 YR Duration Sex Female Country USA

Manufacturer

7284727 Date FDA Received

10-Aug-2010 Preferred Term

Case # 7284727

Case Type EXPEDITED (15-DAY) Product NUVARING NUVARING

Health Professional Y

Manufacturer

PULMONARY EMBOLISM HAEMOPTYSIS NIGHT SWEATS GARDNERELLA TEST POSITIVE RED BLOOD CELL COUNT DECREASED RENAL CYST VULVOVAGINAL MYCOTIC INFECTION

MULTI-VITAMIN

7549450 Date FDA Received

10-Aug-2010 Preferred Term SWOLLEN TONGUE

Case # 7549450

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S C C Outcomes DS Role Route S VAGINAL VAGINAL

Manufacturer Control # 2010SP041861 Dosage Text 120 MCG;QD;VAG

Age 32 YR Duration

Sex Female

Country GBR

Manufacturer

CITALOPRAM HYDROBROMIDE ORTHO EVRA

7544713 Date FDA Received

11-Aug-2010 Preferred Term RASH PRURITIC PAIN

Case # 7544713

Case Type DIRECT Product NUVARING

Health Professional N

Manufacturer Control #

Age 33 YR

Sex Female

Country USA

Dosage Text 1 RING 1X PER MONTH VAG

Duration

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 183 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7472803 Date FDA Received
13-Aug-2010 Preferred Term ABORTION SPONTANEOUS INCORRECT DRUG ADMINISTRATION DURATION MATERNAL EXPOSURE DURING PREGNANCY PREGNANCY WITH CONTRACEPTIVE DEVICE Case # 7472803 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO Role Route S VAGINAL Manufacturer Control # 2010SP035689 Dosage Text 1 DF; ; VAG Age 25 YR Duration Sex Female Country FRA

Manufacturer

7554253 Date FDA Received

16-Aug-2010 Preferred Term DEPRESSION SUICIDAL IDEATION

Case # 7554253

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2010SP043082 Dosage Text

Age 30 YR Duration

Sex Female

Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 184 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7568873 Date FDA Received
16-Aug-2010 Preferred Term PULMONARY EMBOLISM SCAR BLOOD CHOLESTEROL INCREASED PHLEBITIS ATELECTASIS DEHYDRATION DISEASE COMPLICATION HEPATOMEGALY HYPERCOAGULATION HYPONATRAEMIA INFECTION LEUKOCYTOSIS LOBAR PNEUMONIA LUNG INFILTRATION NAUSEA PLEURAL EFFUSION PULMONARY INFARCTION VOMITING Case # 7568873 Case Type EXPEDITED (15-DAY) Product NUVARING DEPO-PROVERA CLARITIN PAXIL Health Professional Y Outcomes HO,OT Role Route S S C C Manufacturer Control # 2009SP201085 Dosage Text Age 27 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 185 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6884978 Date FDA Received
20-Aug-2010 Preferred Term URINARY TRACT INFECTION PNEUMONIA ACUTE RESPIRATORY DISTRESS SYNDROME PAIN PULSELESS ELECTRICAL ACTIVITY ABDOMINAL PAIN BLOOD PRESSURE FLUCTUATION BRAIN DEATH BRAIN HERNIATION BRAIN OEDEMA CANDIDIASIS CARDIAC ARREST COMA HEART RATE ABNORMAL HYPERNATRAEMIA HYPOAESTHESIA HYPOXIC-ISCHAEMIC ENCEPHALOPATHY INTRACRANIAL PRESSURE INCREASED MUSCLE STRAIN MUSCULOSKELETAL CHEST PAIN MUSCULOSKELETAL PAIN PELVIC PAIN PLEURAL EFFUSION PULMONARY EMBOLISM PUPIL FIXED RESPIRATORY ARREST UPPER RESPIRATORY TRACT INFECTION Case # 6884978 Case Type EXPEDITED (15-DAY) Product NUVARING LEXAPRO CIPROFLOXACIN BENZONATATE ALBUTEROL Health Professional Y Outcomes DE,HO,OT Role Route S C C C C VAGINAL Manufacturer Control # 2009-189203-NL Dosage Text ;VAG Age 36 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 186 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7553294 Date FDA Received
20-Aug-2010 Preferred Term MENTAL DISORDER ANGER DEPRESSED MOOD MOOD SWINGS PARTNER STRESS Case # 7553294 Case Type DIRECT Product NUVARING Health Professional N Outcomes OT Role Route S VAGINAL Dosage Text 1 RING MONTHLY VAG Manufacturer Control # Age 39 YR Duration Sex Female Country USA

Manufacturer

7553431 Date FDA Received

20-Aug-2010 Preferred Term LOSS OF LIBIDO

Case # 7553431

Case Type DIRECT Product

Health Professional N

Outcomes OT Role Route S S

Manufacturer Control #

Age

Sex Female

Country USA

Dosage Text

Duration

Manufacturer

DEPO-PROVERA NUVARING

7546049 Date FDA Received

24-Aug-2010 Preferred Term

Case # 7546049

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO,OT Role Route S

Manufacturer Control # 2010SP040953 Dosage Text

Age 23 YR Duration

Sex Female

Country AUT

Manufacturer

PREGNANCY WITH CONTRACEPTIVE DEVICE ABDOMINAL PAIN LOWER ABORTION MISSED FOETAL DEATH MATERNAL EXPOSURE DURING PREGNANCY

7570403 Date FDA Received

24-Aug-2010 Preferred Term PREGNANCY

Case # 7570403

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2010SP044181 Dosage Text

Age

Sex Female

Country FIN

Duration

Manufacturer

ABORTION SPONTANEOUS MATERNAL EXPOSURE DURING PREGNANCY

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 187 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7575577 Date FDA Received
25-Aug-2010 Preferred Term ARTHRALGIA Case # 7575577 Case Type EXPEDITED (15-DAY) Product NUVARING Case # 7527536 Case Type EXPEDITED (15-DAY) Product NUVARING LEVOTHYROXINE SODIUM Health Professional Y Health Professional Y Outcomes HO Role Route S Outcomes HO Role Route S C VAGINAL Manufacturer Control # 2009SP035409 Dosage Text VAG Age 41 YR Duration Sex Female Country USA Manufacturer Control # 2010SP044330 Dosage Text Duration Age Sex Female Country USA

Manufacturer

7527536 Date FDA Received

26-Aug-2010 Preferred Term

Manufacturer

DEEP VEIN THROMBOSIS HEADACHE CELLULITIS HYPERCOAGULATION INTERNATIONAL NORMALISED RATIO INCREASED NASAL POLYPS OEDEMA PERIPHERAL PROTHROMBIN TIME PROLONGED PSORIASIS

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 188 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7571934 Date FDA Received
27-Aug-2010 Preferred Term MOOD SWINGS Case # 7571934 Case Type DIRECT Product NUVARING Health Professional N Outcomes OT Role Route S VAGINAL Dosage Text .120 ESTONOGESTERAL DAILY VAG .015 ETHINYL DAILY VAG Manufacturer Control # Age 26 YR Duration Sex Female Country USA

Manufacturer SCHERING PLOUGH

AGGRESSION AMNESIA ANGER CRYING HEADACHE NO THERAPEUTIC RESPONSE SUICIDAL IDEATION

7571633 Date FDA Received

30-Aug-2010 Preferred Term

Case # 7571633

Case Type DIRECT Product NUVARING

Health Professional

Outcomes HO,LT Role Route S INTRAUTERINE

Manufacturer Control #

Age 24 YR

Sex Female

Country USA

Dosage Text 1 USE ONCE MONTHLY INTRAUTERI NE

Duration

Manufacturer

CEREBRAL THROMBOSIS

FATIGUE MIGRAINE PAIN PHOTOPHOBIA

7571733 Date FDA Received

30-Aug-2010 Preferred Term

Case # 7571733

Case Type DIRECT Product NUVARING

Health Professional Y

Outcomes LT Role Route S VAGINAL

Manufacturer Control #

Age 43 YR

Sex Female

Country USA

Dosage Text 1 RING MONTHLY VAG

Duration

Manufacturer ORGANON

PULMONARY EMBOLISM DEEP VEIN THROMBOSIS

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 189 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7577949 Date FDA Received
30-Aug-2010 Preferred Term DEEP VEIN THROMBOSIS APPARENT LIFE THREATENING EVENT INFARCTION PNEUMONIA PULMONARY EMBOLISM Case # 7577949 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO,DS,LT,OT Role Route S Manufacturer Control # 2010SP045041 Dosage Text Age 24 YR Duration Sex Female Country DEU

Manufacturer

7574883 Date FDA Received

31-Aug-2010 Preferred Term

Case # 7574883

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO,DS Role Route S C C

Manufacturer Control # 2009SP040696 Dosage Text

Age 20 YR Duration

Sex Female

Country USA

Manufacturer

CEREBROVASCULAR ACCIDENT PULMONARY EMBOLISM CEREBROVASCULAR DISORDER CEREBRAL INFARCTION COAGULATION FACTOR V LEVEL INCREASED CONVULSION GASTRITIS GASTRITIS EROSIVE GRAND MAL CONVULSION HYPOKALAEMIA LEUKOCYTOSIS MALFORMATION VENOUS NAUSEA PROTEIN C INCREASED SUPERIOR SAGITTAL SINUS THROMBOSIS VOMITING

SOMATROPIN PHENERGAN

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 190 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7575539 Date FDA Received
02-Sep-2010 Preferred Term MIGRAINE ACTIVITIES OF DAILY LIVING IMPAIRED IMPAIRED DRIVING ABILITY IMPAIRED WORK ABILITY Case # 7575539 Case Type DIRECT Product NUVARING Health Professional Y Outcomes OT Role Route S VAGINAL Dosage Text 1 RING INSERT Q3W, REMOVE, VAG Manufacturer Control # Age 24 YR Duration Sex Female Country USA

Manufacturer

7577112 Date FDA Received

02-Sep-2010 Preferred Term PNEUMOTHORAX

Case # 7577112

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO,DS,LT Role Route S C C C C

Manufacturer Control # 2010SP045433 Dosage Text

Age 33 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM

ADVAIR DISKUS LEXAPRO CALCIUM WITH VITAMIN D ALBUTEROL

7582754 Date FDA Received

02-Sep-2010 Preferred Term

Case # 7582754

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO,OT Role Route S C VAGINAL

Manufacturer Control # 2009SP032162 Dosage Text VAG

Age 36 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM HYPOAESTHESIA DRUG INEFFECTIVE OVARIAN CYST

METHOTREXATE

7582755 Date FDA Received

02-Sep-2010 Preferred Term ECTOPIC PREGNANCY

Case # 7582755

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2010SP045745 Dosage Text

Age

Sex Female

Country DEU

Duration

Manufacturer

PREGNANCY WITH CONTRACEPTIVE DEVICE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 191 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7583224 Date FDA Received
02-Sep-2010 Preferred Term PREGNANCY WITH CONTRACEPTIVE DEVICE ABORTION SPONTANEOUS MATERNAL EXPOSURE DURING PREGNANCY Case # 7583224 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes OT Role Route S Manufacturer Control # 2010SP046195 Dosage Text Duration Age Sex Female Country BEL

Manufacturer

7583226 Date FDA Received

02-Sep-2010 Preferred Term OVARIAN CYST

Case # 7583226

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2010SP046506 Dosage Text VAG

Age

Sex Female

Country BRA

Duration

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 192 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7555563 Date FDA Received
03-Sep-2010 Preferred Term PULMONARY EMBOLISM MULTIPLE INJURIES THROMBOSIS ATELECTASIS BACK PAIN DEEP VEIN THROMBOSIS DEPRESSED MOOD FACTOR V LEIDEN MUTATION FATIGUE FEELING ABNORMAL LIBIDO DISORDER MIGRAINE MUSCLE SPASMS MUSCLE STRAIN OROPHARYNGEAL PAIN PHARYNGITIS PREGNANCY WITH CONTRACEPTIVE DEVICE PULMONARY INFARCTION REFUSAL OF TREATMENT BY PATIENT SINUSITIS URINARY TRACT INFECTION Case # 7555563 Case Type EXPEDITED (15-DAY) Product NUVARING UNSPECIFIED INGREDIENT SYNTHROID Health Professional Y Outcomes HO,OT Role Route S S C VAGINAL Manufacturer Control # 2010SP002128 Dosage Text VAG Age 24 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 193 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7580918 Date FDA Received
03-Sep-2010 Preferred Term DISCOMFORT PAIN LOSS OF EMPLOYMENT LUNG DISORDER PULMONARY FIBROSIS RESPIRATORY DISORDER THROMBOSIS Case # 7580918 Case Type DIRECT Product NUVARING COUMADIN Health Professional N Outcomes HO,DS,LT,RI Role Route S C Dosage Text 1 RING ONCE A MONTH Manufacturer Control # Age 20 YR Duration Sex Female Country USA

Manufacturer

7586748 Date FDA Received

03-Sep-2010 Preferred Term METRORRHAGIA

Case # 7586748

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2010SP046724 Dosage Text

Age

Sex Female

Country NLD

Duration

Manufacturer

ABORTION SPONTANEOUS DRUG DOSE OMISSION MATERNAL EXPOSURE DURING PREGNANCY

7586975 Date FDA Received

03-Sep-2010 Preferred Term

Case # 7586975

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO Role Route S VAGINAL

Manufacturer Control # 2010SP045764 Dosage Text ; VAG

Age 23 YR Duration

Sex Female

Country NLD

Manufacturer

VAGINAL HAEMORRHAGE HAEMOGLOBIN DECREASED

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 194 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7552797 Date FDA Received
07-Sep-2010 Preferred Term PULMONARY EMBOLISM DEEP VEIN THROMBOSIS INJURY BLOOD CHOLESTEROL INCREASED ATELECTASIS PLEURAL EFFUSION IMMOBILE Case # 7552797 Case Type EXPEDITED (15-DAY) Product NUVARING MUTI-VITAMIN ASCORBIC ACID VITAMIN E FISH OIL FLAX SEED OIL SELENIUM ADVIL MIGRAINE Health Professional Y Outcomes HO Role Route S C C C C C C C Outcomes DS Role Route S VAGINAL Dosage Text 1 RING ONCE EVERY 28 DAYS VAG Manufacturer Control # Age 33 YR Duration Sex Female Country USA VAGINAL Manufacturer Control # 2009SP035328 Dosage Text QM, VAG Age 41 YR Duration Sex Female Country USA

Manufacturer

7581245 Date FDA Received

07-Sep-2010 Preferred Term URTICARIA ARTHRALGIA AURICULAR SWELLING DIZZINESS ERYTHEMA

Case # 7581245

Case Type DIRECT Product NUVARING

Health Professional N

Manufacturer SCHERING PLOUGH

RASH ERYTHEMATOUS

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 195 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7427424 Date FDA Received
09-Sep-2010 Preferred Term PRURITUS RASH DYSPNOEA INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION LIP SWELLING SWOLLEN TONGUE Case # 7427424 Case Type EXPEDITED (15-DAY) Product NUVARING EFFEXOR Health Professional Y Outcomes OT Role Route S C VAGINAL Manufacturer Control # 2010SP031536 Dosage Text ; VAG Age 34 YR Duration Sex Female Country USA

Manufacturer

7615731 Date FDA Received

09-Sep-2010 Preferred Term

Case # 7615731

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes HO Role Route S

Manufacturer Control # 2010SP046648 Dosage Text

Age 34 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS CHEST DISCOMFORT PELVIC PAIN

7612361 Date FDA Received

10-Sep-2010 Preferred Term

Case # 7612361

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO Role Route S VAGINAL

Manufacturer Control # 2010SP038007 Dosage Text VAG

Age 26 YR Duration

Sex Female

Country USA

Manufacturer

MITRAL VALVE INCOMPETENCE APHASIA COMPLICATED MIGRAINE HEMIPARESIS VIITH NERVE PARALYSIS

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 196 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7437630 Date FDA Received
13-Sep-2010 Preferred Term PULMONARY EMBOLISM AFFECTIVE DISORDER ANXIETY BLOOD CHOLESTEROL INCREASED BRONCHITIS CHEST PAIN COGNITIVE DISORDER CONTRAST MEDIA ALLERGY COSTOCHONDRITIS CRYING DEEP VEIN THROMBOSIS EMOTIONAL DISORDER FATIGUE FIBROMYALGIA GASTROOESOPHAGEAL REFLUX DISEASE HAEMATOMA HAEMOPTYSIS HYPERLIPIDAEMIA MENTAL DISORDER MULTIPLE ALLERGIES PANIC ATTACK POLYCYSTIC OVARIES SINUS DISORDER SUPRAVENTRICULAR TACHYCARDIA THERAPEUTIC RESPONSE DECREASED TREATMENT FAILURE VIRAL INFECTION WEIGHT INCREASED Case # 7437630 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO,OT Role Route S VAGINAL Manufacturer Control # 2009SP043059 Dosage Text ;VAG Age 27 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 197 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7613762 Date FDA Received
14-Sep-2010 Preferred Term DEEP VEIN THROMBOSIS ANTITHROMBIN III DECREASED CERVICAL DYSPLASIA METRORRHAGIA PULMONARY EMBOLISM Case # 7613762 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO,OT Role Route S Manufacturer Control # 2010SP003812 Dosage Text Age 26 YR Duration Sex Female Country USA

Manufacturer

7616852 Date FDA Received

15-Sep-2010 Preferred Term PARANOIA CRYING

Case # 7616852

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2010SP047952 Dosage Text VAG

Age 43 YR Duration

Sex Female

Country USA

Manufacturer

7555663 Date FDA Received

16-Sep-2010 Preferred Term

Case # 7555663

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes

Manufacturer Control # 2010SP041675

Age 26 YR Duration

Sex Female

Country PRT

Role Route S

Dosage Text

Manufacturer

MATERNAL EXPOSURE BEFORE PREGNANCY ABORTION SPONTANEOUS DEVICE EXPULSION PREGNANCY

7158304 Date FDA Received

17-Sep-2010 Preferred Term DRUG INTERACTION NEPHROLITHIASIS SINUSITIS

Case # 7158304

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S S S S S VAGINAL ORAL ORAL

Manufacturer Control # 2009SP028557 Dosage Text VAG PO PO

Age 32 YR Duration

Sex Female

Country BRA

Manufacturer

DICLOFENAC SODIUM MONUROL AZITHROMYCIN DEXAMETHASONE PHOSPHATE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 198 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7617055 Date FDA Received
17-Sep-2010 Preferred Term EYE PAIN Case # 7617055 Case Type EXPEDITED (15-DAY) Product NUVARING Case # 7535586 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Health Professional Y Outcomes HO Role Route S VAGINAL Manufacturer Control # 2010SP048257 Dosage Text VAG Manufacturer Control # 2010SP038303 Dosage Text ; VAG Age 30 YR Duration Sex Female Country USA Duration Age Sex Female Country USA

Manufacturer

7535586 Date FDA Received

20-Sep-2010 Preferred Term BREAST TENDERNESS

Outcomes HO,DS Role Route S VAGINAL

Manufacturer

BREAST ENLARGEMENT BREAST MASS BREAST PAIN CARDIAC MURMUR EMOTIONAL DISORDER FATIGUE HEART RATE IRREGULAR INSOMNIA PAIN SENSATION OF HEAVINESS

7613682 Date FDA Received

20-Sep-2010 Preferred Term

Case # 7613682

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2010SP048657 Dosage Text VAG

Age 21 YR Duration

Sex Female

Country USA

Manufacturer

PREGNANCY WITH CONTRACEPTIVE DEVICE ABORTION SPONTANEOUS MATERNAL EXPOSURE DURING PREGNANCY

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 199 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7610918 Date FDA Received
22-Sep-2010 Preferred Term MIGRAINE Case # 7610918 Case Type DIRECT Product NUVARING Case # 7619338 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional N Health Professional Y Outcomes OT Role Route S VAGINAL Dosage Text 1 RING PER MONTH 1 TIME PER MONTH VAG Manufacturer Control # 2010SP030338 Dosage Text Age 33 YR Duration Sex Female Country USA Manufacturer Control # Age 26 YR Duration Sex Female Country USA

Manufacturer

7619338 Date FDA Received

22-Sep-2010 Preferred Term

Outcomes HO,OT Role Route S

Manufacturer

MESENTERIC VEIN THROMBOSIS ABORTION SPONTANEOUS BACK INJURY BACK PAIN FALL GALLBLADDER DISORDER HYPOTHYROIDISM MATERNAL EXPOSURE BEFORE PREGNANCY PREGNANCY

7554058 Date FDA Received

23-Sep-2010 Preferred Term SYNCOPE NAUSEA VOMITING

Case # 7554058

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2010SP043217 Dosage Text VAG

Age 23 YR Duration

Sex Female

Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 200 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7611756 Date FDA Received
23-Sep-2010 Preferred Term PULMONARY EMBOLISM BLINDNESS TRANSIENT DIZZINESS PLEURISY PNEUMOTHORAX SYNCOPE Case # 7611756 Case Type DIRECT Product NUVARING Health Professional N Outcomes HO,LT Role Route S VAGINAL Dosage Text 1 RING EVERY 4 WEEKS VAG Manufacturer Control # Age 35 YR Duration Sex Female Country USA

Manufacturer ORGANON

7621014 Date FDA Received

23-Sep-2010 Preferred Term OEDEMA PERIPHERAL DEPRESSION FACE OEDEMA IRRITABILITY MOOD SWINGS WEIGHT INCREASED

Case # 7621014

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2010SP048765 Dosage Text

Age

Sex Female

Country DEU

Duration

Manufacturer

7621470 Date FDA Received

23-Sep-2010 Preferred Term MALAISE CRYING HALLUCINATION HYPERHIDROSIS NAUSEA SUICIDAL IDEATION TREMOR

Case # 7621470

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2010SP049134 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 201 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7621076 Date FDA Received
24-Sep-2010 Preferred Term LIP SWELLING CHEILITIS Case # 7621076 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional N Outcomes OT Role Route S VAGINAL Manufacturer Control # 2010SP049404 Dosage Text VAG Age 22 YR Duration Sex Female Country USA

Manufacturer

7626190 Date FDA Received

24-Sep-2010 Preferred Term

Case # 7626190

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO Role Route S S VAGINAL ORAL

Manufacturer Control # 2010SP050038 Dosage Text 1 DF; VAG 250 MG;QD;PO Manufacturer Control # 2010SP044743

Age 37 YR Duration

Sex Female

Country FRA

Manufacturer

ACUTE GENERALISED EXANTHEMATOUS PUSTULOSIS

TERBINAFINE HYDROCHLORIDE

7583914 Date FDA Received

27-Sep-2010 Preferred Term

Case # 7583914

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes

Age 22 YR Duration

Sex Female

Country USA

Role Route S C

Dosage Text 1 DF

Manufacturer

PREGNANCY WITH CONTRACEPTIVE DEVICE ABORTION SPONTANEOUS MATERNAL EXPOSURE DURING PREGNANCY

SERTRALINE HYDROCHLORIDE

7179880 Date FDA Received

28-Sep-2010 Preferred Term PAIN

Case # 7179880

Case Type EXPEDITED (15-DAY) Product NUVARING ZITHROMAX HISTENEX

Health Professional Y

Outcomes HO,OT Role Route S C C C C C C C VAGINAL

Manufacturer Control # 2009-198860-NL Dosage Text VAG

Age 32 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM NIGHT SWEATS DECREASED APPETITE WEIGHT DECREASED UPPER RESPIRATORY TRACT INFECTION PNEUMONIA SPLINTER HAEMORRHAGES

ORTHO TRI CYCLEN ORTHO CYCLEN DESOGEN ORTHO-NOVUM 7/7/7-21 DEPO-MEDROL

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 202 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7179880
Preferred Term NAUSEA INSOMNIA ABDOMINAL PAIN LOWER CHEST PAIN BRONCHITIS PALPITATIONS ANGINA PECTORIS ARTHRALGIA ATRIAL TACHYCARDIA BACK INJURY COGNITIVE DISORDER EMOTIONAL DISORDER FALL HYPERTENSION INTERNATIONAL NORMALISED RATIO DECREASED MAMMOPLASTY MATERNAL EXPOSURE BEFORE PREGNANCY MENTAL DISORDER NON-CARDIAC CHEST PAIN PREGNANCY PROTHROMBIN TIME SHORTENED PULMONARY INFARCTION SUPRAVENTRICULAR EXTRASYSTOLES Product ZOFRAN TRANSDERM SCOP MIEPERIDINE/PROMETHAZINE DIAZEPAM HYDROCODONE BITARTRATE AND ACETAMINOPHEN ALBUTEROL Role Route C C C C C C Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 203 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7630006 Date FDA Received
28-Sep-2010 Preferred Term PULMONARY EMBOLISM DEEP VEIN THROMBOSIS PNEUMONIA Case # 7630006 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO,OT Role Route S Manufacturer Control # 2010SP047838 Dosage Text Age 21 YR Duration Sex Female Country DEU

Manufacturer

7630128 Date FDA Received

28-Sep-2010 Preferred Term

Case # 7630128

Case Type EXPEDITED (15-DAY) Product NUVARING IBUPROFEN MEDROL

Health Professional Y

Outcomes OT Role Route S C C VAGINAL

Manufacturer Control # 2010SP048125 Dosage Text VAG

Age 25 YR Duration

Sex Female

Country USA

Manufacturer

SYSTEMIC LUPUS ERYTHEMATOSUS CIRCULATORY COLLAPSE FALL

7618110 Date FDA Received

29-Sep-2010 Preferred Term

Case # 7618110

Case Type DIRECT Product NUVARING

Health Professional N

Outcomes HO,LT Role Route S VAGINAL

Manufacturer Control #

Age 33 YR

Sex Female

Country USA

Dosage Text 1 EVERY 3 WEEKS VAG Manufacturer Control # 2010SP050981 Dosage Text QM;VAG

Duration

Manufacturer

DEEP VEIN THROMBOSIS

7633560 Date FDA Received

30-Sep-2010 Preferred Term MOOD SWINGS AMENORRHOEA CYSTITIS HEADACHE HYPOAESTHESIA NAUSEA OVARIAN CYST

Case # 7633560

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Age 24 YR Duration

Sex Female

Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 204 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7635512 Date FDA Received
30-Sep-2010 Preferred Term OFF LABEL USE ANAEMIA Case # 7635512 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional N Outcomes OT Role Route S VAGINAL Manufacturer Control # 2010SP051082 Dosage Text VAG Age 30 YR Duration Sex Female Country BRA

Manufacturer

7277725 Date FDA Received

01-Oct-2010 Preferred Term

Case # 7277725

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes HO,DS,OT Role Route S C C

Manufacturer Control # 2009SP023450 Dosage Text 1 DF;

Age 30 YR Duration

Sex Female

Country USA

Manufacturer

CEREBROVASCULAR ACCIDENT EPILEPSY DEPRESSION ANXIETY

ADVIL COLD AND SINUS ACETAMINOPHEN

7635672 Date FDA Received

01-Oct-2010 Preferred Term

Case # 7635672

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2010SP051261 Dosage Text VAG

Age 24 YR Duration

Sex Female

Country USA

Manufacturer

ABORTION SPONTANEOUS MATERNAL EXPOSURE DURING PREGNANCY PREGNANCY WITH CONTRACEPTIVE DEVICE

7635841 Date FDA Received

01-Oct-2010 Preferred Term

Case # 7635841

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2010SP051219 Dosage Text ; VAG

Age 40 YR Duration

Sex Female

Country USA

Manufacturer

VENTRICULAR EXTRASYSTOLES

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 205 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7628968 Date FDA Received
06-Oct-2010 Preferred Term HEADACHE ABDOMINAL PAIN UPPER CHOLECYSTECTOMY GALLBLADDER DISORDER MOOD SWINGS NAUSEA VOMITING Case # 7628968 Case Type DIRECT Product NUVARING Health Professional N Outcomes OT Role Route S Dosage Text Manufacturer Control # Age 24 YR Duration Sex Female Country USA

Manufacturer MERCK

7871702 Date FDA Received

06-Oct-2010 Preferred Term WEIGHT INCREASED ABDOMINAL PAIN

Case # 7871702

Case Type DIRECT Product NUVARING

Health Professional N

Outcomes HO,OT,RI Role Route S INTRAUTERINE

Manufacturer Control #

Age 22 YR

Sex Female

Country USA

Dosage Text 0.15MG PER DAY INTRA-UTERI

Duration

Manufacturer ORGANON

DISTURBANCE IN ATTENTION DIZZINESS DRUG INEFFECTIVE MIGRAINE NO THERAPEUTIC RESPONSE RECTAL HAEMORRHAGE UNEMPLOYMENT

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 206 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7612370 Date FDA Received
07-Oct-2010 Preferred Term CERVIX CARCINOMA BREAST CANCER FEMALE OESTROGEN RECEPTOR ASSAY POSITIVE PROGESTERONE RECEPTOR ASSAY POSITIVE Case # 7612370 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes OT Role Route S VAGINAL Manufacturer Control # 2010SP047671 Dosage Text VAG Age 45 YR Duration Sex Female Country USA

Manufacturer

6885112 Date FDA Received

08-Oct-2010 Preferred Term

Case # 6885112

Case Type EXPEDITED (15-DAY) Product NUVARING MARIJUANA TYLENOL

Health Professional Y

Outcomes DE,OT Role Route S C C

Manufacturer Control # 2009-189155-NL Dosage Text

Age 23 YR Duration

Sex Female

Country USA

Manufacturer

BLOOD POTASSIUM DECREASED CYANOSIS PUPILS UNEQUAL BRADYCARDIA CARDIO-RESPIRATORY ARREST CONVULSION DEVICE CAPTURING ISSUE GENERAL PHYSICAL HEALTH DETERIORATION MYDRIASIS NASOPHARYNGITIS POSTURING PULMONARY EMBOLISM PULSELESS ELECTRICAL ACTIVITY SPEECH DISORDER VARICOSE VEIN VASOCONSTRICTION

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 207 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7277786 Date FDA Received
12-Oct-2010 Preferred Term CEREBROVASCULAR ACCIDENT BLOOD PRESSURE INCREASED BLOOD POTASSIUM DECREASED HEART RATE INCREASED ANXIETY ARTHRALGIA CEREBRAL INFARCTION FLUID RETENTION HYPERSOMNIA HYPERVENTILATION MUSCLE SPASMS NEURALGIA OEDEMA PERIPHERAL PAIN IN EXTREMITY PHARYNGITIS TEMPERATURE INTOLERANCE Case # 7277786 Case Type EXPEDITED (15-DAY) Product NUVARING LEVOTHYROXINE IBUPROFEN FUROSEMIDE ZITHROMAX Health Professional Y Outcomes HO Role Route S C C C C Manufacturer Control # 2009-199324-NL Dosage Text Age 32 YR Duration Sex Female Country USA

Manufacturer

7279971 Date FDA Received

12-Oct-2010 Preferred Term

Case # 7279971

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes HO,DS,OT Role Route S VAGINAL

Manufacturer Control # 2010SP004550 Dosage Text VAG

Age 35 YR Duration

Sex Female

Country USA

Manufacturer

MYOCARDIAL INFARCTION ANGINA PECTORIS HYPERTENSION

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 208 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7541315 Date FDA Received
12-Oct-2010 Preferred Term PULMONARY EMBOLISM VAGINITIS BACTERIAL ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED ANAL FISSURE ASTHMA BLOOD HOMOCYSTEINE DECREASED BRONCHITIS CARDIAC ARREST CARDIAC DISORDER CONVULSION DERMATITIS HAEMORRHAGE HEADACHE HYPERCOAGULATION INTERNATIONAL NORMALISED RATIO INCREASED MIGRAINE OVARIAN CYST OVULATION PAIN PNEUMOTHORAX PROTEIN S DECREASED PROTHROMBIN TIME PROLONGED PULMONARY HYPERTENSION RECTAL HAEMORRHAGE RIGHT VENTRICULAR FAILURE UPPER RESPIRATORY TRACT INFECTION VARICOSE VEIN Case # 7541315 Case Type EXPEDITED (15-DAY) Product NUVARING ADVAIR DISKUS Health Professional Y Outcomes HO,OT Role Route S C Manufacturer Control # 2009SP035850 Dosage Text Age 29 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 209 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7368413 Date FDA Received
13-Oct-2010 Preferred Term PULMONARY EMBOLISM PANCREATITIS ACUTE CHOLELITHIASIS GOITRE ANAEMIA ATRIAL SEPTAL DEFECT CONSTIPATION DECREASED APPETITE DEEP VEIN THROMBOSIS DIARRHOEA DIZZINESS DYSPEPSIA HEPATIC STEATOSIS LEFT VENTRICULAR HYPERTROPHY NAUSEA WEIGHT INCREASED Case # 7368413 Case Type EXPEDITED (15-DAY) Product NUVARING PROVERA CELEXA ALBUTEROL Health Professional Y Outcomes HO,OT Role Route S S C C Manufacturer Control # 2009SP036537 Dosage Text Age 30 YR Duration Sex Female Country USA

Manufacturer

7657617 Date FDA Received

13-Oct-2010 Preferred Term

Case # 7657617

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO,DS,OT Role Route S VAGINAL

Manufacturer Control # 2010SP000788 Dosage Text QM; VAG

Age 43 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM INTERNATIONAL NORMALISED RATIO DECREASED TREATMENT NONCOMPLIANCE WHITE BLOOD CELL COUNT INCREASED

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 210 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7657905 Date FDA Received
13-Oct-2010 Preferred Term DEEP VEIN THROMBOSIS ABDOMINAL PAIN ANTIPHOSPHOLIPID SYNDROME BLOOD BILIRUBIN INCREASED BLOOD LACTATE DEHYDROGENASE INCREASED HYPERGLYCAEMIA HYPERTRIGLYCERIDAEMIA HYPOTHYROIDISM METABOLIC SYNDROME POLYCYSTIC OVARIES STRESS VAGINAL HAEMORRHAGE WEIGHT INCREASED Case # 7657905 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO Role Route S Manufacturer Control # 2009SP031688 Dosage Text Age 40 YR Duration Sex Female Country USA

Manufacturer

7658021 Date FDA Received

13-Oct-2010 Preferred Term

Case # 7658021

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes HO,OT Role Route S VAGINAL

Manufacturer Control # 2009SP043063 Dosage Text VAG

Age 32 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM BASEDOW'S DISEASE DEEP VEIN THROMBOSIS STRESS THROMBOSIS

Date - Time: 02-04-2013 9:43:10 AM EST

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Page: 211 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7662892 Date FDA Received
13-Oct-2010 Preferred Term PELVIC VENOUS THROMBOSIS DEEP VEIN THROMBOSIS PULMONARY EMBOLISM SYNCOPE Case # 7662892 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO,OT Role Route S VAGINAL Manufacturer Control # 2009SP038368 Dosage Text 1 DF;QM;VG Age 29 YR Duration Sex Female Country CHE

Manufacturer

7662952 Date FDA Received

13-Oct-2010 Preferred Term OVARIAN CYST MALAISE

Case # 7662952

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2010SP052387 Dosage Text VAG

Age 29 YR Duration

Sex Female

Country BRA

Manufacturer

MATERNAL EXPOSURE DURING PREGNANCY PREGNANCY WITH CONTRACEPTIVE DEVICE

7662969 Date FDA Received

13-Oct-2010 Preferred Term MALAISE CHOLECYSTECTOMY MUSCLE SPASMS

Case # 7662969

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2010SP031660 Dosage Text VAG

Age

Sex Female

Country USA

Duration

Manufacturer

7663232 Date FDA Received

13-Oct-2010 Preferred Term LEUKOPENIA EOSINOPHILIA LYMPHOCYTOSIS MONOCYTOSIS

Case # 7663232

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2010SP052295 Dosage Text

Age 30 YR Duration

Sex Female

Country DEU

Manufacturer

7284670
Date - Time: 02-04-2013 9:43:10 AM EST Note: If the field is blank, there is no data Page: 212 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7284670
FDA Received Date 14-Oct-2010 Preferred Term COLLATERAL CIRCULATION ILIAC VEIN OCCLUSION ANKLE FRACTURE ANXIETY ASTHENIA BACK PAIN BLOOD URINE PRESENT BONE GRAFT CELLULITIS CHEST PAIN COLONIC POLYP CONFUSIONAL STATE DEEP VEIN THROMBOSIS DEHYDRATION DIARRHOEA DISORIENTATION DIZZINESS DYSSTASIA ECCHYMOSIS EMOTIONAL DISORDER EPISTAXIS FALL FEELING HOT FRACTURE NONUNION GASTROENTERITIS NOROVIRUS GASTROINTESTINAL HAEMORRHAGE HAEMORRHAGE INTRACRANIAL HAEMORRHAGIC DIATHESIS Case # 7284670 Case Type EXPEDITED (15-DAY) Product NUVARING WELCHOL Health Professional Y Outcomes HO,DS Role Route S C Manufacturer Control # 2009-193753-NL Dosage Text 1 DF;QM Age 32 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

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Page: 213 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7284670
Preferred Term HALLUCINATION HEADACHE HEAD INJURY HYPERCOAGULATION IMPAIRED DRIVING ABILITY INTERNATIONAL NORMALISED RATIO DECREASED INTERNATIONAL NORMALISED RATIO INCREASED INTESTINAL OBSTRUCTION JOINT INJURY LEUKOCYTOSIS MATERNAL EXPOSURE BEFORE PREGNANCY MAY-THURNER SYNDROME MEDICAL DEVICE COMPLICATION MENORRHAGIA MIGRAINE NAUSEA OSTEOMYELITIS PHLEBITIS PLATELET COUNT INCREASED PLEURITIC PAIN POST THROMBOTIC SYNDROME PREGNANCY PROCEDURAL PAIN PULMONARY EMBOLISM RECTAL HAEMORRHAGE ROAD TRAFFIC ACCIDENT THROMBOPHLEBITIS SUPERFICIAL TOXICITY TO VARIOUS AGENTS TREATMENT NONCOMPLIANCE Product Role Route Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

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Page: 214 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7284670
Preferred Term URINARY TRACT INFECTION Product Role Route Dosage Text Duration Manufacturer

7652643 Date FDA Received

14-Oct-2010 Preferred Term LIBIDO DECREASED

Case # 7652643

Case Type DIRECT Product NUVARING

Health Professional Y

Outcomes OT Role Route S VAGINAL

Manufacturer Control #

Age 28 YR

Sex Female

Country USA

Dosage Text 1 RING VAGINAL EVERY 3 WKS MONTHLY VAG

Duration

Manufacturer ORGANON

ASTHENIA DEPRESSION FATIGUE HYPERSOMNIA INSOMNIA MIGRAINE MOOD SWINGS SUICIDAL IDEATION THYROID DISORDER TREATMENT NONCOMPLIANCE

7662996 Date FDA Received

14-Oct-2010 Preferred Term

Case # 7662996

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2010SP052889 Dosage Text

Age 21 YR Duration

Sex Female

Country DEU

Manufacturer

PREGNANCY WITH CONTRACEPTIVE DEVICE ABORTION MATERNAL EXPOSURE DURING PREGNANCY PREGNANCY

Date - Time: 02-04-2013 9:43:10 AM EST

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Page: 215 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7663026 Date FDA Received
14-Oct-2010 Preferred Term MENSTRUATION DELAYED BREAST PAIN ACNE DISCOMFORT INCORRECT DRUG ADMINISTRATION DURATION PNEUMONIA UTERINE DISORDER Case # 7663026 Case Type EXPEDITED (15-DAY) Product NUVARING PAROXETINE HYDROCHLORIDE Health Professional N Outcomes OT Role Route S C VAGINAL Manufacturer Control # 2010SP053740 Dosage Text ; QM; VAG Age 24 YR Duration Sex Female Country CHL

Manufacturer

7357888 Date FDA Received

18-Oct-2010 Preferred Term PAIN IN EXTREMITY

Case # 7357888

Case Type EXPEDITED (15-DAY) Product NUVARING CENTRUM

Health Professional Y

Outcomes HO,OT Role Route S C C C

Manufacturer Control # 2010SP016727 Dosage Text

Age 30 YR Duration

Sex Female

Country USA

Manufacturer

ABNORMAL WEIGHT GAIN PULMONARY EMBOLISM FACTOR V DEFICIENCY HEADACHE MENORRHAGIA MENSTRUAL DISORDER PELVIC VENOUS THROMBOSIS SINUS BRADYCARDIA SUPRAVENTRICULAR EXTRASYSTOLES

EXCEDRIN MIGRAINE TYLENOL

7653932 Date FDA Received

18-Oct-2010 Preferred Term

Case # 7653932

Case Type DIRECT Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control #

Age 35 YR

Sex Female

Country USA

Dosage Text ETHINYL ESTRADIOL; ETONOGESTRE ONCE MONTHLY VAG

Duration 9 MTH

Manufacturer NOVARTIS

BLOOD CHOLESTEROL INCREASED

Date - Time: 02-04-2013 9:43:10 AM EST

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Page: 216 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7655276 Date FDA Received
18-Oct-2010 Preferred Term DEPRESSION ALOPECIA DYSMENORRHOEA MOOD SWINGS PREMENSTRUAL SYNDROME WEIGHT INCREASED Case # 7655276 Case Type DIRECT Product NUVARING Health Professional N Outcomes DS,OT Role Route S VAGINAL Dosage Text 1 3 WEEKS VAG Duration Manufacturer Control # Age Sex Unknown Country USA

Manufacturer ORGANON

7655859 Date FDA Received

18-Oct-2010 Preferred Term

Case # 7655859

Case Type DIRECT Product NUVARING

Health Professional Y

Outcomes HO Role Route S VAGINAL

Manufacturer Control #

Age 18 YR

Sex Female

Country USA

Dosage Text 1 RING 3 OF 4 WEEKS/ MONTH VAG

Duration 6 MTH

Manufacturer ORGANON

SUPERIOR SAGITTAL SINUS THROMBOSIS INTRACRANIAL VENOUS SINUS THROMBOSIS JUGULAR VEIN THROMBOSIS TRANSVERSE SINUS THROMBOSIS

7661392 Date FDA Received

18-Oct-2010 Preferred Term

Case # 7661392

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes HO,OT Role Route S VAGINAL

Manufacturer Control # 2010SP004926 Dosage Text ; VAG

Age 21 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM DEEP VEIN THROMBOSIS

Date - Time: 02-04-2013 9:43:10 AM EST

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Page: 217 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7660981 Date FDA Received
19-Oct-2010 Preferred Term BIPOLAR I DISORDER HYPOTHYROIDISM AMENORRHOEA INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION INCORRECT DRUG ADMINISTRATION DURATION Case # 7660981 Case Type EXPEDITED (15-DAY) Product NUVARING LAMOTRIGINE LEVOTHYROXINE OMEPRAZOL /00661201/ Health Professional N Outcomes OT Role Route S C C C VAGINAL Manufacturer Control # 2010SP053793 Dosage Text ; QM; VAG Age 31 YR Duration Sex Female Country CHL

Manufacturer

7664719 Date FDA Received

19-Oct-2010 Preferred Term UTERINE POLYP

Case # 7664719

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2010SP054792 Dosage Text QM;VAG, QM;VAG

Age 37 YR Duration

Sex Female

Country CHL

Manufacturer

INCORRECT DRUG ADMINISTRATION DURATION

7665362 Date FDA Received

20-Oct-2010 Preferred Term URTICARIA LIP SWELLING PRURITUS

Case # 7665362

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2010SP054903 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

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Page: 218 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7344880 Date FDA Received
21-Oct-2010 Preferred Term VAGINAL HAEMORRHAGE PSYCHOSOMATIC DISEASE INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION ANXIETY COITAL BLEEDING INADEQUATE LUBRICATION INCORRECT DRUG ADMINISTRATION DURATION INFLAMMATION WEIGHT INCREASED Case # 7344880 Case Type EXPEDITED (15-DAY) Product NUVARING CENTELLA ASIATICA SPIRULINA /01514001/ Health Professional N Outcomes HO Role Route S C C VAGINAL Manufacturer Control # 2009-196616-NL Dosage Text ; VAG Age 26 YR Duration Sex Female Country CHL

Manufacturer

5948312 Date FDA Received

22-Oct-2010 Preferred Term

Case # 5948312

Case Type EXPEDITED (15-DAY) Product

Health Professional Y

Outcomes HO Role Route S S S S S S ORAL INTRAMUSCULAR ORAL ORAL ORAL

Manufacturer Control # B0403338A Dosage Text 300MG Per day

Age 24 YR Duration 1 DAY

Sex Female

Country USA

Manufacturer GLAXOSMITHKLINE GLAXOSMITHKLINE GLAXOSMITHKLINE MERCK

CHOLECYSTITIS ACUTE BILE DUCT STONE HYPERBILIRUBINAEMIA ABDOMINAL PAIN UPPER

WELLBUTRIN HERPES SIMPLEX VACCINE LAMICTAL ELAVIL PROZAC NUVARING

30MG Per day 40MG Per day 78 DAY

ELI LILLY AND CO ORGANON

7670838 Date FDA Received

22-Oct-2010 Preferred Term

Case # 7670838

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes HO Role Route S VAGINAL

Manufacturer Control # 2010SP054778 Dosage Text VAG

Age 29 YR Duration

Sex Female

Country ESP

Manufacturer

UTERINE CONTRACTIONS ABNORMAL OVARIAN CYST PAIN

Date - Time: 02-04-2013 9:43:10 AM EST

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Page: 219 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7676559 Date FDA Received
25-Oct-2010 Preferred Term WEIGHT INCREASED ABDOMINAL PAIN BLOOD CHOLESTEROL INCREASED CYST UTERINE LEIOMYOMA VAGINAL DISCHARGE Case # 7676559 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional N Outcomes OT Role Route S Manufacturer Control # 2010SP032428 Dosage Text Duration Age Sex Female Country DEU

Manufacturer

7676564 Date FDA Received

25-Oct-2010 Preferred Term

Case # 7676564

Case Type EXPEDITED (15-DAY) Product NUVARING Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes HO Role Route S

Manufacturer Control # 2010SP055824 Dosage Text

Age

Sex Female

Country ESP

Duration

Manufacturer

DRUG DOSE OMISSION

7676571 Date FDA Received

25-Oct-2010 Preferred Term PANCREATITIS

Case # 7676571

Health Professional N

Outcomes OT Role Route S C VAGINAL

Manufacturer Control # 2010SP055606 Dosage Text QM;VAG

Age 26 YR Duration

Sex Female

Country CHL

Manufacturer

INCORRECT DRUG ADMINISTRATION DURATION

METFORMIN HYDROCHLORIDE

7668057 Date FDA Received

27-Oct-2010 Preferred Term HAEMORRHAGE DEVICE DISLOCATION

Case # 7668057

Case Type DIRECT Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control #

Age 29 YR

Sex Female

Country USA

Dosage Text INSERT RING MONTHLY VAG

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

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Page: 220 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7668785 Date FDA Received
27-Oct-2010 Preferred Term PULMONARY EMBOLISM Case # 7668785 Case Type DIRECT Product NUVARING Case Type EXPEDITED (15-DAY) Product NUVARING Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional N Health Professional Y Health Professional Y Outcomes HO,LT Role Route S VAGINAL Dosage Text 0.12-0.015 MG/24 HRS VAG Manufacturer Control # 2010SP056059 Dosage Text Manufacturer Control # Age 40 YR Duration 13 DAY Age 23 YR Duration Sex Male Country CHE Manufacturer Sex Female Country USA

Manufacturer

7678907 Date FDA Received

27-Oct-2010 Preferred Term

Case # 7678907

Outcomes OT Role Route S Outcomes OT Role Route S VAGINAL

ERECTILE DYSFUNCTION

7677112 Date FDA Received

28-Oct-2010 Preferred Term

Case # 7677112

Manufacturer Control # 2010SP056634 Dosage Text ; VAG

Age 38 YR Duration

Sex Female

Country BRA

Manufacturer

INCORRECT DRUG ADMINISTRATION DURATION CERVIX CARCINOMA OFF LABEL USE

7678837 Date FDA Received

28-Oct-2010 Preferred Term MUSCLE TWITCHING DYSKINESIA METRORRHAGIA

Case # 7678837

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2010SP056130 Dosage Text VAG

Age

Sex Female

Country GBR

Duration

Manufacturer

7718784 Date FDA Received

28-Oct-2010 Preferred Term THROMBOSIS

Case # 7718784

Case Type DIRECT Product NUVARING

Health Professional N

Outcomes HO,LT,OT Role Route S VAGINAL

Manufacturer Control #

Age 45 YR

Sex Female

Country USA

Dosage Text .120-.015 NUVA RING INSERTED INSERT FOR 21 DAYS VAG

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 221 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7679816 Date FDA Received
29-Oct-2010 Preferred Term METRORRHAGIA DEVICE EXPULSION OVARIAN CYST WEIGHT INCREASED Case # 7679816 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional N Outcomes OT Role Route S Manufacturer Control # 2010SP048533 Dosage Text Age 29 YR Duration Sex Female Country RUS

Manufacturer

7680138 Date FDA Received

29-Oct-2010 Preferred Term DIABETES MELLITUS

Case # 7680138

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2010SP056365 Dosage Text 1 DF; ; VAG Manufacturer Control # 2010SP056192 Dosage Text

Age

Sex Female

Country FRA

Duration

Manufacturer

7681481 Date FDA Received

29-Oct-2010 Preferred Term

Case # 7681481

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S

Age 35 YR Duration

Sex Female

Country USA

Manufacturer

EMOTIONAL DISORDER AGORAPHOBIA ASTHENIA CRYING HYPOAESTHESIA MOVEMENT DISORDER PARAESTHESIA

7681525 Date FDA Received

29-Oct-2010 Preferred Term AMYLASE INCREASED LIPASE INCREASED

Case # 7681525

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2010SP055844 Dosage Text

Age 32 YR Duration

Sex Female

Country DEU

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 222 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7684145 Date FDA Received
01-Nov-2010 Preferred Term ABDOMINAL PAIN FOCAL NODULAR HYPERPLASIA Case # 7684145 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes OT Role Route S Manufacturer Control # 2010SP054553 Dosage Text Age 46 YR Duration Sex Female Country BEL

Manufacturer

7055057 Date FDA Received

02-Nov-2010 Preferred Term MIGRAINE CONVULSION

Case # 7055057

Case Type EXPEDITED (15-DAY) Product NUVARING AVELOX

Health Professional Y

Outcomes HO,OT Role Route S C C C

Manufacturer Control # 2008-187930-NL Dosage Text

Age 42 YR Duration

Sex Female

Country USA

Manufacturer

HAEMORRHAGIC CEREBRAL INFARCTION TRANSVERSE SINUS THROMBOSIS AMNESIA CHRONIC SINUSITIS DEEP VEIN THROMBOSIS ENCEPHALOMALACIA EXCORIATION FACIAL BONES FRACTURE FALL JUGULAR VEIN THROMBOSIS LIP INJURY MYOFASCIAL PAIN SYNDROME NASAL OEDEMA STATUS EPILEPTICUS SYNCOPE SYNOVITIS VISUAL ACUITY REDUCED

PREDNISOLONE BIAXIN

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 223 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7378276 Date FDA Received
03-Nov-2010 Preferred Term PULMONARY EMBOLISM THROMBOSIS VISION BLURRED ANAEMIA ATELECTASIS BREAST ENLARGEMENT CHEST PAIN COAGULATION FACTOR V LEVEL DECREASED DIZZINESS DYSPNOEA ESCHERICHIA TEST POSITIVE FATIGUE HEADACHE HYPOKALAEMIA MALAISE NAUSEA OROPHARYNGEAL PAIN PLEURITIC PAIN PNEUMONIA PREGNANCY PRESYNCOPE PULMONARY INFARCTION SYNCOPE UPPER RESPIRATORY TRACT INFECTION Case # 7378276 Case Type EXPEDITED (15-DAY) Product NUVARING TOPAMAX IMITREX Health Professional Y Outcomes HO,OT Role Route S C C Manufacturer Control # 2009SP037338 Dosage Text Age 29 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 224 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7654925 Date FDA Received
03-Nov-2010 Preferred Term UNINTENDED PREGNANCY ASTHENIA FATIGUE GAIT DISTURBANCE MALAISE HEPATIC PAIN Maternal exposure during pregnancy RENAL PAIN Case # 7654925 Case Type EXPEDITED (15-DAY) Product SORIATANE UNSPECIFIED INGREDIENT NUVARING ENBREL PROZAC Health Professional N Outcomes OT Role Route S S S C C ORAL Manufacturer Control # A0890356A Dosage Text Duration Age Sex Female Country USA

Manufacturer GLAXOSMITHKLINE

7703625 Date FDA Received

03-Nov-2010 Preferred Term METRORRHAGIA DIZZINESS SYNCOPE VOMITING

Case # 7703625

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2010SP056992 Dosage Text VAG

Age

Sex Female

Country USA

Duration

Manufacturer

7703668 Date FDA Received

03-Nov-2010 Preferred Term PAIN MULTIPLE INJURIES

Case # 7703668

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2010SP055790 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

7704631 Date FDA Received

03-Nov-2010 Preferred Term

Case # 7704631

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes DE,HO Role Route S VAGINAL

Manufacturer Control # 2010SP057426 Dosage Text VAG

Age 29 YR Duration 6 MTH

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 225 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7619365 Date FDA Received
04-Nov-2010 Preferred Term MIGRAINE DEEP VEIN THROMBOSIS CEREBRAL VENOUS THROMBOSIS CHEST PAIN FOLLICULITIS HYPERCOAGULATION NAUSEA SINUSITIS SUBARACHNOID HAEMORRHAGE SUPERIOR SAGITTAL SINUS THROMBOSIS VOMITING Case # 7619365 Case Type EXPEDITED (15-DAY) Product NUVARING PREDNISONE AUGMENTIN '125' Health Professional Y Outcomes HO,OT Role Route S C C Manufacturer Control # 2010SP025231 Dosage Text Age 29 YR Duration Sex Female Country USA

Manufacturer

7633608 Date FDA Received

04-Nov-2010 Preferred Term

Case # 7633608

Case Type EXPEDITED (15-DAY) Product NUVARING LOVENOX COUMADIN AVELOX TYLENOL

Health Professional Y

Outcomes HO,DS,OT Role Route S S S S C C C C VAGINAL

Manufacturer Control # 2010SP005483 Dosage Text VAG BID; TDER

Age 26 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM ANGINA PECTORIS PNEUMONIA IMMOBILE CONTUSION INJECTION SITE NODULE PANIC ATTACK INJECTION SITE HAEMATOMA ABDOMINAL DISCOMFORT ASTHMA BRONCHITIS BRONCHOSPASM CERVICAL DYSPLASIA CONDITION AGGRAVATED

ADVAIR DISKUS PROAIR HFA RELPAX

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 226 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7633608
Preferred Term DEPRESSION DRUG INTOLERANCE DYSPNOEA EPISTAXIS FATIGUE FEELING JITTERY FIBRIN D DIMER INCREASED HAEMOPTYSIS HYPOKALAEMIA IMPAIRED WORK ABILITY INJECTION SITE PAIN INJECTION SITE SWELLING MATERNAL EXPOSURE DURING PREGNANCY MIGRAINE MUSCLE SPASMS MYALGIA PLEURISY PLEURITIC PAIN PREGNANCY PROTEIN C DECREASED PROTEIN S DECREASED PULMONARY INFARCTION SINUSITIS TEMPOROMANDIBULAR JOINT SYNDROME TREATMENT NONCOMPLIANCE WEIGHT DECREASED Product Role Route Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 227 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7651828 Date FDA Received
05-Nov-2010 Preferred Term CEREBRAL VENOUS THROMBOSIS Case # 7651828 Case Type EXPEDITED (15-DAY) Product NUVARING Case Type DIRECT Product NUVARING Case Type DIRECT Product NUVARING Case # 7530330 Case Type EXPEDITED (15-DAY) Product NUVARING AMBIEN ZOLOFT Health Professional Y Health Professional N Health Professional Health Professional Y Outcomes HO Role Route S VAGINAL Manufacturer Control # 2010SP052058 Dosage Text VAG Manufacturer Control # Age 21 YR Dosage Text 1 RING 1/MONTH VAG Manufacturer Control # Age 24 YR Dosage Text MONTHLY VAG Manufacturer Control # 2010SP040149 Dosage Text Age 35 YR Duration Sex Female Country USA Duration Sex Female Duration Sex Female Country USA Age 21 YR Duration Sex Female Country USA

Manufacturer

7682155 Date FDA Received

05-Nov-2010 Preferred Term

Case # 7682155

Outcomes OT Role Route S VAGINAL

Manufacturer ORGANON Country USA

VAGINAL HAEMORRHAGE

7686787 Date FDA Received

08-Nov-2010 Preferred Term BREAST MASS

Case # 7686787

Outcomes OT Role Route S VAGINAL

Manufacturer

7530330 Date FDA Received

10-Nov-2010 Preferred Term

Outcomes DE,HO Role Route S C C

Manufacturer

CEREBRAL VENOUS THROMBOSIS INTRACRANIAL PRESSURE INCREASED ANEURYSM BRAIN DEATH CEREBRAL HAEMORRHAGE HEADACHE LEUKOCYTOSIS PRESYNCOPE SUBARACHNOID HAEMORRHAGE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 228 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7397234 Date FDA Received
12-Nov-2010 Preferred Term TREATMENT NONCOMPLIANCE DEHYDRATION ORTHOSTATIC HYPOTENSION BLOOD UREA DECREASED HYPOKALAEMIA EAR PAIN TINNITUS CEREBRAL INFARCTION FOOD POISONING DIZZINESS GASTROENTERITIS CEREBRAL THROMBOSIS MUSCLE SPASMS DIARRHOEA INFLUENZA Case # 7397234 Case Type EXPEDITED (15-DAY) Product NUVARING ARMOUR THYROID VITAMINS NOS PLAVIX SYNTHROID LEXAPRO XANAX TAMIFLU DARVOCET-N 100 PROZAC IBUPROFEN LEVOXYL CALCIUM Health Professional Y Outcomes HO Role Route S C C C C C C C C C C C C VAGINAL Manufacturer Control # 2009SP038212 Dosage Text 1 DF QM, VAG Age 37 YR Duration Sex Female Country USA

Manufacturer

7696751 Date FDA Received

12-Nov-2010 Preferred Term SCIATICA

Case # 7696751

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes HO Role Route S VAGINAL

Manufacturer Control # 2010SP058095 Dosage Text ;VAG

Age

Sex Female

Country ESP

Duration

Manufacturer

INCORRECT DRUG ADMINISTRATION DURATION

7699032 Date FDA Received

12-Nov-2010 Preferred Term CERVICAL DYSPLASIA DISCOMFORT

Case # 7699032

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2010SP058552 Dosage Text VAG

Age 23 YR Duration

Sex Female

Country ESP

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 229 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7702172 Date FDA Received
12-Nov-2010 Preferred Term HYPERTENSION FOCAL NODULAR HYPERPLASIA Case # 7702172 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional N Outcomes OT Role Route S Manufacturer Control # 2010SP058550 Dosage Text Duration Age Sex Female Country DEU

Manufacturer

7704903 Date FDA Received

12-Nov-2010 Preferred Term OVARIAN CYST

Case # 7704903

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes HO Role Route S

Manufacturer Control # 2010SP058381 Dosage Text 1 DF Manufacturer Control # 2010SP058512 Dosage Text ; VAG

Age

Sex Female

Country USA

Duration

Manufacturer

7704912 Date FDA Received

12-Nov-2010 Preferred Term OFF LABEL USE ARRHYTHMIA

Case # 7704912

Case Type EXPEDITED (15-DAY) Product NUVARING ASMANEX

Health Professional N

Outcomes OT Role Route S C VAGINAL

Age 31 YR Duration

Sex Female

Country USA

Manufacturer

7209574 Date FDA Received

16-Nov-2010 Preferred Term COLITIS ISCHAEMIC MIGRAINE ABDOMINAL PAIN NAUSEA VOMITING INTESTINAL POLYP

Case # 7209574

Case Type EXPEDITED (15-DAY) Product NUVARING MORPHINE IMITREX

Health Professional Y

Outcomes HO,OT Role Route S S C C C C Outcomes OT Role Route S

Manufacturer Control # 2009SP036158 Dosage Text

Age 33 YR Duration

Sex Female

Country USA

Manufacturer

EXCEDRIN MIGRAINE ATENOLOL P-EPHEDRINE Case # 7702059 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y

7702059 Date FDA Received

16-Nov-2010 Preferred Term CERVICAL DYSPLASIA

Manufacturer Control # 2010SP057221 Dosage Text

Age 30 YR Duration

Sex Female

Country DEU

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 230 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7707119 Date FDA Received
16-Nov-2010 Preferred Term ABASIA ARTHROPOD BITE ACUTE VESTIBULAR SYNDROME Case # 7707119 Case Type EXPEDITED (15-DAY) Product NUVARING UNSPECIFIED INGREDIENT ANTIDEPRESSANT Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional N Health Professional Y Outcomes OT Role Route S S C Outcomes OT Role Route S VAGINAL Manufacturer Control # 2010SP058688 Dosage Text VAG Age 33 YR Duration Sex Female Country BRA VAGINAL Manufacturer Control # 2010SP052009 Dosage Text ; VAG Age 36 YR Duration Sex Female Country LTU

Manufacturer

7707392 Date FDA Received

16-Nov-2010 Preferred Term HAEMORRHAGIC CYST

Case # 7707392

Manufacturer

INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION

7714120 Date FDA Received

22-Nov-2010 Preferred Term HAEMORRHAGE

Case # 7714120

Case Type DIRECT Product NUVARING

Health Professional N

Outcomes DS,OT Role Route S INTRAUTERINE

Manufacturer Control #

Age 19 YR

Sex Female

Country USA

Dosage Text 1 RING 1 RING EVERY 3 WKS INTRAUTERINE

Duration

Manufacturer

ANAEMIA BLOOD IRON DECREASED

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 231 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7727189 Date FDA Received
22-Nov-2010 Preferred Term INTRACRANIAL VENOUS SINUS THROMBOSIS BLOOD GLUCOSE INCREASED CEREBROVASCULAR ACCIDENT DEPRESSION DERMATITIS DISTURBANCE IN ATTENTION EMOTIONAL DISORDER HEADACHE INFLUENZA LIKE ILLNESS INITIAL INSOMNIA INJURY LOSS OF CONSCIOUSNESS MEMORY IMPAIRMENT PAIN PAPILLOMA VIRAL INFECTION SUBARACHNOID HAEMORRHAGE SUPERIOR SAGITTAL SINUS THROMBOSIS URINARY TRACT INFECTION UTERINE CERVICAL SQUAMOUS METAPLASIA VAGINITIS BACTERIAL Case # 7727189 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO Role Route S VAGINAL Manufacturer Control # 200SP017154 Dosage Text 1 DF;QM;VAG Age 23 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 232 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7368348 Date FDA Received
23-Nov-2010 Preferred Term IRRITABILITY AGGRESSION ANGER FATIGUE MENORRHAGIA PHLEBITIS SUPERFICIAL VAGINAL DISCHARGE Case # 7368348 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes OT Role Route S VAGINAL Manufacturer Control # 2010SP019461 Dosage Text 0.135 MG; VAG Age 29 YR Duration Sex Female Country HRV

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 233 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7551885 Date FDA Received
23-Nov-2010 Preferred Term PULMONARY EMBOLISM FIBRIN D DIMER INCREASED ANAEMIA VITAMIN B12 DEFICIENCY HYPERLIPIDAEMIA TROPONIN INCREASED ELECTROCARDIOGRAM ST SEGMENT ABNORMAL MITRAL VALVE INCOMPETENCE TRICUSPID VALVE INCOMPETENCE LEFT VENTRICULAR HYPERTROPHY ABORTION INCOMPLETE ABORTION SPONTANEOUS CARDIAC VALVE DISEASE DEEP VEIN THROMBOSIS FALL FLUSHING FOETAL DEATH MATERNAL EXPOSURE BEFORE PREGNANCY MIGRAINE PREGNANCY SYNCOPE THROMBOSIS Case # 7551885 Case Type EXPEDITED (15-DAY) Product NUVARING SEASONIQUE ZYRTEC BENICAR HCT LEXAPRO FEOSOL VITAMINS NOS VITAMIN B12 LISINOPRIL HYDROCHLOROTHIAZIDE Health Professional Y Outcomes HO,OT Role Route S S C C C C C C C C Manufacturer Control # 2009SP029587 Dosage Text Age 31 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 234 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7702088 Date FDA Received
23-Nov-2010 Preferred Term ECTOPIC PREGNANCY ABORTION INDUCED MATERNAL EXPOSURE DURING PREGNANCY Case # 7702088 Case Type EXPEDITED (15-DAY) Product NUVARING CHAMPIX /05703001/ Health Professional Y Outcomes OT Role Route S C VAGINAL Manufacturer Control # 2010SP058239 Dosage Text VAG Age 32 YR Duration Sex Female Country ESP

Manufacturer

7739832 Date FDA Received

23-Nov-2010 Preferred Term LICHEN SCLEROSUS CANDIDIASIS

Case # 7739832

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2010SP059389 Dosage Text

Age 33 YR Duration

Sex Female

Country AUS

Manufacturer

7739842 Date FDA Received

23-Nov-2010 Preferred Term THROMBOSIS

Case # 7739842

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes DE Role Route S VAGINAL

Manufacturer Control # 2010SP060999 Dosage Text VAG Manufacturer Control # 2005-124959-NL Dosage Text QM

Age

Sex Female

Country BRA

Duration

Manufacturer

5963771 Date FDA Received

30-Nov-2010 Preferred Term

Case # 5963771

Case Type NON-EXPEDITED Product NUVARING LEXAPRO

Health Professional Y

Outcomes HO,OT Role Route S C C

Age 26 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM CERVICAL DYSPLASIA CONTUSION ANXIETY CERVICITIS DEPRESSION FATIGUE FUNGAL INFECTION HEADACHE WITHDRAWAL BLEED

NORTRIPTYLINE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 235 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6262860 Date FDA Received
30-Nov-2010 Preferred Term PULMONARY EMBOLISM ENDOMETRIAL HYPERTROPHY OVARIAN CYST OFF LABEL USE Case # 6262860 Case Type NON-EXPEDITED Product NUVARING SARAFEM NEXIUM ADVIL Case # 6877910 Case Type NON-EXPEDITED Product NUVARING AMBIEN FIORICET ACETAMINOPHEN AND CODEINE PROVERA TOPAMAX MOTRIN Health Professional Y Health Professional Y Outcomes HO Role Route S C C C Outcomes HO Role Route S C C C C C C VAGINAL Manufacturer Control # 2008-188531-NL Dosage Text 1 DF; VAG Age 36 YR Duration Sex Female Country USA VAGINAL Manufacturer Control # 2006-138037-NL Dosage Text 1 DF;QM;VAG Age 41 YR Duration Sex Female Country USA

Manufacturer

6877910 Date FDA Received

30-Nov-2010 Preferred Term

Manufacturer

PULMONARY EMBOLISM MIGRAINE MYALGIA DEHYDRATION NAUSEA VOMITING

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 236 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6877914 Date FDA Received
30-Nov-2010 Preferred Term DEEP VEIN THROMBOSIS HYPOKALAEMIA HIDRADENITIS GASTROOESOPHAGEAL REFLUX DISEASE PHARYNGITIS SINUSITIS POLLAKIURIA BACK PAIN HYPERTENSION BREAST CYST URINARY TRACT INFECTION Case # 6877914 Case Type NON-EXPEDITED Product NUVARING DEPO-PROVERA ALLEGRA--D 24 HOUR BIAXIN AUGMENTIN '125' MACROBID OLUX ACIPHEX TEQUIN CEFZIL FLEXERIL MOTRIN Health Professional Y Outcomes HO Role Route S S C C C C C C C C C C Health Professional Y Outcomes HO Role Route S C C Manufacturer Control # 2008-181679-NL Dosage Text Age 26 YR Duration Sex Female Country USA VAGINAL Manufacturer Control # 2008-177914-NL Dosage Text Q3W;VAG Age 30 YR Duration Sex Female Country USA

Manufacturer

6898108 Date FDA Received

30-Nov-2010 Preferred Term

Case # 6898108

Case Type NON-EXPEDITED Product NUVARING ALBUTEROL ATROVENT

Manufacturer

PULMONARY EMBOLISM SMEAR CERVIX ABNORMAL PANIC ATTACK EXPOSURE TO TOXIC AGENT

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 237 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6980177 Date FDA Received
30-Nov-2010 Preferred Term DEPRESSION HEADACHE PULMONARY EMBOLISM MOOD SWINGS OEDEMA PERIPHERAL PRURITUS PULMONARY INFARCTION SWELLING Case # 6980177 Case Type NON-EXPEDITED Product NUVARING ORTHO TRI CYCLEN DICYCLOMINE HYDROCHLORIDE Health Professional Y Outcomes HO Role Route S C C Manufacturer Control # 2008-178511-NL Dosage Text Age 25 YR Duration Sex Female Country USA

Manufacturer

6994097 Date FDA Received

30-Nov-2010 Preferred Term

Case # 6994097

Case Type NON-EXPEDITED Product NUVARING CLARITIN ADVIL

Health Professional Y

Outcomes HO,OT Role Route S C C

Manufacturer Control # 2009-189966-NL Dosage Text

Age 29 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS PULMONARY EMBOLISM MICROCYTIC ANAEMIA

6994746 Date FDA Received

30-Nov-2010 Preferred Term

Case # 6994746

Case Type NON-EXPEDITED Product NUVARING ALEVE

Health Professional Y

Outcomes HO,OT Role Route S C

Manufacturer Control # 2009-195542-NL Dosage Text

Age 27 YR Duration

Sex Female

Country USA

Manufacturer

CEREBROVASCULAR ACCIDENT EMBOLISM VENOUS BRONCHITIS PHARYNGITIS RHINITIS SINUSITIS

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 238 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6999162 Date FDA Received
30-Nov-2010 Preferred Term PULMONARY EMBOLISM ANXIETY Case # 6999162 Case Type NON-EXPEDITED Product NUVARING Health Professional Y Outcomes HO Role Route S VAGINAL Manufacturer Control # 2009-195804-NL Dosage Text VAG Age 32 YR Duration Sex Female Country USA

Manufacturer

7007359 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7007359

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes HO Role Route S

Manufacturer Control # 2009-189561-NL Dosage Text 1 DF

Age 45 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS LOBAR PNEUMONIA

7012854 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7012854

Case Type NON-EXPEDITED Product NUVARING PENICILLIN CALTRATE AMOXIL

Health Professional Y

Outcomes HO Role Route S C C C

Manufacturer Control # 2008-181666-NL Dosage Text

Age 36 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS IRRITABLE BOWEL SYNDROME TOOTHACHE

7035168 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7035168

Case Type NON-EXPEDITED Product NUVARING EX-LAX ADVIL

Health Professional Y

Outcomes HO Role Route S C C C C

Manufacturer Control # 2009-198253-NL Dosage Text

Age 24 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS TENDONITIS

ORTHO TRI CYCLEN YASMIN

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 239 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7056862 Date FDA Received
30-Nov-2010 Preferred Term PULMONARY EMBOLISM GOITRE PHARYNGITIS Case # 7056862 Case Type NON-EXPEDITED Product NUVARING SYNTHROID PERCOCET PHENERGAN LEXAPRO INDERAL IMITREX CARISOPRODOL Health Professional Y Outcomes HO Role Route S C C C C C C C Outcomes HO Role Route S C Outcomes HO Role Route S Health Professional N Outcomes OT Role Route S Manufacturer Control # 2009SP023495 Dosage Text Duration Age Sex Female Country USA Manufacturer Control # 2009SP023242 Dosage Text Age 36 YR Duration Sex Female Country USA Manufacturer Control # 2009SP023293 Dosage Text 1 DF Age 33 YR Duration Sex Female Country USA Manufacturer Control # 2009-190406-NL Dosage Text 1 DF Age 31 YR Duration Sex Female Country USA

Manufacturer

7271454 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7271454

Case Type NON-EXPEDITED Product NUVARING

Health Professional N

Manufacturer

PULMONARY EMBOLISM

ACETAMINOPHEN

7271458 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7271458

Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Manufacturer

DEEP VEIN THROMBOSIS

7271462 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7271462

Manufacturer

DEEP VEIN THROMBOSIS

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 240 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7271476 Date FDA Received
30-Nov-2010 Preferred Term PULMONARY EMBOLISM DEEP VEIN THROMBOSIS VENA CAVA THROMBOSIS BILIARY DILATATION OCCULT BLOOD POSITIVE ATRIAL THROMBOSIS Case # 7271476 Case Type NON-EXPEDITED Product NUVARING BENADRYL TYLENOL WITH CODEINE ALEVE SKELAXIN IMITREX AMBIEN Health Professional Y Outcomes HO,OT Role Route S C C C C C C Health Professional N Outcomes HO Role Route S Manufacturer Control # 2009SP023489 Dosage Text Age 21 YR Duration Sex Female Country USA Manufacturer Control # 2009SP021058 Dosage Text Age 43 YR Duration Sex Female Country USA

Manufacturer

7271508 Date FDA Received

30-Nov-2010 Preferred Term VENOUS THROMBOSIS DYSPNOEA

Case # 7271508

Case Type NON-EXPEDITED Product NUVARING

Manufacturer

7276523 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7276523

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes HO Role Route S C

Manufacturer Control # 2009SP024439 Dosage Text 1 DF; QM

Age 29 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS VULVAL ABSCESS MENSTRUATION DELAYED NAUSEA PULMONARY EMBOLISM

ACETAMINOPHEN

7277671 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7277671

Case Type NON-EXPEDITED Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2009SP023522 Dosage Text 1 DF

Age

Sex Female

Country USA

Duration

Manufacturer

PULMONARY EMBOLISM DEEP VEIN THROMBOSIS

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 241 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7277698 Date FDA Received
30-Nov-2010 Preferred Term PULMONARY EMBOLISM Case # 7277698 Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING MOTRIN Case # 7278958 Case Type NON-EXPEDITED Product NUVARING ZOLOFT Health Professional Y Health Professional Y Health Professional N Health Professional N Outcomes OT Role Route S Outcomes OT Role Route S Outcomes HO Role Route S C Outcomes HO Role Route S C Manufacturer Control # 2009-200090-NL Dosage Text 1 DF Age 19 YR Duration Sex Female Country USA Manufacturer Control # 2009SP023408 Dosage Text 1 DF Manufacturer Control # 2009SP023423 Dosage Text 1 DF Manufacturer Control # 2009-194319-NL Dosage Text Age 35 YR Duration Sex Female Country USA Duration Age Sex Female Country USA Duration Age Sex Female Country USA

Manufacturer

7277713 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7277713

Manufacturer

DEEP VEIN THROMBOSIS

7278880 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7278880

Manufacturer

PULMONARY EMBOLISM GASTROENTERITIS

7278958 Date FDA Received

30-Nov-2010 Preferred Term

Manufacturer

DEEP VEIN THROMBOSIS DEPRESSION ANXIETY

7278960 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7278960

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2009-200084-NL Dosage Text 1 DF; QM; VAG

Age 36 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS BREAST PAIN DYSURIA VULVOVAGINAL PRURITUS

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 242 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7278962 Date FDA Received
30-Nov-2010 Preferred Term PULMONARY EMBOLISM DEEP VEIN THROMBOSIS PANIC ATTACK WEIGHT INCREASED Case # 7278962 Case Type NON-EXPEDITED Product NUVARING ADVAIR COMBIVENT Health Professional Y Outcomes HO Role Route S C C Manufacturer Control # 2009-200050-NL Dosage Text Age 46 YR Duration Sex Female Country USA

Manufacturer

7279180 Date FDA Received

30-Nov-2010 Preferred Term THROMBOTIC STROKE

Case # 7279180

Case Type NON-EXPEDITED Product NUVARING ACYCLOVIR

Health Professional Y

Outcomes HO Role Route S C C Outcomes HO Role Route S C C C C VAGINAL VAGINAL

Manufacturer Control # 2009SP021080 Dosage Text 1 DF;VAG

Age 30 YR Duration

Sex Female

Country USA

Manufacturer

ESTROGENS CONJUGATED

7280936 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7280936

Case Type NON-EXPEDITED Product NUVARING RAPTIVA

Health Professional Y

Manufacturer Control # 2009SP020332 Dosage Text 1 DF;QM;VAG

Age 38 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS GENITAL HERPES POST THROMBOTIC SYNDROME UPPER RESPIRATORY TRACT INFECTION

METHOTREXATE VALTREX FOLIC ACID

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 243 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7281009 Date FDA Received
30-Nov-2010 Preferred Term PULMONARY EMBOLISM ANXIETY FATIGUE GASTRITIS HYPERCHOLESTEROLAEMIA HYPOMENORRHOEA LIPOMA MIGRAINE NAUSEA Case # 7281009 Case Type NON-EXPEDITED Product NUVARING Health Professional Y Outcomes HO Role Route S VAGINAL Manufacturer Control # 2009SP017698 Dosage Text 1 DF; VAG Age 28 YR Duration Sex Female Country USA

Manufacturer

7281036 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7281036

Case Type NON-EXPEDITED Product NUVARING LODINE

Health Professional Y

Outcomes HO Role Route S C VAGINAL

Manufacturer Control # 2009SP017666 Dosage Text 1 DF; QM; VAG

Age 42 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM PAIN HEADACHE PITYRIASIS ROSEA

7281747 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7281747

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes HO,OT Role Route S C C VAGINAL

Manufacturer Control # 2009-189324-NL Dosage Text 1 DF; Q3W; VAG

Age 33 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS HYPERTENSION HEADACHE

MULTI-VITAMIN HYDROCHLOROTHIAZIDE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 244 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7281760 Date FDA Received
30-Nov-2010 Preferred Term PULMONARY EMBOLISM BRONCHITIS DERMATITIS CONTACT PLEURISY Case # 7281760 Case Type NON-EXPEDITED Product NUVARING Health Professional Y Outcomes HO Role Route S Manufacturer Control # 2008-188067-NL Dosage Text 1 DF Age 20 YR Duration Sex Female Country USA

Manufacturer

7281796 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7281796

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes HO Role Route S C C C C VAGINAL

Manufacturer Control # 2009SP017693 Dosage Text 1 DF; QM; VAG

Age 26 YR Duration

Sex Female

Country USA

Manufacturer

CEREBELLAR INFARCTION LIPOMA BLOOD PRESSURE INCREASED WEIGHT INCREASED

NORTRIPTYLINE PROPRANOLOL ACEON TOPAMAX

7281811 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7281811

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes HO Role Route S C VAGINAL

Manufacturer Control # 2009SP017178 Dosage Text 1 DF; QM; VAG

Age 24 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY INFARCTION PULMONARY EMBOLISM HEADACHE PAIN

ACETAMINOPHEN

7282122 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7282122

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes HO Role Route S C C VAGINAL

Manufacturer Control # 2009SP016940 Dosage Text 1 DF; QM; VAG

Age 28 YR Duration

Sex Female

Country USA

Manufacturer

TRANSVERSE SINUS THROMBOSIS SKIN PAPILLOMA

WELLBUTRIN ORTHO EVRA

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 245 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7283327 Date FDA Received
30-Nov-2010 Preferred Term DEEP VEIN THROMBOSIS PULMONARY EMBOLISM HEPATIC CYST Case # 7283327 Case Type NON-EXPEDITED Product NUVARING IBUPROFEN Health Professional Y Outcomes HO,OT Role Route S C Manufacturer Control # 2009-196598-NL Dosage Text 1 DF;QM Age 32 YR Duration Sex Female Country USA

Manufacturer

7284210 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7284210

Case Type NON-EXPEDITED Product NUVARING IBUPROFEN LEXAPRO

Health Professional Y

Outcomes OT Role Route S C C C C C C

Manufacturer Control # 2008-186350-NL Dosage Text 1 DF

Age 36 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS CHEST PAIN OFF LABEL USE

LORAZEPAM ALBUTEROL NEXIUM ALLEGRA

7284401 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7284401

Case Type NON-EXPEDITED Product NUVARING TYLENOL ASPIRIN ATIVAN

Health Professional Y

Outcomes HO,DS,OT Role Route S C C C

Manufacturer Control # 2008-182620-NL Dosage Text 1 DF

Age 36 YR Duration

Sex Female

Country USA

Manufacturer

BASAL GANGLIA INFARCTION DEPRESSION

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 246 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7284410 Date FDA Received
30-Nov-2010 Preferred Term PULMONARY EMBOLISM Case # 7284410 Case Type NON-EXPEDITED Product NUVARING ZOLOFT MOBIC PRILOSEC NEURONTIN LORTAB PREDNISONE ANCEF PERCOCET PLAQUENIL ZOLOFT Health Professional Y Outcomes HO Role Route S C C C C C C C C C C Manufacturer Control # 2008-183075-NL Dosage Text Age 41 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 247 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7284684 Date FDA Received
30-Nov-2010 Preferred Term VERTIGO POSITIONAL OVARIAN CYST RUPTURED SINUS DISORDER RHINITIS ALLERGIC HYDRONEPHROSIS BLOOD GLUCOSE ABNORMAL CONTUSION ARTHRALGIA URINARY TRACT INFECTION PULMONARY EMBOLISM OFF LABEL USE UTERINE LEIOMYOMA HUMAN BITE Case # 7284684 Case Type NON-EXPEDITED Product NUVARING ZYRTEC SINGULAIR VERAMYST FLUTICASONE PROPIONATE IBUPROFEN DIFFERIN BREVOXYL-4 CIPROFLOXACIN EXTENDEDRELEASE GUAIFEN PSE KETEK FLONASE ALPHAQUIN GUAIFENEX GP AZITHROMYCIN AMOXICILLIN ZYRTEC-D CLINDAMYCIN ACETAMINOPHEN AND CODEINE PHOSPHATE Health Professional Y Outcomes HO Role Route S C C C C C C C C C C C C C C C C C C Outcomes HO,OT Role Route S Manufacturer Control # 2009-193316-NL Dosage Text 1 DF Age 24 YR Duration Sex Female Country USA Manufacturer Control # 2008-185833-NL Dosage Text Age 33 YR Duration Sex Female Country USA

Manufacturer

7284729 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7284729

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Manufacturer

PULMONARY EMBOLISM VIRAL INFECTION

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 248 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7284745 Date FDA Received
30-Nov-2010 Preferred Term INTRACRANIAL VENOUS SINUS THROMBOSIS FALL LUMBAR RADICULOPATHY Case # 7284745 Case Type NON-EXPEDITED Product NUVARING CELEBREX SILVER SULFADIAZINE TRIMETHOPRIM & SULFAMETHOXAZOLE NAPROXEN Health Professional Y Outcomes HO Role Route S C C C C Health Professional Y Outcomes HO Role Route S C C C C C C Outcomes HO Role Route S C Manufacturer Control # 2009-200786-NL Dosage Text QM Age 20 YR Duration Sex Female Country USA VAGINAL Manufacturer Control # 2009-189961-NL Dosage Text 1 DF;VAG Age 32 YR Duration Sex Female Country USA Manufacturer Control # 2009-189942-NL Dosage Text Age 30 YR Duration Sex Female Country USA

Manufacturer

7284749 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7284749

Case Type NON-EXPEDITED Product NUVARING CAFFEINE ASPIRIN MOTRIN VICODIN

Manufacturer

PULMONARY EMBOLISM DEEP VEIN THROMBOSIS IRON DEFICIENCY ANAEMIA MENORRHAGIA

FLUCONAZOLE AMOXICILLIN

7284751 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7284751

Case Type NON-EXPEDITED Product NUVARING IMITREX

Health Professional

Manufacturer

CEREBRAL ARTERY THROMBOSIS MENSTRUATION IRREGULAR

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 249 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7284757 Date FDA Received
30-Nov-2010 Preferred Term PULMONARY EMBOLISM PULMONARY INFARCTION ANAEMIA RASH ERYTHEMATOUS Case # 7284757 Case Type NON-EXPEDITED Product NUVARING LEVOXYL IBUPROFEN Health Professional Outcomes HO,OT Role Route S C C VAGINAL Manufacturer Control # 2009-200633-NL Dosage Text 1 DF;QM;VAG Age 33 YR Duration Sex Female Country USA

Manufacturer

7284772 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7284772

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes HO,OT Role Route S C C C

Manufacturer Control # 2009-189708-NL Dosage Text 1 DF;QM

Age 31 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM DEEP VEIN THROMBOSIS CLOSTRIDIUM DIFFICILE COLITIS GASTROINTESTINAL HAEMORRHAGE BLOOD GLUCOSE INCREASED BRONCHITIS HYPERSENSITIVITY

LEVOTHROID PROTONIX CARAFATE

7284779 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7284779

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes HO,OT Role Route S VAGINAL

Manufacturer Control # 2009-198574-NL Dosage Text VAG

Age 32 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM BACK PAIN HAEMATURIA HYPOTENSION SUBCUTANEOUS NODULE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 250 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7284800 Date FDA Received
30-Nov-2010 Preferred Term DEEP VEIN THROMBOSIS Case # 7284800 Case Type NON-EXPEDITED Product NUVARING BENADRYL IBUPROFEN SUDAFED 12 HOUR RHINOCORT Health Professional Y Outcomes OT Role Route S C C C C Health Professional Y Outcomes OT Role Route S S VAGINAL SUBCUTANEOUS Manufacturer Control # 2009-196995-NL Dosage Text 1 DF;VAG 150 MG;QD;SC ; 100 MG;BID;SC Age 41 YR Duration Sex Female Country USA VAGINAL Manufacturer Control # 2009-197158-NL Dosage Text 1 DF; QW; VAG Age 36 YR Duration Sex Female Country USA

Manufacturer

7284802 Date FDA Received

30-Nov-2010 Preferred Term CONTUSION

Case # 7284802

Case Type NON-EXPEDITED Product NUVARING LOVENOX

Manufacturer

INJECTION SITE REACTION DEEP VEIN THROMBOSIS HEADACHE NAUSEA PYREXIA WEIGHT INCREASED

7284808 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7284808

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes HO Role Route S S C C C C ORAL

Manufacturer Control # 2009-197020-NL Dosage Text PO

Age 49 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM ERYTHEMA NODOSUM EPICONDYLITIS DERMATITIS ACNEIFORM

POTASSIUM IODIDE MAXALT MIDRIN IBUPROFEN ZOLOFT

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 251 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7284823 Date FDA Received
30-Nov-2010 Preferred Term PULMONARY EMBOLISM FATIGUE URINARY TRACT INFECTION Case # 7284823 Case Type NON-EXPEDITED Product NUVARING Health Professional Y Outcomes HO Role Route S VAGINAL Manufacturer Control # 2009-196760-NL Dosage Text VAG Age 33 YR Duration Sex Female Country USA

Manufacturer

7284825 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7284825

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes HO Role Route S C C C C C C C C C C C

Manufacturer Control # 2009-194924-NL Dosage Text 1 DF

Age 31 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM SKIN INFECTION

HYDROCHLOROTHIAZIDE IMITREX METOPROLOL TARTRATE CLINDAMYCIN FLUOXETINE NASACORT ACETAMINOPHEN AND CODEINE PHOSPHATE CEFUROXIME DOXYCYCLINE MONOHYDRATE OXYCODONE WITH APAP / 00554201/ TOPROL XL

7284828 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7284828

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes HO Role Route S C C C VAGINAL

Manufacturer Control # 2009-194926-NL Dosage Text VAG

Age 21 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS

WELLBUTRIN VITAMINS NOS ZOLOFT

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 252 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7284831 Date FDA Received
30-Nov-2010 Preferred Term DEEP VEIN THROMBOSIS Case # 7284831 Case Type NON-EXPEDITED Product NUVARING EFFEXOR GEODON TRAZODONE HYDROCHLORIDE Health Professional Y Outcomes HO Role Route S C C C Outcomes HO Role Route S C Manufacturer Control # 2009-200093-NL Dosage Text 1 DF Age 26 YR Duration Sex Female Country USA Manufacturer Control # 2009-194897-NL Dosage Text Age 48 YR Duration Sex Female Country USA

Manufacturer

7284833 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7284833

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Manufacturer

DEEP VEIN THROMBOSIS PULMONARY EMBOLISM POST THROMBOTIC SYNDROME

ORTHO EVRA

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 253 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7284834 Date FDA Received
30-Nov-2010 Preferred Term PULMONARY EMBOLISM DEEP VEIN THROMBOSIS GASTROENTERITIS VIRAL MUSCULOSKELETAL CHEST PAIN AMENORRHOEA GASTROENTERITIS BACTERIAL SINUSITIS OEDEMA PERIPHERAL INFLUENZA Case # 7284834 Case Type NON-EXPEDITED Product NUVARING SULFAMETHOXAZOLE FUROSEMIDE CYMBALTA VYTORIN ADVAIR ZYRTEC POTASSIUM CHLORIDE BENAZEPRIL HYDROCHLORIDE PROCHLORPERAZINE AMBIEN CR DARVOCET-N 100 ZITHROMAX NAPROXEN CYCLOBENZAPRINE PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN LIPITOR CLONAZEPAM CEFADROXIL Health Professional Y Outcomes HO Role Route S C C C C C C C C C C C C C C C C C C Manufacturer Control # 2009-194900-NL Dosage Text 1 DF Age 43 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 254 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7284855 Date FDA Received
30-Nov-2010 Preferred Term PULMONARY EMBOLISM Case # 7284855 Case Type NON-EXPEDITED Product NUVARING ZANTAC PREVACID PROTONIX PRILOSEC NEXIUM Health Professional Y Outcomes HO Role Route S C C C C C Health Professional Y Outcomes HO Role Route S C C C C C C Health Professional Y Outcomes HO Role Route S C C VAGINAL Manufacturer Control # 2008-182094-NL Dosage Text 1 DF;QM;VAG Age 35 YR Duration Sex Female Country USA VAGINAL Manufacturer Control # 2008-182080-NL Dosage Text 1 DF;VAG Age 43 YR Duration Sex Female Country USA VAGINAL Manufacturer Control # 2008-181337-NL Dosage Text VAG Age 23 YR Duration Sex Female Country USA

Manufacturer

7284860 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7284860

Case Type NON-EXPEDITED Product NUVARING TOPAMAX ALTACE DIOVAN

Manufacturer

PULMONARY EMBOLISM DEEP VEIN THROMBOSIS

ADDERALL XR TOPROL XL CONCERTA

7284866 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7284866

Case Type NON-EXPEDITED Product NUVARING LEVAQUIN VICODIN

Manufacturer

PULMONARY EMBOLISM STAPHYLOCOCCAL INFECTION TRAUMATIC FRACTURE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 255 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7284868 Date FDA Received
30-Nov-2010 Preferred Term INTRACRANIAL VENOUS SINUS THROMBOSIS CONJUNCTIVITIS ALLERGIC MYOPIA VITREOUS FLOATERS Case # 7284868 Case Type NON-EXPEDITED Product NUVARING Health Professional Y Outcomes HO Role Route S Manufacturer Control # 2008-181036-NL Dosage Text 1 DF Age 28 YR Duration Sex Female Country USA

Manufacturer

7284875 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7284875

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes HO Role Route S C C C C C VAGINAL

Manufacturer Control # 2008-179102-NL Dosage Text VAG

Age 35 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM DEEP VEIN THROMBOSIS

WARFARIN SODIUM ALBUTEROL VITAMINS NOS TYLENOL MOTRIN

7284877 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7284877

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes HO,DS Role Route S VAGINAL

Manufacturer Control # 2008-177156-NL Dosage Text 1 DF;QM;VAG

Age 37 YR Duration

Sex Female

Country USA

Manufacturer

CEREBROVASCULAR ACCIDENT BACK PAIN BLOOD PRESSURE DIASTOLIC INCREASED DEEP VEIN THROMBOSIS HEADACHE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 256 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7284879 Date FDA Received
30-Nov-2010 Preferred Term PULMONARY EMBOLISM DYSPNOEA Case # 7284879 Case Type NON-EXPEDITED Product NUVARING Health Professional Y Outcomes HO Role Route S VAGINAL Manufacturer Control # 2008-178171-NL Dosage Text VAG Age 32 YR Duration Sex Female Country USA

Manufacturer

7284881 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7284881

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes HO Role Route S C C C C C C C C C C C C C C C VAGINAL

Manufacturer Control # 2008-178223-NL Dosage Text 1 DF;QM;VAG

Age 29 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS DEPRESSION

LEVOTHYROXINE SODIUM SYNTHROID LEVOXYL MOBIC COMPAZINE HYDROCODONE BITARTRATE TOPAMAX ORPHENADRINE CITRATE ZOLOFT METHYLPREDNISOLONE RELPAX PROCHLORPERAZINE SERTRALINE HCL CHANTX PERCOCET

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 257 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7284883 Date FDA Received
30-Nov-2010 Preferred Term PULMONARY EMBOLISM ANXIETY OFF LABEL USE MYOPIA Case # 7284883 Case Type NON-EXPEDITED Product NUVARING LEVOCYL TRILEPTAL Health Professional Y Outcomes HO Role Route S C C VAGINAL Manufacturer Control # 2008-178224-NL Dosage Text 1 DF; VAG Age 21 YR Duration Sex Female Country USA

Manufacturer

7284888 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7284888

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes HO Role Route S C C Outcomes HO Role Route S C Outcomes HO Role Route S C C C C VAGINAL VAGINAL

Manufacturer Control # 2008-176269-NL Dosage Text 1 DF;QM;VAG

Age 33 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM UPPER RESPIRATORY TRACT INFECTION ANXIETY

AMOXICILLIN GUAIFEN (GUAIFENESIN)

7284889 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7284889

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Manufacturer Control # 2008-173126-NL Dosage Text

Age 29 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM

LORATADINE

7284914 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7284914

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Manufacturer Control # 2009-191024-NL Dosage Text 1 DF; VAG

Age 32 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM DEEP VEIN THROMBOSIS

ASCORBIC ACID VITAMIN D METFORMIN ADVAIR DISKUS

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 258 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7285083 Date FDA Received
30-Nov-2010 Preferred Term PULMONARY EMBOLISM LACERATION ACNE ALOPECIA HAEMANGIOMA MELANOCYTIC NAEVUS Case # 7285083 Case Type NON-EXPEDITED Product NUVARING LEVOXYL Health Professional Y Outcomes HO,OT Role Route S C Manufacturer Control # 2008-183092-NL Dosage Text Age 27 YR Duration Sex Female Country USA

Manufacturer

7285452 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7285452

Case Type NON-EXPEDITED Product NUVARING TYLENOL MOTRIN CALCIUM FISH OIL SYNTHROID

Health Professional Y

Outcomes HO,OT Role Route S C C C C C VAGINAL

Manufacturer Control # 2009-195832-NL Dosage Text VAG

Age 47 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS TENDONITIS HEPATIC LESION UPPER RESPIRATORY TRACT INFECTION PULMONARY EMBOLISM THROMBOPHLEBITIS

7285530 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7285530

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes HO Role Route S C Outcomes OT Role Route S

Manufacturer Control # 2009-195783-NL Dosage Text 1 DF

Age 36 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM

WARFARIN SODIUM

7286260 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7286260

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Manufacturer Control # 2009-195380-NL Dosage Text

Age 20 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 259 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7286309 Date FDA Received
30-Nov-2010 Preferred Term PULMONARY EMBOLISM IRON DEFICIENCY ANAEMIA HYPERSENSITIVITY MIGRAINE Case # 7286309 Case Type NON-EXPEDITED Product NUVARING EPINEPHRINE DECADRON PEPCID PREDNISONE SINGULAIR NEXIUM NASONEX BENADRYL ATARAX Health Professional Y Outcomes HO,OT Role Route S C C C C C C C C C Health Professional N Outcomes OT Role Route S Health Professional Y Outcomes HO Role Route S VAGINAL Manufacturer Control # 2008-181668-NL Dosage Text VAG Age 34 YR Duration Sex Female Country USA Manufacturer Control # 2009SP023300 Dosage Text Duration Age Sex Female Country USA Manufacturer Control # 2009-194910-NL Dosage Text 1 DF Age 41 YR Duration Sex Female Country USA

Manufacturer

7288528 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7288528

Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING

Manufacturer

PULMONARY EMBOLISM

7294747 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7294747

Manufacturer

PELVIC VENOUS THROMBOSIS MENORRHAGIA

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 260 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7305060 Date FDA Received
30-Nov-2010 Preferred Term ISCHAEMIC STROKE CEREBRAL THROMBOSIS THROMBOSIS Case # 7305060 Case Type NON-EXPEDITED Product NUVARING DEXFENFLURAMINE HYDROCHLORIDE UNSPECIFIED INGREDIENT Case # 7658088 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Health Professional Y Outcomes HO,OT Role Route S S S Outcomes HO Role Route S VAGINAL Manufacturer Control # 2010SP053193 Dosage Text 1 DF;VAG Age 22 YR Duration Sex Female Country FRA ORAL PO Manufacturer Control # 2009-189737-NL Dosage Text Age 29 YR Duration Sex Female Country USA

Manufacturer

7658088 Date FDA Received

30-Nov-2010 Preferred Term MANIA

Manufacturer

ABNORMAL BEHAVIOUR AFFECTIVE DISORDER AGGRESSION DISINHIBITION FEMALE SEXUAL DYSFUNCTION LOGORRHOEA PSYCHOMOTOR HYPERACTIVITY

7704905 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7704905

Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING

Health Professional N

Outcomes HO,DS Role Route S

Manufacturer Control # 2010SP026401 Dosage Text

Age 29 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM

7727796 Date FDA Received

30-Nov-2010 Preferred Term EMBOLISM VENOUS

Case # 7727796

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2010SP040278 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 261 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7734447 Date FDA Received
30-Nov-2010 Preferred Term PULMONARY EMBOLISM DEEP VEIN THROMBOSIS Case # 7734447 Case Type DIRECT Product NUVARING Health Professional N Outcomes HO,LT Role Route S VAGINAL Dosage Text .120MG/0.015MG PER DAY VAG Manufacturer Control # Age 51 YR Duration Sex Female Country USA

Manufacturer

7740208 Date FDA Received

30-Nov-2010 Preferred Term VASCULITIS

Case # 7740208

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2010SP060910 Dosage Text

Age 32 YR Duration

Sex Female

Country DEU

Manufacturer

7740251 Date FDA Received

30-Nov-2010 Preferred Term FACE OEDEMA ABDOMINAL PAIN AMENORRHOEA

Case # 7740251

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2010SP060134 Dosage Text

Age 35 YR Duration

Sex Female

Country DEU

Manufacturer

7805080 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7805080

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes

Manufacturer Control # 2009-190293-NL

Age 25 YR Duration

Sex Female

Country USA

Role Route S VAGINAL

Dosage Text VAG

Manufacturer

UNINTENDED PREGNANCY MEDICAL DEVICE DISCOMFORT

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 262 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7805131 Date FDA Received
30-Nov-2010 Preferred Term PULMONARY EMBOLISM PLEURITIC PAIN GASTROENTERITIS DEPRESSION HEADACHE INSOMNIA Case # 7805131 Case Type NON-EXPEDITED Product NUVARING NAPROXEN TORADEL Health Professional Y Outcomes HO Role Route S C C VAGINAL Manufacturer Control # 2007-167545-NL Dosage Text VAG Age 25 YR Duration Sex Female Country USA

Manufacturer

7805379 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7805379

Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING VICODIN SINGULAIR ADVAIR IBUPROFEN

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2010SP023814 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

DEEP VEIN THROMBOSIS

7805391 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7805391

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2010SP023819 Dosage Text

Age 47 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS

7805396 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7805396

Health Professional Y

Outcomes HO,LT,OT Role Route S C C C C VAGINAL

Manufacturer Control # 2010SP021372 Dosage Text 1 DF;VAG

Age

Sex Female

Country USA

Duration

Manufacturer

SUPERIOR SAGITTAL SINUS THROMBOSIS HAEMORRHAGE INTRACRANIAL

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 263 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7805403 Date FDA Received
30-Nov-2010 Preferred Term PULMONARY EMBOLISM FLATULENCE Case # 7805403 Case Type NON-EXPEDITED Product NUVARING TYLENOL LEVOXYL AMOXIL PRILOSEC Health Professional Y Outcomes HO Role Route S C C C C Health Professional N Outcomes HO,DS Role Route S Manufacturer Control # 2010SP052638 Dosage Text Age 22 YR Duration Sex Female Country USA Manufacturer Control # 2010SP021200 Dosage Text Age 35 YR Duration Sex Female Country USA

Manufacturer

7805885 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7805885

Case Type NON-EXPEDITED Product NUVARING

Manufacturer

PULMONARY THROMBOSIS THROMBOSIS

7805908 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7805908

Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2010SP053021 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

DEEP VEIN THROMBOSIS

7805916 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7805916

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2010SP025087 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

DEEP VEIN THROMBOSIS PULMONARY EMBOLISM

7805994 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7805994

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2010SP020549 Dosage Text

Age 20 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 264 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7806008 Date FDA Received
30-Nov-2010 Preferred Term DEEP VEIN THROMBOSIS PULMONARY EMBOLISM Case # 7806008 Case Type NON-EXPEDITED Product NUVARING Health Professional N Outcomes OT Role Route S Manufacturer Control # 2010SP020532 Dosage Text Duration Age Sex Female Country USA

Manufacturer

7806013 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7806013

Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes HO Role Route S VAGINAL

Manufacturer Control # 2010SP020389 Dosage Text 1 DF;QM;VAG Manufacturer Control # 2009SP016867

Age 20 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM

7806855 Date FDA Received

30-Nov-2010 Preferred Term SINUS DISORDER ACNE FLUSHING

Case # 7806855

Health Professional N

Outcomes

Age

Sex Female

Country USA

Role Route S VAGINAL

Dosage Text VAG

Duration

Manufacturer

7807498 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7807498

Case Type NON-EXPEDITED Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2010SP051460 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

PULMONARY EMBOLISM CHILLS FATIGUE HEADACHE INSOMNIA PAIN IN EXTREMITY

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 265 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7807527 Date FDA Received
30-Nov-2010 Preferred Term CEREBROVASCULAR ACCIDENT Case # 7807527 Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Health Professional Y Health Professional Y Health Professional Y Outcomes OT Role Route S Outcomes OT Role Route S Outcomes HO,LT,OT Role Route S Manufacturer Control # 2009SP030361 Dosage Text Age 42 YR Duration Sex Female Country USA Manufacturer Control # 2010SP047026 Dosage Text Age 24 YR Duration Sex Female Country USA Manufacturer Control # 2010SP048318 Dosage Text Age 21 YR Duration Sex Female Country USA

Manufacturer

7807602 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7807602

Manufacturer

CEREBRAL THROMBOSIS

7807604 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7807604

Manufacturer

PULMONARY EMBOLISM ILEUS

7807610 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7807610

Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING BOTOX

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2009SP029999 Dosage Text

Age

Sex Female

Country USA

Duration 3 WEEK

Manufacturer

DEEP VEIN THROMBOSIS

7807644 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7807644

Health Professional Y

Outcomes LT Role Route S C VAGINAL

Manufacturer Control # 2009SP029036 Dosage Text QM;VAG

Age 31 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 266 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7807657 Date FDA Received
30-Nov-2010 Preferred Term BLOOD PRESSURE INCREASED INCORRECT DRUG ADMINISTRATION DURATION Case # 7807657 Case Type NON-EXPEDITED Product NUVARING Health Professional N Outcomes OT Role Route S Manufacturer Control # 2009SP029318 Dosage Text Duration Age Sex Female Country USA

Manufacturer

7808138 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7808138

Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING IBUPROFEN

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2009SP029807 Dosage Text

Age 47 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM

7808331 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7808331

Health Professional N

Outcomes HO Role Route S C

Manufacturer Control # 2010SP004885 Dosage Text

Age 31 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM DEEP VEIN THROMBOSIS DYSMENORRHOEA

7808334 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7808334

Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2010SP004891 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

DEEP VEIN THROMBOSIS

7808339 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7808339

Health Professional Y

Outcomes HO Role Route S VAGINAL

Manufacturer Control # 2009SP032956 Dosage Text VAG

Age

Sex Female

Country USA

Duration

Manufacturer

PULMONARY EMBOLISM

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 267 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7808343 Date FDA Received
30-Nov-2010 Preferred Term THROMBOSIS Case # 7808343 Case Type NON-EXPEDITED Product NUVARING Case # 7808344 Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Health Professional Y Health Professional Y Health Professional N Health Professional Y Health Professional Y Health Professional Y Outcomes HO Role Route S Outcomes HO,OT Role Route S VAGINAL Manufacturer Control # 2009SP032781 Dosage Text 1 DF;Q3W; VAG Manufacturer Control # 2009SP031890 Dosage Text Age 51 YR Duration Sex Female Country USA Age 21 YR Duration Sex Female Country USA Manufacturer Control # 2009SP032912 Dosage Text Age 36 YR Duration Sex Female Country USA

Manufacturer

7808344 Date FDA Received

30-Nov-2010 Preferred Term

Manufacturer

PULMONARY EMBOLISM

7808347 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7808347

Outcomes OT Role Route S Outcomes OT Role Route S Outcomes OT Role Route S Outcomes OT Role Route S

Manufacturer

PULMONARY EMBOLISM

7808348 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7808348

Manufacturer Control # 2009SP031860 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

PULMONARY EMBOLISM

7808350 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7808350

Manufacturer Control # 2009SP030842 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

DEEP VEIN THROMBOSIS

7808352 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7808352

Manufacturer Control # 2009SP030843 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

HEPATIC VEIN THROMBOSIS

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 268 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7808354 Date FDA Received
30-Nov-2010 Preferred Term CEREBRAL INFARCTION CAROTID ARTERY OCCLUSION SINUS BRADYCARDIA Case # 7808354 Case Type NON-EXPEDITED Product NUVARING Health Professional Y Outcomes HO Role Route S Manufacturer Control # 2009SP030531 Dosage Text Age 46 YR Duration Sex Female Country USA

Manufacturer

7808357 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7808357

Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING GARDASIL Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2010SP038282 Dosage Text

Age 33 YR Duration

Sex Female

Country USA

Manufacturer

CEREBROVASCULAR ACCIDENT

7808370 Date FDA Received

30-Nov-2010 Preferred Term HEADACHE

Case # 7808370

Health Professional Y

Outcomes OT Role Route S C VAGINAL

Manufacturer Control # 2010SP038010 Dosage Text VAG

Age

Sex Female

Country USA

Duration

Manufacturer

CEREBROVASCULAR ACCIDENT

7808371 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7808371

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2010SP036324 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

CEREBROVASCULAR ACCIDENT

7808402 Date FDA Received

30-Nov-2010 Preferred Term THROMBOSIS

Case # 7808402

Health Professional Y

Outcomes HO Role Route S VAGINAL

Manufacturer Control # 2010SP035987 Dosage Text 1 DF; VAG

Age 33 YR Duration

Sex Female

Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 269 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7808403 Date FDA Received
30-Nov-2010 Preferred Term DEEP VEIN THROMBOSIS Case # 7808403 Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Health Professional Y Health Professional Y Health Professional Y Outcomes OT Role Route S VAGINAL Manufacturer Control # 2010SP034085 Dosage Text VAG Manufacturer Control # 2010SP032469 Dosage Text 1 DF; VAG Manufacturer Control # 2010SP040327 Dosage Text VAG Duration Age Sex Female Country USA Age 27 YR Duration Sex Female Country USA Age 33 YR Duration Sex Female Country USA

Manufacturer

7808414 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7808414

Outcomes OT Role Route S VAGINAL

Manufacturer

TRANSIENT ISCHAEMIC ATTACK

7808430 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7808430

Outcomes OT Role Route S VAGINAL

Manufacturer

DEEP VEIN THROMBOSIS PULMONARY EMBOLISM

7808432 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7808432

Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING VICODIN ADDERALL AMBIEN

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2010SP040146 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

PULMONARY EMBOLISM

7808447 Date FDA Received

30-Nov-2010 Preferred Term MIGRAINE

Case # 7808447

Health Professional N

Outcomes HO Role Route S C C C C C VAGINAL

Manufacturer Control # 2010SP039183 Dosage Text VAG

Age 40 YR Duration

Sex Female

Country USA

Manufacturer

THERAPEUTIC RESPONSE UNEXPECTED

PHENERGAN LEXAPRO

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 270 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7808457 Date FDA Received
30-Nov-2010 Preferred Term CEREBRAL ARTERY THROMBOSIS Case # 7808457 Case Type NON-EXPEDITED Product NUVARING DEPAKOTE SEROQUEL Health Professional N Outcomes HO Role Route S C C Health Professional N Outcomes OT Role Route S Health Professional Y Outcomes HO Role Route S Health Professional N VAGINAL Manufacturer Control # 2010SP028833 Dosage Text 1 DF; ;VAG Manufacturer Control # 2010SP028813 Dosage Text Age 24 YR Duration Sex Female Country USA Age 40 YR Duration Sex Female Country USA Manufacturer Control # 2010SP038523 Dosage Text Duration Age Sex Female Country USA Manufacturer Control # 2010SP029016 Dosage Text 1 DF; QM; Age 16 YR Duration Sex Female Country USA

Manufacturer

7808462 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7808462

Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING

Manufacturer

CEREBROVASCULAR ACCIDENT

7808467 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7808467

Manufacturer

TOXIC SHOCK SYNDROME

7808472 Date FDA Received

30-Nov-2010 Preferred Term MIGRAINE

Case # 7808472

Outcomes HO,OT Role Route S

Manufacturer

PULMONARY EMBOLISM THROMBOSIS

7808539 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7808539

Case Type NON-EXPEDITED Product NUVARING

Health Professional N

Outcomes HO Role Route S

Manufacturer Control # 2010SP018437 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

PULMONARY EMBOLISM DEEP VEIN THROMBOSIS

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 271 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7808540 Date FDA Received
30-Nov-2010 Preferred Term DEEP VEIN THROMBOSIS Case # 7808540 Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case # 7808614 Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Health Professional Y Health Professional Y Health Professional Y Health Professional Y Health Professional Y Health Professional N Outcomes OT Role Route S Outcomes OT Role Route S Outcomes HO,DS,LT,OT Role Route S VAGINAL Manufacturer Control # 2010SP047016 Dosage Text 1 DF; QM; VAG Manufacturer Control # 2010SP046831 Dosage Text Duration Age Sex Female Country USA Age 22 YR Duration Sex Female Country USA Manufacturer Control # 2010SP018426 Dosage Text Age 22 YR Duration Sex Female Country USA Manufacturer Control # 2010SP046933 Dosage Text Duration Age Sex Female Country USA

Manufacturer

7808542 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7808542

Manufacturer

PULMONARY EMBOLISM

7808558 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7808558

Manufacturer

PULMONARY EMBOLISM

7808613 Date FDA Received

30-Nov-2010 Preferred Term THROMBOSIS

Case # 7808613

Outcomes OT Role Route S Outcomes OT Role Route S VAGINAL

Manufacturer

7808614 Date FDA Received

30-Nov-2010 Preferred Term

Manufacturer Control # 2010SP044692 Dosage Text VAG Manufacturer Control # 2010SP044334 Dosage Text VAG

Age

Sex Female

Country USA

Duration

Manufacturer

CEREBROVASCULAR ACCIDENT

7808626 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7808626

Outcomes HO,LT Role Route S VAGINAL

Age 22 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 272 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7808628 Date FDA Received
30-Nov-2010 Preferred Term TOXIC SHOCK SYNDROME URINARY INCONTINENCE BREAST TENDERNESS VULVOVAGINAL BURNING SENSATION Case # 7808628 Case Type NON-EXPEDITED Product NUVARING SYNTHROID Health Professional N Outcomes OT Role Route S C VAGINAL Manufacturer Control # 2010SP043735 Dosage Text VAG Duration Age Sex Female Country USA

Manufacturer

7810055 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7810055

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes HO,OT Role Route S S C

Manufacturer Control # 2009SP043049 Dosage Text

Age 24 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM CEREBROVASCULAR ACCIDENT DEEP VEIN THROMBOSIS CANDIDIASIS CONTUSION EMOTIONAL DISTRESS GASTROOESOPHAGEAL REFLUX DISEASE LIGAMENT SPRAIN

PHENOTHIAZINE NAPROSYN

7810058 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7810058

Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2009SP042811 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

DEEP VEIN THROMBOSIS

7810059 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7810059

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2009SP042813 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

DEEP VEIN THROMBOSIS

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 273 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7810060 Date FDA Received
30-Nov-2010 Preferred Term DEEP VEIN THROMBOSIS Case # 7810060 Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Health Professional N Health Professional Y Health Professional Y Outcomes OT Role Route S Outcomes OT Role Route S Outcomes HO Role Route S Manufacturer Control # 2009SP042315 Dosage Text Age 32 YR Duration Sex Female Country USA Manufacturer Control # 2009SP042819 Dosage Text Duration Age Sex Female Country USA Manufacturer Control # 2009SP042815 Dosage Text Duration Age Sex Female Country USA

Manufacturer

7810063 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7810063

Manufacturer

DEEP VEIN THROMBOSIS

7810064 Date FDA Received

30-Nov-2010 Preferred Term THROMBOSIS

Case # 7810064

Manufacturer

PULMONARY EMBOLISM

7810066 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7810066

Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2009SP042054 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

PULMONARY EMBOLISM

7810068 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7810068

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2009SP041860 Dosage Text VAG

Age

Sex Female

Country USA

Duration

Manufacturer

DEEP VEIN THROMBOSIS

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 274 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7821331 Date FDA Received
30-Nov-2010 Preferred Term PULMONARY EMBOLISM Case # 7821331 Case Type NON-EXPEDITED Product NUVARING ZOFRAN SINGULAIR Health Professional Y Outcomes HO Role Route S C C Health Professional Y Outcomes HO,OT Role Route S Manufacturer Control # 2010SP000821 Dosage Text Age 38 YR Duration Sex Female Country USA VAGINAL Manufacturer Control # 2010SP001325 Dosage Text 1 DF;VAG Age 34 YR Duration Sex Female Country USA

Manufacturer

7821347 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7821347

Case Type NON-EXPEDITED Product NUVARING

Manufacturer

DEEP VEIN THROMBOSIS HYPERPHOSPHATAEMIA MIGRAINE PULMONARY EMBOLISM PULMONARY INFARCTION TENDONITIS

7821373 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7821373

Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2010SP000522 Dosage Text VAG Manufacturer Control # 2010SP018432 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

DEEP VEIN THROMBOSIS

7821571 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7821571

Health Professional Y

Outcomes OT Role Route S

Age 34 YR Duration

Sex Female

Country USA

Manufacturer

CEREBROVASCULAR ACCIDENT CAROTID ARTERY OCCLUSION

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 275 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7821575 Date FDA Received
30-Nov-2010 Preferred Term DEEP VEIN THROMBOSIS Case # 7821575 Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Health Professional Y Health Professional Y Outcomes OT Role Route S Outcomes OT Role Route S Manufacturer Control # 2010SP016907 Dosage Text 1 DF; QM Manufacturer Control # 2010SP016135 Dosage Text Age 31 YR Duration Sex Female Country USA Age 39 YR Duration Sex Female Country USA

Manufacturer

7821604 Date FDA Received

30-Nov-2010 Preferred Term DIZZINESS

Case # 7821604

Manufacturer

CEREBROVASCULAR ACCIDENT VISION BLURRED

7821712 Date FDA Received

30-Nov-2010 Preferred Term DEVICE DISLOCATION

Case # 7821712

Case Type NON-EXPEDITED Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2010SP001846 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

7821757 Date FDA Received

30-Nov-2010 Preferred Term MUSCLE RUPTURE

Case # 7821757

Case Type NON-EXPEDITED Product NUVARING

Health Professional N

Outcomes HO,OT Role Route S

Manufacturer Control # 2010SP015492 Dosage Text

Age 37 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM THROMBOSIS

7821777 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7821777

Case Type NON-EXPEDITED Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2010SP013232 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

DEEP VEIN THROMBOSIS PULMONARY EMBOLISM

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 276 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7823110 Date FDA Received
30-Nov-2010 Preferred Term PULMONARY EMBOLISM Case # 7823110 Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Health Professional Y Health Professional Y Health Professional Y Outcomes LT,OT Role Route S Outcomes OT Role Route S Outcomes HO Role Route S VAGINAL Manufacturer Control # 2010SP007353 Dosage Text 1 DF;QM;VAG, 1 DF;QM;VAG Age 26 YR Duration Sex Female Country USA Manufacturer Control # 2010SP007574 Dosage Text Age 44 YR Duration Sex Female Country USA Manufacturer Control # 2010SP007369 Dosage Text Duration Age Sex Female Country USA

Manufacturer

7823199 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7823199

Manufacturer

PORTAL VEIN THROMBOSIS

7823216 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7823216

Manufacturer

PULMONARY EMBOLISM DEEP VEIN THROMBOSIS

7823319 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7823319

Case Type NON-EXPEDITED Product NUVARING IBUPROFEN ALBUTEROL

Health Professional N

Outcomes HO Role Route S C C

Manufacturer Control # 2010SP007156 Dosage Text 1 DF

Age 22 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM HEADACHE ANXIETY

7825024 Date FDA Received

30-Nov-2010 Preferred Term METRORRHAGIA

Case # 7825024

Case Type NON-EXPEDITED Product NUVARING

Health Professional N

Outcomes

Manufacturer Control # 2009-197319-NL

Age 17 YR Duration

Sex Female

Country USA

Role Route S

Dosage Text

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 277 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7825110 Date FDA Received
30-Nov-2010 Preferred Term CEREBROVASCULAR ACCIDENT Case # 7825110 Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Health Professional N Health Professional Y Health Professional N Health Professional Y Outcomes OT Role Route S Outcomes OT Role Route S Outcomes OT Role Route S Outcomes OT Role Route S Manufacturer Control # 2010SP008149 Dosage Text Duration Age Sex Female Country USA Manufacturer Control # 2010SP009195 Dosage Text Duration Age Sex Female Country USA Manufacturer Control # 2010SP010782 Dosage Text Duration Age Sex Female Country USA Manufacturer Control # 2010SP028244 Dosage Text Duration Age Sex Female Country USA

Manufacturer

7825122 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7825122

Manufacturer

PULMONARY EMBOLISM

7825136 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7825136

Manufacturer

DEEP VEIN THROMBOSIS

7825179 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7825179

Manufacturer

CEREBROVASCULAR ACCIDENT DEEP VEIN THROMBOSIS

7825260 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7825260

Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2010SP013652 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

CEREBROVASCULAR ACCIDENT

7825288 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7825288

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2010SP027765 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

DEEP VEIN THROMBOSIS

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 278 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7825292 Date FDA Received
30-Nov-2010 Preferred Term PULMONARY EMBOLISM Case # 7825292 Case Type NON-EXPEDITED Product NUVARING MIRENA Health Professional Y Outcomes HO,LT Role Route S S Health Professional N Outcomes OT Role Route S Health Professional N Outcomes OT Role Route S Health Professional N Outcomes OT Role Route S C C Health Professional N Outcomes OT Role Route S Manufacturer Control # 2010SP013657 Dosage Text Duration Age Sex Female Country USA Manufacturer Control # 2010SP026677 Dosage Text Age 29 YR Duration Sex Female Country USA Manufacturer Control # 2010SP013654 Dosage Text Duration Age Sex Female Country USA IU Manufacturer Control # 2010SP013653 Dosage Text Duration Age Sex Female Country USA Manufacturer Control # 2010SP026808 Dosage Text Age 23 YR Duration Sex Female Country USA

Manufacturer

7825305 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7825305

Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING

Manufacturer

CEREBROVASCULAR ACCIDENT

7825308 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7825308

Manufacturer

CEREBROVASCULAR ACCIDENT

7825309 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7825309

Manufacturer

DEEP VEIN THROMBOSIS

RISPERIDONE ZOLOFT

7825320 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7825320

Case Type NON-EXPEDITED Product NUVARING

Manufacturer

CEREBROVASCULAR ACCIDENT

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 279 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7825340 Date FDA Received
30-Nov-2010 Preferred Term THROMBOSIS BACK PAIN OEDEMA PERIPHERAL VAGINAL HAEMORRHAGE Case # 7825340 Case Type NON-EXPEDITED Product NUVARING Health Professional N Outcomes HO,OT Role Route S Manufacturer Control # 2010SP026600 Dosage Text 1 DF Age 24 YR Duration Sex Female Country USA

Manufacturer

7825341 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7825341

Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2010SP013658 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

CEREBROVASCULAR ACCIDENT

7825352 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7825352

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2010SP013661 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

CEREBROVASCULAR ACCIDENT

7825354 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7825354

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2010SP013662 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

CEREBROVASCULAR ACCIDENT

7825374 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7825374

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2010SP013663 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

CEREBROVASCULAR ACCIDENT

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 280 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7825408 Date FDA Received
30-Nov-2010 Preferred Term CEREBROVASCULAR ACCIDENT Case # 7825408 Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING XOPENEX ADVAIR DISKUS PROVENTIL PRENATAL VITAMINS Health Professional Y Health Professional N Health Professional N Outcomes OT Role Route S Outcomes OT Role Route S Outcomes HO Role Route S C C C C Outcomes HO Role Route S C VAGINAL Manufacturer Control # 2009SP037373 Dosage Text VAG Age 24 YR Duration Sex Female Country USA Manufacturer Control # 2009SP037341 Dosage Text Age 22 YR Duration Sex Female Country USA Manufacturer Control # 2010SP013665 Dosage Text Duration Age Sex Female Country USA Manufacturer Control # 2010SP013664 Dosage Text Duration Age Sex Female Country USA

Manufacturer

7825428 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7825428

Manufacturer

CEREBROVASCULAR ACCIDENT

7825435 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7825435

Manufacturer

PULMONARY EMBOLISM PYREXIA

7825451 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7825451

Case Type NON-EXPEDITED Product NUVARING GARDASIL

Health Professional Y

Manufacturer

PULMONARY EMBOLISM VAGINAL DISCHARGE CERVICAL DYSPLASIA PAPILLOMA VIRAL INFECTION

7825454 Date FDA Received

30-Nov-2010 Preferred Term THROMBOSIS

Case # 7825454

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes HO Role Route S

Manufacturer Control # 2009SP037200 Dosage Text

Age 40 YR Duration

Sex Female

Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 281 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7825465 Date FDA Received
30-Nov-2010 Preferred Term DEEP VEIN THROMBOSIS Case # 7825465 Case Type NON-EXPEDITED Product NUVARING IRON SUPPLEMENT Health Professional Y Outcomes HO Role Route S C Outcomes HO,OT Role Route S C C VAGINAL Manufacturer Control # 2009SP036859 Dosage Text QM; VAG Age 35 YR Duration Sex Female Country USA Manufacturer Control # 2009SP040402 Dosage Text Age 21 YR Duration Sex Female Country USA

Manufacturer

7825474 Date FDA Received

30-Nov-2010 Preferred Term THROMBOSIS PARAESTHESIA OTITIS MEDIA

Case # 7825474

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Manufacturer

FAMOTIDINE IBUPROFEN

BLOOD PRESSURE INCREASED CELLULITIS DEEP VEIN THROMBOSIS DYSURIA HYPERSENSITIVITY OTITIS EXTERNA PULMONARY EMBOLISM

7825477 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7825477

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes HO,OT Role Route S VAGINAL

Manufacturer Control # 2009SP040180 Dosage Text VAG

Age 27 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM HAEMOGLOBIN INCREASED

7825480 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7825480

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2009SP036698 Dosage Text

Age 33 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 282 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7825490 Date FDA Received
30-Nov-2010 Preferred Term MEDICATION ERROR COLITIS Case # 7825490 Case Type NON-EXPEDITED Product NUVARING Health Professional Y Outcomes HO Role Route S Manufacturer Control # 2009SP039287 Dosage Text Age 25 YR Duration Sex Female Country USA

Manufacturer

7825495 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7825495

Case Type NON-EXPEDITED Product NUVARING THERAFLU

Health Professional Y

Outcomes HO,OT Role Route S C

Manufacturer Control # 2009SP038948 Dosage Text

Age 25 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM OEDEMA PERIPHERAL BREAST TENDERNESS CHEST PAIN DEEP VEIN THROMBOSIS METRORRHAGIA THROMBOSIS

7825520 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7825520

Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2009SP035941 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

PULMONARY EMBOLISM

7825529 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7825529

Health Professional Y

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2009SP035873 Dosage Text VAG Manufacturer Control # 2009SP035874 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

PULMONARY EMBOLISM

7825540 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7825540

Health Professional Y

Outcomes OT Role Route S

Age

Sex Female

Country USA

Duration

Manufacturer

PULMONARY EMBOLISM

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 283 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7825544 Date FDA Received
30-Nov-2010 Preferred Term PULMONARY EMBOLISM Case # 7825544 Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING CENTRUM TYLENOL EXCEDRIN MIGRAINE CEFDINIR PHENAVENT LA PROMETHAZINE HYDROCODONE BITARTRATE & ACETAMINOPHEN OXYCODONE AND ACETAMINOPHEN PROMETHAZINE ALBUTEROL Health Professional Y Health Professional Y Outcomes OT Role Route S VAGINAL Manufacturer Control # 2009SP035875 Dosage Text VAG Manufacturer Control # 2009SP035378 Dosage Text Age 35 YR Duration Sex Female Country USA Duration Age Sex Female Country USA

Manufacturer

7825548 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7825548

Outcomes HO,DS,OT Role Route S C C C C C C C C C C

Manufacturer

CEREBRAL VENOUS THROMBOSIS CEREBRAL INFARCTION SINUSITIS MIGRAINE BRONCHITIS

7825735 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7825735

Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2010SP013562 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

DEEP VEIN THROMBOSIS

7825750 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7825750

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2010SP013632 Dosage Text

Age 17 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 284 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7825751 Date FDA Received
30-Nov-2010 Preferred Term CEREBROVASCULAR ACCIDENT Case # 7825751 Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Health Professional N Health Professional N Health Professional N Health Professional N Health Professional N Health Professional N Outcomes OT Role Route S Outcomes OT Role Route S Outcomes OT Role Route S Outcomes OT Role Route S Outcomes OT Role Route S Outcomes OT Role Route S Manufacturer Control # 2010SP013644 Dosage Text Duration Age Sex Female Country USA Manufacturer Control # 2010SP013642 Dosage Text Duration Age Sex Female Country USA Manufacturer Control # 2010SP013640 Dosage Text Duration Age Sex Female Country USA Manufacturer Control # 2010SP013639 Dosage Text Duration Age Sex Female Country USA Manufacturer Control # 2010SP013636 Dosage Text Duration Age Sex Female Country USA Manufacturer Control # 2010SP013635 Dosage Text Duration Age Sex Female Country USA

Manufacturer

7825895 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7825895

Manufacturer

CEREBROVASCULAR ACCIDENT

7825899 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7825899

Manufacturer

CEREBROVASCULAR ACCIDENT

7825909 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7825909

Manufacturer

CEREBROVASCULAR ACCIDENT

7825920 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7825920

Manufacturer

CEREBROVASCULAR ACCIDENT

7825927 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7825927

Manufacturer

CEREBROVASCULAR ACCIDENT

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 285 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7825941 Date FDA Received
30-Nov-2010 Preferred Term CEREBROVASCULAR ACCIDENT Case # 7825941 Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Health Professional N Health Professional N Health Professional N Health Professional N Health Professional N Health Professional N Outcomes OT Role Route S Outcomes OT Role Route S Outcomes OT Role Route S Outcomes OT Role Route S Outcomes OT Role Route S Outcomes OT Role Route S Manufacturer Control # 2010SP013671 Dosage Text Duration Age Sex Female Country USA Manufacturer Control # 2010SP013668 Dosage Text Duration Age Sex Female Country USA Manufacturer Control # 2010SP013667 Dosage Text Duration Age Sex Female Country USA Manufacturer Control # 2010SP013666 Dosage Text Duration Age Sex Female Country USA Manufacturer Control # 2010SP013649 Dosage Text Duration Age Sex Female Country USA Manufacturer Control # 2010SP013648 Dosage Text Duration Age Sex Female Country USA

Manufacturer

7825946 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7825946

Manufacturer

CEREBROVASCULAR ACCIDENT

7825963 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7825963

Manufacturer

CEREBROVASCULAR ACCIDENT

7825964 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7825964

Manufacturer

CEREBROVASCULAR ACCIDENT

7825989 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7825989

Manufacturer

CEREBROVASCULAR ACCIDENT

7826010 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7826010

Manufacturer

CEREBROVASCULAR ACCIDENT

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 286 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7826054 Date FDA Received
30-Nov-2010 Preferred Term CEREBROVASCULAR ACCIDENT Case # 7826054 Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING TOPAMAX Case Type NON-EXPEDITED Product NUVARING Health Professional Y Health Professional Y Health Professional N Health Professional N Health Professional N Health Professional N Outcomes OT Role Route S Outcomes DS Role Route S Outcomes OT Role Route S Outcomes OT Role Route S Outcomes OT Role Route S C Outcomes OT Role Route S Manufacturer Control # 2009SP035112 Dosage Text 1 DF Duration Age Sex Female Country USA Manufacturer Control # 2010SP010806 Dosage Text Age 39 YR Duration Sex Female Country USA Manufacturer Control # 2010SP012053 Dosage Text Duration Age Sex Female Country USA Manufacturer Control # 2010SP013675 Dosage Text Duration Age Sex Female Country USA Manufacturer Control # 2010SP013673 Dosage Text Duration Age Sex Female Country USA Manufacturer Control # 2010SP013672 Dosage Text Duration Age Sex Female Country USA

Manufacturer

7826068 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7826068

Manufacturer

CEREBROVASCULAR ACCIDENT

7826086 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7826086

Manufacturer

CEREBROVASCULAR ACCIDENT

7826150 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7826150

Manufacturer

DEEP VEIN THROMBOSIS

7826225 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7826225

Manufacturer

PULMONARY EMBOLISM DEEP VEIN THROMBOSIS

7826299 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7826299

Manufacturer

DEEP VEIN THROMBOSIS

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 287 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7826780 Date FDA Received
30-Nov-2010 Preferred Term PULMONARY EMBOLISM Case # 7826780 Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING PREVACID Health Professional N Health Professional Y Outcomes HO Role Route S Outcomes OT Role Route S C VAGINAL Manufacturer Control # 2009SP033298 Dosage Text 1 DF;QM;VAG Age 25 YR Duration Sex Female Country USA Manufacturer Control # 2009SP034025 Dosage Text Age 22 YR Duration Sex Female Country USA

Manufacturer

7826787 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7826787

Manufacturer

GALLBLADDER DISORDER LACTOSE INTOLERANCE ABDOMINAL PAIN ACNE DYSPEPSIA EXERTIONAL HEADACHE IRRITABLE BOWEL SYNDROME MUSCLE SPASMS

7826788 Date FDA Received

30-Nov-2010 Preferred Term THROMBOSIS

Case # 7826788

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2009SP033386 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

7826789 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7826789

Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING

Health Professional N

Outcomes HO Role Route S

Manufacturer Control # 2009SP033197 Dosage Text

Age 39 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS

7826791 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7826791

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2009SP032936 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

DEEP VEIN THROMBOSIS

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 288 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7826796 Date FDA Received
30-Nov-2010 Preferred Term DEEP VEIN THROMBOSIS PULMONARY EMBOLISM Case # 7826796 Case Type NON-EXPEDITED Product NUVARING Health Professional Y Outcomes OT Role Route S VAGINAL Manufacturer Control # 2010SP042481 Dosage Text VAG Duration Age Sex Female Country USA

Manufacturer

7826806 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7826806

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes HO,LT,OT Role Route S C C Outcomes HO,DS,LT Role Route S VAGINAL VAGINAL

Manufacturer Control # 2010SP041565 Dosage Text 1 DF;QM;VAG

Age 41 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM

OMEPRAZOLE GLUCOSAMINE

7826808 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7826808

Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Manufacturer Control # 2010SP041249 Dosage Text 1 DF; VAG, 1 DF; VAG Manufacturer Control # 2010SP006074 Dosage Text

Age 49 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM

7826839 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7826839

Health Professional N

Outcomes OT Role Route S

Age

Sex Female

Country USA

Duration

Manufacturer

DEEP VEIN THROMBOSIS

7826843 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7826843

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2010SP006080 Dosage Text VAG

Age

Sex Female

Country USA

Duration

Manufacturer

PULMONARY EMBOLISM

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 289 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7826844 Date FDA Received
30-Nov-2010 Preferred Term DEEP VEIN THROMBOSIS Case # 7826844 Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Health Professional N Health Professional Y Outcomes OT Role Route S Outcomes OT Role Route S Manufacturer Control # 2010SP004579 Dosage Text Duration Age Sex Female Country USA Manufacturer Control # 2010SP005614 Dosage Text Age 26 YR Duration Sex Female Country USA

Manufacturer

7826862 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7826862

Manufacturer

DEEP VEIN THROMBOSIS THROMBOSIS

7826882 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7826882

Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2010SP004269 Dosage Text VAG Manufacturer Control # 2010SP003982 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

PULMONARY EMBOLISM

7826910 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7826910

Health Professional N

Outcomes OT Role Route S

Age

Sex Female

Country USA

Duration

Manufacturer

DEEP VEIN THROMBOSIS

7827002 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7827002

Health Professional N

Outcomes

Manufacturer Control # 2009SP018434

Age 29 YR Duration

Sex Female

Country USA

Role Route S C VAGINAL

Dosage Text VAG

Manufacturer

WRONG TECHNIQUE IN DRUG USAGE PROCESS FEELING ABNORMAL HYPERTENSION

LOPRESSOR

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 290 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7827175 Date FDA Received
30-Nov-2010 Preferred Term HEPATIC ENZYME INCREASED Case # 7827175 Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Health Professional N Health Professional Y Outcomes OT Role Route S VAGINAL Manufacturer Control # 2010SP046142 Dosage Text VAG Manufacturer Control # 2010SP045397 Dosage Text VAG Age 22 YR Duration Sex Female Country USA Duration Age Sex Female Country USA

Manufacturer

7827195 Date FDA Received

30-Nov-2010 Preferred Term MENORRHAGIA PAIN

Case # 7827195

Outcomes HO Role Route S VAGINAL

Manufacturer

UNINTENDED PREGNANCY

7827211 Date FDA Received

30-Nov-2010 Preferred Term MIGRAINE

Case # 7827211

Case Type NON-EXPEDITED Product NUVARING

Health Professional N

Outcomes HO Role Route S VAGINAL

Manufacturer Control # 2010SP045409 Dosage Text 1 DF; VAG Manufacturer Control # 2010SP045359 Dosage Text Q3W; VAG Manufacturer Control # 2010SP045122 Dosage Text 1 DF; QM; VAG

Age 28 YR Duration

Sex Female

Country USA

Manufacturer

7827238 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7827238

Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes HO,DS,LT Role Route S VAGINAL

Age 33 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM

7827277 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7827277

Health Professional Y

Outcomes HO,LT Role Route S VAGINAL

Age 29 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 291 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7827388 Date FDA Received
30-Nov-2010 Preferred Term PULMONARY EMBOLISM BACK PAIN Case # 7827388 Case Type NON-EXPEDITED Product NUVARING COUMADIN Case # 7828745 Case Type NON-EXPEDITED Product NUVARING PROZAC BONIVA ZOVIRAX PREVACID Health Professional Y Health Professional Y Outcomes HO,DS,LT Role Route S C Outcomes HO,LT Role Route S C C C C Health Professional N Outcomes OT Role Route S Manufacturer Control # 2010SP031958 Dosage Text Duration Age Sex Female Country USA VAGINAL Manufacturer Control # 2010SP035160 Dosage Text VAG Age 42 YR Duration Sex Female Country USA VAGINAL Manufacturer Control # 2010SP042475 Dosage Text VAG Age 26 YR Duration 4 YEAR Sex Female Country USA

Manufacturer

7828745 Date FDA Received

30-Nov-2010 Preferred Term

Manufacturer

BREAST CANCER IN SITU

7828757 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7828757

Case Type NON-EXPEDITED Product NUVARING

Manufacturer

DEEP VEIN THROMBOSIS THROMBOPHLEBITIS SUPERFICIAL

7828780 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7828780

Case Type NON-EXPEDITED Product NUVARING

Health Professional N

Outcomes HO Role Route S VAGINAL

Manufacturer Control # 2010SP031217 Dosage Text VAG

Age 30 YR Duration

Sex Female

Country CHE

Manufacturer

DEEP VEIN THROMBOSIS PULMONARY EMBOLISM

7828783 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7828783

Case Type NON-EXPEDITED Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2010SP030337 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

PULMONARY EMBOLISM

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 292 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7834552 Date FDA Received
30-Nov-2010 Preferred Term DEEP VEIN THROMBOSIS Case # 7834552 Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Health Professional Y Health Professional Y Outcomes HO,OT Role Route S Outcomes OT Role Route S Manufacturer Control # 2009-19449-NL Dosage Text 1 DF Manufacturer Control # 2010SP023073 Dosage Text Age 29 YR Duration Sex Female Country USA Age 45 YR Duration Sex Female Country USA

Manufacturer

7845546 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7845546

Manufacturer

DEEP VEIN THROMBOSIS PULMONARY EMBOLISM

7847241 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7847241

Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes

Manufacturer Control # 2009SP019177

Age 24 YR Duration

Sex Female

Country USA

Role Route S Health Professional N Outcomes HO Role Route S Health Professional Y Outcomes OT Role Route S Health Professional N VAGINAL

Dosage Text

Manufacturer

MEDICAL DEVICE DISCOMFORT

7847646 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7847646

Manufacturer Control # 2010SP044750 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

PULMONARY THROMBOSIS

7847861 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7847861

Manufacturer Control # 2010SP032466 Dosage Text 1 DF; VAG Manufacturer Control # 2010SP016187 Dosage Text

Age 27 YR Duration

Sex Female

Country USA

Manufacturer

TRANSIENT ISCHAEMIC ATTACK

7871245 Date FDA Received

30-Nov-2010 Preferred Term

Case # 7871245

Outcomes OT Role Route S

Age 17 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 293 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7704790 Date FDA Received
01-Dec-2010 Preferred Term PULMONARY EMBOLISM ACTIVITIES OF DAILY LIVING IMPAIRED FIBRIN D DIMER INCREASED HAEMORRHOIDS LIGAMENT SPRAIN OSTEOARTHRITIS PAIN PULMONARY HAEMORRHAGE SMEAR CERVIX ABNORMAL UNEVALUABLE EVENT URINARY TRACT INFECTION Case # 7704790 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO,OT Role Route S Manufacturer Control # 2010SP004919 Dosage Text Age 28 YR Duration Sex Female Country USA

Manufacturer

7743725 Date FDA Received

02-Dec-2010 Preferred Term DEPRESSION

Case # 7743725

Case Type DIRECT Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control #

Age 40 YR

Sex Female

Country USA

Dosage Text 1 RING MONTHLY

Duration

Manufacturer

CONDITION AGGRAVATED

7414669 Date FDA Received

03-Dec-2010 Preferred Term

Case # 7414669

Case Type EXPEDITED (15-DAY) Product NUVARING ALEVE TYLENOL

Health Professional Y

Outcomes HO,OT Role Route S C C VAGINAL

Manufacturer Control # 2010SP014796 Dosage Text QM; VAG

Age 36 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM DEEP VEIN THROMBOSIS ABORTION SPONTANEOUS PREGNANCY WITH CONTRACEPTIVE DEVICE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 294 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7749918 Date FDA Received
03-Dec-2010 Preferred Term SURGERY INTRA-UTERINE CONTRACEPTIVE DEVICE REMOVAL Case # 7749918 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional N Outcomes HO,OT Role Route S VAGINAL Manufacturer Control # 2010SP061723 Dosage Text VAG Duration Age Sex Female Country ESP

Manufacturer

7750723 Date FDA Received

03-Dec-2010 Preferred Term

Case # 7750723

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO Role Route S

Manufacturer Control # 2010SP053769 Dosage Text

Age 36 YR Duration

Sex Female

Country CHE

Manufacturer

BARTHOLIN'S ABSCESS BARTHOLIN'S CYST

7688351 Date FDA Received

06-Dec-2010 Preferred Term THYROIDITIS WEIGHT DECREASED ANXIETY INSOMNIA NECK PAIN TREMOR

Case # 7688351

Case Type EXPEDITED (15-DAY) Product NUVARING NORDETTE

Health Professional N

Outcomes OT Role Route S C VAGINAL

Manufacturer Control # 2010SP056563 Dosage Text QM; VAG

Age 29 YR Duration

Sex Female

Country MEX

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 295 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7271467 Date FDA Received
07-Dec-2010 Preferred Term CEREBROVASCULAR ACCIDENT HYPERSENSITIVITY SWELLING CENTRAL NERVOUS SYSTEM DERMOID TUMOUR CHEST PAIN CONFUSIONAL STATE DIZZINESS DYSLIPIDAEMIA ERYTHEMA FEELING HOT HAEMATOMA MENTAL DISORDER MIGRAINE NECROSIS PAIN IN EXTREMITY PANIC REACTION PULMONARY VALVE INCOMPETENCE SWELLING FACE VISION BLURRED Case # 7271467 Case Type EXPEDITED (15-DAY) Product NUVARING EFFEXOR XR MIRALAX Health Professional Y Outcomes HO Role Route S C C Manufacturer Control # 2009SP023505 Dosage Text 1 DF Age 27 YR Duration Sex Female Country USA

Manufacturer

7753274 Date FDA Received

07-Dec-2010 Preferred Term CONVULSION

Case # 7753274

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2010SP062365 Dosage Text VAG

Age

Sex Female

Country USA

Duration

Manufacturer

ROAD TRAFFIC ACCIDENT

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 296 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7751550 Date FDA Received
08-Dec-2010 Preferred Term CERVIX CARCINOMA STAGE I Case # 7751550 Case Type EXPEDITED (15-DAY) Product NUVARING Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Health Professional N Outcomes HO,LT Role Route S VAGINAL Manufacturer Control # 2010SP063197 Dosage Text ;VAG Manufacturer Control # 2010SP063185 Dosage Text ;VAG Age 32 YR Duration 1.25 YEAR Age 26 YR Duration 3 MTH Sex Female Country CAN Sex Female Country CAN

Manufacturer

7751624 Date FDA Received

08-Dec-2010 Preferred Term CERVICAL DYSPLASIA CERVIX CARCINOMA

Case # 7751624

Outcomes LT,OT Role Route S VAGINAL

Manufacturer

7773016 Date FDA Received

08-Dec-2010 Preferred Term SUICIDAL IDEATION

Case # 7773016

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S C Outcomes HO,DS Role Route S S C VAGINAL TRANSDERMAL VAGINAL

Manufacturer Control # 2010SP061923 Dosage Text ;QM;VAG

Age 46 YR Duration

Sex Female

Country NLD

Manufacturer

SERTRALINE

7773992 Date FDA Received

08-Dec-2010 Preferred Term DEPRESSION

Case # 7773992

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Manufacturer Control # 2007-152597 Dosage Text VAG TDER

Age 23 YR Duration

Sex Female

Country USA

Manufacturer

PROTEIN S DEFICIENCY ARTERIAL OCCLUSIVE DISEASE ABORTION INDUCED ACUTE MYOCARDIAL INFARCTION ALCOHOL USE ANXIETY CHEST PAIN COGNITIVE DISORDER CONGESTIVE CARDIOMYOPATHY CONTUSION

ORTHO EVRA NEXIUM

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 297 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7773992
Preferred Term CORONARY ARTERY DISEASE CORONARY ARTERY OCCLUSION CORONARY ARTERY THROMBOSIS COUGH DYSLIPIDAEMIA DYSPNOEA DYSPNOEA EXERTIONAL DYSTHYMIC DISORDER FATIGUE HERPES SIMPLEX HYPERCOAGULATION ILIAC ARTERY OCCLUSION INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION INTERMITTENT CLAUDICATION INTERNATIONAL NORMALISED RATIO DECREASED ISCHAEMIC CARDIOMYOPATHY LEFT VENTRICULAR DYSFUNCTION MAJOR DEPRESSION MATERNAL EXPOSURE BEFORE PREGNANCY MITRAL VALVE INCOMPETENCE MUSCLE SPASMS MUSCLE STRAIN MYOGLOBIN BLOOD INCREASED NEURALGIA NICOTINE DEPENDENCE OBESITY PAIN IN EXTREMITY PALPITATIONS PANIC DISORDER Product Role Route Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 298 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7773992
Preferred Term PARTNER STRESS PERICARDIAL EFFUSION Peripheral artery stenosis Peripheral artery thrombosis PERIPHERAL VASCULAR DISORDER POST-TRAUMATIC STRESS DISORDER PREGNANCY REFUSAL OF TREATMENT BY PATIENT ROAD TRAFFIC ACCIDENT SINUS TACHYCARDIA SUPRAVENTRICULAR TACHYCARDIA TREATMENT NONCOMPLIANCE TRICUSPID VALVE INCOMPETENCE UNEMPLOYMENT Product Role Route Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 299 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7281045 Date FDA Received
09-Dec-2010 Preferred Term PULMONARY EMBOLISM MIGRAINE PAIN IRON DEFICIENCY ANAEMIA ASTHMA CONDITION AGGRAVATED POSTPARTUM DEPRESSION SELF-INJURIOUS IDEATION PREMATURE LABOUR ROAD TRAFFIC ACCIDENT MENISCUS LESION CHONDROMALACIA ANTIPHOSPHOLIPID ANTIBODIES ATELECTASIS CONSTIPATION LABORATORY TEST ABNORMAL PLEURAL EFFUSION RECTAL HAEMORRHAGE VIRAL UPPER RESPIRATORY TRACT INFECTION Case # 7281045 Case Type EXPEDITED (15-DAY) Product NUVARING MIRENA SINGULAIR ALBUTEROL MAXALT AMERGE IBUPROFEN LEXAPRO NEURONTIN NIFEDIPINE METHOTREXATE ZONEGRAN Health Professional Y Outcomes HO,OT Role Route S S C C C C C C C C C C VAGINAL Manufacturer Control # 2009SP017675 Dosage Text 1 DF; QM; VAG Age 25 YR Duration Sex Female Country USA

Manufacturer

7352796 Date FDA Received

09-Dec-2010 Preferred Term PAIN

Case # 7352796

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO,OT Role Route S

Manufacturer Control # 2010SP017466 Dosage Text

Age 27 YR Duration

Sex Female

Country USA

Manufacturer

ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED ANAEMIA ANTIPHOSPHOLIPID SYNDROME

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 300 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7352796
Preferred Term ANXIETY APHASIA ARTHRALGIA BRONCHOSPASM COAGULOPATHY DECREASED APPETITE DEEP VEIN THROMBOSIS ENDOCARDITIS HAEMATOCRIT DECREASED HAEMOPTYSIS HEADACHE INFECTIOUS MONONUCLEOSIS INJURY JOINT SWELLING LYMPHADENOPATHY MEMORY IMPAIRMENT MIGRAINE MITRAL VALVE INCOMPETENCE PAIN IN EXTREMITY PANCYTOPENIA PHOTOPSIA PLEURISY PNEUMONIA PULMONARY EMBOLISM RHEUMATOID ARTHRITIS SEPTIC EMBOLUS SPLENOMEGALY SPLINTER HAEMORRHAGES SYSTEMIC LUPUS ERYTHEMATOSUS THROMBOCYTOPENIA THROMBOSIS Product Role Route Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 301 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7352796
Preferred Term TRANSIENT ISCHAEMIC ATTACK TRICUSPID VALVE INCOMPETENCE VIRAL INFECTION VITAMIN B12 DEFICIENCY VOMITING WEIGHT DECREASED Product Role Route Dosage Text Duration Manufacturer

7751590 Date FDA Received

09-Dec-2010 Preferred Term BREAST MASS UTERINE LEIOMYOMA FUNGAL INFECTION VULVITIS

Case # 7751590

Case Type EXPEDITED (15-DAY) Product NUVARING TINIDAZOLE

Health Professional N

Outcomes OT Role Route S C VAGINAL

Manufacturer Control # 2010SP062892 Dosage Text ; QM; VAG

Age 39 YR Duration

Sex Female

Country CHL

Manufacturer

7751625 Date FDA Received

09-Dec-2010 Preferred Term AFFECTIVE DISORDER DEPRESSION

Case # 7751625

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2010SP063272 Dosage Text

Age 23 YR Duration

Sex Female

Country CAN

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 302 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7332567 Date FDA Received
13-Dec-2010 Preferred Term DEEP VEIN THROMBOSIS PANCREATITIS ABDOMINAL PAIN ADNEXA UTERI CYST DECREASED APPETITE GALLBLADDER DISORDER GASTRITIS GASTROINTESTINAL OEDEMA HEPATIC FUNCTION ABNORMAL INFLAMMATION LYMPHADENOPATHY NAUSEA SURGICAL FAILURE THROMBOSIS Case # 7332567 Case Type EXPEDITED (15-DAY) Product NUVARING UNSPECIFIED INGREDIENT Health Professional Y Outcomes HO,OT Role Route S S Manufacturer Control # 2010SP012136 Dosage Text Age 31 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 303 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7582212 Date FDA Received
13-Dec-2010 Preferred Term PULMONARY EMBOLISM PLEURAL EFFUSION BLOOD CHOLESTEROL INCREASED COGNITIVE DISORDER CONNECTIVE TISSUE DISORDER COSTOCHONDRITIS DEPRESSION EMOTIONAL DISORDER HAEMOTHORAX HYPERTENSION INTERNATIONAL NORMALISED RATIO DECREASED MENTAL DISORDER MYOCARDIAL INFARCTION NEPHROTIC SYNDROME NEUROPATHY PERIPHERAL NORMOCHROMIC NORMOCYTIC ANAEMIA OVARIAN CYST PERICARDITIS PULMONARY INFARCTION PYELONEPHRITIS ACUTE REFUSAL OF TREATMENT BY PATIENT RENAL DISORDER URINARY TRACT INFECTION Case # 7582212 Case Type EXPEDITED (15-DAY) Product NUVARING UNSPECIFIED INGREDIENT Health Professional Y Outcomes HO,OT Role Route S S VAGINAL Manufacturer Control # 2010SP025302 Dosage Text VAG Age 36 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 304 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7631788 Date FDA Received
13-Dec-2010 Preferred Term MYCOPLASMA INFECTION HYPERSENSITIVITY INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION LUNG INFECTION METRORRHAGIA Case # 7631788 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional N Outcomes OT Role Route S VAGINAL Manufacturer Control # 2010SP050568 Dosage Text ; QM; VAG Age 25 YR Duration Sex Female Country CHL

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 305 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7635842 Date FDA Received
13-Dec-2010 Preferred Term DEEP VEIN THROMBOSIS BACK PAIN BUNION OPERATION ACUTE SINUSITIS ATELECTASIS BRONCHITIS CARPAL TUNNEL SYNDROME DIARRHOEA FOOT DEFORMITY HYPOAESTHESIA HYSTERECTOMY INTESTINAL ADHESION LYSIS LACERATION MENORRHAGIA MIGRAINE MUSCLE SPASMS NO THERAPEUTIC RESPONSE POLYCYSTIC OVARIES POST PROCEDURAL PULMONARY EMBOLISM RHINITIS SEASONAL TEMPOROMANDIBULAR JOINT SYNDROME Case # 7635842 Case Type EXPEDITED (15-DAY) Product NUVARING IMITREX MOTRIN Health Professional Y Outcomes HO Role Route S C C Manufacturer Control # 2010SP004586 Dosage Text Age 38 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 306 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7751210 Date FDA Received
13-Dec-2010 Preferred Term PELVIC PAIN ABORTION INDUCED DEVICE DISLOCATION ECTOPIC PREGNANCY HAEMORRHAGE MATERNAL EXPOSURE DURING PREGNANCY PREGNANCY WITH IMPLANT CONTRACEPTIVE Case # 7751210 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes OT Role Route S Manufacturer Control # 2010SP062659 Dosage Text Age 29 YR Duration Sex Female Country FRA

Manufacturer

7752260 Date FDA Received

13-Dec-2010 Preferred Term CHEST PAIN VISUAL FIELD DEFECT VISUAL IMPAIRMENT

Case # 7752260

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2010SP063258 Dosage Text

Age 24 YR Duration

Sex Female

Country CAN

Manufacturer

7752271 Date FDA Received

13-Dec-2010 Preferred Term ARTHRALGIA BACK PAIN HYPOAESTHESIA

Case # 7752271

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2010SP063268 Dosage Text

Age 27 YR Duration

Sex Female

Country CAN

Manufacturer

MOVEMENT DISORDER MUSCLE ATROPHY MUSCLE INJURY MUSCULAR WEAKNESS PAIN IN EXTREMITY

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 307 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7750637 Date FDA Received
14-Dec-2010 Preferred Term MULTIPLE PREGNANCY ABORTION SPONTANEOUS MATERNAL EXPOSURE DURING PREGNANCY PREGNANCY WITH CONTRACEPTIVE DEVICE Case # 7750637 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional N Outcomes OT Role Route S VAGINAL Manufacturer Control # 2010SP063222 Dosage Text QM;VAG Age 28 YR Duration Sex Female Country USA

Manufacturer

7753346 Date FDA Received

14-Dec-2010 Preferred Term DRY EYE

Case # 7753346

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes HO Role Route S VAGINAL

Manufacturer Control # 2010SP063193 Dosage Text VAG

Age 43 YR Duration 2 MTH

Sex Female

Country CAN

Manufacturer

GALLBLADDER DISORDER GALLBLADDER OPERATION HAEMORRHAGE

7756716 Date FDA Received

14-Dec-2010 Preferred Term

Case # 7756716

Case Type EXPEDITED (15-DAY) Product NUVARING IRON LOVAZA VENTOLIN

Health Professional

Outcomes OT Role Route S C C C

Manufacturer Control # 2010SP063182 Dosage Text

Age 24 YR Duration 1 DAY

Sex Female

Country CAN

Manufacturer

ABDOMINAL DISCOMFORT ASTHMA DIZZINESS DYSPNOEA COLD SWEAT SYNCOPE VISUAL IMPAIRMENT

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 308 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7754969 Date FDA Received
15-Dec-2010 Preferred Term DYSPHAGIA SWOLLEN TONGUE Case # 7754969 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional N Outcomes OT Role Route S Manufacturer Control # 2010SP063247 Dosage Text Duration Age Sex Female Country DEU

Manufacturer

7281755 Date FDA Received

16-Dec-2010 Preferred Term

Case # 7281755

Case Type EXPEDITED (15-DAY) Product NUVARING RETIN-A BENTYL

Health Professional Y

Outcomes HO,OT Role Route S C C

Manufacturer Control # 2009-189353-NL Dosage Text 1 DF

Age 23 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM PALPITATIONS ABORTION SPONTANEOUS ABDOMINAL PAIN ASTHMA BREAST MASS BRONCHITIS CHRONIC TONSILLITIS CONTUSION COUGH CYST DIZZINESS FATIGUE GASTROOESOPHAGEAL REFLUX DISEASE HAEMORRHAGE INSOMNIA IRRITABLE BOWEL SYNDROME LIPASE INCREASED NASAL TURBINATE HYPERTROPHY OVARIAN CYST PLEURISY PROTEIN C INCREASED

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 309 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7281755
Preferred Term PROTEIN S INCREASED RASH SINUS BRADYCARDIA SINUS DISORDER SLEEP APNOEA SYNDROME THROMBOSIS UPPER AIRWAY OBSTRUCTION UPPER RESPIRATORY TRACT INFECTION URINARY TRACT INFECTION VULVOVAGINAL CANDIDIASIS Product Role Route Dosage Text Duration Manufacturer

7634325 Date FDA Received

16-Dec-2010 Preferred Term

Case # 7634325

Case Type EXPEDITED (15-DAY) Product NUVARING IBUPROFEN

Health Professional Y

Outcomes HO,OT Role Route S C

Manufacturer Control # 2010SP004922 Dosage Text

Age 27 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS PELVIC FRACTURE BRAIN INJURY BRONCHITIS HEPATIC VEIN THROMBOSIS LIP INJURY LOSS OF CONSCIOUSNESS RADIUS FRACTURE RASH RENAL FAILURE ACUTE RHABDOMYOLYSIS ROAD TRAFFIC ACCIDENT ULNAR NERVE INJURY URINARY BLADDER RUPTURE VENOMOUS STING WEIGHT DECREASED WRIST FRACTURE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 310 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7759631 Date FDA Received
17-Dec-2010 Preferred Term INTERVERTEBRAL DISC PROTRUSION BLOOD CHOLESTEROL INCREASED SCIATICA Case # 7759631 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional N Outcomes OT Role Route S Manufacturer Control # 2010SP064163 Dosage Text Duration Age Sex Female Country FRA

Manufacturer

7988230 Date FDA Received

21-Dec-2010 Preferred Term UTERINE LEIOMYOMA

Case # 7988230

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2010SP063583 Dosage Text

Age

Sex Female

Country DEU

Duration

Manufacturer

7764055 Date FDA Received

22-Dec-2010 Preferred Term

Case # 7764055

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 201SP004890 Dosage Text

Age 27 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS ANGINA PECTORIS DYSPNOEA HEART RATE IRREGULAR MIGRAINE VARICOSE VEIN

7271500 Date FDA Received

23-Dec-2010 Preferred Term

Case # 7271500

Case Type EXPEDITED (15-DAY) Product NUVARING COUMADIN LOVENOX

Health Professional Y

Outcomes HO Role Route S S S C VAGINAL

Manufacturer Control # 2009SP023487 Dosage Text VAG SEE IMAGE

Age 23 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS PULMONARY EMBOLISM PULMONARY THROMBOSIS HYPERCOAGULATION CONTUSION

PEPTO-BISMAL

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 311 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7767992 Date FDA Received
23-Dec-2010 Preferred Term DEEP VEIN THROMBOSIS Case # 7767992 Case Type DIRECT Product NUVARING Health Professional Y Outcomes HO,DS,LT Role Route S VAGINAL Dosage Text 1 RING VAGINALLY X 3 WEEKS/MON EVERY MONTH VAG Manufacturer Control # Age 31 YR Duration Sex Female Country USA

Manufacturer MERCK

PULMONARY EMBOLISM

7772655 Date FDA Received

23-Dec-2010 Preferred Term NAUSEA DIZZINESS SYNCOPE

Case # 7772655

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2010SP064909 Dosage Text VAG

Age 21 YR Duration

Sex Female

Country USA

Manufacturer

6995227 Date FDA Received

27-Dec-2010 Preferred Term HYPOAESTHESIA

Case # 6995227

Case Type EXPEDITED (15-DAY) Product NUVARING ALBUTEROL

Health Professional Y

Outcomes HO Role Route S C C C C C C C C C VAGINAL

Manufacturer Control # 2008-177916-NL Dosage Text 1 DF; VAG

Age 38 YR Duration

Sex Female

Country USA

Manufacturer

SKIN DISCOLOURATION BACK PAIN PAIN IN EXTREMITY ARTHRALGIA OEDEMA PERIPHERAL DIZZINESS IATROGENIC INJURY VESSEL PERFORATION COMPARTMENT SYNDROME BIPOLAR DISORDER CHEST PAIN COITAL BLEEDING DEEP VEIN THROMBOSIS

PULMICORT FLEXHALER FLONASE VALTREX WELLBUTRIN CYMBALTA LUNESTA TYLENOL IBUPROFEN

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 312 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6995227
Preferred Term DEVICE MISUSE EPISTAXIS FUNGAL INFECTION GENITAL HERPES HYPERCOAGULATION INTERNATIONAL NORMALISED RATIO ABNORMAL INTERNATIONAL NORMALISED RATIO DECREASED LIPOMA MENORRHAGIA OVARIAN CYST PELVIC VENOUS THROMBOSIS POST THROMBOTIC SYNDROME PROTHROMBIN TIME ABNORMAL SCAR URINARY TRACT INFECTION WHITE BLOOD CELL COUNT INCREASED Product Role Route Dosage Text Duration Manufacturer

7772871 Date FDA Received

27-Dec-2010 Preferred Term

Case # 7772871

Case Type DIRECT Product NUVARING Case Type DIRECT Product NUVARING

Health Professional N

Outcomes DS,RI Role Route S

Manufacturer Control #

Age

Sex Female

Country USA

Dosage Text SEE ATTACHED FORM Manufacturer Control #

Duration

Manufacturer SCHERING PLOUGH

PULMONARY EMBOLISM

7777369 Date FDA Received

28-Dec-2010 Preferred Term BACK PAIN

Case # 7777369

Health Professional Y

Outcomes HO,LT Role Route S INTRAUTERINE

Age 26 YR

Sex Female

Country USA

Dosage Text 1 RING MONTHLY INTRA-UTERINE

Duration

Manufacturer

PULMONARY EMBOLISM PULMONARY INFARCTION

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 313 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7657415 Date FDA Received
30-Dec-2010 Preferred Term PULMONARY EMBOLISM DEEP VEIN THROMBOSIS ANHEDONIA ATELECTASIS DEPRESSION FATIGUE Case # 7657415 Case Type EXPEDITED (15-DAY) Product NUVARING EXCEDRIN MIGRAINE Health Professional Y Outcomes HO,DS Role Route S C VAGINAL Manufacturer Control # 2010SP004577 Dosage Text ; VAG Age 46 YR Duration Sex Female Country USA

Manufacturer

7741419 Date FDA Received

30-Dec-2010 Preferred Term

Case # 7741419

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S C C C Outcomes HO,OT Role Route S

Manufacturer Control # 2010SP061608 Dosage Text

Age 24 YR Duration

Sex Female

Country FRA

Manufacturer

ABORTION SPONTANEOUS PREGNANCY WITH CONTRACEPTIVE DEVICE

YELLOW FEVER VACCINE HEPATITIS A VACCINE PARACETAMOL

7633540 Date FDA Received

03-Jan-2011 Preferred Term

Case # 7633540

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Manufacturer Control # 2010SP012073 Dosage Text

Age 38 YR Duration

Sex Female

Country USA

Manufacturer

CEREBROVASCULAR ACCIDENT ALCOHOL USE ANXIETY BACK PAIN BALANCE DISORDER BLOOD CREATININE INCREASED BLOOD UREA INCREASED DIARRHOEA DIZZINESS DYSARTHRIA

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 314 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7633540
Preferred Term DYSPNOEA EMBOLIC CEREBRAL INFARCTION FALL FEELING ABNORMAL FEELING DRUNK HEADACHE HEPATIC STEATOSIS HYPERCOAGULATION HYPERHIDROSIS LOSS OF CONSCIOUSNESS MUSCLE TIGHTNESS MUSCULAR WEAKNESS MUSCULOSKELETAL CHEST PAIN PULMONARY EMBOLISM SINUS TACHYCARDIA SNORING THROMBOSIS TROPONIN INCREASED UTERINE LEIOMYOMA VAGINITIS BACTERIAL VISION BLURRED VOMITING WHITE BLOOD CELL COUNT INCREASED Product Role Route Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 315 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7657541 Date FDA Received
03-Jan-2011 Preferred Term PULMONARY EMBOLISM ABORTION INDUCED ABORTION SPONTANEOUS DEEP VEIN THROMBOSIS HYPERCOAGULATION INTERNATIONAL NORMALISED RATIO DECREASED INTERNATIONAL NORMALISED RATIO INCREASED MATERNAL EXPOSURE BEFORE PREGNANCY MATERNAL EXPOSURE DURING PREGNANCY PLEURITIC PAIN PREGNANCY WITH CONTRACEPTIVE DEVICE THYROID NEOPLASM Case # 7657541 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO,OT Role Route S VAGINAL Manufacturer Control # 2010SP025075 Dosage Text VAG Age 23 YR Duration Sex Female Country USA

Manufacturer

7776666 Date FDA Received

03-Jan-2011 Preferred Term

Case # 7776666

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2010SP066422 Dosage Text QM; VAG

Age 31 YR Duration

Sex Female

Country CHL

Manufacturer

GLOMERULONEPHRITIS INCORRECT DRUG ADMINISTRATION DURATION METRORRHAGIA

7777277 Date FDA Received

03-Jan-2011 Preferred Term CARDIAC MURMUR

Case # 7777277

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S TRANSPLACENTAL

Manufacturer Control # 2010SP066021 Dosage Text TRPL

Age

Sex Female

Country DEU

Duration

Manufacturer

MATERNAL DRUGS AFFECTING FOETUS

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 316 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7782879 Date FDA Received
04-Jan-2011 Preferred Term BREAST ENLARGEMENT BREAST PAIN Case # 7782879 Case Type DIRECT Product NUVARING Health Professional N Outcomes OT Role Route S VAGINAL Dosage Text VAG Manufacturer Control # Age 19 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 317 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7156242 Date FDA Received
05-Jan-2011 Preferred Term HOT FLUSH MOOD SWINGS PULMONARY EMBOLISM INTERVERTEBRAL DISC PROTRUSION LUMBAR RADICULOPATHY SKIN CANCER FOLLICULITIS URINARY TRACT DISORDER VULVAL DISORDER DIVERTICULUM INTESTINAL HAEMORRHOIDS URINARY TRACT INFECTION HYPOTHYROIDISM GASTROOESOPHAGEAL REFLUX DISEASE HYPERTONIC BLADDER HEPATIC CYST Case # 7156242 Case Type EXPEDITED (15-DAY) Product NUVARING MOBIC SKELAXIN ALEVE AMBIEN CR ALLEGRA ZOLOFT EFFEXOR XR PREDNISOLONE\PREDNISONE TRETINOIN FLUOROMETHOLONE HYDROCODONE BITARTRATE & ACETAMINOPHEN TOBRADEX ZITHROMAX BACTROBAN DOXYCYCLINE TRILYTE SULFAMETHOXAZOLE AND TRIMETHOPRIM HYDROCODONE BITARTRATE & ACETAMINOPHEN TRANSDERM SCOP NITROFURANTOIN Health Professional Y Outcomes HO,OT Role Route S C C C C C C C C C C C C C C C C C C C C VAGINAL Manufacturer Control # 2009SP017372 Dosage Text 1 DF;QM;VAG Age 53 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 318 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7635666 Date FDA Received
05-Jan-2011 Preferred Term PULMONARY EMBOLISM THROMBOSIS ALCOHOL POISONING DEEP VEIN THROMBOSIS ENDOMETRITIS HEPATITIS C INSOMNIA MALAISE OVERDOSE PROCEDURAL PAIN PULMONARY INFARCTION SUICIDAL IDEATION SUICIDE ATTEMPT Case # 7635666 Case Type EXPEDITED (15-DAY) Product NUVARING TYLENOL COLD MULTISYMPTOM DAYTIME Health Professional Y Outcomes HO,OT Role Route S S VAGINAL Manufacturer Control # 2010SP005479 Dosage Text ;QM;VAG; VAG Age 27 YR Duration Sex Female Country USA

Manufacturer

7705224 Date FDA Received

06-Jan-2011 Preferred Term

Case # 7705224

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO,OT Role Route S

Manufacturer Control # 2010SP026407 Dosage Text SEE CONT PAGE

Age 29 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS DIZZINESS MULTIPLE INJURIES OVARIAN CYST PULMONARY EMBOLISM

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 319 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7770787 Date FDA Received
06-Jan-2011 Preferred Term CROHN'S DISEASE CONDITION AGGRAVATED Case # 7770787 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional N Outcomes OT Role Route S Manufacturer Control # 2010SP065147 Dosage Text Duration Age Sex Female Country DEU

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 320 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6882791 Date FDA Received
11-Jan-2011 Preferred Term WEIGHT INCREASED NAUSEA CONVULSION LETHARGY DEPRESSED LEVEL OF CONSCIOUSNESS TRANSVERSE SINUS THROMBOSIS SUBARACHNOID HAEMORRHAGE ABNORMAL SENSATION IN EYE CEREBROVASCULAR ACCIDENT COLONIC POLYP DISORIENTATION DYSPEPSIA FATIGUE FLATULENCE GASTRIC ULCER GASTRITIS HYPERHIDROSIS MITRAL VALVE PROLAPSE NECK PAIN PARAESTHESIA PROTEIN TOTAL DECREASED ROTATOR CUFF REPAIR STRESS TACHYCARDIA TENSION HEADACHE Case # 6882791 Case Type EXPEDITED (15-DAY) Product NUVARING PRASTERONE B-COMPLEX + VITAMIN C ADVIL LAMISIL TESTOSTERONE SUDAFED 12 HOUR Health Professional Y Outcomes HO,OT Role Route S S C C C C C VAGINAL Manufacturer Control # 2008-182154-NL Dosage Text VAG Age 46 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 321 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7271453 Date FDA Received
11-Jan-2011 Preferred Term DEEP VEIN THROMBOSIS AMENORRHOEA BIPOLAR DISORDER CYSTITIS DRUG HYPERSENSITIVITY ENDOCRINE DISORDER HYPERCOAGULATION HYPOTHYROIDISM MATERNAL EXPOSURE BEFORE PREGNANCY MENORRHAGIA OVARIAN CYST PNEUMONIA PYELONEPHRITIS URINARY TRACT INFECTION Case # 7271453 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO,OT Role Route S Manufacturer Control # 2009SP023393 Dosage Text Age 17 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 322 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7284873 Date FDA Received
11-Jan-2011 Preferred Term URINARY TRACT INFECTION PULMONARY EMBOLISM ATELECTASIS BRONCHIAL SECRETION RETENTION BUNION OPERATION DEEP VEIN THROMBOSIS DILATATION VENTRICULAR FEELING HOT JOINT RANGE OF MOTION DECREASED OEDEMA PERIPHERAL PLEURAL EFFUSION PULMONARY ARTERIAL HYPERTENSION PULMONARY INFARCTION RIGHT VENTRICULAR FAILURE TRICUSPID VALVE INCOMPETENCE VENOUS PRESSURE JUGULAR INCREASED Case # 7284873 Case Type EXPEDITED (15-DAY) Product NUVARING COUMADIN Health Professional Y Outcomes HO,DS Role Route S S VAGINAL Manufacturer Control # 2008-179019-NL Dosage Text QM; VAG Age 45 YR Duration Sex Female Country USA

Manufacturer

7794386 Date FDA Received

11-Jan-2011 Preferred Term ANAEMIA

Case # 7794386

Case Type EXPEDITED (15-DAY) Product NUVARING PAXIL

Health Professional N

Outcomes OT Role Route S C C VAGINAL

Manufacturer Control # 2010SP066423 Dosage Text VAG

Age 35 YR Duration

Sex Female

Country USA

Manufacturer

INCORRECT DRUG ADMINISTRATION DURATION

WELLBUTRIN

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 323 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7794716 Date FDA Received
11-Jan-2011 Preferred Term METRORRHAGIA ACCIDENT AT WORK ANKLE FRACTURE INCORRECT DRUG ADMINISTRATION DURATION Case # 7794716 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes OT Role Route S VAGINAL Manufacturer Control # 2010SP024081 Dosage Text ;QM; VAG Age 33 YR Duration Sex Female Country CHL

Manufacturer

7281772 Date FDA Received

13-Jan-2011 Preferred Term

Case # 7281772

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO,DS Role Route S S C VAGINAL ORAL

Manufacturer Control # 2008-188046-NL Dosage Text VAG PO

Age 19 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS PULMONARY EMBOLISM THROMBOSIS ABDOMINAL TENDERNESS ABORTION ANTITHROMBIN III DECREASED CERVICAL DYSPLASIA COMPLICATION OF PREGNANCY CRANIOCEREBRAL INJURY CYSTITIS HAEMORRHAGIC DYSPNOEA FALL FOLLICULITIS HEADACHE HIGH RISK PREGNANCY INJURY IRON DEFICIENCY LIGAMENT INJURY LIGAMENT RUPTURE LIGAMENT SPRAIN

ORTHO TRI CYCLEN POLYTRIM

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 324 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7281772
Preferred Term LIMB INJURY MATERNAL EXPOSURE BEFORE PREGNANCY MUSCLE STRAIN NORMOCHROMIC NORMOCYTIC ANAEMIA OEDEMA PERIPHERAL OVARIAN CYST PAIN PALPITATIONS PLATELET COUNT INCREASED PLEURITIC PAIN PREGNANCY PRESYNCOPE PROTHROMBIN TIME PROLONGED PUNCTURE SITE HAEMORRHAGE SCIATICA STRESS THROMBOPHLEBITIS SUPERFICIAL VENOUS RECANALISATION VERTIGO VISION BLURRED Product Role Route Dosage Text Duration Manufacturer

7796612 Date FDA Received

13-Jan-2011 Preferred Term

Case # 7796612

Case Type EXPEDITED (15-DAY) Product NUVARING BACLOFEN

Health Professional Y

Outcomes HO,DS,LT Role Route S C

Manufacturer Control # 2011SP000603 Dosage Text VAG

Age 37 YR Duration

Sex Female

Country USA

Manufacturer

TOXIC SHOCK SYNDROME STREPTOCOCCAL INFECTION

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 325 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7820703 Date FDA Received
18-Jan-2011 Preferred Term VASCULITIS PETECHIAE Case # 7820703 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes OT Role Route S Manufacturer Control # 2011SP001122 Dosage Text Duration Age Sex Female Country DEU

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 326 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7704647 Date FDA Received
19-Jan-2011 Preferred Term DEEP VEIN THROMBOSIS TACHYCARDIA TREMOR BACK PAIN ARTERIOSCLEROSIS CORONARY ARTERY ASTHMA BRONCHITIS CAROTID BRUIT CONJUNCTIVITIS CYSTITIS ELECTROCARDIOGRAM ST-T CHANGE GASTROOESOPHAGEAL REFLUX DISEASE HOT FLUSH HYPERTENSION HYPOAESTHESIA MULTIPLE ALLERGIES NECK PAIN PALPITATIONS PHLEBITIS RADICULOPATHY SINUSITIS UPPER RESPIRATORY TRACT INFECTION URINARY TRACT INFECTION UTERINE HAEMORRHAGE Case # 7704647 Case Type EXPEDITED (15-DAY) Product NUVARING LOPRESSOR NASAL DECONGESTANT PROZAC Health Professional Y Outcomes HO,OT Role Route S S S C Manufacturer Control # 2010SP042284 Dosage Text Age 39 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 327 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7805014 Date FDA Received
19-Jan-2011 Preferred Term AMENORRHOEA UTERINE CERVIX STENOSIS UTERINE HAEMORRHAGE Case # 7805014 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes OT Role Route S VAGINAL Manufacturer Control # 2011SP001744 Dosage Text ;QM;VAG Duration Age Sex Female Country PAN

Manufacturer

7805052 Date FDA Received

19-Jan-2011 Preferred Term

Case # 7805052

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2011SP002053 Dosage Text ;VAG

Age 25 YR Duration

Sex Female

Country RUS

Manufacturer

OCULAR HYPERTENSION HEADACHE PAIN IN EXTREMITY

7803750 Date FDA Received

20-Jan-2011 Preferred Term

Case # 7803750

Case Type EXPEDITED (15-DAY) Product NUVARING Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes DE Role Route S

Manufacturer Control # 2011SP001057 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

DEEP VEIN THROMBOSIS

7803754 Date FDA Received

20-Jan-2011 Preferred Term CARDIAC DISORDER

Case # 7803754

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2011SP001723 Dosage Text

Age 24 YR Duration

Sex Female

Country USA

Manufacturer

VENTRICULAR EXTRASYSTOLES

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 328 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7271450 Date FDA Received
21-Jan-2011 Preferred Term DEEP VEIN THROMBOSIS GAIT DISTURBANCE IMPAIRED WORK ABILITY MENTAL DISORDER PULMONARY EMBOLISM VAGINITIS BACTERIAL Case # 7271450 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO,OT Role Route S Manufacturer Control # 2009SP023299 Dosage Text 1 DF QM; Age 25 YR Duration Sex Female Country USA

Manufacturer

7271482 Date FDA Received

21-Jan-2011 Preferred Term

Case # 7271482

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO,DS,OT Role Route S

Manufacturer Control # 2009SP021075 Dosage Text

Age 41 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS ADJUSTMENT DISORDER ANXIETY ARTHROPATHY AUTOIMMUNE DISORDER CARPAL TUNNEL SYNDROME CERVICAL CYST DEPRESSION GASTROOESOPHAGEAL REFLUX DISEASE HYPERCOAGULATION MAJOR DEPRESSION OSTEOARTHRITIS OVARIAN CYST PNEUMONIA PULMONARY EMBOLISM THROMBOSIS VAGINAL HAEMORRHAGE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 329 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7805290 Date FDA Received
21-Jan-2011 Preferred Term ABDOMINAL PAIN DIARRHOEA RASH GENERALISED Rubber sensitivity URTICARIA WEIGHT DECREASED Case # 7805290 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional N Outcomes HO Role Route S Manufacturer Control # 2011SP001704 Dosage Text Age 20 YR Duration Sex Female Country CAN

Manufacturer

7335324 Date FDA Received

25-Jan-2011 Preferred Term

Case # 7335324

Case Type EXPEDITED (15-DAY) Product NUVARING ZITHROMAX

Health Professional Y

Outcomes OT Role Route S S C C C C C

Manufacturer Control # 2010SP007657 Dosage Text

Age 36 YR Duration

Sex Female

Country PRT

Manufacturer

RESPIRATORY TRACT INFECTION PREGNANCY WITH CONTRACEPTIVE DEVICE MATERNAL EXPOSURE DURING PREGNANCY CAESAREAN SECTION PREMATURE SEPARATION OF PLACENTA HAEMORRHAGE IN PREGNANCY

SALOFALK /00747601/ HYDROCORTISONE SERETAIDE XENICAL SINGULAIR

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 330 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7704656 Date FDA Received
26-Jan-2011 Preferred Term PULMONARY EMBOLISM PAIN IN EXTREMITY MUSCULAR WEAKNESS AMENORRHOEA ANXIETY APPENDICITIS ASTHENIA CHEST PAIN CONTUSION CONVERSION DISORDER DEEP VEIN THROMBOSIS DIZZINESS DYSARTHRIA FATIGUE FEELING ABNORMAL GAIT DISTURBANCE HEAD INJURY HYPERTENSION HYPOAESTHESIA HYPOAESTHESIA ORAL NAUSEA PARAESTHESIA POLYCYSTIC OVARIES SEASONAL ALLERGY SINUS TACHYCARDIA TRANSIENT ISCHAEMIC ATTACK UNRESPONSIVE TO STIMULI VISION BLURRED Case # 7704656 Case Type EXPEDITED (15-DAY) Product NUVARING MULTI-VITAMIN XANAX Health Professional Y Outcomes HO,OT Role Route S C C VAGINAL Manufacturer Control # 2010SP028727 Dosage Text VAG Age 22 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 331 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7825687 Date FDA Received
26-Jan-2011 Preferred Term FALL HIP FRACTURE THROMBOSIS Case # 7825687 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO,LT Role Route S VAGINAL Manufacturer Control # 2011SP002759 Dosage Text 1 DF;VAG Duration Age Sex Female Country USA

Manufacturer

7271492 Date FDA Received

31-Jan-2011 Preferred Term UTERINE LEIOMYOMA ATELECTASIS CHOLELITHIASIS

Case # 7271492

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO,OT Role Route S

Manufacturer Control # 2009SP023465 Dosage Text

Age 42 YR Duration

Sex Female

Country USA

Manufacturer

COAGULATION FACTOR VIII LEVEL INCREASED HEPATIC CYST ILEUS LUNG INFILTRATION OVARIAN CYST OVARIAN ENLARGEMENT PELVIC INFLAMMATORY DISEASE PLEURAL EFFUSION PULMONARY EMBOLISM

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 332 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7823547 Date FDA Received
31-Jan-2011 Preferred Term PULMONARY EMBOLISM HYPERCOAGULATION ABDOMINAL PAIN UPPER AORTIC VALVE INCOMPETENCE AUTOIMMUNE THYROIDITIS BACTERAEMIA BREAST PROSTHESIS USER GASTROOESOPHAGEAL REFLUX DISEASE HAEMATURIA IMPAIRED WORK ABILITY LEUKOCYTOSIS LOBAR PNEUMONIA MIGRAINE MITRAL VALVE INCOMPETENCE MITRAL VALVE PROLAPSE MULTIPLE INJURIES OVARIAN CYST PULMONARY HYPERTENSION PULMONARY INFARCTION SEPSIS THROMBOSIS UNEVALUABLE EVENT UTERINE LEIOMYOMA VITAMIN B12 DEFICIENCY Case # 7823547 Case Type EXPEDITED (15-DAY) Product NUVARING SYNTHROID Health Professional Y Outcomes HO,OT Role Route S C Manufacturer Control # 2006-139623 Dosage Text 1 DF; Age 36 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 333 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7827384 Date FDA Received
01-Feb-2011 Preferred Term PULMONARY EMBOLISM HYPERCOAGULATION PLEURAL EFFUSION PNEUMONIA PULMONARY INFARCTION URINARY TRACT INFECTION Case # 7827384 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Outcomes HO Role Route S Manufacturer Control # 2010SP042285 Dosage Text Age 19 YR Duration Sex Female Country USA

Manufacturer

7844436 Date FDA Received

01-Feb-2011 Preferred Term PANCREATITIS

Case # 7844436

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S C C C C

Manufacturer Control # 2011SP003441 Dosage Text

Age

Sex Female

Country DEU

Duration

Manufacturer

METHOTREXATE MUTAFLOR MESALAMINE CORTISONE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 334 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7315590 Date FDA Received
02-Feb-2011 Preferred Term PULMONARY EMBOLISM HISTOPLASMOSIS SARCOIDOSIS IRON DEFICIENCY ANAEMIA CERVICAL DYSPLASIA GASTROINTESTINAL EROSION COELIAC DISEASE ACNE BACK PAIN CHEST PAIN DYSMENORRHOEA EXCORIATION HILAR LYMPHADENOPATHY INTERNATIONAL NORMALISED RATIO INCREASED LEUKOPENIA MENORRHAGIA PROTEIN S DECREASED PULMONARY INFARCTION ROAD TRAFFIC ACCIDENT SINUSITIS UTERINE ENLARGEMENT UTERINE MALPOSITION VAGINITIS BACTERIAL Case # 7315590 Case Type EXPEDITED (15-DAY) Product NUVARING NEXIUM HYDROCODONE BACTRIM DS PLAN B DOXYCYCLINE ACCUTANE Health Professional Y Outcomes HO Role Route S C C C C C C VAGINAL Manufacturer Control # 2009SP021931 Dosage Text ; VAG Age 24 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 335 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7816913 Date FDA Received
02-Feb-2011 Preferred Term WEIGHT INCREASED DISSOCIATION DISTURBANCE IN ATTENTION HEADACHE IMPAIRED WORK ABILITY INCREASED APPETITE IRRITABLE BOWEL SYNDROME LOSS OF LIBIDO MOOD SWINGS Case # 7816913 Case Type DIRECT Product NUVARING Health Professional N Outcomes OT,RI Role Route S Dosage Text Manufacturer Control # Age 17 YR Duration Sex Female Country USA

Manufacturer

7818352 Date FDA Received

02-Feb-2011 Preferred Term MOOD SWINGS SKIN DISORDER SUICIDAL IDEATION URTICARIA

Case # 7818352

Case Type DIRECT Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control #

Age 24 YR

Sex Female

Country USA

Dosage Text 2 WK

Duration

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 336 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7818975 Date FDA Received
02-Feb-2011 Preferred Term NAUSEA Case # 7818975 Case Type DIRECT Product NUVARING Health Professional Y Outcomes OT Role Route S VAGINAL Dosage Text STANDARD RING DOSAGE EVERY 3 WEEKS VAG Manufacturer Control # Age 47 YR Duration Sex Female Country USA

Manufacturer

DIARRHOEA FAECES PALE HEADACHE HYPERTENSION OEDEMA RETCHING VAGINAL INFECTION VULVOVAGINAL DISCOMFORT

7554129 Date FDA Received

03-Feb-2011 Preferred Term CERVICAL DYSPLASIA

Case # 7554129

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S C Outcomes HO,LT,OT VAGINAL

Manufacturer Control # 2010SP041226 Dosage Text VAG

Age 43 YR Duration

Sex Female

Country USA

Manufacturer

CONTRACEPTIVE

7247765 Date FDA Received

04-Feb-2011

Case # 7247765

Case Type EXPEDITED (15-DAY)

Health Professional Y

Manufacturer Control # 2009SP043064

Age 28 YR

Sex Female

Country USA

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 337 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7247765
Preferred Term DEEP VEIN THROMBOSIS PULMONARY EMBOLISM EXTRADURAL HAEMATOMA ABDOMINAL PAIN UPPER ANGINA PECTORIS ANHEDONIA ANXIETY CHOLELITHIASIS COSTOCHONDRITIS DEPRESSION DIZZINESS DRY MOUTH ECONOMIC PROBLEM GASTRIC ULCER GASTRITIS HAEMORRHAGIC CYST HYPERSENSITIVITY HYPOAESTHESIA INJURY INSOMNIA MIGRAINE MUSCULAR WEAKNESS NAUSEA OVARIAN CYST PAIN PALPITATIONS PANCREATITIS STRESS THROMBOSIS VAGINITIS BACTERIAL VULVOVAGINAL MYCOTIC INFECTION Product NUVARING TRAZODONE HYDROCHLORIDE SEROQUEL Role Route S S S VAGINAL Dosage Text VAG Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 338 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7841229 Date FDA Received
07-Feb-2011 Preferred Term DEVICE DISLOCATION MATERNAL EXPOSURE DURING PREGNANCY PREGNANCY WITH IMPLANT CONTRACEPTIVE Case # 7841229 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes OT Role Route S Manufacturer Control # 2010SP061938 Dosage Text Age 25 YR Duration Sex Female Country SWE

Manufacturer

7841383 Date FDA Received

07-Feb-2011 Preferred Term

Case # 7841383

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S C C

Manufacturer Control # 2011SP002890 Dosage Text

Age 27 YR Duration

Sex Female

Country CHE

Manufacturer

MENSTRUAL DISORDER CATAPLEXY

MODASOMIL REBOXETIN

7841970 Date FDA Received

08-Feb-2011 Preferred Term CERVIX DISORDER

Case # 7841970

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2011SP004621 Dosage Text

Age 23 YR Duration

Sex Female

Country USA

Manufacturer

7854544 Date FDA Received

08-Feb-2011 Preferred Term CROHN'S DISEASE

Case # 7854544

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2011SP003894 Dosage Text

Age 25 YR Duration

Sex Female

Country DEU

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 339 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7283328 Date FDA Received
09-Feb-2011 Preferred Term RENAL VEIN THROMBOSIS PREGNANCY ABDOMINAL HERNIA ABORTION INDUCED ASTHENIA BREAST FIBROSIS CAESAREAN SECTION DEHYDRATION DIZZINESS FLANK PAIN GASTROENTERITIS HAEMORRHAGE HYPOKALAEMIA IRON DEFICIENCY ANAEMIA KIDNEY ENLARGEMENT MAMMOGRAM ABNORMAL MUSCLE SPASMS MUSCULOSKELETAL PAIN MYALGIA NAUSEA PREMATURE LABOUR RENAL VEIN OCCLUSION RETAINED PRODUCTS OF CONCEPTION THIRST TREATMENT FAILURE VIRAL INFECTION WEIGHT DECREASED Case # 7283328 Case Type EXPEDITED (15-DAY) Product NUVARING ALBUTEROL Health Professional Y Outcomes HO Role Route S C Manufacturer Control # 2009-196587-NL Dosage Text 1 DF Age 36 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 340 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7827287 Date FDA Received
09-Feb-2011 Preferred Term PULMONARY EMBOLISM VENOUS THROMBOSIS LIMB Case # 7827287 Case Type DIRECT Product NUVARING Health Professional Y Outcomes HO,LT Role Route S VAGINAL Dosage Text INSERT ONE RING Q 30 DAYS VAG Manufacturer Control # Age 42 YR Duration Sex Female Country USA

Manufacturer ORGANON

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 341 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7660263 Date FDA Received
10-Feb-2011 Preferred Term PULMONARY EMBOLISM HEADACHE ABDOMINAL PAIN UPPER ALOPECIA AMNESIA ATELECTASIS BACK PAIN CHEST PAIN DEPRESSION FIBRIN D DIMER INCREASED GASTRITIS IRON DEFICIENCY LUNG INFILTRATION MUSCLE SPASMS PLEURAL EFFUSION PNEUMONIA PRODUCTIVE COUGH PULMONARY INFARCTION PULMONARY NECROSIS PULMONARY OEDEMA SMEAR CERVIX ABNORMAL THROMBOSIS UTERINE HAEMORRHAGE UTERINE POLYP WEIGHT INCREASED Case # 7660263 Case Type EXPEDITED (15-DAY) Product NUVARING ADVIL Health Professional Y Outcomes HO,OT Role Route S C VAGINAL Manufacturer Control # 2010SP004854 Dosage Text VAG Age 40 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 342 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7842782 Date FDA Received
10-Feb-2011 Preferred Term CERVIX DISORDER Case # 7842782 Case Type EXPEDITED (15-DAY) Product NUVARING Case # 7849263 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Health Professional N Outcomes OT Role Route S VAGINAL Manufacturer Control # 2011SP005244 Dosage Text ; VAG Manufacturer Control # 2010SP014804 Dosage Text Age 21 YR Duration Sex Female Country USA Age 26 YR Duration Sex Female Country ESP

Manufacturer

7849263 Date FDA Received

10-Feb-2011 Preferred Term

Outcomes HO,OT Role Route S

Manufacturer

PULMONARY EMBOLISM ABDOMINAL PAIN LOWER HYDRONEPHROSIS MIGRAINE MUSCULOSKELETAL PAIN ROAD TRAFFIC ACCIDENT

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 343 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6349668 Date FDA Received
11-Feb-2011 Preferred Term CEREBROVASCULAR ACCIDENT UNRESPONSIVE TO STIMULI CAROTID ARTERY THROMBOSIS CEREBRAL THROMBOSIS CONFUSIONAL STATE BRAIN DEATH BRAIN HERNIATION CARDIAC ARREST CEREBRAL INFARCTION CYST GRAND MAL CONVULSION HYPOKALAEMIA MENTAL IMPAIRMENT RESPIRATORY FAILURE SINUS TACHYCARDIA SUBCLAVIAN VEIN THROMBOSIS TRICUSPID VALVE INCOMPETENCE VENOUS THROMBOSIS VENTRICULAR EXTRASYSTOLES Case # 6349668 Case Type EXPEDITED (15-DAY) Product NUVARING LEVOXYL ALLEGRA ZOLOFT LUNESTA Health Professional Y Outcomes DE,HO Role Route S C C C C Manufacturer Control # 2007-160271-NL Dosage Text 1 DF Age 31 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 344 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7672925 Date FDA Received
11-Feb-2011 Preferred Term DEEP VEIN THROMBOSIS ACCIDENT ACQUIRED DIAPHRAGMATIC EVENTRATION ANXIETY BLOOD CREATININE INCREASED BLOOD UREA INCREASED CHILLS DIZZINESS DYSPEPSIA FEELING ABNORMAL HAEMORRHAGIC OVARIAN CYST HYPERTENSION INJURY MUSCLE STRAIN MUSCULOSKELETAL PAIN NAUSEA OBESITY PERICARDIAL EFFUSION PHARYNGITIS PULMONARY EMBOLISM TENDONITIS Case # 7672925 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO,OT Role Route S Manufacturer Control # 2010SP016445 Dosage Text Age 33 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 345 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7825111 Date FDA Received
11-Feb-2011 Preferred Term PULMONARY EMBOLISM FIBRIN D DIMER INCREASED LABORATORY TEST INTERFERENCE LUNG CONSOLIDATION Case # 7825111 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO Role Route S Manufacturer Control # 2010SP010777 Dosage Text Age 30 YR Duration Sex Female Country USA

Manufacturer

7845414 Date FDA Received

11-Feb-2011 Preferred Term

Case # 7845414

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2011SP004977 Dosage Text VAG

Age

Sex Female

Country ESP

Duration

Manufacturer

ABORTION SPONTANEOUS MATERNAL EXPOSURE DURING PREGNANCY PREGNANCY WITH CONTRACEPTIVE DEVICE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 346 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7845519 Date FDA Received
11-Feb-2011 Preferred Term ABDOMINAL PAIN ATTENTION DEFICIT/HYPERACTIVITY DISORDER BLOOD DISORDER COAGULOPATHY COCCIDIOIDOMYCOSIS DEEP VEIN THROMBOSIS ESCHERICHIA SEPSIS HYPOTENSION INJURY OVARIAN CYST PULMONARY EMBOLISM PYELONEPHRITIS ACUTE SEPSIS URINARY TRACT INFECTION Case # 7845519 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO,OT Role Route S Manufacturer Control # 2010SP025277 Dosage Text Age 22 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 347 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7277785 Date FDA Received
14-Feb-2011 Preferred Term DEEP VEIN THROMBOSIS ALCOHOL USE AMENORRHOEA ARTHRALGIA BACK PAIN BENIGN BREAST NEOPLASM CONTUSION ENCHONDROMA EXOSTOSIS FIBROCYSTIC BREAST DISEASE HAEMOPTYSIS INADEQUATE ANALGESIA INJECTION SITE PAIN INTERNATIONAL NORMALISED RATIO INCREASED LIGAMENT SPRAIN MIGRAINE OSTEOPENIA OSTEOSCLEROSIS OTITIS MEDIA PHARYNGITIS PREMATURE MENOPAUSE TOBACCO ABUSE VAGINAL DISCHARGE Case # 7277785 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO,OT Role Route S Manufacturer Control # 2009-199325-NL Dosage Text Age 31 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 348 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7680807 Date FDA Received
15-Feb-2011 Preferred Term INFLUENZA AMENORRHOEA ANXIETY CHEST PAIN DEEP VEIN THROMBOSIS DEPRESSION DYSPNOEA EMOTIONAL DISORDER INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION INTERNATIONAL NORMALISED RATIO DECREASED JOINT RANGE OF MOTION DECREASED MENORRHAGIA MUSCULOSKELETAL DISORDER OEDEMA PERIPHERAL PAIN IN EXTREMITY PHLEBITIS PLEURITIC PAIN POST THROMBOTIC SYNDROME ROAD TRAFFIC ACCIDENT TEARFULNESS TUBERCULIN TEST POSITIVE UNEVALUABLE EVENT VARICOSE VEIN WEIGHT INCREASED Case # 7680807 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO,OT Role Route S Manufacturer Control # 2010SP039924 Dosage Text Age 32 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 349 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7053576 Date FDA Received
16-Feb-2011 Preferred Term MITRAL VALVE PROLAPSE PULMONARY EMBOLISM HYPOTENSION LEUKOCYTOSIS IRON DEFICIENCY ANAEMIA THROMBOCYTOSIS DEEP VEIN THROMBOSIS PRODUCTIVE COUGH UPPER RESPIRATORY TRACT INFECTION BRONCHITIS COAGULOPATHY HYPERCOAGULATION INCREASED TENDENCY TO BRUISE BONE PAIN LIPODYSTROPHY ACQUIRED LIPOSUCTION Case # 7053576 Case Type EXPEDITED (15-DAY) Product NUVARING ADIPEX-P ADVIL CEPHALEXIN MEPERIDINE HCL DIAZEPAM PROMETHAZINE HYDROCODONE BITARTRATE & ACETAMINOPHEN CALCIUM LORTAB MULTI-VITAMIN HYROXYCUT CLA Health Professional Y Outcomes HO,OT Role Route S S C C C C C C C C C C C VAGINAL Manufacturer Control # 2008-183474-NL Dosage Text 1 DF;QM;VAG Age 29 YR Duration Sex Female Country USA

Manufacturer

7841006 Date FDA Received

16-Feb-2011 Preferred Term

Case # 7841006

Case Type DIRECT Product NUVARING SINGULAIR

Health Professional Y

Outcomes HO,LT Role Route S C VAGINAL

Manufacturer Control #

Age 22 YR

Sex Female

Country USA

Dosage Text 1 RING EVERY 3 WEEKS VAG

Duration

Manufacturer SCHERING PLOUGH

CEREBROVASCULAR ACCIDENT FLANK PAIN COUGH MUSCLE SPASMS PULMONARY EMBOLISM VIRAL UPPER RESPIRATORY TRACT INFECTION

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 350 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7847598 Date FDA Received
16-Feb-2011 Preferred Term PULMONARY EMBOLISM EMBOLIC STROKE HAEMATURIA HYPERTENSION WEIGHT DECREASED Case # 7847598 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO,DS,OT Role Route S Manufacturer Control # 2010SP004869 Dosage Text Age 48 YR Duration Sex Female Country USA

Manufacturer

7835064 Date FDA Received

17-Feb-2011 Preferred Term

Case # 7835064

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO,DS Role Route S

Manufacturer Control # 2010SP020851 Dosage Text

Age 22 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM ATELECTASIS HEART RATE IRREGULAR MULTIPLE INJURIES PLEURAL EFFUSION PNEUMONIA VENTRICULAR DYSFUNCTION WOLFF-PARKINSON-WHITE SYNDROME

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 351 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7281754 Date FDA Received
18-Feb-2011 Preferred Term PORTAL VEIN THROMBOSIS COAGULOPATHY SPLENIC VEIN THROMBOSIS OVARIAN CYST BRONCHITIS CARDIOLIPIN ANTIBODY POSITIVE CHEST DISCOMFORT CHROMATURIA COMPUTERISED TOMOGRAM ABDOMEN ABNORMAL CONSTIPATION DEGENERATION OF UTERINE LEIOMYOMA EPISTAXIS FIBRIN D DIMER INCREASED HAEMATOCRIT DECREASED HAEMOGLOBIN DECREASED INFLAMMATION INTERNATIONAL NORMALISED RATIO INCREASED LEUKOCYTOSIS NAUSEA POLLAKIURIA PROTEIN S DEFICIENCY SINUSITIS SPLENOMEGALY UTERINE POLYPECTOMY VOMITING Case # 7281754 Case Type EXPEDITED (15-DAY) Product NUVARING HEPARIN FLUOXETINE VALTREX Health Professional Y Outcomes HO Role Route S S C C INTRAVENOUS IV Manufacturer Control # 2009-189352-NL Dosage Text Age 35 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 352 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7586753 Date FDA Received
18-Feb-2011 Preferred Term PULMONARY EMBOLISM PULMONARY HYPERTENSION SYNCOPE SUPRAVENTRICULAR TACHYCARDIA DYSPNOEA ABORTION INDUCED AMENORRHOEA ANXIETY DISORDER ATRIAL SEPTAL DEFECT ACQUIRED CARDIAC ANEURYSM CARDIAC MURMUR CARDIOMEGALY CAROTID ARTERY STENOSIS CHEST DISCOMFORT DYSURIA HAEMATURIA MATERNAL EXPOSURE DURING PREGNANCY MITRAL VALVE INCOMPETENCE PALPITATIONS PREGNANCY WITH CONTRACEPTIVE DEVICE PULMONARY INFARCTION PULMONARY OEDEMA PULMONARY VALVE INCOMPETENCE THROMBOSIS TRICUSPID VALVE INCOMPETENCE Case # 7586753 Case Type EXPEDITED (15-DAY) Product NUVARING LEVOXYL MS CONTIN NEURONTIN BACLOFEN Health Professional Y Outcomes HO,OT Role Route S C C C C Manufacturer Control # 2009SP036144 Dosage Text Age 39 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 353 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7845112 Date FDA Received
18-Feb-2011 Preferred Term BRONCHITIS CHRONIC ANOXIA CARDIAC ARREST DYSPNOEA HYPOXIA OEDEMA PERIPHERAL PLEURISY Case # 7845112 Case Type DIRECT Product NUVARING Health Professional N Outcomes LT,OT,RI Role Route S VAGINAL Dosage Text MONTHLY VAG Manufacturer Control # Age 40 YR Duration Sex Female Country USA

Manufacturer SCHERING PLOUGH

7856864 Date FDA Received

22-Feb-2011 Preferred Term SWELLING FACE EYE SWELLING

Case # 7856864

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S C Outcomes OT Role Route S C C C VAGINAL

Manufacturer Control # 2011SP005299 Dosage Text 1 DF; VAG

Age 19 YR Duration

Sex Female

Country USA

Manufacturer

IRON SUPPLEMENT Case # 7858836 Case Type EXPEDITED (15-DAY) Product NUVARING ADVIL SERC /00034201/ TYLENOL Health Professional N

7858836 Date FDA Received

22-Feb-2011 Preferred Term

Manufacturer Control # 2011SP006460 Dosage Text

Age 36 YR Duration 8 DAY

Sex Female

Country CAN

Manufacturer

BLOOD PRESSURE DECREASED DYSARTHRIA FATIGUE HEART RATE DECREASED HYPOTONIA MOVEMENT DISORDER SYNCOPE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 354 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7860350 Date FDA Received
22-Feb-2011 Preferred Term DYSPNOEA PALPITATIONS PULMONARY ARTERY STENOSIS PULMONARY EMBOLISM RUSSELL'S VIPER VENOM TIME ABNORMAL VENTILATION/PERFUSION SCAN ABNORMAL Case # 7860350 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO Role Route S VAGINAL Manufacturer Control # 2011SP006450 Dosage Text VAG Age 28 YR Duration 26 DAY Sex Female Country CAN

Manufacturer

7860555 Date FDA Received

22-Feb-2011 Preferred Term

Case # 7860555

Case Type EXPEDITED (15-DAY) Product NUVARING MARIJUANA

Health Professional Y

Outcomes HO Role Route S C VAGINAL

Manufacturer Control # 2011SP006455 Dosage Text VAG

Age 24 YR Duration

Sex Female

Country CAN

Manufacturer

ATRIAL SEPTAL DEFECT NECK PAIN PAIN IN JAW PLEURISY PULMONARY EMBOLISM VENTILATION PERFUSION MISMATCH

7860644 Date FDA Received

22-Feb-2011 Preferred Term HAEMORRHOIDS PAIN

Case # 7860644

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2011SP006458 Dosage Text VAG

Age 33 YR Duration 19 DAY

Sex Female

Country CAN

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 355 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7617492 Date FDA Received
24-Feb-2011 Preferred Term CEREBROVASCULAR ACCIDENT HYPERCOAGULATION BRAIN NEOPLASM CYST DEPRESSION HAEMORRHAGIC STROKE HYPERLIPIDAEMIA HYPERTENSION RESPIRATORY FAILURE URINARY TRACT INFECTION Case # 7617492 Case Type EXPEDITED (15-DAY) Product NUVARING HEPARIN SODIUM Health Professional Y Outcomes HO Role Route S S VAGINAL Manufacturer Control # 2010SP000796 Dosage Text VAG Age 43 YR Duration Sex Female Country USA

Manufacturer

7873416 Date FDA Received

24-Feb-2011 Preferred Term

Case # 7873416

Case Type EXPEDITED (15-DAY) Product NUVARING MOTRIN

Health Professional Y

Outcomes HO Role Route S C

Manufacturer Control # 2010SP054447 Dosage Text

Age 37 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM PANIC ATTACK INTERNATIONAL NORMALISED RATIO DECREASED LUNG NEOPLASM MUSCLE SPASMS NAUSEA UTERINE LEIOMYOMA

7857530 Date FDA Received

25-Feb-2011 Preferred Term

Case # 7857530

Case Type DIRECT Product NUVARING

Health Professional Y

Outcomes HO,LT Role Route S VAGINAL

Manufacturer Control #

Age 30 YR

Sex Female

Country USA

Dosage Text 1 NUVA RING 3 WEEKS VAG

Duration

Manufacturer SCHERING PLOUGH

PULMONARY EMBOLISM PULMONARY INFARCTION

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 356 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7846207 Date FDA Received
28-Feb-2011 Case # 7846207 Case Type EXPEDITED (15-DAY) Health Professional Y Outcomes HO,OT Manufacturer Control # 2010SP025234 Age 27 YR Sex Female Country USA

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 357 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7846207
Preferred Term DEEP VEIN THROMBOSIS THROMBOSIS ARTHRALGIA ASTHMA DEPRESSION DIZZINESS DRUG HYPERSENSITIVITY ESCHERICHIA INFECTION ESCHERICHIA URINARY TRACT INFECTION HYPOKALAEMIA INCORRECT DRUG ADMINISTRATION DURATION INTERNATIONAL NORMALISED RATIO DECREASED IRON DEFICIENCY LEUKOCYTOSIS MULTIPLE INJURIES NAUSEA PHARYNGITIS STREPTOCOCCAL PHLEBITIS INFECTIVE POST THROMBOTIC SYNDROME PULMONARY EMBOLISM STAPHYLOCOCCAL INFECTION THROMBOPHLEBITIS URINARY TRACT INFECTION STAPHYLOCOCCAL VENA CAVA THROMBOSIS VERTIGO POSITIONAL VESTIBULAR NEURONITIS WEIGHT DECREASED Product NUVARING PENICILLIN Role Route S S VAGINAL Dosage Text 1 DF, QW, VAG Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 358 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7859918 Date FDA Received
28-Feb-2011 Preferred Term DYSPAREUNIA ATROPHIC VULVOVAGINITIS CONDITION AGGRAVATED LICHEN SCLEROSUS Case # 7859918 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes DS Role Route S Manufacturer Control # 2011SP002046 Dosage Text Age 21 YR Duration Sex Female Country FRA

Manufacturer

7859961 Date FDA Received

28-Feb-2011 Preferred Term

Case # 7859961

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO,OT Role Route S

Manufacturer Control # 2010SP057916 Dosage Text

Age 26 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM ANGINA PECTORIS ARRHYTHMIA HEART RATE IRREGULAR MENSTRUATION IRREGULAR MIGRAINE MUSCULOSKELETAL CHEST PAIN NO THERAPEUTIC RESPONSE OVARIAN CYST PHOTOPHOBIA PLEURITIC PAIN STRESS URINARY TRACT INFECTION

7869338 Date FDA Received

02-Mar-2011 Preferred Term

Case # 7869338

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2011SP008631 Dosage Text VAG

Age 21 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS ANKLE FRACTURE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 359 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7810091 Date FDA Received
03-Mar-2011 Preferred Term EMBOLISM ARTERIAL PULMONARY EMBOLISM Case # 7810091 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes OT Role Route S Manufacturer Control # 2011SP002221 Dosage Text Age 41 YR Duration Sex Female Country SVN

Manufacturer

7881428 Date FDA Received

04-Mar-2011 Preferred Term

Case # 7881428

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes HO Role Route S VAGINAL

Manufacturer Control # 2011SP008471 Dosage Text QM; VAG

Age 31 YR Duration

Sex Female

Country CHL

Manufacturer

INCORRECT DRUG ADMINISTRATION DURATION APPENDICITIS

7658204 Date FDA Received

08-Mar-2011 Preferred Term

Case # 7658204

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO,OT Role Route S VAGINAL

Manufacturer Control # 2010SP012619 Dosage Text VAG

Age 27 YR Duration

Sex Female

Country USA

Manufacturer

CEREBROVASCULAR ACCIDENT DEEP VEIN THROMBOSIS DYSARTHRIA HEADACHE HYPERTENSION MIGRAINE OVARIAN CYST PUPILS UNEQUAL SOMNOLENCE TACHYCARDIA THALAMIC INFARCTION THROMBOSIS TRANSVERSE SINUS THROMBOSIS UNRESPONSIVE TO STIMULI VOMITING

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 360 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7848341 Date FDA Received
09-Mar-2011 Preferred Term PULMONARY EMBOLISM Case # 7848341 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO,LT Role Route S VAGINAL Manufacturer Control # 2011SP002934 Dosage Text ; QD; VAG Age 18 YR Duration Sex Female Country SVN

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 361 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7753514 Date FDA Received
10-Mar-2011 Preferred Term DEEP VEIN THROMBOSIS COLITIS ULCERATIVE MALAISE IMPAIRED WORK ABILITY ROAD TRAFFIC ACCIDENT BACK PAIN ANAEMIA VITAMIN B12 DEFICIENCY ANXIETY CONTUSION GASTROINTESTINAL HAEMORRHAGE HAEMORRHAGE HAEMORRHAGIC DIATHESIS HAEMORRHOIDS INSOMNIA INTERNATIONAL NORMALISED RATIO INCREASED IRON DEFICIENCY ANAEMIA LEUKOCYTOSIS LOWER GASTROINTESTINAL HAEMORRHAGE NECK PAIN OSTEOPENIA POLYP COLORECTAL RENAL VEIN THROMBOSIS SINUS TACHYCARDIA SMEAR CERVIX ABNORMAL UNEVALUABLE EVENT Case # 7753514 Case Type EXPEDITED (15-DAY) Product NUVARING COUMADIN UNSPECIFIED INGREDIENT UNSPECIFIED INGREDIENT PREDNISONE COLAZAL Health Professional Y Outcomes HO,DS,OT Role Route S S S S C C Manufacturer Control # 2010SP050517 Dosage Text 1 DF; QM Age 28 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 362 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7841989 Date FDA Received
10-Mar-2011 Preferred Term INTESTINAL OBSTRUCTION Case # 7841989 Case Type EXPEDITED (15-DAY) Product NUVARING Case Type EXPEDITED (15-DAY) Product NUVARING GINGO BILOBA Case Type DIRECT Product NUVARING Health Professional Y Health Professional Y Health Professional Y Outcomes OT Role Route S VAGINAL Manufacturer Control # 2011SP004608 Dosage Text VAG Manufacturer Control # 2010SP028496 Dosage Text Age 19 YR Duration Sex Female Country USA Duration Age Sex Female Country USA

Manufacturer

7808479 Date FDA Received

11-Mar-2011 Preferred Term

Case # 7808479

Outcomes HO,OT Role Route S C Outcomes HO Role Route S VAGINAL

Manufacturer

DEEP VEIN THROMBOSIS PULMONARY EMBOLISM

7874108 Date FDA Received

11-Mar-2011 Preferred Term

Case # 7874108

Manufacturer Control #

Age 20 YR

Sex Female

Country USA

Dosage Text 0.120MG/0.015MG PER DAY ONCE MONTHLY VAGINAL RING Manufacturer Control # A0880687A

Duration

Manufacturer ORGANON

PULMONARY EMBOLISM

7853846 Date FDA Received

14-Mar-2011 Preferred Term ASTHENIA METRORRHAGIA DRUG INTERACTION

Case # 7853846

Case Type NON-EXPEDITED Product

Health Professional N

Outcomes

Age 27 YR Duration

Sex Female

Country USA

Role Route S S UNKNOWN VAGINAL

Dosage Text 500MG Unknown

Manufacturer GLAXOSMITHKLINE

AMOXICILLIN NUVARING

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 363 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7856912 Date FDA Received
15-Mar-2011 Preferred Term PREGNANCY WITH CONTRACEPTIVE DEVICE ABORTION SPONTANEOUS COMPLETE DEPRESSED MOOD MATERNAL EXPOSURE DURING PREGNANCY Case # 7856912 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Role Route S VAGINAL Outcomes Manufacturer Control # 2011SP006552 Dosage Text QM;VAG Age 22 YR Duration Sex Female Country MEX

Manufacturer

7888552 Date FDA Received

15-Mar-2011 Preferred Term

Case # 7888552

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2011SP010466 Dosage Text VAG

Age 20 YR Duration

Sex Female

Country USA

Manufacturer

TREATMENT NONCOMPLIANCE ABORTION SPONTANEOUS MATERNAL EXPOSURE BEFORE PREGNANCY PREGNANCY

7888607 Date FDA Received

15-Mar-2011 Preferred Term

Case # 7888607

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2011SP003654 Dosage Text VAG

Age 42 YR Duration

Sex Female

Country DEU

Manufacturer

PREGNANCY WITH CONTRACEPTIVE DEVICE ABORTION MATERNAL EXPOSURE DURING PREGNANCY

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 364 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7294741 Date FDA Received
16-Mar-2011 Preferred Term ABDOMINAL PAIN UPPER DIZZINESS ATELECTASIS CHEST PAIN COAGULOPATHY CONDITION AGGRAVATED CONTUSION DIARRHOEA FIBRIN D DIMER INCREASED HEART RATE IRREGULAR HYPERGLYCAEMIA HYPERHIDROSIS HYPERLIPIDAEMIA HYSTEROSCOPY IRON DEFICIENCY ANAEMIA LEUKOCYTOSIS LIMB INJURY MENORRHAGIA MIGRAINE NASOPHARYNGITIS NAUSEA PNEUMONIA PULMONARY EMBOLISM PULMONARY INFARCTION THYROID DISORDER TRAUMATIC HAEMATOMA TREMOR UTERINE POLYP VOMITING Case # 7294741 Case Type EXPEDITED (15-DAY) Product NUVARING PHENTERMINE Health Professional Y Outcomes HO Role Route S C Manufacturer Control # 2007-168983-NL Dosage Text Age 34 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 365 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7331045 Date FDA Received
16-Mar-2011 Preferred Term CONFUSIONAL STATE DYSPNOEA VOMITING RESPIRATORY RATE INCREASED MALAISE BLOOD ALBUMIN DECREASED BLOOD CALCIUM DECREASED BLOOD GLUCOSE INCREASED BLOOD POTASSIUM DECREASED ELECTROCARDIOGRAM ABNORMAL LIP INJURY PROTEIN TOTAL DECREASED SINUS TACHYCARDIA Case # 7331045 Case Type EXPEDITED (15-DAY) Product NUVARING LUNESTA ARMOUR THYROID SYNTHROID COMBIPATCH Health Professional Y Outcomes DE,HO Role Route S C C C C VAGINAL Manufacturer Control # 2010SP012801 Dosage Text VAG Age 60 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 366 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7332428 Date FDA Received
16-Mar-2011 Preferred Term HAEMORRHAGE DEEP VEIN THROMBOSIS DEPRESSION ABDOMINAL PAIN ANXIETY BACK PAIN BURNING SENSATION COGNITIVE DISORDER DIZZINESS DYSPAREUNIA DYSURIA EMOTIONAL DISORDER FLANK PAIN MENSTRUATION IRREGULAR MENTAL DISORDER OVARIAN CYST PARAESTHESIA PROCEDURAL SITE REACTION RECTAL TENESMUS RUPTURED ECTOPIC PREGNANCY VAGINAL HAEMORRHAGE Case # 7332428 Case Type EXPEDITED (15-DAY) Product NUVARING ALBUTEROL ADVAIR HFA Health Professional Y Outcomes HO,DS,LT,OT Role Route S C C Manufacturer Control # 2010SP012145 Dosage Text Age 23 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 367 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7808333 Date FDA Received
16-Mar-2011 Preferred Term HEART RATE IRREGULAR ABORTION INCOMPLETE ANGINA PECTORIS ANGIOPATHY BACK PAIN CERVICAL DYSPLASIA CYSTITIS DYSPNOEA HYDRONEPHROSIS MATERNAL EXPOSURE BEFORE PREGNANCY MIGRAINE MUSCLE SPASMS OEDEMA PERIPHERAL PAIN IN EXTREMITY PAPILLOMA VIRAL INFECTION PREGNANCY RENAL FAILURE ROAD TRAFFIC ACCIDENT THROMBOSIS VARICOSE VEIN VENOUS INSUFFICIENCY Case # 7808333 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes OT Role Route S VAGINAL Manufacturer Control # 2010SP004890 Dosage Text 1 DF;GM;VAG Age 24 YR Duration Sex Female Country USA

Manufacturer

7868418 Date FDA Received

16-Mar-2011 Preferred Term BACK PAIN

Case # 7868418

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO Role Route S

Manufacturer Control # 2011SP007335 Dosage Text

Age 30 YR Duration

Sex Female

Country ESP

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 368 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7884693 Date FDA Received
17-Mar-2011 Preferred Term CHEST DISCOMFORT CHEST PAIN DYSPNOEA NO THERAPEUTIC RESPONSE Case # 7884693 Case Type DIRECT Product NUVARING PREDNISONE BURST IBUPROFEN Health Professional Outcomes HO Role Route S C C Dosage Text Manufacturer Control # Age 20 YR Duration Sex Female Country USA

Manufacturer

7889059 Date FDA Received

17-Mar-2011 Preferred Term DECUBITUS ULCER VAGINAL DISORDER

Case # 7889059

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2010SP059435 Dosage Text 1 DF; ; VAG

Age

Sex Female

Country DEU

Duration

Manufacturer

7889091 Date FDA Received

17-Mar-2011 Preferred Term

Case # 7889091

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2011SP009933 Dosage Text ;VAG

Age 31 YR Duration

Sex Female

Country DEU

Manufacturer

PSYCHOSOMATIC DISEASE ARRHYTHMIA

7889367 Date FDA Received

17-Mar-2011 Preferred Term CROHN'S DISEASE

Case # 7889367

Case Type EXPEDITED (15-DAY) Product NUVARING HYPERICUM

Health Professional Y

Outcomes OT Role Route S S

Manufacturer Control # 2011SP010771 Dosage Text VAG

Age 30 YR Duration

Sex Female

Country DEU

Manufacturer

VITAMIN D DEFICIENCY DRUG INTERACTION METRORRHAGIA MOOD ALTERED

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 369 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7890640 Date FDA Received
17-Mar-2011 Preferred Term LOSS OF CONSCIOUSNESS Case # 7890640 Case Type EXPEDITED (15-DAY) Product NUVARING Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Health Professional Y Outcomes OT Role Route S VAGINAL Manufacturer Control # 2011SP010666 Dosage Text ; VAG Manufacturer Control # 2011SP010849 Dosage Text 1 DF; Duration Age Sex Female Country USA Age 35 YR Duration Sex Female Country USA

Manufacturer

7892592 Date FDA Received

17-Mar-2011 Preferred Term

Case # 7892592

Outcomes OT Role Route S

Manufacturer

VESTIBULAR DISORDER IMPAIRED HEALING

7882993 Date FDA Received

21-Mar-2011 Preferred Term ABORTION MISSED

Case # 7882993

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO Role Route S

Manufacturer Control # 2011SP008116 Dosage Text

Age 41 YR Duration

Sex Female

Country DEU

Manufacturer

MATERNAL EXPOSURE DURING PREGNANCY PREGNANCY WITH CONTRACEPTIVE DEVICE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 370 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7888700 Date FDA Received
22-Mar-2011 Preferred Term ABDOMINAL PAIN PYREXIA CYSTITIS PRURITUS PELVIC VENOUS THROMBOSIS Case # 7888700 Case Type DIRECT Product NUVARING WARFARIN ATENOLOL AMBIEN REMERON AMITRIPTYLINE HYDROCHLORIDE SEPTRA DITROPAN LORTAB SOMA GEODON METHYLIN TOPAMAX KLONOPIN Health Professional N Outcomes HO,LT Role Route S S C C C C C C C C C C C C Health Professional N Outcomes HO Role Route S C C VAGINAL Manufacturer Control # 2011SP011266 Dosage Text QM;VAG Age 31 YR Duration Sex Female Country CHL VAGINAL ORAL Dosage Text 1 MONTHLY VAG 5MG DAILY PO Manufacturer Control # Age 35 YR Duration Sex Female Country USA

Manufacturer

7897763 Date FDA Received

22-Mar-2011 Preferred Term METRORRHAGIA

Case # 7897763

Case Type EXPEDITED (15-DAY) Product NUVARING

Manufacturer

POST PROCEDURAL COMPLICATION GASTRIC BYPASS INFLAMMATION POST PROCEDURAL OEDEMA

LANSOPRAZOLE LOMOTRIGINE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 371 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7284695 Date FDA Received
23-Mar-2011 Preferred Term DEEP VEIN THROMBOSIS OEDEMA PERIPHERAL INTERNATIONAL NORMALISED RATIO DECREASED ABDOMINAL PAIN LOWER DISCOMFORT MENSTRUATION IRREGULAR NAUSEA POSTPARTUM DEPRESSION PYELONEPHRITIS SEASONAL AFFECTIVE DISORDER SMALL INTESTINAL OBSTRUCTION UTERINE LEIOMYOMA VOMITING Case # 7284695 Case Type EXPEDITED (15-DAY) Product NUVARING TUMS SYNTHROID Health Professional Y Outcomes OT Role Route S C C VAGINAL Manufacturer Control # 2008-185657-NL Dosage Text 1 DF;QM;VAG Age 26 YR Duration Sex Female Country USA

Manufacturer

7860105 Date FDA Received

23-Mar-2011 Preferred Term BACK PAIN

Case # 7860105

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO,LT Role Route S

Manufacturer Control # 2011SP007853 Dosage Text QM

Age 29 YR Duration

Sex Female

Country EST

Manufacturer

PELVIC VENOUS THROMBOSIS VENOUS INSUFFICIENCY

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 372 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7895688 Date FDA Received
23-Mar-2011 Preferred Term THYROXINE INCREASED BLOOD IRON DECREASED HYPOMENORRHOEA TRI-IODOTHYRONINE INCREASED WHITE BLOOD CELL COUNT INCREASED Case # 7895688 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional N Outcomes OT Role Route S VAGINAL Manufacturer Control # 2011SP011008 Dosage Text QM; VAG Duration Age Sex Female Country ESP

Manufacturer

7897266 Date FDA Received

23-Mar-2011 Preferred Term

Case # 7897266

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO,OT Role Route S VAGINAL

Manufacturer Control # 2011SP010418 Dosage Text VAG

Age 32 YR Duration

Sex Female

Country USA

Manufacturer

CEREBRAL INFARCTION PARTIAL SEIZURES SUBARACHNOID HAEMORRHAGE SUPERIOR SAGITTAL SINUS THROMBOSIS TRANSVERSE SINUS THROMBOSIS

7284895 Date FDA Received

24-Mar-2011 Preferred Term MUSCLE STRAIN

Case # 7284895

Case Type EXPEDITED (15-DAY) Product NUVARING NAPROXEN ULTRACET DARVOCET

Health Professional Y

Outcomes HO,DS Role Route S C C C VAGINAL

Manufacturer Control # 2007-163591-NL Dosage Text 1 DF; QM; VAG

Age 28 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM SINUS BRADYCARDIA ELECTROCARDIOGRAM T WAVE INVERSION ABDOMINAL PAIN ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED AMENORRHOEA ARTHRALGIA BACK PAIN BREAST DISCHARGE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 373 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7284895
Preferred Term BREAST TENDERNESS CHOLELITHIASIS DEEP VEIN THROMBOSIS EPISTAXIS EYE COMPLICATION ASSOCIATED WITH DEVICE GINGIVAL BLEEDING HAEMATOMA HAEMOPTYSIS HYPOAESTHESIA IMPAIRED WORK ABILITY INSOMNIA INTERNATIONAL NORMALISED RATIO INCREASED INTERVERTEBRAL DISC PROTRUSION LACERATION LIPOMA MUSCULOSKELETAL PAIN NAUSEA NECK PAIN OCULAR HYPERAEMIA OVARIAN CYST PAIN IN EXTREMITY PARAESTHESIA PELVIC PAIN PROTHROMBIN TIME PROLONGED ROAD TRAFFIC ACCIDENT SARCOMA SCAR SEROMA SPINAL OSTEOARTHRITIS Product Role Route Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 374 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7284895
Preferred Term SUPRAPUBIC PAIN UROGENITAL TRICHOMONIASIS VAGINAL HAEMORRHAGE VAGINITIS BACTERIAL VOMITING Product Role Route Dosage Text Duration Manufacturer

7892553 Date FDA Received

24-Mar-2011 Preferred Term

Case # 7892553

Case Type DIRECT Product NUVARING Case Type EXPEDITED (15-DAY) Product NUVARING TOPAMAX STEROIDS

Health Professional Y

Outcomes HO Role Route S VAGINAL

Manufacturer Control #

Age 19 YR

Sex Female

Country USA

Dosage Text 1 RING DAILY VAG Manufacturer Control # 2010SP002792 Dosage Text

Duration

Manufacturer SCHERING PLOUGH

PULMONARY EMBOLISM

7582214 Date FDA Received

25-Mar-2011 Preferred Term DISORIENTATION

Case # 7582214

Health Professional Y

Outcomes HO,DS,OT Role Route S S C C

Age 27 YR Duration

Sex Female

Country USA

Manufacturer

VITH NERVE PARALYSIS SUPERIOR SAGITTAL SINUS THROMBOSIS TRANSVERSE SINUS THROMBOSIS ABDOMINAL PAIN AGITATION ALTERED STATE OF CONSCIOUSNESS ANGER ANXIETY BACK PAIN BILIARY DILATATION BIPOLAR DISORDER BLINDNESS BREAST DISCHARGE BRONCHITIS CEREBRAL VENOUS THROMBOSIS

VITAMINS NOS

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 375 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7582214
Preferred Term CEREBROVASCULAR ACCIDENT CLAUSTROPHOBIA COGNITIVE DISORDER DEHYDRATION DEPRESSION DIPLOPIA DIZZINESS DRUG INEFFECTIVE EAR INFECTION ECONOMIC PROBLEM EMOTIONAL DISORDER FEELING JITTERY FOLLICULITIS GALACTORRHOEA GOITRE HAEMATURIA HEADACHE HYPERSENSITIVITY HYPERTENSION IMPAIRED WORK ABILITY INSOMNIA INTERNATIONAL NORMALISED RATIO DECREASED INTRACRANIAL VENOUS SINUS THROMBOSIS IRRITABILITY LOCAL SWELLING LOSS OF CONSCIOUSNESS MEMORY IMPAIRMENT MENTAL DISORDER MIGRAINE Product Role Route Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 376 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7582214
Preferred Term MOOD DISORDER DUE TO A GENERAL MEDICAL CONDITION MUSCLE SPASMS MUSCLE STRAIN NERVOUS SYSTEM DISORDER OVARIAN CYST PANIC ATTACK PHARYNGITIS PHOTOPHOBIA PROTEIN S DEFICIENCY ROAD TRAFFIC ACCIDENT SCOTOMA SINUSITIS SKIN PAPILLOMA SUBARACHNOID HAEMORRHAGE SYNCOPE TENSION HEADACHE UPPER RESPIRATORY TRACT INFECTION URINARY TRACT INFECTION VACCINATION SITE PAIN VAGINAL DISCHARGE VENOUS RECANALISATION VISION BLURRED VISUAL FIELD DEFECT VULVOVAGINAL DISCOMFORT WEIGHT INCREASED Product Role Route Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 377 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7660164 Date FDA Received
25-Mar-2011 Preferred Term DEEP VEIN THROMBOSIS AGORAPHOBIA AMNESIA ANEURYSM BIOPSY ENDOMETRIUM ABNORMAL BLOOD TRIGLYCERIDES INCREASED CEREBROVASCULAR ACCIDENT COSTOCHONDRITIS FALL FRACTURED COCCYX HEADACHE HYPOAESTHESIA MAJOR DEPRESSION MENOMETRORRHAGIA MIGRAINE NECK PAIN OVARIAN CYST PANIC DISORDER PARAESTHESIA PHOTOPHOBIA PNEUMONIA SCOLIOSIS THYROID DISORDER VISUAL IMPAIRMENT Case # 7660164 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO,OT Role Route S Manufacturer Control # 2010SP004556 Dosage Text Age 30 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 378 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7897792 Date FDA Received
25-Mar-2011 Preferred Term DIABETES MELLITUS MENSTRUAL DISORDER Case # 7897792 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional N Outcomes OT Role Route S VAGINAL Manufacturer Control # 2011SP012400 Dosage Text ;VAG Duration Age Sex Female Country DEU

Manufacturer

7897806 Date FDA Received

25-Mar-2011 Preferred Term HAEMOPTYSIS

Case # 7897806

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2011SP013053 Dosage Text ;QM; VAG Manufacturer Control # 2011SP012705 Dosage Text

Age

Sex Female

Country CHL

Duration

Manufacturer

7904011 Date FDA Received

25-Mar-2011 Preferred Term

Case # 7904011

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S

Age

Sex Female

Country USA

Duration

Manufacturer

PULMONARY EMBOLISM HAEMOPTYSIS

5960396 Date FDA Received

28-Mar-2011 Preferred Term

Case # 5960396

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO,DS,OT Role Route S C C C C C C VAGINAL

Manufacturer Control # 2005-136056-NL Dosage Text VAG

Age 36 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS PULMONARY EMBOLISM MENSTRUATION DELAYED GAIT DISTURBANCE ACNE MITRAL VALVE PROLAPSE FIBROUS DYSPLASIA OF BONE ACROCHORDON BACK PAIN BREAST ENLARGEMENT

ADVAIR DISKUS ALBUTEROL PROMETHAZINE HYDROCODONE BITARTRATE AND ACETAMINOPHEN ZYRTEC LORTAB

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 379 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 5960396
Preferred Term BREAST PAIN BRONCHITIS CHONDROSARCOMA COLITIS CYST DYSMENORRHOEA ENDOMETRIAL DISORDER ENDOMETRIOSIS EYE DISORDER FIBROUS HISTIOCYTOMA HAEMATURIA HEADACHE HYPERCOAGULATION LARYNGITIS LENTIGO LEUKOCYTOSIS MENOMETRORRHAGIA MILIA NECK PAIN NEPHROLITHIASIS NEURILEMMOMA NEUROFIBROMA NEUROPATHY PERIPHERAL OVARIAN CYST PALPITATIONS PNEUMONIA RASH SCAR SEBORRHOEIC KERATOSIS SINUSITIS SKIN PAPILLOMA Product Role Route Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 380 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 5960396
Preferred Term TONSILLITIS UPPER RESPIRATORY TRACT INFECTION UROBILINOGEN URINE INCREASED UTERINE POLYP WEIGHT DECREASED Product Role Route Dosage Text Duration Manufacturer

7907526 Date FDA Received

29-Mar-2011 Preferred Term SYNCOPE

Case # 7907526

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2011SP012712 Dosage Text ; VAG Manufacturer Control # 2008-183928-NL Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

6787919 Date FDA Received

30-Mar-2011 Preferred Term MIGRAINE BREAST CYST

Case # 6787919

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S

Age 32 YR Duration

Sex Female

Country USA

Manufacturer

FIBROADENOMA OF BREAST TRANSIENT ISCHAEMIC ATTACK VISUAL FIELD DEFECT

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 381 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6877911 Date FDA Received
30-Mar-2011 Preferred Term SUPERIOR SAGITTAL SINUS THROMBOSIS GRAND MAL CONVULSION MIGRAINE DEPRESSION CEREBRAL ISCHAEMIA ANAEMIA ANXIETY BRAIN OEDEMA CALCULUS URETERIC CEREBRAL HAEMORRHAGE CEREBRAL INFARCTION CHOLELITHIASIS DIABETES MELLITUS ENCEPHALOMALACIA HYPERCOAGULATION NEPHROLITHIASIS OBSTRUCTIVE UROPATHY OEDEMA PERIPHERAL OVARIAN CYST PAIN IN EXTREMITY URINARY TRACT INFECTION Case # 6877911 Case Type EXPEDITED (15-DAY) Product NUVARING YAZ GARDASIL ZOCOR ATIVAN Health Professional Y Outcomes HO,DS,OT Role Route S S C C C VAGINAL ORAL Manufacturer Control # 2007-155874-NL Dosage Text VAG PO Age 22 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 382 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7271464 Date FDA Received
30-Mar-2011 Preferred Term THROMBOPHLEBITIS SUPERFICIAL GASTROENTERITIS VIRAL HEADACHE MASS NECK MASS SINUS HEADACHE TOOTH EXTRACTION TREATMENT NONCOMPLIANCE UTERINE CERVICAL SQUAMOUS METAPLASIA Case # 7271464 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes OT Role Route S Manufacturer Control # 2009SP023500 Dosage Text Age 36 YR Duration Sex Female Country USA

Manufacturer

7494469 Date FDA Received

30-Mar-2011 Preferred Term HEADACHE SINUSITIS ABDOMINAL PAIN

Case # 7494469

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO,DS,LT,OT Role Route S C

Manufacturer Control # 2010SP036928 Dosage Text

Age 27 YR Duration

Sex Female

Country USA

Manufacturer

METFORMIN HYDROCHLORIDE

ACUTE RESPIRATORY FAILURE ATELECTASIS BRAIN INJURY BRAIN OEDEMA CEREBRAL VENTRICLE DILATATION COMPLEX PARTIAL SEIZURES COMPLEX REGIONAL PAIN SYNDROME DEHYDRATION DISTURBANCE IN ATTENTION DRUG SCREEN POSITIVE DYSMENORRHOEA ENCEPHALOMALACIA FEELING ABNORMAL

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 383 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7494469
Preferred Term FOOT FRACTURE HAEMORRHAGIC CEREBRAL INFARCTION HAEMORRHAGIC TRANSFORMATION STROKE HEPATIC STEATOSIS HYDROCEPHALUS HYPERTENSION IMPAIRED WORK ABILITY INTRACRANIAL PRESSURE INCREASED ISCHAEMIC STROKE JOINT CONTRACTURE LEUKOCYTOSIS LOSS OF CONSCIOUSNESS MIGRAINE NASAL SEPTUM DEVIATION OEDEMA PERIPHERAL PARTIAL SEIZURES PLEURAL EFFUSION PNEUMONIA PULMONARY EMBOLISM SINUS TACHYCARDIA SUBARACHNOID HAEMORRHAGE SUBDURAL HAEMATOMA SUPERIOR SAGITTAL SINUS THROMBOSIS TRANSVERSE SINUS THROMBOSIS UNEVALUABLE EVENT WEIGHT INCREASED Product Role Route Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 384 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7904953 Date FDA Received
30-Mar-2011 Preferred Term PREGNANCY WITH CONTRACEPTIVE DEVICE MATERNAL EXPOSURE DURING PREGNANCY PREMATURE LABOUR Case # 7904953 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO Role Route S VAGINAL Manufacturer Control # 2011SP013321 Dosage Text VAG Age 18 YR Duration Sex Female Country USA

Manufacturer

7271470 Date FDA Received

31-Mar-2011 Preferred Term

Case # 7271470

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO,OT Role Route S

Manufacturer Control # 2009SP023510 Dosage Text 1 DF;

Age 37 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS CONDITION AGGRAVATED CONSTIPATION OVARIAN CYST PAIN PELVIC PAIN

7892853 Date FDA Received

31-Mar-2011 Preferred Term

Case # 7892853

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO,OT Role Route S C

Manufacturer Control # 2010SP062590 Dosage Text

Age 21 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS HEADACHE ABORTION CHLAMYDIAL INFECTION MYALGIA OVARIAN CYST PREGNANCY WITH CONTRACEPTIVE DEVICE THROMBOPHLEBITIS

ACETYLSALICYLIC ACID W/ CAFFEIN/SALICYLAMIDE

7071231 Date FDA Received

04-Apr-2011

Case # 7071231

Case Type EXPEDITED (15-DAY)

Health Professional Y

Outcomes OT

Manufacturer Control # 2008-178051-NL

Age 24 YR

Sex Female

Country USA

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 385 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7071231
Preferred Term PHARYNGITIS UPPER RESPIRATORY TRACT INFECTION APHTHOUS STOMATITIS VOMITING PAIN MUSCULOSKELETAL PAIN SINUS TACHYCARDIA DRUG INEFFECTIVE BASEDOW'S DISEASE COUGH ASTHMA SPEECH DISORDER VISUAL IMPAIRMENT ALOPECIA AMENORRHOEA AREFLEXIA BALANCE DISORDER BLINDNESS UNILATERAL CHEST PAIN CHRONIC SINUSITIS COAGULOPATHY C-REACTIVE PROTEIN INCREASED DYSKINESIA DYSPHAGIA FATIGUE FEELING JITTERY INCORRECT DOSE ADMINISTERED MATERNAL EXPOSURE BEFORE PREGNANCY MENSTRUATION IRREGULAR MIGRAINE MUSCLE SPASMS Product NUVARING BENADRYL ACETAMINOPHEN SYNTHROID PROPOXYPHENE NAPSYLATE W/ACETAMINOPHENE CEPHALEXIN HFA SSKI METOPROLOL /00376902/ NADOLOL LEVOTHYROXINE SODIUM METHIMAZOLE Role Route S C C C C C C C C C C C C VAGINAL Dosage Text VAG Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 386 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7071231
Preferred Term NAUSEA OVARIAN CYST PAIN IN EXTREMITY PARAESTHESIA POST PROCEDURAL HYPOTHYROIDISM PREGNANCY TRANSIENT ISCHAEMIC ATTACK TREMOR VIITH NERVE PARALYSIS WEIGHT DECREASED Product Role Route Dosage Text Duration Manufacturer

7284784 Date FDA Received

05-Apr-2011 Preferred Term ARTHROPOD BITE

Case # 7284784

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO Role Route S

Manufacturer Control # 2009-198545-NL Dosage Text

Age 24 YR Duration

Sex Female

Country USA

Manufacturer

BUNDLE BRANCH BLOCK RIGHT CAROTID ARTERY DISSECTION CAROTID ARTERY STENOSIS CEREBRAL ARTERY STENOSIS CEREBRAL INFARCTION CEREBROVASCULAR ACCIDENT DIZZINESS FIBRIN D DIMER INCREASED HYPERCHOLESTEROLAEMIA INTERNATIONAL NORMALISED RATIO DECREASED METABOLIC SYNDROME PAIN IN EXTREMITY PARAESTHESIA PROTHROMBIN TIME PROLONGED PROTHROMBIN TIME SHORTENED

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 387 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7916286 Date FDA Received
05-Apr-2011 Preferred Term HEADACHE INTRACRANIAL PRESSURE INCREASED VISUAL IMPAIRMENT Case # 7916286 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional N Outcomes HO Role Route S VAGINAL Manufacturer Control # 2011SP014061 Dosage Text VAGINAL Age 17 YR Duration Sex Female Country USA

Manufacturer

7917681 Date FDA Received

05-Apr-2011 Preferred Term CYST

Case # 7917681

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2011SP014579 Dosage Text VAGINAL Manufacturer Control # 2011SP014532 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

7918413 Date FDA Received

06-Apr-2011 Preferred Term

Case # 7918413

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S

Age

Sex Female

Country DEU

Duration

Manufacturer

CEREBROVASCULAR ACCIDENT VISUAL IMPAIRMENT

7918472 Date FDA Received

06-Apr-2011 Preferred Term NO ADVERSE EVENT

Case # 7918472

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2011SP014909 Dosage Text ; VAG Manufacturer Control # 2011SP014700 Dosage Text

Age 24 YR Duration

Sex Female

Country DEU

Manufacturer

7918482 Date FDA Received

06-Apr-2011 Preferred Term BLINDNESS

Case # 7918482

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S

Age

Sex Female

Country ESP

Duration

Manufacturer

COORDINATION ABNORMAL HYPOAESTHESIA SPEECH DISORDER

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 388 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7678967 Date FDA Received
07-Apr-2011 Preferred Term METRORRHAGIA GENITAL DISCHARGE DEVICE DISLOCATION NEOPLASM MALIGNANT Case # 7678967 Case Type EXPEDITED (15-DAY) Product NUVARING EUTIROX Health Professional N Outcomes OT Role Route S C VAGINAL Manufacturer Control # 2010SP000674 Dosage Text 1 DF; QM; VAG Age 28 YR Duration Sex Female Country CHL

Manufacturer

7888677 Date FDA Received

07-Apr-2011

Case # 7888677

Case Type NON-EXPEDITED

Health Professional Y

Outcomes OT

Manufacturer Control # US-PFIZER INC-2011072129 Dosage Text UNK, 1DF Manufacturer Control # 2011SP014771 Dosage Text 1 DF; VAG

Age

Sex Female

Country USA

Preferred Term DRUG INEFFECTIVE UNINTENDED PREGNANCY

Product DEPO-PROVERA NUVARING Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional N

Role Route S S Outcomes OT Role Route S VAGINAL

Duration

Manufacturer PFIZER

7917939 Date FDA Received

07-Apr-2011 Preferred Term MOOD SWINGS PITUITARY TUMOUR

Case # 7917939

Age 18 YR Duration

Sex Female

Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 389 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7808482 Date FDA Received
08-Apr-2011 Preferred Term DEEP VEIN THROMBOSIS ALCOHOL USE ANTITHROMBIN III DECREASED C-REACTIVE PROTEIN INCREASED DERMATITIS ATOPIC HEADACHE HYPERLIPIDAEMIA INTERNATIONAL NORMALISED RATIO DECREASED PROTHROMBIN TIME SHORTENED PULMONARY EMBOLISM RASH RHINITIS ALLERGIC RIGHT ATRIAL PRESSURE INCREASED SINUSITIS Case # 7808482 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO Role Route S Manufacturer Control # 2010SP019253 Dosage Text Age 31 YR Duration Sex Female Country USA

Manufacturer

7918446 Date FDA Received

08-Apr-2011 Preferred Term

Case # 7918446

Case Type EXPEDITED (15-DAY) Product NUVARING Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO Role Route S VAGINAL

Manufacturer Control # 2011SP015353 Dosage Text VAG Manufacturer Control # 2011SP014930 Dosage Text VAG

Age 30 YR Duration

Sex Female

Country USA

Manufacturer

DEVICE DEPLOYMENT ISSUE

7918814 Date FDA Received

08-Apr-2011 Preferred Term

Case # 7918814

Health Professional Y

Outcomes OT Role Route S VAGINAL

Age 41 YR Duration

Sex Female

Country USA

Manufacturer

MAY-THURNER SYNDROME THROMBOSIS

7279184 Date FDA Received

13-Apr-2011

Case # 7279184

Case Type EXPEDITED (15-DAY)

Health Professional Y

Outcomes HO,DS,OT

Manufacturer Control # 2009SP021082

Age 24 YR

Sex Female

Country USA

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 390 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7279184
Preferred Term PULMONARY EMBOLISM ALCOHOL USE BLOOD CHOLESTEROL INCREASED ABDOMINAL DISCOMFORT ABDOMINAL DISTENSION AFFECTIVE DISORDER AGGRESSION ALCOHOL POISONING AMYLASE INCREASED ANHEDONIA ANXIETY ASTHENIA BACK PAIN BLOOD TRIGLYCERIDES INCREASED CHEST PAIN CHOLECYSTITIS CHRONIC CHOLELITHIASIS CONSTIPATION COORDINATION ABNORMAL COUGH DECREASED APPETITE DEHYDRATION DEVICE BREAKAGE DIARRHOEA DRUG DOSE OMISSION DYSMENORRHOEA DYSPNOEA ENDOMETRIOSIS EXPIRED DRUG ADMINISTERED FALL FLANK PAIN Product NUVARING PAXIL PAROXETINE HYDROCHLORIDE Role Route S S C Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 391 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7279184
Preferred Term FLATULENCE HERPES SIMPLEX SEROLOGY POSITIVE HUMAN PAPILLOMA VIRUS TEST POSITIVE IMPAIRED WORK ABILITY INCISION SITE PAIN INCORRECT DOSE ADMINISTERED INSOMNIA INTERNATIONAL NORMALISED RATIO DECREASED KERATOSIS PILARIS LIPASE INCREASED LOW DENSITY LIPOPROTEIN INCREASED MAJOR DEPRESSION MUSCLE INJURY NAUSEA NEPHROLITHIASIS OVARIAN CYST RUPTURED PAIN PAIN IN EXTREMITY PANCREATITIS PELVIC INFLAMMATORY DISEASE PLEURITIC PAIN PRESYNCOPE RASH PRURITIC SEDATION SINUSITIS SUICIDE ATTEMPT TREATMENT NONCOMPLIANCE URINARY TRACT INFECTION VARICOSE VEIN WEIGHT DECREASED Product Role Route Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 392 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7698961 Date FDA Received
13-Apr-2011 Preferred Term DEEP VEIN THROMBOSIS BLOOD DISORDER THROMBOSIS DEPRESSION IMPAIRED WORK ABILITY ACUTE SINUSITIS ADNEXA UTERI CYST ANXIETY BALANCE DISORDER CARDIAC MURMUR HYPERCOAGULATION HYPERVENTILATION MAY-THURNER SYNDROME PAIN PARAESTHESIA PARAESTHESIA ORAL POSTOPERATIVE WOUND INFECTION PREGNANCY STRESS SUICIDAL IDEATION URINARY TRACT INFECTION Case # 7698961 Case Type EXPEDITED (15-DAY) Product NUVARING PROZAC LEXAPRO TERAMIN PHENTERMINE Health Professional Y Outcomes HO,DS,LT Role Route S S C C C Manufacturer Control # 2009SP043060 Dosage Text Age 20 YR Duration Sex Female Country USA

Manufacturer

7929853 Date FDA Received

13-Apr-2011 Preferred Term

Case # 7929853

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2011SP015840 Dosage Text VAG

Age

Sex Female

Country USA

Duration

Manufacturer

PREGNANCY WITH CONTRACEPTIVE DEVICE ABORTION SPONTANEOUS MATERNAL EXPOSURE DURING PREGNANCY

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 393 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7941081 Date FDA Received
14-Apr-2011 Preferred Term SYNCOPE DIZZINESS DRY MOUTH TACHYCARDIA Case # 7941081 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes OT Role Route S Manufacturer Control # 2011SP016790 Dosage Text Age 39 YR Duration Sex Female Country RUS

Manufacturer

7825125 Date FDA Received

15-Apr-2011 Preferred Term

Case # 7825125

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes HO,DS,OT Role Route S VAGINAL

Manufacturer Control # 2010SP009228 Dosage Text 1 DF;QM;VAG

Age 19 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS ABDOMINAL PAIN ADNEXA UTERI CYST BRONCHITIS COUGH DISEASE RECURRENCE DRUG DOSE OMISSION DYSSTASIA OROPHARYNGEAL PAIN RECTAL HAEMORRHAGE VOMITING

7932801 Date FDA Received

15-Apr-2011 Preferred Term

Case # 7932801

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2011SP015434 Dosage Text VAG

Age 28 YR Duration

Sex Female

Country BRA

Manufacturer

INCORRECT DRUG ADMINISTRATION DURATION HYPOTHYROIDISM INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 394 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7934536 Date FDA Received
15-Apr-2011 Preferred Term ENDOMETRIOSIS Case # 7934536 Case Type EXPEDITED (15-DAY) Product NUVARING Case # 7934725 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional N Health Professional N Outcomes OT Role Route S VAGINAL Manufacturer Control # 2011SP015158 Dosage Text VAG Manufacturer Control # 2011SP015970 Dosage Text VAG Age 30 YR Duration Sex Female Country ESP Age 30 YR Duration Sex Female Country ESP

Manufacturer

7934725 Date FDA Received

15-Apr-2011 Preferred Term ENDOMETRIOSIS

Outcomes HO Role Route S VAGINAL

Manufacturer

INTESTINAL RESECTION

7978858 Date FDA Received

16-Apr-2011 Preferred Term CYST PAIN

Case # 7978858

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2011SP020677 Dosage Text

Age

Sex Female

Country DEU

Duration

Manufacturer

7924394 Date FDA Received

19-Apr-2011 Preferred Term SWELLING DYSURIA ERYTHEMA RASH

Case # 7924394

Case Type DIRECT Product NUVARING

Health Professional N

Outcomes

Manufacturer Control #

Age 26 YR

Sex Female

Country USA

Role Route S VAGINAL

Dosage Text 1 RING CONSISTANT VAG

Duration

Manufacturer

7918384 Date FDA Received

21-Apr-2011 Preferred Term

Case # 7918384

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2011SP012126 Dosage Text

Age 25 YR Duration

Sex Female

Country NOR

Manufacturer

PHOTOSENSITIVITY REACTION

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 395 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7931484 Date FDA Received
21-Apr-2011 Preferred Term HAEMOPTYSIS PULMONARY EMBOLISM Case # 7931484 Case Type DIRECT Product NUVARING Health Professional Y Outcomes HO,LT Role Route S Dosage Text Manufacturer Control # Age 21 YR Duration Sex Female Country USA

Manufacturer MERCK

7284728 Date FDA Received

25-Apr-2011 Preferred Term

Case # 7284728

Case Type EXPEDITED (15-DAY) Product NUVARING FIORICET VICODIN

Health Professional Y

Outcomes HO,OT Role Route S C C

Manufacturer Control # 2009-201000-NL Dosage Text

Age 33 YR Duration

Sex Female

Country USA

Manufacturer

DYSPNOEA EXERTIONAL CHEST PAIN PULMONARY EMBOLISM ALCOHOL USE INTERVERTEBRAL DISC PROTRUSION MIGRAINE NEPHROLITHIASIS PLEURAL EFFUSION ROAD TRAFFIC ACCIDENT SPONDYLOLISTHESIS

7825103 Date FDA Received

25-Apr-2011 Preferred Term

Case # 7825103

Case Type EXPEDITED (15-DAY) Product NUVARING NUVARING LOVENOX COUMADIN ADVIL

Health Professional Y

Outcomes HO,LT,OT Role Route S S S S C C C SUBCUTANEOUS

Manufacturer Control # 2010SP010768 Dosage Text

Age 35 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM HEADACHE COAGULOPATHY CARDIOLIPIN ANTIBODY POSITIVE PAIN NASAL CONGESTION MIGRAINE ABSCESS INTESTINAL

80 MG;BID;SC 6 MG;QD ; 10 MG;QD

SUDAFED 12 HOUR METFORMIN HYDROCHLORIDE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 396 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7825103
Preferred Term ATELECTASIS BILE DUCT OBSTRUCTION BILE DUCT STONE CERVICAL CYST CHOLECYSTITIS CHRONIC CHOLELITHIASIS COAGULATION FACTOR IX LEVEL DECREASED CONSTIPATION DEEP VEIN THROMBOSIS DYSPHAGIA DYSURIA EXERCISE TOLERANCE DECREASED HAEMORRHAGIC ANAEMIA HAEMORRHOIDS HOT FLUSH HYPERTENSION HYPOXIA INTERNATIONAL NORMALISED RATIO DECREASED INTERSTITIAL LUNG DISEASE LOSS OF CONSCIOUSNESS LUNG CONSOLIDATION MELANOSIS COLI MENOMETRORRHAGIA NEPHROLITHIASIS ORAL HERPES OVARIAN CYST PELVIC FLUID COLLECTION PITUITARY TUMOUR BENIGN PLEURAL EFFUSION PNEUMOTHORAX Product Role Route Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 397 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7825103
Preferred Term PROCTOCOLITIS PULMONARY INFARCTION RESPIRATORY ARREST RIGHT VENTRICULAR FAILURE SACROILIITIS SINUS DISORDER UPPER GASTROINTESTINAL HAEMORRHAGE URINARY TRACT INFECTION VIRAL PHARYNGITIS Product Role Route Dosage Text Duration Manufacturer

7943589 Date FDA Received

25-Apr-2011 Preferred Term

Case # 7943589

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2011SP015508 Dosage Text VAG

Age

Sex Female

Country USA

Duration

Manufacturer

PREGNANCY WITH CONTRACEPTIVE DEVICE ABORTION SPONTANEOUS MATERNAL EXPOSURE DURING PREGNANCY

7935060 Date FDA Received

26-Apr-2011 Preferred Term

Case # 7935060

Case Type DIRECT Product NUVARING

Health Professional Y

Outcomes HO,OT Role Route S VAGINAL

Manufacturer Control #

Age 36 YR

Sex Female

Country USA

Dosage Text ONE RING INSERTED ONCE EVERY 3 WEEKS VAG

Duration 4 YEAR

Manufacturer

PULMONARY EMBOLISM

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 398 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6246720 Date FDA Received
27-Apr-2011 Preferred Term PULMONARY EMBOLISM HYPERCOAGULATION ABDOMINAL PAIN UPPER AORTIC VALVE INCOMPETENCE AUTOIMMUNE THYROIDITIS BACTERAEMIA BRACHIAL PLEXOPATHY BREAST PROSTHESIS USER GASTROOESOPHAGEAL REFLUX DISEASE HAEMATURIA IMPAIRED WORK ABILITY LEUKOCYTOSIS LOBAR PNEUMONIA MIGRAINE MITRAL VALVE INCOMPETENCE MITRAL VALVE PROLAPSE MONONEUROPATHY MULTIPLEX NEURALGIA OVARIAN CYST PULMONARY HYPERTENSION PULMONARY INFARCTION SEPSIS THROMBOSIS UTERINE LEIOMYOMA VASCULITIS VITAMIN B12 DEFICIENCY Case # 6246720 Case Type EXPEDITED (15-DAY) Product NUVARING SYNTHROID Health Professional Y Outcomes HO,OT Role Route S C VAGINAL Manufacturer Control # 2006-139623-NL Dosage Text 1 DF; VAG Age 36 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 399 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7901953 Date FDA Received
27-Apr-2011 Preferred Term ECTOPIC PREGNANCY MATERNAL EXPOSURE DURING PREGNANCY PREGNANCY WITH CONTRACEPTIVE DEVICE Case # 7901953 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes OT Role Route S Manufacturer Control # 2011SP012669 Dosage Text Age 31 YR Duration Sex Female Country FRA

Manufacturer

7938262 Date FDA Received

27-Apr-2011 Preferred Term LOSS OF LIBIDO PANIC REACTION STRESS

Case # 7938262

Case Type DIRECT Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control #

Age 40 YR

Sex Female

Country USA

Dosage Text

Duration

Manufacturer ORGANON

7805930 Date FDA Received

28-Apr-2011 Preferred Term

Case # 7805930

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO Role Route S S

Manufacturer Control # 2010SP025097 Dosage Text

Age 27 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM PLEURAL EFFUSION DYSMENORRHOEA URINE ANALYSIS ABNORMAL

DEPO-PROVERA

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 400 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7808337 Date FDA Received
29-Apr-2011 Preferred Term DEEP VEIN THROMBOSIS BLOOD PRESSURE INADEQUATELY CONTROLLED DEPRESSION INJECTION SITE ANAESTHESIA INJECTION SITE PAIN MIGRAINE PAIN PULMONARY EMBOLISM WALKING AID USER Case # 7808337 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO Role Route S Manufacturer Control # 2010SP004575 Dosage Text Age 25 YR Duration Sex Female Country USA

Manufacturer

7919655 Date FDA Received

29-Apr-2011

Case # 7919655

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes OT

Manufacturer Control # USJNJFOC-20110407351 Dosage Text

Age

Sex Female

Country USA

Preferred Term Foetal death ABORTION SPONTANEOUS DRUG INTERACTION Maternal exposure during pregnancy

Product TOPAMAX NUVARING

Role Route S S ORAL UNKNOWN

Duration

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 401 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7949863 Date FDA Received
29-Apr-2011 Preferred Term PULMONARY EMBOLISM MESENTERIC VEIN THROMBOSIS ARRHYTHMIA ATRIAL FIBRILLATION BLOOD DISORDER BRADYCARDIA COAGULOPATHY COGNITIVE DISORDER DEEP VEIN THROMBOSIS EMOTIONAL DISORDER HEART RATE IRREGULAR INJURY MENTAL DISORDER PAIN PORTAL VEIN THROMBOSIS SPLENIC VEIN THROMBOSIS TACHYCARDIA THROMBOSIS Case # 7949863 Case Type EXPEDITED (15-DAY) Product NUVARING ACETAMINOPHEN Health Professional N Outcomes HO,DS,OT Role Route S C Manufacturer Control # 2010SP065480 Dosage Text Age 36 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 402 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7107782 Date FDA Received
02-May-2011 Preferred Term DEEP VEIN THROMBOSIS RENAL ATROPHY MICROCYTIC ANAEMIA ANTIPHOSPHOLIPID ANTIBODIES POSITIVE BACK PAIN BLOOD DISORDER BREAST MASS CHOLELITHIASIS INFECTION MENOMETRORRHAGIA NECK PAIN OEDEMA PERIPHERAL PELVIC CONGESTION Case # 7107782 Case Type EXPEDITED (15-DAY) Product NUVARING LASIX METRONIDAZOLE Health Professional Y Outcomes HO,OT Role Route S C C VAGINAL Manufacturer Control # 2007-165251-NL Dosage Text ;VAG Age 30 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 403 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7271489 Date FDA Received
02-May-2011 Preferred Term PULMONARY EMBOLISM BIPOLAR DISORDER ABDOMINAL PAIN HYPOKALAEMIA INFECTION INTENTIONAL OVERDOSE MENTAL STATUS CHANGES PREGNANCY SUBSTANCE ABUSE SUICIDE ATTEMPT TREATMENT NONCOMPLIANCE UNRESPONSIVE TO STIMULI VICTIM OF SEXUAL ABUSE Case # 7271489 Case Type EXPEDITED (15-DAY) Product NUVARING ASTHMA MEDICATION Health Professional Y Outcomes HO,OT Role Route S C Manufacturer Control # 2009SP023460 Dosage Text 1 DF Age 23 YR Duration Sex Female Country USA

Manufacturer

7277409 Date FDA Received

02-May-2011 Preferred Term APRAXIA APHASIA SEXUAL ABUSE

Case # 7277409

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO,DS,OT Role Route S C C

Manufacturer Control # 2009SP028658 Dosage Text

Age 22 YR Duration

Sex Female

Country USA

Manufacturer

MULTI-VITAMIN ACETAMINOPHEN

ADJUSTMENT DISORDER AMINO ACID LEVEL INCREASED BRAIN HERNIATION BRAIN OEDEMA CAROTID ARTERY DISSECTION CAROTID ARTERY OCCLUSION CEREBRAL ARTERY OCCLUSION CEREBRAL HAEMORRHAGE CEREBRAL INFARCTION

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 404 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7277409
Preferred Term CONVULSION DECREASED APPETITE DEPRESSION DYSPHAGIA EDUCATIONAL PROBLEM FALL FATIGUE HEAD INJURY HYPERCOAGULATION HYPERTENSION IMPAIRED WORK ABILITY INSOMNIA ISCHAEMIC STROKE MIGRAINE MITRAL VALVE PROLAPSE NIGHTMARE PNEUMONIA POST-TRAUMATIC STRESS DISORDER RENAL FAILURE RESPIRATORY FAILURE RHABDOMYOLYSIS SUICIDAL BEHAVIOUR UNRESPONSIVE TO STIMULI URINARY TRACT INFECTION VISUAL IMPAIRMENT WEIGHT DECREASED Product Role Route Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 405 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7282110 Date FDA Received
02-May-2011 Preferred Term DEEP VEIN THROMBOSIS PELVIC VENOUS THROMBOSIS ANAEMIA BREAST DISCHARGE DYSPLASTIC NAEVUS FIBRIN D DIMER INCREASED FIBROADENOMA OF BREAST FIBROCYSTIC BREAST DISEASE GAIT DISTURBANCE HEADACHE MAY-THURNER SYNDROME PAIN PHOTOPSIA VENOUS INSUFFICIENCY VENOUS STENOSIS Case # 7282110 Case Type EXPEDITED (15-DAY) Product NUVARING ADVIL Health Professional Y Outcomes HO,DS,OT Role Route S C VAGINAL Manufacturer Control # 2009SP017417 Dosage Text 1 DF;QM;VAG Age 23 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 406 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7753710 Date FDA Received
02-May-2011 Preferred Term INJURY APHASIA ABORTION SPONTANEOUS ASTHENIA CERVICAL DYSPLASIA COORDINATION ABNORMAL DIZZINESS DYSARTHRIA DYSKINESIA DYSPAREUNIA FALL HAEMORRHOIDS HEADACHE HYPOGLYCAEMIA LOSS OF CONSCIOUSNESS MEDICAL DEVICE DISCOMFORT MENORRHAGIA OVARIAN CYST OVARIAN FIBROMA PAIN PELVIC PAIN POSTPARTUM DEPRESSION PREGNANCY ROAD TRAFFIC ACCIDENT SYNCOPE TREMOR UTERINE LEIOMYOMA VERTIGO Case # 7753710 Case Type EXPEDITED (15-DAY) Product NUVARING ACETAMINOPHEN Health Professional Y Outcomes HO,OT Role Route S C Manufacturer Control # 2010SP062391 Dosage Text Age 28 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 407 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7766225 Date FDA Received
02-May-2011 Preferred Term MULTIPLE INJURIES ABDOMINAL DISCOMFORT CONSTIPATION DIZZINESS DYSPNOEA ECONOMIC PROBLEM ELECTROCARDIOGRAM T WAVE ABNORMAL GASTRITIS HEPATIC NECROSIS IMPAIRED WORK ABILITY IRON DEFICIENCY ANAEMIA LIVER FUNCTION TEST ABNORMAL LIVER SCAN ABNORMAL PAIN PALPITATIONS PELVIC DISCOMFORT PLATELET COUNT INCREASED PORTAL VEIN THROMBOSIS PRESYNCOPE QUALITY OF LIFE DECREASED VAGINAL HAEMORRHAGE WHITE BLOOD CELL COUNT DECREASED Case # 7766225 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes DS,OT Role Route S Manufacturer Control # 2010SP064891 Dosage Text Age 35 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 408 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7772445 Date FDA Received
02-May-2011 Preferred Term ACUTE MYOCARDIAL INFARCTION MULTIPLE INJURIES PAIN Case # 7772445 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional N Outcomes HO Role Route S Manufacturer Control # 2010SP065557 Dosage Text QM Age 38 YR Duration Sex Female Country USA

Manufacturer

7888974 Date FDA Received

02-May-2011 Preferred Term

Case # 7888974

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO Role Route S VAGINAL

Manufacturer Control # 2011SP010448 Dosage Text VAG

Age 37 YR Duration

Sex Female

Country LVA

Manufacturer

PREGNANCY WITH CONTRACEPTIVE DEVICE ABORTION SPONTANEOUS MATERNAL EXPOSURE DURING PREGNANCY

7953496 Date FDA Received

02-May-2011 Preferred Term

Case # 7953496

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes HO,DS,OT Role Route S C

Manufacturer Control # 2011SP000347 Dosage Text

Age 30 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS HEPATIC INFECTION BEDRIDDEN DEPRESSION ECONOMIC PROBLEM IMPAIRED WORK ABILITY MENTAL DISORDER

LISINOPRIL AND HYDROCHLOROTHIAZIDE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 409 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7953727 Date FDA Received
02-May-2011 Preferred Term DEEP VEIN THROMBOSIS INJURY ABORTION ANAEMIA CHEST PAIN DYSPNOEA HYPERCOAGULATION MENSTRUATION IRREGULAR PAIN IN EXTREMITY PELVIC PAIN PLEURITIC PAIN SINUSITIS THROMBOPHLEBITIS VAGINAL INFECTION VULVOVAGINITIS Case # 7953727 Case Type EXPEDITED (15-DAY) Product NUVARING ACETYSALICYLIC ACID W/ CAFFEINE/SALICYLAMIDE Health Professional Y Outcomes HO,OT Role Route S C Manufacturer Control # 2011SP062590 Dosage Text Age 21 YR Duration Sex Female Country USA

Manufacturer

7960749 Date FDA Received

02-May-2011 Preferred Term

Case # 7960749

Case Type EXPEDITED (15-DAY) Product NUVARING TOPAMAX

Health Professional N

Outcomes OT Role Route S S

Manufacturer Control # 2011SP017751 Dosage Text

Age 35 YR Duration

Sex Female

Country USA

Manufacturer

PREGNANCY WITH CONTRACEPTIVE DEVICE MATERNAL EXPOSURE DURING PREGNANCY ABORTION SPONTANEOUS DRUG EFFECT DECREASED MIGRAINE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 410 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7955036 Date FDA Received
03-May-2011 Preferred Term ABDOMINAL PAIN AGGRESSION BACK PAIN CRYING DEPRESSED MOOD EMOTIONAL DISORDER FEELING ABNORMAL PALPITATIONS PANIC ATTACK SUICIDAL IDEATION Case # 7955036 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional N Outcomes OT Role Route S VAGINAL Manufacturer Control # 2011SP016654 Dosage Text VAG Age 40 YR Duration Sex Female Country NLD

Manufacturer

7955063 Date FDA Received

03-May-2011 Preferred Term INFECTION ABORTION

Case # 7955063

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO Role Route S VAGINAL

Manufacturer Control # 2011SP018848 Dosage Text VAG

Age 19 YR Duration

Sex Female

Country DEU

Manufacturer

MATERNAL EXPOSURE DURING PREGNANCY PREGNANCY WITH CONTRACEPTIVE DEVICE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 411 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7957175 Date FDA Received
03-May-2011 Preferred Term PULMONARY EMBOLISM FOOT OPERATION BACK PAIN NEUROLOGICAL SYMPTOM PYREXIA HAEMOPTYSIS PNEUMONIA VOMITING Case # 7957175 Case Type EXPEDITED (15-DAY) Product NUVARING SPINAL ANESTHESIA ACETAMINOPHEN CODEINE ACETAMINOPHEN AND CODEINE Health Professional Y Outcomes HO Role Route S C C C C VAGINAL Manufacturer Control # 2011SP018611 Dosage Text VAG Age 45 YR Duration Sex Female Country SWE

Manufacturer

6542063 Date FDA Received

04-May-2011 Preferred Term

Case # 6542063

Case Type EXPEDITED (15-DAY) Product NUVARING ZOLOFT RANITIDINE

Health Professional Y

Outcomes DE Role Route S C C VAGINAL

Manufacturer Control # 2008-170662-NL Dosage Text 1 DF, QM, VAG

Age 32 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM DEEP VEIN THROMBOSIS CARDIAC ARREST ACUTE MYOCARDIAL INFARCTION AGITATION ANOXIA APNOEA CEREBROVASCULAR ACCIDENT ELECTROLYTE IMBALANCE LOSS OF CONSCIOUSNESS OVERDOSE PUPIL FIXED

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 412 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7828688 Date FDA Received
04-May-2011 Preferred Term GRAND MAL CONVULSION SUBARACHNOID HAEMORRHAGE ANXIETY CEREBRAL INFARCTION DEPRESSION EMBOLIC STROKE EMOTIONAL DISORDER FEAR HYPERCOAGULATION IMPAIRED WORK ABILITY MOOD ALTERED OVARIAN CYST SPINAL CORD DISORDER Case # 7828688 Case Type EXPEDITED (15-DAY) Product NUVARING ZYRTEC Health Professional Y Outcomes HO,DS,OT Role Route S C Manufacturer Control # 2010SP034933 Dosage Text Age 25 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 413 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7961595 Date FDA Received
04-May-2011 Preferred Term COITAL BLEEDING ABDOMINAL PAIN ASCARIASIS DIARRHOEA GENITOURINARY TRACT INFECTION HYMENOLEPIASIS HYPERBILIRUBINAEMIA INFECTION PROTOZOAL OVARIAN CYST PRODUCT QUALITY ISSUE Rubber sensitivity VULVOVAGINAL BURNING SENSATION VULVOVAGINAL PRURITUS Case # 7961595 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional N Outcomes OT Role Route S VAGINAL Manufacturer Control # 2011SP005215 Dosage Text QM, VAG Age 22 YR Duration Sex Female Country CHL

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 414 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7292062 Date FDA Received
06-May-2011 Preferred Term MULTIPLE INJURIES DEEP VEIN THROMBOSIS OEDEMA PERIPHERAL ANAEMIA ARTHRALGIA BREAST CYST CERVICAL DYSPLASIA CONTUSION DYSMENORRHOEA FIBRIN D DIMER INCREASED HEART VALVE INCOMPETENCE HUMAN PAPILLOMA VIRUS TEST POSITIVE METRORRHAGIA REFUSAL OF TREATMENT BY PATIENT VAGINAL DISCHARGE WISDOM TEETH REMOVAL Case # 7292062 Case Type EXPEDITED (15-DAY) Product NUVARING ZOLOFT VITAMINS NOS Health Professional Y Outcomes HO,OT Role Route S C C Manufacturer Control # 2010SP006045 Dosage Text Age 24 YR Duration Sex Female Country USA

Manufacturer

7351745 Date FDA Received

06-May-2011

Case # 7351745

Case Type EXPEDITED (15-DAY)

Health Professional Y

Outcomes HO,DS,OT

Manufacturer Control # 2010SP015815

Age 34 YR

Sex Female

Country USA

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 415 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7351745
Preferred Term CONVULSION ACUTE MYOCARDIAL INFARCTION HYPOXIC-ISCHAEMIC ENCEPHALOPATHY RESPIRATORY FAILURE PULMONARY EMBOLISM ABORTION INDUCED AMNESIA ANGINA PECTORIS ANOSOGNOSIA ANXIETY CARDIO-RESPIRATORY ARREST COGNITIVE DISORDER CORONARY ARTERY OCCLUSION CRANIOCEREBRAL INJURY DEPRESSION HAEMOPHILUS TEST POSITIVE HYPERTENSION IMPAIRED DRIVING ABILITY IMPAIRED WORK ABILITY LACERATION LOSS OF CONSCIOUSNESS MEMORY IMPAIRMENT PAPILLOMA VIRAL INFECTION POLYCYTHAEMIA POSTURE ABNORMAL PREGNANCY SINUS TACHYCARDIA SPUTUM CULTURE POSITIVE SUPRAVENTRICULAR EXTRASYSTOLES TREATMENT NONCOMPLIANCE VENTRICULAR EXTRASYSTOLES Product NUVARING SYNTHROID METOPROLOL TARTRATE CLOPIDOGREL FEXOFENADINE Role Route S C C C C Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 416 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7575566 Date FDA Received
09-May-2011 Preferred Term SYSTEMIC LUPUS ERYTHEMATOSUS LYMPHADENOPATHY PAIN IN EXTREMITY Case # 7575566 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes OT Role Route S VAGINAL Manufacturer Control # 2010SP044339 Dosage Text ;VAG Age 26 YR Duration Sex Female Country USA

Manufacturer

7635668 Date FDA Received

09-May-2011 Preferred Term PNEUMONIA THROMBOSIS ASTHMA

Case # 7635668

Case Type EXPEDITED (15-DAY) Product NUVARING TAMIFLU

Health Professional Y

Outcomes HO,OT Role Route S C

Manufacturer Control # 2010SP014793 Dosage Text

Age 45 YR Duration

Sex Female

Country USA

Manufacturer

ATRIAL SEPTAL DEFECT BRONCHITIS CAROTID ARTERIOSCLEROSIS CEREBELLAR INFARCTION DEAFNESS UNILATERAL DIPLOPIA DIVERTICULITIS DIVERTICULUM DYSMENORRHOEA HYPERTENSION METABOLIC ACIDOSIS MITRAL VALVE INCOMPETENCE THROMBOTIC STROKE TINNITUS TONSILLECTOMY TRICUSPID VALVE INCOMPETENCE VERTIGO

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 417 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7961596 Date FDA Received
09-May-2011 Preferred Term HYPERINSULINAEMIA INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION POLYURIA THIRST WITHDRAWAL BLEED Case # 7961596 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional N Outcomes OT Role Route S VAGINAL Manufacturer Control # 2011SP019723 Dosage Text QM;VAG Age 40 YR Duration Sex Female Country CHL

Manufacturer

7152389 Date FDA Received

11-May-2011 Preferred Term

Case # 7152389

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO,OT Role Route S C C C VAGINAL

Manufacturer Control # 2008-187211-NL Dosage Text 1 DF;Q3W;VAG

Age 29 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS UTERINE LEIOMYOMA POLYP MENORRHAGIA UTERINE DISORDER

METFORMIN HYDROCHLORIDE ALTACE NAPROXIN

7807538 Date FDA Received

11-May-2011 Preferred Term

Case # 7807538

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO Role Route S

Manufacturer Control # 2010SP047114 Dosage Text

Age 34 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM ANGIOPATHY CARDIOMEGALY DEEP VEIN THROMBOSIS PLEURAL EFFUSION PULMONARY INFARCTION VAGINAL HAEMORRHAGE VULVOVAGINAL MYCOTIC INFECTION

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 418 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7969558 Date FDA Received
11-May-2011 Preferred Term HEADACHE BREAST CYST STRESS Case # 7969558 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional N Outcomes OT Role Route S VAGINAL Manufacturer Control # 2011SP019682 Dosage Text QM, VAG Age 35 YR Duration Sex Female Country CHL

Manufacturer

7808420 Date FDA Received

13-May-2011 Preferred Term FATIGUE ABDOMINAL PAIN ANXIETY CANDIDIASIS

Case # 7808420

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO Role Route S

Manufacturer Control # 2010SP034914 Dosage Text QM

Age 48 YR Duration

Sex Female

Country USA

Manufacturer

CONDITION AGGRAVATED COUGH DEEP VEIN THROMBOSIS EAR INFECTION HEPATIC CYST HOT FLUSH SPUTUM DISCOLOURED TREATMENT NONCOMPLIANCE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 419 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7821714 Date FDA Received
13-May-2011 Preferred Term PULMONARY EMBOLISM DEEP VEIN THROMBOSIS BACK PAIN BLOOD CHOLESTEROL INCREASED BLOOD TRIGLYCERIDES INCREASED DYSPNOEA EXERTIONAL INFECTIOUS MONONUCLEOSIS LABORATORY TEST INTERFERENCE OEDEMA PERIPHERAL PAIN IN EXTREMITY PREGNANCY PROTEIN C DECREASED RHINITIS ALLERGIC SINUSITIS UPPER RESPIRATORY TRACT INFECTION VENOUS INSUFFICIENCY VOMITING Case # 7821714 Case Type EXPEDITED (15-DAY) Product NUVARING MULTI-VITAMIN Health Professional Y Outcomes HO,OT Role Route S C Manufacturer Control # 2009SP043048 Dosage Text Age 30 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 420 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7827365 Date FDA Received
13-May-2011 Preferred Term CEREBROVASCULAR ACCIDENT SEASONAL ALLERGY HYPERTENSION CEREBRAL HAEMORRHAGE DEEP VEIN THROMBOSIS ANXIETY ARTHROPOD BITE ASTHMA CANDIDIASIS CELLULITIS CEREBRAL INFARCTION COGNITIVE DISORDER DEPRESSION DIZZINESS DRUG HYPERSENSITIVITY HEADACHE HYPERCALCAEMIA HYPERCOAGULATION HYPOTHYROIDISM HYPOVOLAEMIA INTRACRANIAL VENOUS SINUS THROMBOSIS LABYRINTHITIS LYME DISEASE OEDEMA PERIPHERAL PAIN TINNITUS TRANSIENT ISCHAEMIC ATTACK VISION BLURRED VOMITING Case # 7827365 Case Type EXPEDITED (15-DAY) Product NUVARING SINGULAIR NASONEX VITAMINS NOS ALBUTEROL SULFATE Health Professional Y Outcomes HO,DS,OT Role Route S C C C C Manufacturer Control # 2010SP042534 Dosage Text Age 37 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 421 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7873417 Date FDA Received
13-May-2011 Preferred Term VENA CAVA THROMBOSIS ADNEXA UTERI CYST DEEP VEIN THROMBOSIS HEADACHE MULTIPLE INJURIES NAUSEA PRESYNCOPE PROCEDURAL VOMITING Case # 7873417 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO,OT Role Route S VAGINAL Manufacturer Control # 2010SP054999 Dosage Text 1 DF;QM;VAG Age 19 YR Duration Sex Female Country USA

Manufacturer

7973499 Date FDA Received

13-May-2011 Preferred Term WEIGHT INCREASED INCREASED APPETITE FATIGUE

Case # 7973499

Case Type EXPEDITED (15-DAY) Product NUVARING LEXAPRO

Health Professional Y

Outcomes DS,LT Role Route S C VAGINAL

Manufacturer Control # 2011SP021086 Dosage Text QM;VAG

Age 19 YR Duration

Sex Female

Country USA

Manufacturer

GLUCOSE TOLERANCE IMPAIRED REFUSAL OF TREATMENT BY PATIENT

7704666 Date FDA Received

16-May-2011 Preferred Term

Case # 7704666

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO,DS,OT Role Route S C VAGINAL

Manufacturer Control # 2010SP018401 Dosage Text VAG

Age 25 YR Duration

Sex Female

Country USA

Manufacturer

CEREBROVASCULAR ACCIDENT CEREBRAL HAEMORRHAGE ABASIA ABDOMINAL PAIN ABDOMINAL PAIN UPPER ANXIETY ASTIGMATISM

HYDROCHLOROTHIAZIDE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 422 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7704666
Preferred Term BITE BLOOD ALKALINE PHOSPHATASE INCREASED BLOOD CHOLESTEROL INCREASED BRONCHITIS CAESAREAN SECTION CARDIOVASCULAR DISORDER CARPAL TUNNEL SYNDROME CERVICITIS TRICHOMONAL CERVICOBRACHIAL SYNDROME CHOLELITHIASIS COGNITIVE DISORDER CONSTIPATION CONTUSION CONVERSION DISORDER CYST CYSTITIS DIABETES MELLITUS INADEQUATE CONTROL DILATATION VENTRICULAR DIZZINESS DRUG SCREEN POSITIVE DYSARTHRIA DYSPEPSIA DYSPNOEA EMOTIONAL DISTRESS EYE PAIN GASTRITIS HEADACHE HEMIPARESIS HYPERTENSION MATERNAL EXPOSURE BEFORE PREGNANCY MUSCLE SPASMS Product Role Route Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 423 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7704666
Preferred Term MUSCLE STRAIN NAUSEA OBESITY PAIN PREGNANCY PROTEUS TEST POSITIVE RAYNAUD'S PHENOMENON ROAD TRAFFIC ACCIDENT SLEEP DISORDER THROMBOSIS TREATMENT NONCOMPLIANCE TRICUSPID VALVE INCOMPETENCE URINARY TRACT INFECTION UTERINE CERVICAL SQUAMOUS METAPLASIA VASCULITIS VASOSPASM VISUAL ACUITY REDUCED VOMITING WOUND DEHISCENCE Product Role Route Dosage Text Duration Manufacturer

7971357 Date FDA Received

16-May-2011 Preferred Term

Case # 7971357

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2011SP018318 Dosage Text VAG

Age

Sex Female

Country NLD

Duration

Manufacturer

SMEAR CERVIX ABNORMAL

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 424 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7976836 Date FDA Received
16-May-2011 Preferred Term CONDITION AGGRAVATED DEPRESSION MENTAL DISORDER SUICIDAL IDEATION Case # 7976836 Case Type EXPEDITED (15-DAY) Product NUVARING ESCITALOPRAM OXALATE ZOLOFT Health Professional Y Outcomes LT Role Route S C C VAGINAL Manufacturer Control # 2011SP021163 Dosage Text 1 DF;QM;VAG Age 35 YR Duration 4 MTH Sex Female Country CAN

Manufacturer

7978859 Date FDA Received

16-May-2011 Preferred Term

Case # 7978859

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2011SP0200551 Dosage Text QM; VAG

Age 32 YR Duration

Sex Female

Country CHL

Manufacturer

CARBOHYDRATE INTOLERANCE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 425 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7279224 Date FDA Received
17-May-2011 Preferred Term SUPERIOR SAGITTAL SINUS THROMBOSIS PHLEBITIS PULMONARY EMBOLISM LYMPHADENOPATHY IATROGENIC INJURY INFUSION SITE EXTRAVASATION VENOUS THROMBOSIS LIMB HYPERCOAGULATION SEBORRHOEIC KERATOSIS MELANOCYTIC NAEVUS INFLAMMATION CEREBRAL VENOUS THROMBOSIS DISEASE RECURRENCE EPISCLERITIS HAEMORRHOIDS HIATUS HERNIA OTITIS MEDIA SQUAMOUS CELL CARCINOMA OF SKIN Case # 7279224 Case Type EXPEDITED (15-DAY) Product NUVARING PRILOSEC PREVACID MOTRIN TYLENOL PHENTERMINE HYDROCHLORIDE CELEBREX ULTRAM MOBIC MOTRIN TYLENOL Health Professional Y Outcomes HO,OT Role Route S C C C C C C C C C C Manufacturer Control # 2009SP020359 Dosage Text Age 43 YR Duration Sex Female Country USA

Manufacturer

7660184 Date FDA Received

17-May-2011 Preferred Term

Case # 7660184

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO Role Route S

Manufacturer Control # 2010SP004576 Dosage Text

Age 18 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM ABORTION MISSED ASTHMA ATRIOVENTRICULAR BLOCK FIRST DEGREE CARDIAC DISORDER DEEP VEIN THROMBOSIS

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 426 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7660184
Preferred Term DILATATION VENTRICULAR DIZZINESS DYSPNOEA FOETAL DEATH HAEMATURIA INTERNATIONAL NORMALISED RATIO DECREASED LOSS OF CONSCIOUSNESS LYMPHOEDEMA MATERNAL EXPOSURE BEFORE PREGNANCY OEDEMA PERIPHERAL PNEUMONIA PREGNANCY PRESYNCOPE PROTEIN C DEFICIENCY PROTEIN S DEFICIENCY PULMONARY HYPERTENSION RESPIRATORY DISORDER ROAD TRAFFIC ACCIDENT SINUSITIS THROMBOSIS TREATMENT NONCOMPLIANCE URINARY BLADDER RUPTURE URINARY TRACT INFECTION VAGINITIS BACTERIAL VENTRICULAR HYPOKINESIA VIRAL INFECTION WHITE BLOOD CELL COUNT INCREASED Product Role Route Dosage Text Duration Manufacturer

7752401 Date FDA Received

17-May-2011

Case # 7752401

Case Type EXPEDITED (15-DAY)

Health Professional Y

Outcomes HO,DS

Manufacturer Control # 2010SP046935

Age 40 YR

Sex Female

Country USA

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 427 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7752401
Preferred Term PULMONARY EMBOLISM HAEMORRHAGE IMPAIRED WORK ABILITY CELLULITIS TOOTH ABSCESS MUSCULOSKELETAL DISORDER GASTRIC POLYPS DUODENITIS NEURODERMATITIS ANXIETY ASPIRATION PLEURAL CAVITY ABNORMAL ATELECTASIS BURSITIS FOOT DEFORMITY GAIT DISTURBANCE HAEMATOCRIT DECREASED HAEMOGLOBIN DECREASED LICHEN PLANUS LUNG INFILTRATION MUSCULOSKELETAL CHEST PAIN PALPITATIONS PATELLOFEMORAL PAIN SYNDROME PLEURAL EFFUSION PLEURISY PSORIATIC ARTHROPATHY PULMONARY INFARCTION PULMONARY MASS RECTAL HAEMORRHAGE REPETITIVE STRAIN INJURY TREATMENT NONCOMPLIANCE Product NUVARING COUMADIN FLOVENT ALBUTEROL SULFATE ZYRTEC SINGULAIR ZEGERID PROZAC CALCIUM CARBONATE Role Route S S C C C C C C C Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 428 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7970270 Date FDA Received
17-May-2011 Preferred Term DYSPNOEA ANGINA PECTORIS FATIGUE NAUSEA PULMONARY INFARCTION Case # 7970270 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes LT,OT Role Route S VAGINAL Manufacturer Control # 2011SP021322 Dosage Text ; VAG Age 27 YR Duration 122 DAY Sex Female Country CAN

Manufacturer

7975281 Date FDA Received

17-May-2011 Preferred Term

Case # 7975281

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2011SP013096 Dosage Text ; QM; VAG

Age 27 YR Duration

Sex Female

Country CHL

Manufacturer

URINARY TRACT INFECTION AFFECT LABILITY ANGER DRUG DOSE OMISSION INTENTIONAL SELF-INJURY PETIT MAL EPILEPSY

7975294 Date FDA Received

17-May-2011 Preferred Term CERVICAL DYSPLASIA DEVICE BREAKAGE

Case # 7975294

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2011SP018787 Dosage Text

Age 41 YR Duration

Sex Female

Country FRA

Manufacturer

MEDICAL DEVICE COMPLICATION

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 429 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7979921 Date FDA Received
17-May-2011 Preferred Term PULMONARY EMBOLISM DEEP VEIN THROMBOSIS DYSPNOEA FATIGUE HYPOAESTHESIA IMPAIRED WORK ABILITY MUSCULOSKELETAL CHEST PAIN NECK MASS PALPITATIONS THROMBOSIS WEIGHT INCREASED Case # 7979921 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO,DS,OT Role Route S Manufacturer Control # 2010SP062586 Dosage Text Age 35 YR Duration Sex Female Country USA

Manufacturer

7913066 Date FDA Received

18-May-2011 Preferred Term

Case # 7913066

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes

Manufacturer Control # 2011SP013861

Age 22 YR Duration

Sex Female

Country USA

Role Route S VAGINAL

Dosage Text QM;VAG

Manufacturer

INCORRECT DRUG ADMINISTRATION DURATION MUSCLE SPASMS UTERINE POLYP

7971014 Date FDA Received

18-May-2011 Preferred Term

Case # 7971014

Case Type DIRECT Product NUVARING

Health Professional Y

Outcomes HO,LT Role Route S

Manufacturer Control #

Age 23 YR

Sex Female

Country USA

Dosage Text

Duration

Manufacturer

PULMONARY EMBOLISM ARRHYTHMIA HAEMODYNAMIC INSTABILITY RIGHT VENTRICULAR FAILURE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 430 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7979809 Date FDA Received
18-May-2011 Preferred Term WEIGHT INCREASED DISTURBANCE IN ATTENTION MEMORY IMPAIRMENT Case # 7979809 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional N Outcomes OT Role Route S VAGINAL Manufacturer Control # 2010SP051650 Dosage Text ;QM;VAG Duration Age Sex Female Country CHL

Manufacturer

7979825 Date FDA Received

18-May-2011 Preferred Term

Case # 7979825

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2011SP020750 Dosage Text

Age

Sex Female

Country DEU

Duration

Manufacturer

VAGINAL HAEMORRHAGE OVARIAN CYST

7979470 Date FDA Received

19-May-2011 Preferred Term ANXIETY SCHIZOPHRENIA

Case # 7979470

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2011SP022169 Dosage Text

Age

Sex Female

Country ISR

Duration

Manufacturer

7979826 Date FDA Received

19-May-2011 Preferred Term

Case # 7979826

Case Type EXPEDITED (15-DAY) Product NUVARING ABILIFY

Health Professional Y

Outcomes OT Role Route S C C C VAGINAL

Manufacturer Control # 2011SP021277 Dosage Text 1 DF, VAG

Age

Sex Female

Country AUS

Duration

Manufacturer

UTERINE HAEMORRHAGE DEVICE BREAKAGE

METFORMIN HYDROCHLORIDE PROZAC

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 431 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7412445 Date FDA Received
20-May-2011 Preferred Term DEEP VEIN THROMBOSIS HEART RATE INCREASED BLOOD PRESSURE INCREASED THROMBOSIS AORTIC ANEURYSM COAGULOPATHY PULMONARY EMBOLISM THROMBOPHLEBITIS SUPERFICIAL Case # 7412445 Case Type EXPEDITED (15-DAY) Product NUVARING COMPAZINE KLONOPIN ZEBETA Health Professional Y Outcomes HO,OT Role Route S S C C VAGINAL Manufacturer Control # 2010SP014790 Dosage Text VAG Age 28 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 432 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7848487 Date FDA Received
20-May-2011 Preferred Term PULMONARY EMBOLISM ROAD TRAFFIC ACCIDENT HEAD INJURY MEMORY IMPAIRMENT ATTENTION DEFICIT/HYPERACTIVITY DISORDER HEADACHE ADJUSTMENT DISORDER ANXIETY CONSTIPATION CRANIOCEREBRAL INJURY DRUG HYPERSENSITIVITY DYSMENORRHOEA FEELING ABNORMAL GASTRITIS IRON DEFICIENCY ANAEMIA MASS MENINGIOMA PAIN PICA PLEURITIC PAIN POST CONCUSSION SYNDROME PULMONARY INFARCTION URINARY TRACT INFECTION VERTIGO VOMITING Case # 7848487 Case Type EXPEDITED (15-DAY) Product NUVARING PERCOCET CARVEDILOL ACETAMINOPHEN COREG TYLENOL Health Professional N Outcomes HO,OT Role Route S S S S C C 500 MG; PRN; Manufacturer Control # 2010SP046934 Dosage Text Age 26 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 433 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7980749 Date FDA Received
20-May-2011 Preferred Term PULMONARY EMBOLISM Case # 7980749 Case Type EXPEDITED (15-DAY) Product NUVARING Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Health Professional Y Outcomes DE,HO,DS,LT Role Route S VAGINAL Manufacturer Control # 2011SP022325 Dosage Text VAG Manufacturer Control # 2010SP046454 Dosage Text Age 33 YR Duration Sex Female Country USA Age 16 YR Duration Sex Female Country USA

Manufacturer

7808633 Date FDA Received

23-May-2011 Preferred Term

Case # 7808633

Outcomes OT Role Route S

Manufacturer

DEEP VEIN THROMBOSIS BACK PAIN EMOTIONAL DISORDER HYPERCOAGULATION LYMPHADENOPATHY MENTAL DISORDER MULTIPLE INJURIES NECK MASS THYROID NEOPLASM

7987247 Date FDA Received

23-May-2011 Preferred Term CONVULSION DEVICE DISLOCATION

Case # 7987247

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2011SP022293 Dosage Text ; VAG

Age

Sex Female

Country ESP

Duration

Manufacturer

VAGINAL HAEMORRHAGE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 434 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7678367 Date FDA Received
24-May-2011 Preferred Term DEEP VEIN THROMBOSIS PULMONARY EMBOLISM OVARIAN CYST BREAST PAIN POLYMENORRHOEA GASTROENTERITIS PREMENSTRUAL SYNDROME ALOPECIA DEPRESSION FIBRIN D DIMER INCREASED FIBROCYSTIC BREAST DISEASE HYPERCOAGULATION LIGAMENT SPRAIN MOOD SWINGS STRESS TACHYCARDIA TENDON INJURY TENDONITIS Case # 7678367 Case Type EXPEDITED (15-DAY) Product NUVARING WELLBUTRIN ZOLOFT HERBAL BALANCE METABOLIZERS (HERBAL PREPARATION) PRILOSEC ASPIRIN Health Professional Y Outcomes HO,OT Role Route S C C C C C C Manufacturer Control # 2010SP038557 Dosage Text Age 30 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 435 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7736285 Date FDA Received
24-May-2011 Preferred Term DEEP VEIN THROMBOSIS OVARIAN CYST CHOLECYSTECTOMY MENOMETRORRHAGIA GAIT DISTURBANCE ABDOMINAL PAIN DIVERTICULUM GASTRITIS HAEMORRHOIDS HIATUS HERNIA INTERNATIONAL NORMALISED RATIO INCREASED OESOPHAGITIS SINUS TACHYCARDIA THROMBOPHLEBITIS SUPERFICIAL UPPER GASTROINTESTINAL HAEMORRHAGE Case # 7736285 Case Type EXPEDITED (15-DAY) Product NUVARING ONE-A-DAY MULTIVITAMINS (MULTIVITAMINS) DIGESTIVE ENZYMES PRILOSEC BENADRYL Health Professional Y Outcomes HO,OT Role Route S C C C C VAGINAL Manufacturer Control # 2010SP019265 Dosage Text VAG Age 51 YR Duration Sex Female Country USA

Manufacturer

7979920 Date FDA Received

24-May-2011 Preferred Term

Case # 7979920

Case Type DIRECT Product NUVARING ZOLOFT CRESTOR AMBIEN

Health Professional N

Outcomes HO,LT Role Route S C C C

Manufacturer Control #

Age 44 YR

Sex Female

Country USA

Dosage Text MONTHLY

Duration 8 MTH

Manufacturer MERCK

DEEP VEIN THROMBOSIS PULMONARY EMBOLISM

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 436 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7987613 Date FDA Received
24-May-2011 Preferred Term UTERINE INJURY ABDOMINAL PAIN LOWER DYSPAREUNIA UTERINE HAEMORRHAGE Case # 7987613 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional N Outcomes OT Role Route S Manufacturer Control # 2011SP021687 Dosage Text Age 27 YR Duration Sex Female Country CAN

Manufacturer

7987751 Date FDA Received

24-May-2011 Preferred Term NAUSEA HYPOAESTHESIA PARAESTHESIA

Case # 7987751

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes HO Role Route S VAGINAL

Manufacturer Control # 2011SP022387 Dosage Text VAG

Age 34 YR Duration

Sex Female

Country USA

Manufacturer

7853484 Date FDA Received

26-May-2011 Preferred Term

Case # 7853484

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO,DS Role Route S

Manufacturer Control # 2010SP055002 Dosage Text

Age 23 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM ALVEOLITIS ALLERGIC ATELECTASIS BRONCHITIS COAGULOPATHY CONSTIPATION DEHYDRATION DEPRESSION DIARRHOEA DIVERTICULUM EYE SWELLING GASTROOESOPHAGEAL REFLUX DISEASE GROIN PAIN

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 437 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7853484
Preferred Term HEADACHE HYPERTHYROIDISM LOWER GASTROINTESTINAL HAEMORRHAGE LUNG INFILTRATION MIGRAINE MUSCULOSKELETAL CHEST PAIN NAUSEA OEDEMA PERIPHERAL OVARIAN CYST OVARIAN CYST RUPTURED PELVIC INFLAMMATORY DISEASE PLEURAL EFFUSION PULMONARY INFARCTION PYELONEPHRITIS SCOLIOSIS THROMBOSIS TOOTHACHE VARICOSE VEIN VICTIM OF ABUSE VOMITING Product Role Route Dosage Text Duration Manufacturer

7970734 Date FDA Received

26-May-2011 Preferred Term

Case # 7970734

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes DE,OT Role Route S TRANSPLACENTAL

Manufacturer Control # 2011SP020521 Dosage Text TRPL

Age 1 DAY Duration

Sex Male

Country USA Manufacturer

MATERNAL DRUGS AFFECTING FOETUS FOETAL DEATH LIMB MALFORMATION LOW SET EARS

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 438 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7983595 Date FDA Received
26-May-2011 Preferred Term PULMONARY EMBOLISM Case # 7983595 Case Type DIRECT Product NUVARING WARFARIN SODIUM Health Professional N Outcomes HO Role Route S C Outcomes OT Role Route S Manufacturer Control # 2011SP023427 Dosage Text 1 DF; Age 1 DAY Duration Sex Unknown Country USA Dosage Text Manufacturer Control # Age 25 YR Duration Sex Female Country USA

Manufacturer

7994204 Date FDA Received

26-May-2011 Preferred Term

Case # 7994204

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Manufacturer

PLACENTAL DISORDER CORTICAL LAMINAR NECROSIS MATERNAL EXPOSURE DURING PREGNANCY PLACENTAL HYPERTROPHY PREGNANCY WITH CONTRACEPTIVE DEVICE PREMATURE DELIVERY

7995715 Date FDA Received

26-May-2011 Preferred Term

Case # 7995715

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2011SP022558 Dosage Text

Age 26 YR Duration

Sex Female

Country DEU

Manufacturer

MUSCULOSKELETAL PAIN

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 439 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6781967 Date FDA Received
27-May-2011 Preferred Term BURNING SENSATION AGGRESSION APNOEIC ATTACK ARTHRALGIA CARDIAC ARREST CYSTITIS DEPRESSED LEVEL OF CONSCIOUSNESS DIZZINESS EPISTAXIS OEDEMA PERIPHERAL PAIN IN EXTREMITY POLLAKIURIA PULMONARY EMBOLISM PULSE ABSENT Case # 6781967 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes DE Role Route S VAGINAL Manufacturer Control # 2008-183584-NL Dosage Text 1 DF; ;VAG Age 27 YR Duration Sex Female Country USA

Manufacturer

7271465 Date FDA Received

31-May-2011 Preferred Term

Case # 7271465

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S C VAGINAL

Manufacturer Control # 2009SP023502 Dosage Text ;VAG

Age 27 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS BLOOD DISORDER ANXIETY BLIGHTED OVUM CHEST DISCOMFORT CHEST PAIN CHOKING COAGULOPATHY COSTOCHONDRITIS DYSPNOEA

PHENTERMINE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 440 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7271465
Preferred Term FACTOR V LEIDEN MUTATION FALL GASTRIC BYPASS GASTROOESOPHAGEAL REFLUX DISEASE HAEMORRHAGE HEAD INJURY HYPOTHYROIDISM JOINT INJURY KIDNEY INFECTION LUNG DISORDER MUSCULOSKELETAL STIFFNESS NECROSIS NEPHROLITHIASIS OEDEMA PERIPHERAL OVARIAN CYST PAIN IN EXTREMITY PHLEBITIS PLACENTAL NECROSIS PLEURISY POSTPARTUM HAEMORRHAGE PULMONARY EMBOLISM RETAINED PLACENTA OR MEMBRANES THROMBOPHLEBITIS UMBILICAL CORD ABNORMALITY VAGINAL HAEMORRHAGE VARICOSE VEIN VEIN DISORDER VENOUS OCCLUSION WHITE BLOOD CELL COUNT INCREASED Product Role Route Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 441 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7711397 Date FDA Received
31-May-2011 Preferred Term PULMONARY EMBOLISM THROMBOSIS INSOMNIA DEPRESSION ANXIETY HAEMORRHAGE INTRACRANIAL HEADACHE INTRACRANIAL PRESSURE INCREASED PULMONARY INFARCTION SCHIZOPHRENIA Case # 7711397 Case Type EXPEDITED (15-DAY) Product NUVARING PROPRANOLOL DIAMOX SEQUELS HYDROCODONE XANAX Health Professional Y Outcomes HO Role Route S C C C C Manufacturer Control # 2010SP004920 Dosage Text Age 19 YR Duration Sex Female Country USA

Manufacturer

7963856 Date FDA Received

31-May-2011 Preferred Term

Case # 7963856

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO,OT Role Route S

Manufacturer Control # 2010SP064432 Dosage Text

Age 34 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM ACNE ANAEMIA BACK PAIN CERVICAL DYSPLASIA DEEP VEIN THROMBOSIS FALL HUMAN PAPILLOMA VIRUS TEST POSITIVE HYPERCOAGULATION MUSCLE SPASMS POLYCYSTIC OVARIES PULMONARY HAEMORRHAGE REFUSAL OF TREATMENT BY PATIENT

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 442 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6944083 Date FDA Received
01-Jun-2011 Preferred Term DYSPNOEA FEELING ABNORMAL DEEP VEIN THROMBOSIS PULMONARY EMBOLISM DIZZINESS FATIGUE CARDIO-RESPIRATORY ARREST CONDITION AGGRAVATED HAEMATURIA HYPERSENSITIVITY RENAL CYST SINUS DISORDER SLUGGISHNESS THROAT IRRITATION Case # 6944083 Case Type EXPEDITED (15-DAY) Product NUVARING MAXAIR MDI EXCEDRIN MIGRAINE ADVAIR DISKUS SINGULAIR ZITHROMAX Health Professional Y Outcomes DE,OT Role Route S C C C C C VAGINAL Manufacturer Control # 2009-192474-NL Dosage Text VAG Age 45 YR Duration Sex Female Country USA

Manufacturer

7170691 Date FDA Received

01-Jun-2011 Preferred Term

Case # 7170691

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes DE,HO,OT Role Route S C VAGINAL

Manufacturer Control # 2009SP031709 Dosage Text VAG

Age 21 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM BLOOD POTASSIUM INCREASED BLOOD CHLORIDE INCREASED BLOOD GLUCOSE INCREASED RESPIRATORY ARREST UNRESPONSIVE TO STIMULI

EXCEDRIN /00110301/

7271455 Date FDA Received

01-Jun-2011

Case # 7271455

Case Type EXPEDITED (15-DAY)

Health Professional Y

Outcomes HO,OT

Manufacturer Control # 2009SP023295

Age 51 YR

Sex Female

Country USA

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 443 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7271455
Preferred Term PULMONARY EMBOLISM NEPHROLITHIASIS OVARIAN CYST MENSTRUAL DISORDER EMOTIONAL DISORDER ABDOMINAL WALL HAEMATOMA ARTHRALGIA ATELECTASIS DIVERTICULITIS DIZZINESS DYSURIA FEAR FLANK PAIN GASTRITIS EROSIVE GASTROOESOPHAGEAL REFLUX DISEASE HAEMATOMA HEPATOBILIARY SCAN ABNORMAL HYDRONEPHROSIS HYPERCOAGULATION HYPOAESTHESIA HYPOKALAEMIA INJURY NAUSEA OSTEOPENIA PARAESTHESIA PLEURAL EFFUSION PNEUMONIA REFUSAL OF TREATMENT BY PATIENT SINUS BRADYCARDIA VOMITING Product NUVARING UNSPECIFIED INGREDIENT HEPARIN FROVA TYLENOL Role Route S S S C C Dosage Text 1 DF; Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 444 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7271460 Date FDA Received
01-Jun-2011 Preferred Term DEEP VEIN THROMBOSIS THROMBOSIS ANAEMIA PAIN IN EXTREMITY SCAR URINARY TRACT INFECTION Case # 7271460 Case Type EXPEDITED (15-DAY) Product NUVARING STUDY DRUG Health Professional Y Outcomes HO Role Route S C Manufacturer Control # 2009SP023247 Dosage Text Age 24 YR Duration Sex Female Country USA

Manufacturer

7615038 Date FDA Received

01-Jun-2011 Preferred Term OVARIAN CYST NAUSEA

Case # 7615038

Case Type EXPEDITED (15-DAY) Product NUVARING TYLENOL

Health Professional Y

Outcomes HO,OT Role Route S C

Manufacturer Control # 2010SP028268 Dosage Text

Age 21 YR Duration

Sex Female

Country USA

Manufacturer

CEREBRAL VENOUS THROMBOSIS FALL FEAR FEAR OF DEATH HEADACHE INTRACRANIAL VENOUS SINUS THROMBOSIS JOINT RANGE OF MOTION DECREASED MATERNAL EXPOSURE DURING PREGNANCY PAIN PELVIC PAIN PHLEBITIS PREGNANCY RADIUS FRACTURE THROMBOSIS VAGINAL ODOUR

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 445 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7997452 Date FDA Received
01-Jun-2011 Preferred Term UTERINE LEIOMYOMA ASTHENIA DIZZINESS DYSGEUSIA ENDOMETRIAL HYPERTROPHY HEADACHE IRRITABILITY MALAISE NAUSEA OVARIAN DISORDER UTERINE MALPOSITION Case # 7997452 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional N Outcomes OT Role Route S VAGINAL Manufacturer Control # 2011SP024105 Dosage Text QM;VAG Age 30 YR Duration Sex Female Country MEX

Manufacturer

7997485 Date FDA Received

01-Jun-2011 Preferred Term ECTOPIC PREGNANCY

Case # 7997485

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2011SP024344 Dosage Text QM;VAG

Age

Sex Female

Country MEX

Duration

Manufacturer

MATERNAL EXPOSURE DURING PREGNANCY PREGNANCY WITH CONTRACEPTIVE DEVICE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 446 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7276522 Date FDA Received
02-Jun-2011 Preferred Term PULMONARY EMBOLISM ANOGENITAL DYSPLASIA BLOOD PRESSURE INCREASED BLOODY DISCHARGE BRONCHITIS DEEP VEIN THROMBOSIS DEPRESSION DRUG EFFECT DECREASED ENDOMETRIAL HYPERTROPHY NAUSEA OVARIAN CYST RUPTURED PELVIC PAIN PNEUMONIA UPPER RESPIRATORY TRACT INFECTION VULVOVAGINAL HUMAN PAPILLOMA VIRUS INFECTION Case # 7276522 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO,OT Role Route S Manufacturer Control # 2009SP024643 Dosage Text Age 29 YR Duration Sex Female Country USA

Manufacturer

7870214 Date FDA Received

06-Jun-2011 Preferred Term PAIN IN EXTREMITY ANKLE FRACTURE

Case # 7870214

Case Type EXPEDITED (15-DAY) Product NUVARING PREVIFEM

Health Professional Y

Outcomes OT Role Route S C VAGINAL

Manufacturer Control # 2011SP008882 Dosage Text VAG

Age 22 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS PATELLA FRACTURE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 447 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7823223 Date FDA Received
07-Jun-2011 Preferred Term PULMONARY EMBOLISM CERVICAL DYSPLASIA CERVICITIS HYPERCOAGULATION PHARYNGITIS STREPTOCOCCAL THROMBOSIS UPPER RESPIRATORY TRACT INFECTION Case # 7823223 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO Role Route S Manufacturer Control # 2010SP007164 Dosage Text 1 DF Age 23 YR Duration Sex Female Country USA

Manufacturer

7808495 Date FDA Received

08-Jun-2011 Preferred Term

Case # 7808495

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO,OT Role Route S

Manufacturer Control # 2010SP019264 Dosage Text

Age 25 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS CHOLECYSTITIS ACUTE CHOLECYSTITIS CHRONIC PULMONARY EMBOLISM

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 448 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7854139 Date FDA Received
08-Jun-2011 Preferred Term THROMBOSIS ANAEMIA DIZZINESS DYSFUNCTIONAL UTERINE BLEEDING DYSPNOEA ENDOMETRIOSIS INJURY LEIOMYOMA METRORRHAGIA PAIN PALPITATIONS TACHYCARDIA UTERINE ENLARGEMENT Case # 7854139 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO,OT Role Route S Manufacturer Control # 2010SP057649 Dosage Text Age 42 YR Duration Sex Female Country USA

Manufacturer

7994206 Date FDA Received

08-Jun-2011 Preferred Term

Case # 7994206

Case Type DIRECT Product NUVARING

Health Professional Y

Outcomes HO,LT Role Route S

Manufacturer Control #

Age 47 YR

Sex Female

Country USA

Dosage Text 1 RING INSERTION PER MONTH

Duration

Manufacturer

DEEP VEIN THROMBOSIS PULMONARY EMBOLISM

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 449 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7144678 Date FDA Received
09-Jun-2011 Preferred Term PULMONARY EMBOLISM HYPOTENSION ANAEMIA ABSCESS ASTHENIA BARTHOLIN'S CYST BREAST ABSCESS BREAST PAIN CELLULITIS CHILLS HEPATIC STEATOSIS PALPITATIONS SWELLING ULCER Case # 7144678 Case Type EXPEDITED (15-DAY) Product NUVARING GREEN TEA TYLENOL Health Professional Y Outcomes HO,OT Role Route S C C VAGINAL Manufacturer Control # 2009-201022-NL Dosage Text VAG Age 36 YR Duration Sex Female Country USA

Manufacturer

7199625 Date FDA Received

10-Jun-2011 Preferred Term

Case # 7199625

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO,OT Role Route S

Manufacturer Control # 2009SP020337 Dosage Text

Age 27 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM BRADYCARDIA HEADACHE HYPOKALAEMIA MIGRAINE PAIN PLEURAL EFFUSION PRESYNCOPE PULMONARY INFARCTION

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 450 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7805907 Date FDA Received
10-Jun-2011 Preferred Term PULMONARY EMBOLISM NASOPHARYNGITIS INFLUENZA HYPOCOAGULABLE STATE RASH Case # 7805907 Case Type EXPEDITED (15-DAY) Product NUVARING NUVARING LEXAPRO Health Professional Y Outcomes HO Role Route S S C VAGINAL Manufacturer Control # 2010SP053010 Dosage Text ; VAG Age 37 YR Duration Sex Female Country USA

Manufacturer

7931033 Date FDA Received

10-Jun-2011 Preferred Term HYPERINSULINISM

Case # 7931033

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S C C C Outcomes HO Role Route S VAGINAL VAGINAL

Manufacturer Control # 2011SP015629 Dosage Text QM;VAG

Age 30 YR Duration

Sex Female

Country CHL

Manufacturer

INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION VAGINAL INFECTION

CINNARIZINE MOMETASONE FUROATE DESLORATADINE

8011849 Date FDA Received

10-Jun-2011 Preferred Term THYROID OPERATION METRORRHAGIA

Case # 8011849

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Manufacturer Control # 2011SP025775 Dosage Text VAG

Age

Sex Female

Country ESP

Duration

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 451 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7303153 Date FDA Received
13-Jun-2011 Preferred Term PULMONARY EMBOLISM BLINDNESS UNILATERAL HEADACHE HYPERTENSION HYPOAESTHESIA MATERNAL EXPOSURE BEFORE PREGNANCY MIGRAINE PERIPHERAL VASCULAR DISORDER PRE-ECLAMPSIA RETINAL ARTERY OCCLUSION RETINAL VEIN OCCLUSION THROMBOSIS Case # 7303153 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO,OT Role Route S Manufacturer Control # 2010SP006033 Dosage Text Age 31 YR Duration Sex Female Country USA

Manufacturer

8011903 Date FDA Received

13-Jun-2011 Preferred Term PHARYNGITIS TONSILLITIS DEVICE EXPULSION DRUG INTERACTION

Case # 8011903

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S S S S C C ORAL ORAL ORAL

Manufacturer Control # 2011SP026508 Dosage Text 500 MG;QD;PO 500 MG;BID;PO 500 MG;BID;PO

Age 28 YR Duration

Sex Female

Country PRT

Manufacturer

AZITHROMYCIN CEFATRIZINE CIPROFLOXACIN FLUOXETINE HCL MEXAZOLAM

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 452 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7985638 Date FDA Received
15-Jun-2011 Preferred Term ABORTION SPONTANEOUS MATERNAL EXPOSURE DURING PREGNANCY PREGNANCY WITH CONTRACEPTIVE DEVICE Case # 7985638 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes OT Role Route S Manufacturer Control # 2011SP022570 Dosage Text Age 20 YR Duration Sex Female Country FRA

Manufacturer

8015157 Date FDA Received

15-Jun-2011 Preferred Term

Case # 8015157

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO,LT Role Route S

Manufacturer Control # 2011SP027037 Dosage Text 1 DF

Age

Sex Female

Country USA

Duration

Manufacturer

PULMONARY EMBOLISM ABORTION SPONTANEOUS PREGNANCY WITH CONTRACEPTIVE DEVICE TWIN PREGNANCY

8016467 Date FDA Received

15-Jun-2011 Preferred Term PANCREATITIS

Case # 8016467

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2011SP026319 Dosage Text

Age 36 YR Duration

Sex Female

Country CHE

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 453 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7322061 Date FDA Received
16-Jun-2011 Preferred Term UTERINE LEIOMYOMA OVARIAN CYST UTERINE CYST ACUTE MYOCARDIAL INFARCTION APNOEA CARDIAC FAILURE CONGESTIVE DIASTOLIC DYSFUNCTION DYSLIPIDAEMIA FATIGUE INTRACARDIAC THROMBUS LEFT VENTRICULAR HYPERTROPHY LEIOMYOMA LIPOPROTEIN (A) INCREASED MENSTRUATION IRREGULAR MITRAL VALVE INCOMPETENCE NASAL CONGESTION SNORING SOMNOLENCE TRICUSPID VALVE INCOMPETENCE Case # 7322061 Case Type EXPEDITED (15-DAY) Product NUVARING TRIAMTERENE LISINOPRIL Health Professional Y Outcomes HO,OT Role Route S C C Manufacturer Control # 2010SP009225 Dosage Text Age 36 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 454 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7614433 Date FDA Received
16-Jun-2011 Preferred Term PULMONARY EMBOLISM ABORTION INCOMPLETE ABORTION INDUCED CARDIOMEGALY CERVICAL DYSPLASIA CHILLS DEEP VEIN THROMBOSIS ELECTROCARDIOGRAM P WAVE ABNORMAL ELECTROCARDIOGRAM T WAVE INVERSION HALLUCINATION HEART RATE IRREGULAR HUMAN PAPILLOMA VIRUS TEST POSITIVE HYPERCOAGULATION MALAISE MATERNAL EXPOSURE DURING PREGNANCY MENTAL STATUS CHANGES MULTIPLE INJURIES PALPITATIONS PERICARDIAL EFFUSION PREGNANCY WITH CONTRACEPTIVE DEVICE PROCEDURAL PAIN PULMONARY INFARCTION PYREXIA SINUS TACHYCARDIA SYSTEMIC LUPUS ERYTHEMATOSUS Case # 7614433 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO,OT Role Route S Manufacturer Control # 2010SP016190 Dosage Text Age 36 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 455 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7828712 Date FDA Received
16-Jun-2011 Preferred Term PULMONARY EMBOLISM THROMBOSIS LOSS OF EMPLOYMENT LYMPHADENOPATHY PULMONARY INFARCTION Case # 7828712 Case Type EXPEDITED (15-DAY) Product NUVARING TYLENOL Health Professional Y Outcomes HO,OT Role Route S C Manufacturer Control # 2010SP034934 Dosage Text Age 31 YR Duration Sex Female Country USA

Manufacturer

7859430 Date FDA Received

16-Jun-2011 Preferred Term

Case # 7859430

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2011SP005996 Dosage Text 1 DF; ; VAG

Age 23 YR Duration

Sex Female

Country USA

Manufacturer

RUPTURED ECTOPIC PREGNANCY MATERNAL EXPOSURE DURING PREGNANCY PREGNANCY WITH CONTRACEPTIVE DEVICE

8010411 Date FDA Received

17-Jun-2011 Preferred Term DYSPAREUNIA BURNING SENSATION

Case # 8010411

Case Type DIRECT Product NUVARING

Health Professional N

Outcomes

Manufacturer Control #

Age 28 YR

Sex Female

Country USA

Role Route S

Dosage Text 1 RING 3 WEEKS IN 1 WEEK

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 456 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7885248 Date FDA Received
20-Jun-2011 Preferred Term RETINAL VEIN OCCLUSION BLINDNESS UNILATERAL BREAST CALCIFICATIONS BREAST HYPERPLASIA CHOLESTEATOMA FIBROADENOMA OF BREAST FIBROCYSTIC BREAST DISEASE LABYRINTHINE FISTULA OTITIS MEDIA RETINAL HAEMORRHAGE RETINAL ISCHAEMIA THROMBOSIS Case # 7885248 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes OT Role Route S Manufacturer Control # 2010SP062384 Dosage Text Age 45 YR Duration Sex Female Country USA

Manufacturer

8010985 Date FDA Received

20-Jun-2011 Preferred Term

Case # 8010985

Case Type DIRECT Product NUVARING

Health Professional N

Outcomes HO,LT Role Route S

Manufacturer Control #

Age 18 YR

Sex Female

Country USA

Dosage Text

Duration 8 MTH

Manufacturer

PULMONARY THROMBOSIS

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 457 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7808729 Date FDA Received
21-Jun-2011 Preferred Term THROMBOSIS LOSS OF CONSCIOUSNESS HYPERKALAEMIA ANAEMIA CEREBRAL HAEMORRHAGE CEREBRAL VENOUS THROMBOSIS CEREBROVASCULAR ACCIDENT HYPERCOAGULATION IRON DEFICIENCY ANAEMIA Case # 7808729 Case Type EXPEDITED (15-DAY) Product NUVARING LITHIUM CARBONATE VITAMINS NOS Health Professional Y Outcomes HO,OT Role Route S C C Manufacturer Control # 2010SP038520 Dosage Text Age 26 YR Duration Sex Female Country USA

Manufacturer

8024207 Date FDA Received

21-Jun-2011 Preferred Term

Case # 8024207

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes DE Role Route S

Manufacturer Control # 2011SP028094 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

PULMONARY EMBOLISM

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 458 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7805375 Date FDA Received
22-Jun-2011 Preferred Term PULMONARY EMBOLISM OVARIAN CYST HYPERTENSION HEART RATE IRREGULAR AFFECTIVE DISORDER ARTHRALGIA ATELECTASIS CARDIOMEGALY CHEST PAIN DECREASED ACTIVITY DIASTOLIC DYSFUNCTION EJECTION FRACTION DECREASED FEMUR FRACTURE GRANULOMA HUMAN PAPILLOMA VIRUS TEST POSITIVE HYPERCOAGULATION IMPAIRED WORK ABILITY MUSCULOSKELETAL DEFORMITY NODULE PERICARDITIS CONSTRICTIVE PLEURISY POST-TRAUMATIC STRESS DISORDER PREGNANCY SCAR SMEAR CERVIX ABNORMAL STRESS FRACTURE TACHYCARDIA UTERINE LEIOMYOMA Case # 7805375 Case Type EXPEDITED (15-DAY) Product NUVARING SINGULAIR ZYRTEC PAXIL Health Professional Y Outcomes HO,DS,OT Role Route S C C C Manufacturer Control # 2010SP025276 Dosage Text Age 44 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 459 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7892590 Date FDA Received
22-Jun-2011 Preferred Term CEREBROVASCULAR ACCIDENT CEREBRAL INFARCTION CONTUSION CONVULSION DEVICE DEPLOYMENT ISSUE DIZZINESS DYSFUNCTIONAL UTERINE BLEEDING DYSMENORRHOEA HEADACHE HYPERTENSIVE HEART DISEASE HYPOTHYROIDISM LEFT VENTRICULAR HYPERTROPHY MENORRHAGIA MITRAL VALVE INCOMPETENCE OVARIAN CYST PHOTOPHOBIA PRURITUS SCAR SLEEP DISORDER Case # 7892590 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO,OT Role Route S Manufacturer Control # 2010SP062541 Dosage Text Age 32 YR Duration Sex Female Country USA

Manufacturer

8024120 Date FDA Received

22-Jun-2011 Preferred Term THROMBOSIS

Case # 8024120

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO,LT,OT Role Route S VAGINAL

Manufacturer Control # 2011SP028600 Dosage Text VAG

Age 40 YR Duration

Sex Female

Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 460 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8025259 Date FDA Received
22-Jun-2011 Preferred Term DEHYDRATION PREGNANCY WITH IMPLANT CONTRACEPTIVE Case # 8025259 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional N Outcomes HO Role Route S VAGINAL Manufacturer Control # 2011SP028157 Dosage Text VAG Duration Age Sex Female Country NLD

Manufacturer

8025286 Date FDA Received

22-Jun-2011 Preferred Term

Case # 8025286

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2011SP028191 Dosage Text QM, VAG

Age 31 YR Duration

Sex Female

Country CHL

Manufacturer

GALLBLADDER DISORDER INCORRECT DRUG ADMINISTRATION DURATION

7222577 Date FDA Received

23-Jun-2011 Preferred Term

Case # 7222577

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO Role Route S C C C C C C

Manufacturer Control # 2009-190801-NL Dosage Text

Age 34 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS PULMONARY EMBOLISM CONVULSION THROMBOSIS COLITIS ULCERATIVE ANAEMIA ATELECTASIS BACK PAIN BLOOD MAGNESIUM DECREASED CALCINOSIS NEPHROLITHIASIS SEBORRHOEIC KERATOSIS SMALL INTESTINAL OBSTRUCTION

PREDNISONE ASACOL PROTONIX LEXAPRO PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN ZITHROMAX

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 461 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7808442 Date FDA Received
23-Jun-2011 Preferred Term DEEP VEIN THROMBOSIS THROMBOPHLEBITIS THROMBOSIS Case # 7808442 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO Role Route S Manufacturer Control # 2010SP029130 Dosage Text Age 30 YR Duration Sex Female Country USA

Manufacturer

7217361 Date FDA Received

27-Jun-2011 Preferred Term

Case # 7217361

Case Type EXPEDITED (15-DAY) Product NUVARING GEODON CELEXA XANAX

Health Professional Y

Outcomes HO,OT Role Route S C C C C C C C C C C C C C C C C C C C C VAGINAL

Manufacturer Control # 2009SP028435 Dosage Text VAG

Age 25 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS DYSPNOEA ANKLE OPERATION OEDEMA PERIPHERAL MITRAL VALVE INCOMPETENCE ARTHRALGIA CHEST DISCOMFORT DRUG RESISTANCE CELLULITIS PAINFUL RESPIRATION BIPOLAR II DISORDER DRUG ABUSE ALCOHOL ABUSE BORDERLINE PERSONALITY DISORDER CALCULUS URETHRAL ENDOMETRIOSIS DYSTHYMIC DISORDER PHARYNGITIS STREPTOCOCCAL CONSTIPATION JOINT SWELLING INTERNATIONAL NORMALISED RATIO INCREASED

RABEPRAZOLE SODIUM EFFEXOR XR DIFLUCAN FLUOCINOLONE ACETONIDE METHYLPREDNISOLONE ZITHROMAX TEMAZEPAM LASIX CLONAZEPAM NULYTELY OLUX TOPAMAX ACIPHEX WELLBUTRIN SEROQUEL VALIUM TRAZODONE HYDROCHLORIDE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 462 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7217361
Preferred Term LACERATION INTERNATIONAL NORMALISED RATIO DECREASED HYPOAESTHESIA NERVE COMPRESSION VAGINAL DISCHARGE ANGER APPARENT DEATH DRUG INEFFECTIVE GASTROENTERITIS LIGAMENT SPRAIN LOSS OF CONSCIOUSNESS MELAENA MUSCLE SPASMS PAIN IN EXTREMITY PANIC DISORDER RECTAL HAEMORRHAGE ROAD TRAFFIC ACCIDENT SELF ESTEEM DECREASED SLEEP APNOEA SYNDROME SYSTEMIC LUPUS ERYTHEMATOSUS WEIGHT DECREASED Product ELAVIL FLAGYL LUNESTA HYDROCODONE BITARTRATE AND ACETAMINOPHEN HYDROCODONE BITARTRATE AND ACETAMINOPHEN Role Route C C C C C Dosage Text Duration Manufacturer

7546634 Date FDA Received

28-Jun-2011 Preferred Term

Case # 7546634

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO,DS,OT Role Route S C C

Manufacturer Control # 2009SP035995 Dosage Text

Age 20 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM HYPERTENSION MIGRAINE

EXCEDRIN MIGRAINE TYLENOL RAPID RELEASE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 463 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7546634
Preferred Term ABDOMINAL PAIN UPPER ANXIETY ATELECTASIS CAESAREAN SECTION CEREBROVASCULAR ACCIDENT CHEST PAIN CHOLELITHIASIS DEEP VEIN THROMBOSIS DIZZINESS DYSPNOEA ERUCTATION FATIGUE FLANK PAIN GASTROOESOPHAGEAL REFLUX DISEASE HEADACHE HEPATIC STEATOSIS HYPOAESTHESIA HYPOTHYROIDISM LUNG DISORDER MATERNAL EXPOSURE BEFORE PREGNANCY MULTIPLE INJURIES MUSCULOSKELETAL CHEST PAIN NAUSEA PALPITATIONS PERIPARTUM CARDIOMYOPATHY PLEURAL EFFUSION PNEUMOPERITONEUM PREGNANCY PYELONEPHRITIS SINUS TACHYCARDIA SUPRAVENTRICULAR TACHYCARDIA Product Role Route Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 464 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7546634
Preferred Term TACHYPNOEA TRANSIENT ISCHAEMIC ATTACK URINARY TRACT INFECTION Product Role Route Dosage Text Duration Manufacturer

7740291 Date FDA Received

28-Jun-2011

Case # 7740291

Case Type EXPEDITED (15-DAY)

Health Professional Y

Outcomes HO,OT

Manufacturer Control # 2010SP019235

Age 29 YR

Sex Female

Country USA

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 465 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7740291
Preferred Term DEEP VEIN THROMBOSIS PULMONARY EMBOLISM ABORTION MISSED ASTHMA CERVICAL DYSPLASIA DILATATION VENTRICULAR FALL HUMAN PAPILLOMA VIRUS TEST POSITIVE INFECTION LEIOMYOMA LIGAMENT SPRAIN LYMPHOEDEMA MATERNAL EXPOSURE BEFORE PREGNANCY MIGRAINE MUSCULOSKELETAL CHEST PAIN OBESITY OEDEMA PERIPHERAL OVARIAN CYST PAIN IN EXTREMITY PERICARDIAL EFFUSION PERICARDITIS PHLEBITIS POST THROMBOTIC SYNDROME PREGNANCY RHINITIS ALLERGIC RIGHT ATRIAL DILATATION TRICUSPID VALVE INCOMPETENCE UPPER-AIRWAY COUGH SYNDROME UTERINE ENLARGEMENT VENOUS INSUFFICIENCY VITAMIN D DEFICIENCY Product NUVARING COUMADIN Role Route S S Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 466 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7761050 Date FDA Received
28-Jun-2011 Preferred Term PRIMARY HYPERALDOSTERONISM ADRENAL NEOPLASM HYPERTENSION Case # 7761050 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO,OT Role Route S VAGINAL Manufacturer Control # 2010SP064866 Dosage Text VAG Age 37 YR Duration Sex Female Country DEU

Manufacturer

7846497 Date FDA Received

28-Jun-2011 Preferred Term

Case # 7846497

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2011SP005054 Dosage Text VAG

Age 15 YR Duration

Sex Female

Country USA

Manufacturer

PREGNANCY ON CONTRACEPTIVE ABORTION SPONTANEOUS

8024685 Date FDA Received

29-Jun-2011 Preferred Term MOOD SWINGS DEPRESSION

Case # 8024685

Case Type DIRECT Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control #

Age 24 YR

Sex Female

Country USA

Dosage Text

Duration

Manufacturer MERCK

PSYCHOTIC DISORDER

8039380 Date FDA Received

29-Jun-2011 Preferred Term

Case # 8039380

Case Type EXPEDITED (15-DAY) Product NUVARING Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2011SP028715 Dosage Text 1 DF, VAG Manufacturer Control # 2011SP029066 Dosage Text VAG

Age 17 YR Duration

Sex Female

Country CAN

Manufacturer

VAGINAL HAEMORRHAGE

8039394 Date FDA Received

29-Jun-2011 Preferred Term VAGINAL OPERATION

Case # 8039394

Health Professional N

Outcomes OT Role Route S VAGINAL

Age 17 YR Duration 1 YEAR

Sex Female

Country CAN

Manufacturer

VAGINAL HAEMORRHAGE

7805911
Date - Time: 02-04-2013 9:43:10 AM EST Note: If the field is blank, there is no data Page: 467 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7805911
FDA Received Date 30-Jun-2011 Preferred Term PULMONARY EMBOLISM MENTAL DISORDER ABDOMINAL PAIN UPPER ABORTION INCOMPLETE ASTHMA ATRIAL FLUTTER AUTOIMMUNE DISORDER BRONCHITIS CHEST PAIN CHILLS COGNITIVE DISORDER COUGH DEEP VEIN THROMBOSIS DIZZINESS DYSPNOEA DYSPNOEA EXERTIONAL EMOTIONAL DISORDER FATIGUE FOETAL DEATH GOUT HAEMORRHAGIC DISORDER HAEMORRHAGIC OVARIAN CYST HYPERHIDROSIS HYPERTENSIVE HEART DISEASE HYPOTENSION INSOMNIA LEFT ATRIAL DILATATION Case # 7805911 Case Type EXPEDITED (15-DAY) Product NUVARING DIOVAN Health Professional Y Outcomes HO,OT Role Route S S 160 MG; QD;, 80 MG; QD; Manufacturer Control # 2010SP053024 Dosage Text Age 40 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 468 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7805911
Preferred Term LUNG NEOPLASM MATERNAL EXPOSURE DURING PREGNANCY MIGRAINE MULTIPLE INJURIES PALPITATIONS PREGNANCY WITH CONTRACEPTIVE DEVICE PULMONARY ARTERIAL HYPERTENSION SINUS TACHYCARDIA SLEEP APNOEA SYNDROME SNORING STRESS SUPRAVENTRICULAR TACHYCARDIA TRICUSPID VALVE INCOMPETENCE TRIGEMINAL NEURALGIA TWIN PREGNANCY VISION BLURRED Product Role Route Dosage Text Duration Manufacturer

8041014 Date FDA Received

05-Jul-2011 Preferred Term MENTAL DISORDER

Case # 8041014

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO Role Route S VAGINAL

Manufacturer Control # 2011SP029670 Dosage Text VAG

Age

Sex Female

Country USA

Duration

Manufacturer

CHLAMYDIAL INFECTION

8041055 Date FDA Received

05-Jul-2011 Preferred Term CROHN'S DISEASE

Case # 8041055

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2011SP030046 Dosage Text ;VAG

Age

Sex Female

Country DEU

Duration

Manufacturer

CONDITION AGGRAVATED

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 469 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8053814 Date FDA Received
05-Jul-2011 Preferred Term CHOLELITHIASIS Case # 8053814 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Outcomes OT Role Route S VAGINAL Manufacturer Control # 2011SP029940 Dosage Text ;VAG Duration Age Sex Female Country DEU

Manufacturer

7908044 Date FDA Received

06-Jul-2011 Preferred Term

Case # 7908044

Case Type EXPEDITED (15-DAY) Product NUVARING IBUPROFEN

Health Professional Y

Outcomes HO Role Route S C VAGINAL

Manufacturer Control # 2010SP057063 Dosage Text QM; VAG

Age 40 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM MULTIPLE INJURIES EMOTIONAL DISORDER HEADACHE HYPERCOAGULATION MENTAL DISORDER PULMONARY ALVEOLAR HAEMORRHAGE PULMONARY INFARCTION

7929858 Date FDA Received

06-Jul-2011 Preferred Term ECTOPIC PREGNANCY DEVICE BREAKAGE

Case # 7929858

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2011SP015506 Dosage Text VAG

Age 26 YR Duration

Sex Female

Country USA

Manufacturer

MATERNAL EXPOSURE DURING PREGNANCY PREGNANCY WITH CONTRACEPTIVE DEVICE PRODUCT QUALITY ISSUE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 470 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8033346 Date FDA Received
06-Jul-2011 Preferred Term CEREBRAL THROMBOSIS Case # 8033346 Case Type DIRECT Product NUVARING Health Professional Y Outcomes HO,LT Role Route S VAGINAL Dosage Text ESTONOGESTREL 0.120 MG DAILY VAG ETHINYL ESTRADIOL 0.015 MG DAILY VAG Manufacturer Control # Age 35 YR Duration Sex Female Country USA

Manufacturer MERCK

AMNESIA BLINDNESS TRANSIENT

8044826 Date FDA Received

06-Jul-2011 Preferred Term CAESAREAN SECTION

Case # 8044826

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S TRANSPLACENTAL

Manufacturer Control # 2011SP029890 Dosage Text TRPL

Age

Sex Female

Country USA

Duration

Manufacturer

MATERNAL DRUGS AFFECTING FOETUS PREMATURE BABY SMALL FOR DATES BABY

7727141 Date FDA Received

08-Jul-2011 Preferred Term

Case # 7727141

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes HO,OT Role Route S C C C VAGINAL

Manufacturer Control # 2010SP060785 Dosage Text QM;VAG

Age 45 YR Duration

Sex Female

Country CHL

Manufacturer

CHOLECYSTITIS ACUTE AMENORRHOEA INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION CONFUSIONAL STATE

LANSOPRAZOLE CENTRUM /00554501/ ESOMEPRAZOLE MAGNESIUM

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 471 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7805938 Date FDA Received
08-Jul-2011 Preferred Term DEHYDRATION ABDOMINAL PAIN ABORTION INDUCED AFFECTIVE DISORDER BRONCHITIS CYSTITIS DYSMENORRHOEA FOOD POISONING HEADACHE HYPOAESTHESIA HYPOAESTHESIA ORAL INFLUENZA MATERNAL EXPOSURE BEFORE PREGNANCY MIGRAINE OEDEMA PERIPHERAL PAIN IN EXTREMITY PARAESTHESIA ORAL PREGNANCY PULMONARY EMBOLISM URINARY TRACT INFECTION VISION BLURRED VOMITING Case # 7805938 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO,OT Role Route S VAGINAL Manufacturer Control # 2010SP025225 Dosage Text 1 DF;QM;VAG Age 18 YR Duration 6132 Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 472 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8024205 Date FDA Received
08-Jul-2011 Preferred Term PULMONARY EMBOLISM MULTIPLE INJURIES ANXIETY APHASIA CHEST PAIN COGNITIVE DISORDER CONDITION AGGRAVATED CONTUSION DEPRESSION SUICIDAL DISTURBANCE IN ATTENTION EXERCISE TOLERANCE DECREASED FATIGUE FEAR GINGIVAL BLEEDING INCORRECT DOSE ADMINISTERED INTERNATIONAL NORMALISED RATIO INCREASED LIGAMENT SPRAIN MEMORY IMPAIRMENT MENORRHAGIA MUSCLE SPASMS MUSCULOSKELETAL CHEST PAIN PAIN PNEUMONIA PROTHROMBIN TIME PROLONGED PULMONARY INFARCTION RHINITIS ALLERGIC STRESS TRICUSPID VALVE INCOMPETENCE Case # 8024205 Case Type EXPEDITED (15-DAY) Product NUVARING CITALOPRAM HYDROBROMIDE Health Professional Y Outcomes HO,OT Role Route S C Manufacturer Control # 2010SP057052 Dosage Text Age 43 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 473 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8046263 Date FDA Received
11-Jul-2011 Preferred Term STRESS ANAEMIA BLOOD INSULIN INCREASED INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION Case # 8046263 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional N Outcomes OT Role Route S VAGINAL Manufacturer Control # 2011SP030498 Dosage Text ; QM; VAG Age 33 YR Duration Sex Female Country CHL

Manufacturer

8048943 Date FDA Received

11-Jul-2011 Preferred Term

Case # 8048943

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2011SP031036 Dosage Text 1 DF, VAG

Age 26 YR Duration

Sex Female

Country USA

Manufacturer

MATERNAL EXPOSURE DURING PREGNANCY ABORTION SPONTANEOUS PREGNANCY WITH CONTRACEPTIVE DEVICE

8053044 Date FDA Received

11-Jul-2011 Preferred Term

Case # 8053044

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2011SP030825 Dosage Text

Age

Sex Female

Country DEU

Duration

Manufacturer

MENSTRUATION IRREGULAR PYELONEPHRITIS VULVOVAGINAL MYCOTIC INFECTION

8054049 Date FDA Received

11-Jul-2011 Preferred Term ECTOPIC PREGNANCY

Case # 8054049

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2011SP030555 Dosage Text VAG

Age 26 YR Duration

Sex Female

Country NLD

Manufacturer

PREGNANCY WITH CONTRACEPTIVE DEVICE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 474 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8050943 Date FDA Received
12-Jul-2011 Preferred Term PNEUMONIA Case # 8050943 Case Type EXPEDITED (15-DAY) Product NUVARING Case # 8054064 Case Type EXPEDITED (15-DAY) Product NUVARING TEGRETOL Health Professional Y Health Professional N Outcomes OT Role Route S Outcomes DE Role Route S C Health Professional Y Outcomes HO,OT Role Route S Manufacturer Control # 2010SP019262 Dosage Text Age 41 YR Duration Sex Female Country USA VAGINAL Manufacturer Control # 2011SP030832 Dosage Text VAG Age 29 YR Duration Sex Female Country DEU Manufacturer Control # 2011SP031636 Dosage Text Age 23 YR Duration Sex Female Country DEU

Manufacturer

8054064 Date FDA Received

12-Jul-2011 Preferred Term

Manufacturer

RUPTURED CEREBRAL ANEURYSM

7808492 Date FDA Received

14-Jul-2011 Preferred Term

Case # 7808492

Case Type EXPEDITED (15-DAY) Product NUVARING

Manufacturer

PULMONARY EMBOLISM ANAEMIA ATELECTASIS CHEST PAIN HYPERCOAGULATION LUNG CONSOLIDATION MUSCULOSKELETAL PAIN OESOPHAGITIS PLEURAL FIBROSIS PULMONARY INFARCTION SALPINGITIS

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 475 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8039189 Date FDA Received
14-Jul-2011 Preferred Term THYROID NEOPLASM INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION Case # 8039189 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional N Role Route S VAGINAL Outcomes Manufacturer Control # 2011SP029374 Dosage Text QM, VAG Age 40 YR Duration Sex Female Country CHL

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 476 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8030778 Date FDA Received
15-Jul-2011 Preferred Term CHEST PAIN PULMONARY EMBOLISM PEPTIC ULCER HYPERCOAGULATION HEART RATE IRREGULAR DYSPEPSIA PAIN MENTAL DISORDER ANXIETY ARTHRALGIA ASTHENIA ATELECTASIS DEEP VEIN THROMBOSIS DEPRESSION DIVERTICULUM DIZZINESS FATIGUE HEPATIC STEATOSIS HIATUS HERNIA HOT FLUSH HYPOAESTHESIA LIBIDO DECREASED MUSCLE SPASMS NAUSEA PULMONARY INFARCTION SPINAL OSTEOARTHRITIS Case # 8030778 Case Type EXPEDITED (15-DAY) Product NUVARING SYNTHROID CYTOMEL WOMEN'S MULTIVITAMIN (MULTIVITAMIN) CELEXA WELLBUTRIN XL VIVELLE DOT PRILOSEC Health Professional Y Outcomes HO,OT Role Route S C C C C C C C Manufacturer Control # 2011SP000364 Dosage Text QM Age 34 YR Duration Sex Female Country USA

Manufacturer

6223377
Date - Time: 02-04-2013 9:43:10 AM EST Note: If the field is blank, there is no data Page: 477 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6223377
FDA Received Date 18-Jul-2011 Preferred Term ACUTE MYOCARDIAL INFARCTION CORONARY ARTERY THROMBOSIS CORONARY ARTERY OCCLUSION ABORTION INDUCED ALCOHOL USE ANXIETY BLOOD CHOLESTEROL INCREASED CERVICAL DYSPLASIA CHEST PAIN COGNITIVE DISORDER CONGESTIVE CARDIOMYOPATHY CONTUSION COUGH DILATATION VENTRICULAR DYSLIPIDAEMIA DYSPNOEA DYSTHYMIC DISORDER ECONOMIC PROBLEM EJECTION FRACTION DECREASED FATIGUE HERPES SIMPLEX HYPERCOAGULATION INTERMITTENT CLAUDICATION ISCHAEMIC CARDIOMYOPATHY LEFT VENTRICULAR DYSFUNCTION MAJOR DEPRESSION MATERNAL EXPOSURE BEFORE PREGNANCY MITRAL VALVE INCOMPETENCE Case # 6223377 Case Type EXPEDITED (15-DAY) Product NUVARING ORTHO EVRA NEXIUM Health Professional Y Outcomes HO,DS,OT Role Route S S C VAGINAL TRANSDERMAL Manufacturer Control # 2007-152597-NL Dosage Text ;VAG ;TDER Age 23 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 478 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6223377
Preferred Term MUSCLE SPASMS NEURALGIA NICOTINE DEPENDENCE OBESITY PAIN IN EXTREMITY PALPITATIONS PANIC DISORDER PERICARDIAL EFFUSION PERIPHERAL ARTERIAL OCCLUSIVE DISEASE Peripheral artery stenosis Peripheral artery thrombosis PERIPHERAL VASCULAR DISORDER POST-TRAUMATIC STRESS DISORDER PREGNANCY PROTEIN S DEFICIENCY REFUSAL OF TREATMENT BY PATIENT ROAD TRAFFIC ACCIDENT SINUS TACHYCARDIA TREATMENT NONCOMPLIANCE TRICUSPID VALVE INCOMPETENCE UNEMPLOYMENT VAGINITIS BACTERIAL VENTRICULAR TACHYCARDIA Product Role Route Dosage Text Duration Manufacturer

7676596 Date FDA Received

19-Jul-2011 Preferred Term HYPOTHYROIDISM

Case # 7676596

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2010SP055396 Dosage Text VAG

Age 37 YR Duration

Sex Female

Country BRA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 479 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7828677 Date FDA Received
19-Jul-2011 Preferred Term PULMONARY EMBOLISM CHEST PAIN FIBRIN D DIMER INCREASED HEADACHE HYPOKALAEMIA INTERNATIONAL NORMALISED RATIO INCREASED OVARIAN CYST PROTHROMBIN TIME PROLONGED URINARY TRACT INFECTION VIRAL Case # 7828677 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO Role Route S Manufacturer Control # 2010SP034925 Dosage Text Age 39 YR Duration Sex Female Country USA

Manufacturer

7900329 Date FDA Received

20-Jul-2011 Preferred Term

Case # 7900329

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2011SP011837 Dosage Text VAG

Age 26 YR Duration

Sex Female

Country USA

Manufacturer

PREGNANCY WITH CONTRACEPTIVE DEVICE ABORTION SPONTANEOUS AMENORRHOEA MATERNAL EXPOSURE DURING PREGNANCY MUSCLE SPASMS VAGINAL HAEMORRHAGE

8059065 Date FDA Received

20-Jul-2011 Preferred Term CYSTITIS

Case # 8059065

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2011SP031587 Dosage Text QM;VAG

Age 26 YR Duration

Sex Female

Country CHL

Manufacturer

WRONG TECHNIQUE IN DRUG USAGE PROCESS

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 480 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8062497 Date FDA Received
20-Jul-2011 Preferred Term CERVICAL DYSPLASIA HYPOMENORRHOEA Case # 8062497 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional N Outcomes OT Role Route S VAGINAL Manufacturer Control # 2011SP032211 Dosage Text VAG Age 29 YR Duration Sex Female Country ESP

Manufacturer

8061725 Date FDA Received

26-Jul-2011 Preferred Term

Case # 8061725

Case Type DIRECT Product NUVARING

Health Professional Y

Outcomes HO Role Route S

Manufacturer Control #

Age

Sex Female

Country USA

Dosage Text

Duration

Manufacturer MERCK

TOXIC SHOCK SYNDROME STREPTOCOCCAL SEPSIS

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 481 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6918040 Date FDA Received
27-Jul-2011 Preferred Term PULMONARY EMBOLISM DEEP VEIN THROMBOSIS AMENORRHOEA ATRIAL FIBRILLATION ATRIAL TACHYCARDIA CARDIO-RESPIRATORY ARREST CHEST PAIN COMA SCALE ABNORMAL CYANOSIS DYSLIPIDAEMIA HEADACHE HYPOXIA LETHARGY LUNG INFILTRATION MEDIASTINAL DISORDER MUSCLE SPASMS MUSCULOSKELETAL STIFFNESS NAUSEA PUPIL FIXED RESPIRATORY DISTRESS SINUS TACHYCARDIA VISION BLURRED VOMITING Case # 6918040 Case Type EXPEDITED (15-DAY) Product NUVARING NIACIN Health Professional Y Outcomes DE,HO Role Route S C Manufacturer Control # 2009-191191-NL Dosage Text 1 DF Age 23 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 482 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7927579 Date FDA Received
27-Jul-2011 Preferred Term PULMONARY EMBOLISM ABDOMINAL PAIN LOWER AMENORRHOEA ANALGESIC DRUG LEVEL INCREASED BREAST TENDERNESS CARDIO-RESPIRATORY ARREST DEEP VEIN THROMBOSIS DRUG ABUSE HYPERTENSIVE HEART DISEASE MUSCULOSKELETAL PAIN PULMONARY CONGESTION PULMONARY INFARCTION PULMONARY OEDEMA UNRESPONSIVE TO STIMULI URINARY INCONTINENCE Case # 7927579 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes DE,OT Role Route S Manufacturer Control # 2011SP014807 Dosage Text Duration Age Sex Unknown Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 483 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7944265 Date FDA Received
27-Jul-2011 Preferred Term CEREBRAL VENOUS THROMBOSIS TRANSVERSE SINUS THROMBOSIS CAVERNOUS SINUS THROMBOSIS CEREBROVASCULAR ACCIDENT DEEP VEIN THROMBOSIS EMOTIONAL DISORDER HYPERCOAGULATION INFLUENZA INTRACRANIAL PRESSURE INCREASED MELANOCYTIC NAEVUS MENTAL DISORDER METRORRHAGIA MIGRAINE MULTIPLE INJURIES NASOPHARYNGITIS OVARIAN CYST PAIN PAPILLOEDEMA SUBARACHNOID HAEMORRHAGE SUPERIOR SAGITTAL SINUS THROMBOSIS VISION BLURRED VISUAL FIELD DEFECT Case # 7944265 Case Type EXPEDITED (15-DAY) Product NUVARING FLUOXETINE Health Professional Y Outcomes HO,OT Role Route S C Manufacturer Control # 2010SP057046 Dosage Text Age 20 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 484 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8081796 Date FDA Received
28-Jul-2011 Preferred Term THYROID CANCER ABORTION MATERNAL EXPOSURE DURING PREGNANCY PREGNANCY WITH CONTRACEPTIVE DEVICE Case # 8081796 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes OT Role Route S VAGINAL Manufacturer Control # 2011SP032931 Dosage Text ;VAG Duration Age Sex Female Country BRA

Manufacturer

8081826 Date FDA Received

28-Jul-2011 Preferred Term

Case # 8081826

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes DS,OT Role Route S S VAGINAL

Manufacturer Control # 2011SP032420 Dosage Text ;VAG

Age 23 YR Duration

Sex Female

Country AUS

Manufacturer

PREGNANCY WITH CONTRACEPTIVE DEVICE MATERNAL EXPOSURE DURING PREGNANCY ABORTION SPONTANEOUS COMPLICATED DEVICE FAILURE

HERBAL NOS

8081933 Date FDA Received

28-Jul-2011 Preferred Term

Case # 8081933

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO Role Route S VAGINAL

Manufacturer Control # 2011SP033135 Dosage Text 0.120 MG, QD, VAG

Age

Sex Female

Country USA

Duration

Manufacturer

PREGNANCY WITH CONTRACEPTIVE DEVICE FOETAL DEATH MATERNAL EXPOSURE DURING PREGNANCY

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 485 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8735231 Date FDA Received
28-Jul-2011 Preferred Term NERVOUSNESS DEPRESSION DYSPAREUNIA MOOD SWINGS VAGINAL DISCHARGE WEIGHT INCREASED Case # 8735231 Case Type DIRECT Product NUVARING Health Professional N Outcomes OT Role Route S VAGINAL Dosage Text 0.12MG/0.015MG LEAVE IN 3 WEEKS Manufacturer Control # Age 34 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 486 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7679785 Date FDA Received
29-Jul-2011 Preferred Term PULMONARY EMBOLISM ABDOMINAL PAIN ANXIETY BRONCHIAL HYPERREACTIVITY BRONCHITIS BRONCHOSPASM CHOLECYSTITIS DEEP VEIN THROMBOSIS DIARRHOEA EMOTIONAL DISORDER FACTOR V LEIDEN MUTATION HEART RATE IRREGULAR HYPERCOAGULATION INJURY MENTAL DISORDER TACHYCARDIA THROMBOSIS VENA CAVA THROMBOSIS Case # 7679785 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO,OT Role Route S Manufacturer Control # 2010SP056153 Dosage Text QM Age 22 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 487 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7943471 Date FDA Received
29-Jul-2011 Preferred Term CEREBROVASCULAR ACCIDENT ASTHENIA HERPES SIMPLEX METRORRHAGIA MULTIPLE INJURIES MUSCULAR WEAKNESS MYELITIS NECK PAIN NERVE INJURY PAIN Case # 7943471 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO Role Route S Manufacturer Control # 2010SP065568 Dosage Text Age 19 YR Duration Sex Female Country USA

Manufacturer

7679699 Date FDA Received

01-Aug-2011 Preferred Term CONVULSION CARDIOMEGALY

Case # 7679699

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes DE,OT Role Route S

Manufacturer Control # 2010SP056516 Dosage Text

Age 30 YR Duration

Sex Female

Country USA

Manufacturer

CARDIO-RESPIRATORY ARREST GRAND MAL CONVULSION HEART RATE IRREGULAR HYPERCOAGULATION PALPITATIONS PHARYNGITIS STREPTOCOCCAL PULMONARY CONGESTION PULMONARY EMBOLISM PULMONARY OEDEMA THROMBOSIS VULVOVAGINAL DISCOMFORT

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 488 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7893633 Date FDA Received
01-Aug-2011 Preferred Term ECTOPIC PREGNANCY MATERNAL EXPOSURE DURING PREGNANCY Case # 7893633 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes LT Role Route S VAGINAL Manufacturer Control # 2011SP011384 Dosage Text 1 DF, VAG Age 22 YR Duration Sex Female Country FRA

Manufacturer

7979758 Date FDA Received

01-Aug-2011 Preferred Term

Case # 7979758

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes

Manufacturer Control # 2011SP021563

Age 31 YR Duration

Sex Female

Country FRA

Role Route S

Dosage Text

Manufacturer

VAGINAL HAEMORRHAGE ABORTION SPONTANEOUS BLIGHTED OVUM MATERNAL EXPOSURE DURING PREGNANCY

7989371 Date FDA Received

01-Aug-2011 Preferred Term DENGUE FEVER

Case # 7989371

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2011SP023502 Dosage Text VAG

Age 31 YR Duration

Sex Female

Country BRA

Manufacturer

MENSTRUATION IRREGULAR

8068905 Date FDA Received

01-Aug-2011 Preferred Term

Case # 8068905

Case Type DIRECT Product NUVARING

Health Professional N

Outcomes HO,LT Role Route S

Manufacturer Control #

Age 30 YR

Sex Female

Country USA

Dosage Text

Duration

Manufacturer

PULMONARY EMBOLISM

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 489 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8085085 Date FDA Received
01-Aug-2011 Preferred Term LIP SWELLING EYE SWELLING ALLERGY TO ANIMAL ANGIOEDEMA GASTROINTESTINAL CANDIDIASIS PRURITUS URTICARIA Case # 8085085 Case Type EXPEDITED (15-DAY) Product NUVARING INFLUENZA VIRUS VACCINE NOS Health Professional Y Outcomes HO,OT Role Route S S Manufacturer Control # 2011SP033717 Dosage Text Age 34 YR Duration Sex Female Country DEU

Manufacturer

8735139 Date FDA Received

01-Aug-2011 Preferred Term

Case # 8735139

Case Type DIRECT Product NUVARING NUVARING

Health Professional N

Outcomes OT Role Route S C

Manufacturer Control #

Age 32 YR

Sex Female

Country USA

Dosage Text

Duration

Manufacturer

VULVOVAGINAL DISCOMFORT THROMBOSIS

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 490 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6172883 Date FDA Received
02-Aug-2011 Preferred Term MUSCLE SPASMS BACK PAIN LIGAMENT SPRAIN PLEURAL EFFUSION PERIPARTUM CARDIOMYOPATHY MITRAL VALVE INCOMPETENCE CARDIOMEGALY DEEP VEIN THROMBOSIS ECCHYMOSIS FACTOR V LEIDEN MUTATION FALL FOOT FRACTURE OEDEMA PERIPHERAL PLATELET COUNT INCREASED PNEUMONIA PULMONARY EMBOLISM PULMONARY INFARCTION TRICUSPID VALVE INCOMPETENCE Case # 6172883 Case Type EXPEDITED (15-DAY) Product NUVARING LEVAQUIN SOMA NAPROSYN VICODIN WELLBUTRIN Health Professional Y Outcomes HO,OT Role Route S C C C C C VAGINAL Manufacturer Control # 2006-149793-NL Dosage Text 1 DF; VAG Age 29 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 491 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7109249 Date FDA Received
02-Aug-2011 Preferred Term THORACIC OUTLET SYNDROME SUBCLAVIAN VEIN THROMBOSIS THROMBOSIS PAIN SCAR ASTHMA CELLULITIS CERVICITIS CONDITION AGGRAVATED DYSMENORRHOEA DYSPEPSIA MENORRHAGIA MUSCULOSKELETAL DISCOMFORT OEDEMA PERIPHERAL PALLOR POLYMENORRHOEA SINUSITIS Case # 7109249 Case Type EXPEDITED (15-DAY) Product NUVARING SINGULAIR ALLEGRA ALBUTEROL SULFATE ADDERALL Health Professional Y Outcomes HO,OT Role Route S C C C C VAGINAL Manufacturer Control # 2009SP020449 Dosage Text 1 DF; VAG Age 20 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 492 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7752297 Date FDA Received
02-Aug-2011 Preferred Term PULMONARY EMBOLISM MULTIPLE INJURIES EMOTIONAL DISORDER MENTAL DISORDER ARTHRALGIA ATELECTASIS BRONCHITIS BURSITIS COCCYDYNIA CONSTIPATION CONTUSION ECCHYMOSIS FACTOR V LEIDEN MUTATION FALL GROIN PAIN HEAD INJURY HEPATIC STEATOSIS HYPERCOAGULATION HYPERSENSITIVITY JOINT INJURY MUSCULOSKELETAL PAIN PULMONARY FIBROSIS PULMONARY INFARCTION RIB FRACTURE ROTATOR CUFF SYNDROME TENDONITIS THROMBOSIS URINARY RETENTION URINARY TRACT INFECTION Case # 7752297 Case Type EXPEDITED (15-DAY) Product NUVARING AMBIEN PAROXETINE HYDROCHLORIDE IBUPROFEN Health Professional Y Outcomes HO,OT Role Route S C C C Manufacturer Control # 2010SP063276 Dosage Text Age 34 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 493 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7826813 Date FDA Received
02-Aug-2011 Preferred Term CEREBROVASCULAR ACCIDENT DEPRESSION POST-TRAUMATIC STRESS DISORDER CONVULSION CHOLELITHIASIS AMBLYOPIA AMENORRHOEA ARTERIOVENOUS MALFORMATION BACK PAIN BLOOD FOLLICLE STIMULATING HORMONE INCREASED BLOOD IRON DECREASED BRAIN MIDLINE SHIFT BRAIN OEDEMA CEREBRAL HAEMORRHAGE CEREBRAL INFARCTION CHOLECYSTITIS CYST DIARRHOEA DISORIENTATION DIZZINESS DRUG ERUPTION ENCEPHALOMALACIA EPILEPSY EYE LASER SURGERY FATIGUE GALLBLADDER DISORDER HETEROPHORIA HORMONE LEVEL ABNORMAL Case # 7826813 Case Type EXPEDITED (15-DAY) Product NUVARING LEXAPRO DILANTIN ADVIL MARIJUANA Health Professional N Outcomes HO,DS,OT Role Route S S S C C Manufacturer Control # 2010SP040550 Dosage Text Age 36 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 494 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7826813
Preferred Term HOT FLUSH HYPERCOAGULATION HYPERHIDROSIS HYPERLIPIDAEMIA HYPOAESTHESIA HYPOVITAMINOSIS INSOMNIA INTRACRANIAL VENOUS SINUS THROMBOSIS JAW DISORDER LIBIDO DECREASED MENIERE'S DISEASE MENSTRUATION IRREGULAR MOUNTAIN SICKNESS ACUTE MUSCLE SPASMS MUSCLE TIGHTNESS NAUSEA NERVOUSNESS NIGHT SWEATS NO THERAPEUTIC RESPONSE OBSTRUCTION OLIGOMENORRHOEA PANIC REACTION PAROSMIA PREGNANCY TEST POSITIVE SCOTOMA SINUS CONGESTION STRESS TEMPOROMANDIBULAR JOINT SYNDROME TINNITUS TOXICITY TO VARIOUS AGENTS TRANSAMINASES INCREASED Product Role Route Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 495 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7826813
Preferred Term TRANSIENT ISCHAEMIC ATTACK TRANSVERSE SINUS THROMBOSIS URTICARIA VERTIGO VISUAL FIELD DEFECT VITAMIN D DECREASED Product Role Route Dosage Text Duration Manufacturer

8086848 Date FDA Received

02-Aug-2011 Preferred Term ADVERSE EVENT HOSPITALISATION

Case # 8086848

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes HO Role Route S

Manufacturer Control # 2011SP034023 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

8032122 Date FDA Received

03-Aug-2011

Case # 8032122

Case Type EXPEDITED (15-DAY)

Health Professional Y

Outcomes HO

Manufacturer Control # 2011SP000371

Age 26 YR

Sex Female

Country USA

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 496 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8032122
Preferred Term PULMONARY EMBOLISM ABDOMINAL PAIN UPPER ANKLE FRACTURE BLOOD CREATINE PHOSPHOKINASE INCREASED BLOOD DISORDER CANDIDIASIS CERVICAL DYSPLASIA CYSTITIS EXERCISE TOLERANCE DECREASED FIBRIN D DIMER INCREASED HAEMANGIOMA HAEMATOMA HEADACHE HYPERCOAGULATION HYPOAESTHESIA HYPOTHYROIDISM INJURY CORNEAL IRON DEFICIENCY ANAEMIA LIGAMENT SPRAIN MASS MENORRHAGIA MULTIPLE INJURIES OEDEMA PERIPHERAL PAIN IN EXTREMITY PAPILLOMA VIRAL INFECTION PULMONARY INFARCTION THROMBOSIS TIBIA FRACTURE VARICOSE VEIN Product NUVARING Role Route S Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 497 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7271466 Date FDA Received
05-Aug-2011 Preferred Term PULMONARY EMBOLISM ANGINA PECTORIS ANXIETY ATELECTASIS BRONCHIECTASIS BRONCHITIS CHEST PAIN DEEP VEIN THROMBOSIS DYSPNOEA GASTROOESOPHAGEAL REFLUX DISEASE HEART RATE IRREGULAR HYPERTENSIVE CRISIS INJECTION SITE ANAESTHESIA INJECTION SITE PARAESTHESIA INTERNATIONAL NORMALISED RATIO INCREASED LOBAR PNEUMONIA LYMPHADENOPATHY MENINGITIS VIRAL MIGRAINE MUSCULOSKELETAL CHEST PAIN NASOPHARYNGITIS NODAL RHYTHM PLEURISY PNEUMONITIS TRICUSPID VALVE INCOMPETENCE VIRAL INFECTION VOMITING Case # 7271466 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO,OT Role Route S Manufacturer Control # 2009SP023504 Dosage Text 1 DF Age 26 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 498 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8016851 Date FDA Received
05-Aug-2011 Preferred Term CONFUSIONAL STATE DYSARTHRIA BRADYPHRENIA MENSTRUATION DELAYED PULMONARY TUBERCULOSIS METRORRHAGIA INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION Case # 8016851 Case Type EXPEDITED (15-DAY) Product NUVARING VENLAFAXINE LAMOTRIGINE CLONAZEPAM MIDAZOLAM QUETIAPINE Health Professional N Outcomes OT Role Route S C C C C C VAGINAL Manufacturer Control # 2011SP027356 Dosage Text QM;VAG Age 25 YR Duration Sex Female Country CHL

Manufacturer

8062649 Date FDA Received

05-Aug-2011 Preferred Term

Case # 8062649

Case Type EXPEDITED (15-DAY) Product NUVARING Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2011SP031687 Dosage Text 1 DF, VAG Manufacturer Control # 2011SP034824 Dosage Text

Age 44 YR Duration

Sex Female

Country DEU

Manufacturer

CAROTID ARTERY ANEURYSM

8092389 Date FDA Received

05-Aug-2011 Preferred Term CONVULSION

Case # 8092389

Health Professional N

Outcomes OT Role Route S

Age

Sex Female

Country USA

Duration

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 499 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8106515 Date FDA Received
05-Aug-2011 Preferred Term DEEP VEIN THROMBOSIS PULMONARY EMBOLISM PAIN IN EXTREMITY ABORTION MISSED ATELECTASIS FALL LEIOMYOMA LIGAMENT SPRAIN MATERNAL EXPOSURE DURING PREGNANCY OVARIAN CYST PERICARDIAL EFFUSION PERICARDITIS PLEURAL EFFUSION RHINITIS ALLERGIC SKIN CYST EXCISION TRICUSPID VALVE INCOMPETENCE VITAMIN D DEFICIENCY Case # 8106515 Case Type EXPEDITED (15-DAY) Product NUVARING COUMADIN MAXZIDE Health Professional Y Outcomes HO,OT Role Route S S S Manufacturer Control # 2011SP019235 Dosage Text Age 29 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 500 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7554926 Date FDA Received
08-Aug-2011 Preferred Term MULTIPLE INJURIES PAIN DEEP VEIN THROMBOSIS CHEST PAIN PULMONARY EMBOLISM ABDOMINAL PAIN LOWER ACNE ANXIETY BASAL CELL CARCINOMA BLOOD CHOLESTEROL INCREASED BLOOD TRIGLYCERIDES INCREASED CELLULITIS CHOLELITHIASIS DEHYDRATION EAR PAIN GALLBLADDER DISORDER HEPATIC CYST INSOMNIA INTERVERTEBRAL DISC PROTRUSION MELANOCYTIC NAEVUS OROPHARYNGEAL PAIN PHLEBITIS SEBORRHOEIC KERATOSIS SPINAL OSTEOARTHRITIS TACHYCARDIA THROMBOSIS UTERINE LEIOMYOMA Case # 7554926 Case Type EXPEDITED (15-DAY) Product NUVARING AMBIEN UNSPECIFIED SUPPLEMENT MULTI-VITAMIN ZYRTEC Health Professional Y Outcomes HO,DS,OT Role Route S S C C C VAGINAL Manufacturer Control # 2010SP007781 Dosage Text QM, VAG Age 39 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 501 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7847435 Date FDA Received
08-Aug-2011 Preferred Term OVARIAN CYST ABDOMINAL PAIN ABORTION INDUCED BLOOD GLUCOSE INCREASED CERVICAL DYSPLASIA CHLAMYDIAL INFECTION DEEP VEIN THROMBOSIS ESCHERICHIA TEST POSITIVE MATERNAL EXPOSURE BEFORE PREGNANCY MULTIPLE INJURIES PREGNANCY WHITE BLOOD CELL COUNT DECREASED Case # 7847435 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO,DS,OT Role Route S Manufacturer Control # 2010SP026335 Dosage Text Age 28 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 502 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8025565 Date FDA Received
09-Aug-2011 Preferred Term DEEP VEIN THROMBOSIS MULTIPLE INJURIES CHEST PAIN COSTOCHONDRITIS DEHYDRATION HERPES SIMPLEX HYPOKALAEMIA INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION ORAL HERPES OVARIAN CYST SINUS BRADYCARDIA THROMBOPHLEBITIS Case # 8025565 Case Type EXPEDITED (15-DAY) Product NUVARING VALTREX Health Professional Y Outcomes HO,OT Role Route S C Manufacturer Control # 2011SP007671 Dosage Text Age 29 YR Duration Sex Female Country USA

Manufacturer

8081792 Date FDA Received

09-Aug-2011 Preferred Term

Case # 8081792

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO,OT Role Route S

Manufacturer Control # 2010SP062524 Dosage Text QM

Age 19 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS ANHEDONIA ANXIETY CHEST PAIN COAGULOPATHY FEAR HYPERCOAGULATION MULTIPLE INJURIES PAIN PALPITATIONS PULMONARY EMBOLISM WRIST SURGERY

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 503 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8089094 Date FDA Received
10-Aug-2011 Preferred Term CEREBROVASCULAR ACCIDENT Case # 8089094 Case Type DIRECT Product NUVARING Case Type EXPEDITED (15-DAY) Product NUVARING TYLENOL Health Professional Y Health Professional N Outcomes OT,RI Role Route S Outcomes HO,OT Role Route S C Manufacturer Control # 2009-189399-NL Dosage Text Age 23 YR Duration Sex Female Dosage Text Manufacturer Control # Age 22 YR Duration Sex Female Country USA

Manufacturer SCHERING PLOUGH Country USA

7032837 Date FDA Received

11-Aug-2011 Preferred Term

Case # 7032837

Manufacturer

PULMONARY EMBOLISM LOSS OF CONSCIOUSNESS ANXIETY ATELECTASIS CENTRAL VENOUS PRESSURE INCREASED DILATATION VENTRICULAR FALL FEELING ABNORMAL INFERIOR VENA CAVA DILATATION INTRACARDIAC THROMBUS LUNG INFILTRATION LYMPHADENOPATHY MUSCLE CONTRACTIONS INVOLUNTARY MUSCLE SPASMS PLEURAL EFFUSION PNEUMONIA RESPIRATORY FAILURE RIGHT ATRIAL DILATATION RIGHT VENTRICULAR FAILURE SINUS TACHYCARDIA STREPTOCOCCAL BACTERAEMIA

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 504 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7279203 Date FDA Received
11-Aug-2011 Preferred Term PULMONARY EMBOLISM DEEP VEIN THROMBOSIS ALANINE AMINOTRANSFERASE INCREASED ASPARTATE AMINOTRANSFERASE INCREASED ASTHMA BILE DUCT STONE CHOLECYSTITIS ACUTE DYSPNOEA EXERTIONAL EMPHYSEMA MATERNAL EXPOSURE BEFORE PREGNANCY OBSTRUCTIVE AIRWAYS DISORDER PREGNANCY PREMATURE LABOUR PREMATURE RUPTURE OF MEMBRANES PROTHROMBIN TIME SHORTENED ROAD TRAFFIC ACCIDENT Case # 7279203 Case Type EXPEDITED (15-DAY) Product NUVARING CELEXA Health Professional Y Outcomes HO Role Route S C Manufacturer Control # 2009SP021088 Dosage Text Age 24 YR Duration Sex Female Country USA

Manufacturer

8062622 Date FDA Received

11-Aug-2011 Preferred Term HEPATITIS C

Case # 8062622

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2011SP031843 Dosage Text ; ; VAG

Age 30 YR Duration 21 DAY

Sex Female

Country RUS

Manufacturer

VULVOVAGINAL PRURITUS

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 505 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8099693 Date FDA Received
11-Aug-2011 Preferred Term PAIN ADVERSE REACTION GENERAL SYMPTOM Case # 8099693 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional N Outcomes HO Role Route S VAGINAL Manufacturer Control # 2011SP036940 Dosage Text ; QM; VAG Duration Age Sex Female Country BRA

Manufacturer

8107916 Date FDA Received

12-Aug-2011 Preferred Term LYMPHADENOPATHY

Case # 8107916

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2011SP036523 Dosage Text ;QM; VAG Manufacturer Control # 2011SP036909 Dosage Text VAG; VAG

Age

Sex Female

Country USA

Duration

Manufacturer

8106173 Date FDA Received

15-Aug-2011 Preferred Term HAEMORRHAGE ABDOMINAL PAIN

Case # 8106173

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Age 27 YR Duration

Sex Female

Country BRA

Manufacturer

ABDOMINAL PAIN UPPER NAUSEA OEDEMA PERIPHERAL RETCHING SKIN DISORDER UTERINE INJURY

8106384 Date FDA Received

15-Aug-2011 Preferred Term COLITIS ULCERATIVE

Case # 8106384

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S C

Manufacturer Control # 2011SP021869 Dosage Text

Age 38 YR Duration

Sex Female

Country DEU

Manufacturer

L-THYROX HEXAL

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 506 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8748939 Date FDA Received
15-Aug-2011 Preferred Term ATRIAL FIBRILLATION Case # 8748939 Case Type DIRECT Product NUVARING Health Professional N Outcomes LT Role Route S VAGINAL Dosage Text LEAVE IN 3 WEEKS, REMOVE FOR 1 CONTINUAL Manufacturer Control # Age 42 YR Duration Sex Female Country USA

Manufacturer ORGANON

HYPERTENSION SLEEP APNOEA SYNDROME

7615035 Date FDA Received

16-Aug-2011 Preferred Term

Case # 7615035

Case Type EXPEDITED (15-DAY) Product NUVARING LEXAPRO

Health Professional Y

Outcomes HO Role Route S C

Manufacturer Control # 2010SP012807 Dosage Text

Age 31 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM INJURY AFFECTIVE DISORDER ANGER ANXIETY DISEASE RECURRENCE DYSPAREUNIA INTENTIONAL SELF-INJURY MAJOR DEPRESSION MEDICAL DEVICE COMPLICATION MYALGIA OBSESSIVE-COMPULSIVE DISORDER PLEURAL EFFUSION PNEUMONITIS PULMONARY OEDEMA RHINITIS ALLERGIC SUICIDE ATTEMPT

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 507 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7808417 Date FDA Received
16-Aug-2011 Preferred Term DEEP VEIN THROMBOSIS INFECTION HYPOTENSION HEADACHE VENOUS INSUFFICIENCY PREGNANCY MATERNAL EXPOSURE BEFORE PREGNANCY ABORTION SPONTANEOUS JOINT INJURY MIGRAINE ABDOMINAL PAIN LOWER ASTHMA CONDITION AGGRAVATED COUGH FOETAL DEATH LUNG INFILTRATION LYMPHADENITIS Case # 7808417 Case Type EXPEDITED (15-DAY) Product NUVARING COUMADIN ADVAIR DISKUS SINGULAIR ASTELIN FLONASE TOPROL XL BUSPIRONE CELEXA TYLENOL Health Professional Y Outcomes HO Role Route S S C C C C C C C C Manufacturer Control # 2010SP032251 Dosage Text Age 23 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 508 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7826089 Date FDA Received
19-Aug-2011 Preferred Term DEEP VEIN THROMBOSIS PULMONARY EMBOLISM ABDOMINAL PAIN ADNEXA UTERI CYST CARDIOMEGALY ENDOMETRIAL HYPERPLASIA ENDOMETRIAL HYPERTROPHY IRRITABLE BOWEL SYNDROME LYMPHADENOPATHY OVARIAN CYST PALPITATIONS PERICARDIAL EFFUSION PULMONARY INFARCTION THROMBOPHLEBITIS Case # 7826089 Case Type EXPEDITED (15-DAY) Product NUVARING TOPIRAMATE Health Professional Y Outcomes HO,OT Role Route S C Manufacturer Control # 2010SP012617 Dosage Text Age 46 YR Duration Sex Female Country USA

Manufacturer

8012194 Date FDA Received

19-Aug-2011 Preferred Term DEVICE EXPULSION

Case # 8012194

Case Type NON-EXPEDITED Product MIRENA NUVARING CELEXA

Health Professional Y

Outcomes

Manufacturer Control # US-BAYER-2011-050922

Age 26 YR Duration

Sex Female

Country USA

Role Route S S C ORAL INTRAUTERINE

Dosage Text 20 mcg/24hr, CONT UNK 20 mg, UNK

Manufacturer BAYER

MEDICAL DEVICE DISCOMFORT PREGNANCY WITH CONTRACEPTIVE DEVICE NAUSEA

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 509 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8115907 Date FDA Received
19-Aug-2011 Preferred Term MIGRAINE ABORTION MISSED MATERNAL EXPOSURE DURING PREGNANCY PREGNANCY WITH CONTRACEPTIVE DEVICE Case # 8115907 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO Role Route S VAGINAL Manufacturer Control # 2011SP036796 Dosage Text ;VAG Age 31 YR Duration Sex Female Country FIN

Manufacturer

7176615 Date FDA Received

25-Aug-2011

Case # 7176615

Case Type EXPEDITED (15-DAY)

Health Professional Y

Outcomes HO,OT

Manufacturer Control # 2009-200082-NL

Age 17 YR

Sex Female

Country USA

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 510 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7176615
Preferred Term THROMBOSIS OVARIAN CYST HYPERTENSION MIGRAINE DYSPNOEA PARAESTHESIA ASTHMA INSOMNIA ABORTION SPONTANEOUS ABSCESS ANAEMIA CAESAREAN SECTION CELLULITIS CERVICAL DYSPLASIA CHEST DISCOMFORT CHEST PAIN DEEP VEIN THROMBOSIS DEHYDRATION DRUG HYPERSENSITIVITY FUNGAL INFECTION GESTATIONAL HYPERTENSION GLYCOSURIA MATERNAL EXPOSURE BEFORE PREGNANCY MATERNAL EXPOSURE DURING PREGNANCY PAPILLOMA VIRAL INFECTION PRE-ECLAMPSIA PREGNANCY WITH IMPLANT CONTRACEPTIVE Rubber sensitivity URINARY TRACT INFECTION VAGINITIS BACTERIAL Product NUVARING ALBUTEROL PRENATAL VITAM;INS LOTRIMIN BENADRYL FLAGYL FLEXERIL ZOLOFT Role Route S C C C C C C C Dosage Text 1 DF Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 511 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7277681 Date FDA Received
25-Aug-2011 Preferred Term PULMONARY EMBOLISM PREGNANCY ABDOMINAL PAIN ABORTION MISSED ABORTION SPONTANEOUS AMENORRHOEA CHEST PAIN DYSPNOEA HAEMORRHAGIC ANAEMIA HYPERCOAGULATION INFLUENZA LIKE ILLNESS MATERNAL EXPOSURE BEFORE PREGNANCY MENORRHAGIA NASOPHARYNGITIS NAUSEA OROPHARYNGEAL PAIN OVARIAN CYST PRODUCTIVE COUGH PYREXIA RHINORRHOEA THROMBOSIS WHEEZING Case # 7277681 Case Type EXPEDITED (15-DAY) Product NUVARING UNSPECIFIED INGREDIENT Health Professional Y Outcomes OT Role Route S S VAGINAL Manufacturer Control # 2009SP023524 Dosage Text VAG Age 22 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 512 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7826824 Date FDA Received
25-Aug-2011 Preferred Term DEEP VEIN THROMBOSIS MENORRHAGIA ABDOMINAL PAIN UPPER ACCIDENT ACUTE SINUSITIS ANTIPHOSPHOLIPID ANTIBODIES POSITIVE BACK PAIN CELLULITIS DIARRHOEA FASCIITIS HAEMORRHAGE HYPERHOMOCYSTEINAEMIA INJURY LYMPHOEDEMA MYOSITIS NAUSEA OEDEMA URINARY TRACT INFECTION STAPHYLOCOCCAL VOMITING Case # 7826824 Case Type EXPEDITED (15-DAY) Product NUVARING COUMADIN Health Professional Y Outcomes HO Role Route S S 5 MG Manufacturer Control # 2010SP006068 Dosage Text Age 37 YR Duration Sex Female Country USA

Manufacturer

8081787 Date FDA Received

25-Aug-2011 Preferred Term DIZZINESS

Case # 8081787

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes

Manufacturer Control # 2011SP033178

Age 22 YR Duration

Sex Female

Country PRT

Role Route S

Dosage Text QM

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 513 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8116467 Date FDA Received
25-Aug-2011 Preferred Term PANIC ATTACK NIGHT SWEATS PALPITATIONS PARAESTHESIA Case # 8116467 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Role Route S VAGINAL Outcomes Manufacturer Control # 2011SP037725 Dosage Text VAG Duration Age Sex Female Country DEU

Manufacturer

8745166 Date FDA Received

25-Aug-2011 Preferred Term ALOPECIA

Case # 8745166

Case Type DIRECT Product NUVARING

Health Professional N

Outcomes OT Role Route S INTRA-CERVICAL

Manufacturer Control #

Age 50 YR

Sex Female

Country USA

Dosage Text ONCE A MONTH, INTRACERVICAL Manufacturer Control # 2010SP044546 Dosage Text 75 MG;QD;PO 25 MG;BID;PO

Duration

Manufacturer MERCK

7568940 Date FDA Received

26-Aug-2011 Preferred Term

Case # 7568940

Case Type EXPEDITED (15-DAY) Product NUVARING ZOLOFT VISTARIL

Health Professional Y

Outcomes DE,OT Role Route S S S ORAL ORAL

Age 25 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM LOSS OF CONSCIOUSNESS ACUTE RESPIRATORY FAILURE COAGULOPATHY DRUG INTOLERANCE MUSCLE SPASMS PANIC ATTACK TREMOR

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 514 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7582202 Date FDA Received
26-Aug-2011 Preferred Term PULMONARY EMBOLISM MIGRAINE COMPLICATION OF DEVICE INSERTION THROMBOSIS PNEUMONIA DYSPNOEA ANAEMIA DIZZINESS FATIGUE FIBRIN D DIMER INCREASED HYPERGLYCAEMIA HYPOAESTHESIA INFECTION INTERNATIONAL NORMALISED RATIO DECREASED LIMB DISCOMFORT MALAISE OVARIAN CYST PAIN PLEURISY RADICULITIS CERVICAL ROTATOR CUFF SYNDROME SYNCOPE TENDON DISORDER TREATMENT NONCOMPLIANCE UNEVALUABLE EVENT VAGINITIS BACTERIAL VULVOVAGINAL CANDIDIASIS WEIGHT INCREASED Case # 7582202 Case Type EXPEDITED (15-DAY) Product NUVARING IMPLANON FIORICET TOPAMAX DIFLUCAN ZOCOR Health Professional Y Outcomes HO,OT Role Route S S C C C C VAGINAL Manufacturer Control # 2010SP012023 Dosage Text VAG Age 37 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 515 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7582206 Date FDA Received
26-Aug-2011 Preferred Term PULMONARY EMBOLISM ABNORMAL BEHAVIOUR BLOOD PRESSURE SYSTOLIC DECREASED BONE INFARCTION BONE LESION CHOLELITHIASIS DILATATION VENTRICULAR FALL FUNGAL INFECTION LUNG INFILTRATION MENTAL STATUS CHANGES MITRAL VALVE INCOMPETENCE MULTIPLE INJURIES PLEURAL EFFUSION PNEUMONIA PULMONARY INFARCTION RESPIRATORY ARREST RIGHT ATRIAL DILATATION RIGHT VENTRICULAR DYSFUNCTION SCREAMING SICKLE CELL ANAEMIA WITH CRISIS SPLENIC CALCIFICATION TRICUSPID VALVE INCOMPETENCE VENTRICULAR HYPOKINESIA Case # 7582206 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO Role Route S Manufacturer Control # 2010SP009218 Dosage Text Age 26 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 516 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8006442 Date FDA Received
26-Aug-2011 Preferred Term ROAD TRAFFIC ACCIDENT AORTIC ARTERIOSCLEROSIS ATELECTASIS BACK PAIN DRUG HYPERSENSITIVITY EXCORIATION HAEMORRHAGE HAND FRACTURE HYPERTENSION HYPOKALAEMIA INTERNATIONAL NORMALISED RATIO INCREASED MITRAL VALVE INCOMPETENCE MITRAL VALVE SCLEROSIS NEURALGIA PALPITATIONS PLEURITIC PAIN PULMONARY EMBOLISM PULMONARY VALVE INCOMPETENCE RASH SOFT TISSUE INJURY SUPRAVENTRICULAR TACHYCARDIA VENTRICULAR EXTRASYSTOLES Case # 8006442 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO Role Route S VAGINAL Manufacturer Control # 2010SP018554 Dosage Text QM;VAG Age 23 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 517 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8099687 Date FDA Received
26-Aug-2011 Preferred Term PREGNANCY WITH CONTRACEPTIVE DEVICE ABORTION MATERNAL EXPOSURE DURING PREGNANCY Case # 8099687 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional N Outcomes OT Role Route S VAGINAL Manufacturer Control # 2011SP036663 Dosage Text VAG ; VAG Age 27 YR Duration Sex Female Country BRA

Manufacturer

8139191 Date FDA Received

26-Aug-2011 Preferred Term NIGHT SWEATS

Case # 8139191

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2011SP038155 Dosage Text 1 DF Manufacturer Control # 2010SP053375 Dosage Text

Age 30 YR Duration

Sex Female

Country USA

Manufacturer

8142003 Date FDA Received

26-Aug-2011 Preferred Term

Case # 8142003

Case Type EXPEDITED (15-DAY) Product NUVARING SYNTHROID

Health Professional Y

Outcomes HO,OT Role Route S C

Age 17 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS PULMONARY EMBOLISM ADENOMYOSIS CHOLECYSTITIS CHRONIC CHOLELITHIASIS SINUS ARRHYTHMIA

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 518 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7680770 Date FDA Received
29-Aug-2011 Preferred Term DEEP VEIN THROMBOSIS BILE DUCT STONE CHOLECYSTITIS ACUTE CHOLELITHIASIS JAUNDICE CHOLESTATIC ROAD TRAFFIC ACCIDENT THROMBOPHLEBITIS SUPERFICIAL Case # 7680770 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO,OT Role Route S VAGINAL Manufacturer Control # 2010SP042442 Dosage Text VAG Age 29 YR Duration Sex Female Country USA

Manufacturer

7886810 Date FDA Received

29-Aug-2011 Preferred Term DEVICE BREAKAGE CERVIX DISORDER

Case # 7886810

Case Type EXPEDITED (15-DAY) Product NUVARING ABILIFY

Health Professional Y

Outcomes OT Role Route S C VAGINAL

Manufacturer Control # 2011SP010281 Dosage Text 1 DF;QM;VAG

Age 21 YR Duration

Sex Female

Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 519 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8058082 Date FDA Received
29-Aug-2011 Preferred Term SUPERIOR SAGITTAL SINUS THROMBOSIS ABDOMINAL PAIN ACNE ALCOHOLISM BLOOD GLUCOSE INCREASED BLOOD PRESSURE DECREASED CHANGE OF BOWEL HABIT DEEP VEIN THROMBOSIS DEHYDRATION DYSMENORRHOEA ENCEPHALITIS HERPES GENITAL HERPES GONORRHOEA HYPERCOAGULATION IMPAIRED DRIVING ABILITY INFECTION LYMPHOID TISSUE HYPERPLASIA MIGRAINE PAIN PELVIC INFLAMMATORY DISEASE RECTAL POLYP SYNCOPE THROMBOSIS VISION BLURRED Case # 8058082 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO,DS,OT Role Route S VAGINAL Manufacturer Control # 2010SP065476 Dosage Text VAG Age 22 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 520 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8081852 Date FDA Received
29-Aug-2011 Preferred Term DEEP VEIN THROMBOSIS MULTIPLE INJURIES ABDOMINAL PAIN ANGINA UNSTABLE ANGIOPATHY ANTIPHOSPHOLIPID ANTIBODIES POSITIVE ATELECTASIS BACK INJURY BACK PAIN BACTERIAL TOXAEMIA ENDOMETRITIS DECIDUAL EPISTAXIS FACTOR V LEIDEN MUTATION FEELING COLD HAEMOPTYSIS HEADACHE INTERNATIONAL NORMALISED RATIO INCREASED MATERNAL EXPOSURE BEFORE PREGNANCY MUSCLE STRAIN NECK PAIN PARAESTHESIA PNEUMONIA POSTPARTUM DEPRESSION PRODUCTIVE COUGH PULMONARY FIBROSIS RASH RETAINED PRODUCTS OF CONCEPTION SPUTUM DISCOLOURED Case # 8081852 Case Type EXPEDITED (15-DAY) Product NUVARING ADDERALL XR Health Professional Y Outcomes HO,OT Role Route S C Manufacturer Control # 2010SP057915 Dosage Text Age 16 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 521 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8083891 Date FDA Received
29-Aug-2011 Preferred Term METRORRHAGIA Case # 8083891 Case Type EXPEDITED (15-DAY) Product NUVARING Case # 8140562 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional N Health Professional Y Outcomes OT Role Route S Outcomes OT Role Route S VAGINAL Manufacturer Control # 2011SP039191 Dosage Text VAG Age 26 YR Duration Sex Female Country USA Manufacturer Control # 2011SP033981 Dosage Text Age 27 YR Duration Sex Female Country PRT

Manufacturer

8140562 Date FDA Received

29-Aug-2011 Preferred Term PALPITATIONS CHEST PAIN DIZZINESS NAUSEA NERVOUSNESS SYNCOPE

Manufacturer

8146371 Date FDA Received

29-Aug-2011 Preferred Term RENAL DISORDER

Case # 8146371

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2011SP038774 Dosage Text ;VAG Manufacturer Control # 2011SP039143 Dosage Text VAG

Age

Sex Female

Country ESP

Duration

Manufacturer

8151175 Date FDA Received

29-Aug-2011 Preferred Term

Case # 8151175

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Age 31 YR Duration

Sex Female

Country ESP

Manufacturer

BLOOD THYROID STIMULATING HORMONE ABNORMAL WEIGHT INCREASED

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 522 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8744396 Date FDA Received
29-Aug-2011 Preferred Term DEPRESSION Case # 8744396 Case Type DIRECT Product NUVARING Health Professional Y Outcomes LT Role Route S VAGINAL Dosage Text RING IN PLACE 22 DAYS REMOVED 8/28/11 VAG Manufacturer Control # Age 23 YR Duration Sex Female Country USA

Manufacturer SCHERING PLOUGH

PSYCHOTIC DISORDER SUICIDAL IDEATION SUICIDE ATTEMPT LACERATION

SYNTHROID TOPIRAMATE MEMANTINE CYMBALTA LITHIUM CARBONATE CLOZAPINE IPRATOPIUM 2 SPRAY SENNA VITAMIN B COMPLEX FISH OIL VITAMIN D/CALCIUM 800/600 MULTI-VITAMIN

C C C C C C C C C C C C

ORAL ORAL ORAL ORAL ORAL ORAL ORAL

ORAL

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 523 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7282104 Date FDA Received
30-Aug-2011 Preferred Term DEEP VEIN THROMBOSIS PULMONARY EMBOLISM POST THROMBOTIC SYNDROME ABORTION MISSED ACTIVITIES OF DAILY LIVING IMPAIRED AMNESIA ANTITHROMBIN III DEFICIENCY ANXIETY BALANCE DISORDER BLINDNESS CERVICAL DYSPLASIA DEPRESSION ENDOMETRIOSIS INJECTION SITE HAEMATOMA MATERNAL EXPOSURE DURING PREGNANCY MIGRAINE PREGNANCY WITH CONTRACEPTIVE DEVICE SINUSITIS SLEEP DISORDER VAGINAL HAEMORRHAGE Case # 7282104 Case Type EXPEDITED (15-DAY) Product NUVARING IMITREX IBUPROFEN Health Professional Y Outcomes HO Role Route S C C VAGINAL Manufacturer Control # 2009SP017409 Dosage Text QM;VAG Age 32 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 524 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7322605 Date FDA Received
30-Aug-2011 Preferred Term WITHDRAWAL BLEED EPILEPSY COMPLEX PARTIAL SEIZURES DISEASE RECURRENCE GRAND MAL CONVULSION MENSTRUATION DELAYED Case # 7322605 Case Type EXPEDITED (15-DAY) Product NUVARING NEURACTIN Health Professional N Outcomes OT Role Route S C VAGINAL Manufacturer Control # 2010SP010224 Dosage Text QM;VAG Age 29 YR Duration Sex Female Country CHL

Manufacturer

8054338 Date FDA Received

30-Aug-2011 Preferred Term MULTIPLE INJURIES CHEST PAIN ATELECTASIS

Case # 8054338

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S C

Manufacturer Control # 2010SP064430 Dosage Text

Age 27 YR Duration

Sex Female

Country USA

Manufacturer

MULTI-VITAMIN

DEEP VEIN THROMBOSIS DYSPNOEA EMOTIONAL DISORDER HYPERCOAGULATION MENTAL DISORDER MUSCULOSKELETAL PAIN SCAR THYROID DISORDER

8140509 Date FDA Received

30-Aug-2011 Preferred Term

Case # 8140509

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2011SP038994 Dosage Text VAG

Age 27 YR Duration

Sex Female

Country USA

Manufacturer

PREGNANCY WITH CONTRACEPTIVE DEVICE ABORTION SPONTANEOUS MATERNAL EXPOSURE DURING PREGNANCY

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 525 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8146628 Date FDA Received
30-Aug-2011 Preferred Term RASH BREAST PAIN DIZZINESS JUGULAR VEIN DISTENSION METRORRHAGIA NASOPHARYNGITIS NAUSEA PAIN IN EXTREMITY SENSATION OF HEAVINESS VASCULAR RUPTURE VENOUS INSUFFICIENCY Case # 8146628 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional N Outcomes OT Role Route S VAGINAL Manufacturer Control # 2011SP038601 Dosage Text VAG Age 26 YR Duration Sex Female Country RUS

Manufacturer

7279201 Date FDA Received

31-Aug-2011 Preferred Term

Case # 7279201

Case Type EXPEDITED (15-DAY) Product NUVARING ALBUTEROL

Health Professional Y

Outcomes HO,OT Role Route S C VAGINAL

Manufacturer Control # 2009SP021087 Dosage Text ;VAG

Age 23 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS Peripheral artery thrombosis ABDOMINAL MASS CERVICAL DYSPLASIA FEAR OF DEATH FISTULA HUMAN PAPILLOMA VIRUS TEST NEGATIVE INSOMNIA LYMPHATIC DUCT INJURY THORACIC OUTLET SYNDROME URINARY TRACT INFECTION

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 526 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7590590 Date FDA Received
31-Aug-2011 Preferred Term TEMPORAL ARTERITIS DISEASE RECURRENCE DRUG PRESCRIBING ERROR INCORRECT DRUG ADMINISTRATION DURATION Case # 7590590 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional N Outcomes OT Role Route S VAGINAL Manufacturer Control # 2010SP046334 Dosage Text QM;VAG Age 21 YR Duration Sex Female Country CHL

Manufacturer

8110872 Date FDA Received

31-Aug-2011 Preferred Term

Case # 8110872

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2011SP037160 Dosage Text VAG

Age 31 YR Duration

Sex Female

Country BRA

Manufacturer

URINARY TRACT INFECTION HYPOTHYROIDISM INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION

7167564 Date FDA Received

01-Sep-2011 Preferred Term VAGINITIS BACTERIAL

Case # 7167564

Case Type EXPEDITED (15-DAY) Product NUVARING NUVARING

Health Professional Y

Outcomes HO,OT Role Route S S C C C C C C C C C

Manufacturer Control # 2009SP030810 Dosage Text

Age 40 YR Duration

Sex Female

Country USA

Manufacturer

TRANSVERSE SINUS THROMBOSIS INTRACRANIAL VENOUS SINUS THROMBOSIS JUGULAR VEIN THROMBOSIS NEOPLASM OF APPENDIX BILIARY DYSKINESIA NEURALGIA VAGINAL DISCHARGE AORTIC ARTERIOSCLEROSIS BREAST CYST SINUSITIS

WELLBUTRIN LEXAPRO CANASA CELEXA NYSTATIN MESALAMINE AKNE-MYCIN DOXYCYCLINE HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 527 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7167564
Preferred Term WEIGHT INCREASED ABDOMINAL PAIN UPPER RED BLOOD CELLS CSF POSITIVE CSF PROTEIN INCREASED ALANINE AMINOTRANSFERASE INCREASED ASPARTATE AMINOTRANSFERASE INCREASED CEREBROVASCULAR DISORDER DEEP VEIN THROMBOSIS DYSPAREUNIA FISTULA GARDNERELLA TEST POSITIVE HAEMATOCHEZIA HEADACHE HEPATOTOXICITY HERPES SIMPLEX HIV INFECTION HYPERCOAGULATION RED BLOOD CELL SEDIMENTATION RATE INCREASED STREPTOCOCCUS TEST POSITIVE SUBDURAL HAEMORRHAGE TREATMENT NONCOMPLIANCE VENOUS RECANALISATION Product PREDNISONE DIFFERIN ALPRAZOLAM OXYCODONE AND ACETAMINOPHEN Role Route C C C C Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 528 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7578911 Date FDA Received
01-Sep-2011 Preferred Term DEEP VEIN THROMBOSIS ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED ANAEMIA BLOOD CHOLESTEROL INCREASED BRONCHITIS FIBROCYSTIC BREAST DISEASE HYPERTENSION LEFT VENTRICULAR HYPERTROPHY OVARIAN CYST SALPINGITIS TENDONITIS TENDON RUPTURE UPPER-AIRWAY COUGH SYNDROME UTERINE LEIOMYOMA VENOUS INSUFFICIENCY Case # 7578911 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO,OT Role Route S Manufacturer Control # 2010SP012140 Dosage Text Age 36 YR Duration Sex Female Country USA

Manufacturer

8744682 Date FDA Received

01-Sep-2011 Preferred Term DEVICE BREAKAGE

Case # 8744682

Case Type DIRECT Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control #

Age 28 YR

Sex Female

Country USA

Dosage Text 0.015MG PER DAY VAG

Duration

Manufacturer

VAGINAL HAEMORRHAGE VAGINAL LACERATION

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 529 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7865753 Date FDA Received
02-Sep-2011 Preferred Term PULMONARY EMBOLISM MIGRAINE THROMBOSIS COGNITIVE DISORDER CYST DEPRESSION DRUG LEVEL INCREASED EMOTIONAL DISORDER FALL FIBRIN D DIMER INCREASED FIBROCYSTIC BREAST DISEASE HEAD INJURY IMPAIRED WORK ABILITY JOINT INJURY MENTAL DISORDER MULTIPLE INJURIES NORMOCHROMIC NORMOCYTIC ANAEMIA OVARIAN CYST RUPTURED PLEURAL EFFUSION POST-TRAUMATIC NECK SYNDROME PULMONARY INFARCTION SYNOVIAL CYST VAGINAL ABSCESS VAGINAL HAEMATOMA Case # 7865753 Case Type EXPEDITED (15-DAY) Product NUVARING CLARITIN B6 Health Professional Y Outcomes HO,DS,OT Role Route S C C Manufacturer Control # 2010SP058337 Dosage Text Age 25 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 530 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8140269 Date FDA Received
02-Sep-2011 Preferred Term DECUBITUS ULCER VAGINAL INFECTION VULVAR DYSPLASIA Case # 8140269 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes OT Role Route S Manufacturer Control # 2011SP040769 Dosage Text Duration Age Sex Female Country CZE

Manufacturer

7546581 Date FDA Received

06-Sep-2011 Preferred Term

Case # 7546581

Case Type EXPEDITED (15-DAY) Product NUVARING MOTRIN LOTENSIN

Health Professional Y

Outcomes HO,DS,OT Role Route S C C C C C

Manufacturer Control # 2010SP017471 Dosage Text

Age 42 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM MULTIPLE INJURIES TRANSIENT ISCHAEMIC ATTACK HYPERTENSION CHEST PAIN ATRIAL FIBRILLATION ADJUSTMENT DISORDER ARRHYTHMIA ARTHRALGIA ASTHMA ASTIGMATISM BRADYCARDIA BRONCHITIS CARDIAC MURMUR CAROTID ARTERY STENOSIS CEREBROVASCULAR ACCIDENT CERVICAL DYSPLASIA DERMAL CYST DYSLEXIA EMOTIONAL DISORDER GASTROOESOPHAGEAL REFLUX DISEASE

HYDROCHLOROTHIAZIDE ALBUTEROL ASPIRIN

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 531 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7546581
Preferred Term HEADACHE HEMIPARESIS HYPERLIPIDAEMIA LUMBAR RADICULOPATHY MENORRHAGIA MIGRAINE OTITIS MEDIA PAPILLOMA VIRAL INFECTION PARAESTHESIA PARAKERATOSIS PRESBYOPIA PROCEDURAL PAIN RASH SEBORRHOEIC DERMATITIS SINUS TACHYCARDIA TACHYCARDIA VISION BLURRED VISUAL ACUITY REDUCED Product Role Route Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 532 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7808531 Date FDA Received
06-Sep-2011 Preferred Term PULMONARY EMBOLISM ACQUIRED GENE MUTATION ADNEXA UTERI MASS ANAEMIA DEEP VEIN THROMBOSIS DISEASE RECURRENCE ECTOPIC PREGNANCY WITH INTRAUTERINE DEVICE ECZEMA HAEMORRHAGE IN PREGNANCY MATERNAL EXPOSURE DURING PREGNANCY PLATELET COUNT DECREASED PROTEIN C DECREASED PROTEIN S DECREASED RHINITIS ALLERGIC UTERINE LEIOMYOMA VAGINAL INFECTION Case # 7808531 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO,OT Role Route S Manufacturer Control # 2010SP019044 Dosage Text Age 30 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 533 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7821774 Date FDA Received
06-Sep-2011 Preferred Term PROTHROMBIN TIME PROLONGED APPENDICITIS HEPARIN-INDUCED THROMBOCYTOPENIA DYSPNOEA APATHY DEEP VEIN THROMBOSIS DISTURBANCE IN ATTENTION DRUG INEFFECTIVE DYSURIA FACTOR V DEFICIENCY HERPES SIMPLEX POLLAKIURIA SKIN IRRITATION SUPRAPUBIC PAIN VAGINAL HAEMORRHAGE Case # 7821774 Case Type EXPEDITED (15-DAY) Product NUVARING HEPARIN INH VITAMINS NOS Health Professional Y Outcomes HO Role Route S S C C VAGINAL Manufacturer Control # 2010SP014821 Dosage Text QM;VAG Age 18 YR Duration Sex Female Country USA

Manufacturer

7827359 Date FDA Received

06-Sep-2011 Preferred Term

Case # 7827359

Case Type EXPEDITED (15-DAY) Product NUVARING LEXAPRO ADVIL

Health Professional Y

Outcomes HO,OT Role Route S C C

Manufacturer Control # 2010SP042967 Dosage Text

Age 39 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM CEREBROVASCULAR ACCIDENT HYPERTENSION ABDOMINAL DISCOMFORT ABORTION MISSED ANAEMIA BACK PAIN BACTERIAL INFECTION BASAL GANGLIA HAEMORRHAGE BASAL GANGLIA INFARCTION

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 534 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7827359
Preferred Term BLOOD CULTURE POSITIVE CARDIOGENIC SHOCK CAROTID ARTERY DISSECTION CEREBRAL ARTERY OCCLUSION CEREBRAL HAEMORRHAGE CEREBRAL INFARCTION COAGULOPATHY CONSTIPATION CONVULSION DEVICE RELATED SEPSIS ELECTROCARDIOGRAM ST-T CHANGE FACTOR V DEFICIENCY GALLBLADDER DISORDER HEAD INJURY HYPOKALAEMIA HYPOMAGNESAEMIA HYPOTENSION IATROGENIC INJURY LOSS OF EMPLOYMENT MATERNAL EXPOSURE DURING PREGNANCY MENTAL STATUS CHANGES MITRAL VALVE PROLAPSE PLEURAL EFFUSION RESPIRATORY DISTRESS THROMBOTIC STROKE TOBACCO ABUSE VENTRICULAR TACHYCARDIA Product Role Route Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 535 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8748981 Date FDA Received
06-Sep-2011 Preferred Term PULMONARY EMBOLISM Case # 8748981 Case Type DIRECT Product NUVARING Case Type DIRECT Product NUVARING Health Professional Y Health Professional Y Outcomes HO,LT Role Route S Outcomes HO,DS,LT Role Route S VAGINAL Dosage Text 0.120MG/0.015MG PER DAY NEW RING Q MONTH (TRANSVAGINAL) 066 Manufacturer Control # Age 40 YR Duration Sex Female Country USA Dosage Text Manufacturer Control # Age 34 YR Duration Sex Female Country USA

Manufacturer

8137387 Date FDA Received

07-Sep-2011 Preferred Term

Case # 8137387

Manufacturer SCHERING PLOUGH

TRANSVERSE SINUS THROMBOSIS

HAEMORRHAGE INTRACRANIAL

8151032 Date FDA Received

07-Sep-2011 Preferred Term HEADACHE HEPATIC NEOPLASM

Case # 8151032

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2011SP021776 Dosage Text QM;VAG

Age 23 YR Duration

Sex Female

Country CHL

Manufacturer

INCORRECT DOSE ADMINISTERED BY DEVICE

8151157 Date FDA Received

07-Sep-2011 Preferred Term CARDIAC DISORDER

Case # 8151157

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes HO Role Route S VAGINAL

Manufacturer Control # 2011SP041063 Dosage Text VAG Manufacturer Control # 2011SP040763 Dosage Text

Age

Sex Female

Country NLD

Duration

Manufacturer

8151168 Date FDA Received

07-Sep-2011 Preferred Term CERVIX DISORDER INFERTILITY FEMALE

Case # 8151168

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S

Age 25 YR Duration

Sex Female

Country ISR

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 536 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7806018 Date FDA Received
08-Sep-2011 Preferred Term PULMONARY EMBOLISM EMOTIONAL DISTRESS ECONOMIC PROBLEM FEAR PLEURITIC PAIN CARDIAC MURMUR ASPIRATION PNEUMONIA PULMONARY INFARCTION LUNG NEOPLASM SCOLIOSIS BACK PAIN CERVICOBRACHIAL SYNDROME DECREASED ACTIVITY HEADACHE MUSCLE SPASMS MUSCULAR WEAKNESS MUSCULOSKELETAL STIFFNESS PAIN Case # 7806018 Case Type EXPEDITED (15-DAY) Product NUVARING COUMADIN ACIDPHILUS BIOTIN FISH OIL CENTRUM CARDIO ZOVIRAX ATENOLOL CEPHALEXIN NAPHCON ASCORBIC ACID Health Professional Y Outcomes HO,DS,OT Role Route S S C C C C C C C C C VAGINAL Manufacturer Control # 2010SP020085 Dosage Text VAG Age 41 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 537 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8023524 Date FDA Received
08-Sep-2011 Preferred Term CHOLELITHIASIS INCORRECT DRUG ADMINISTRATION DURATION CONFUSIONAL STATE INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION WITHDRAWAL BLEED NASOPHARYNGITIS ABDOMINAL DISTENSION BLOOD PRESSURE INCREASED CHOLECYSTITIS ACUTE METRORRHAGIA PELVIC PAIN URINARY TRACT INFECTION WEIGHT DECREASED Case # 8023524 Case Type EXPEDITED (15-DAY) Product NUVARING PARGEVERINE HYDROCHLORIDE RANITIDINE MORPHINE THIETHYLPERAZINE BLADURIL Health Professional N Outcomes HO,OT Role Route S C C C C C VAGINAL Manufacturer Control # 2011SP027373 Dosage Text QM;VAG ; QM;VAG Age 30 YR Duration Sex Female Country CHL

Manufacturer

8146360 Date FDA Received

08-Sep-2011 Preferred Term UTERINE LEIOMYOMA

Case # 8146360

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2011SP041450 Dosage Text VAG

Age

Sex Female

Country BRA

Duration

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 538 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7953167 Date FDA Received
09-Sep-2011 Preferred Term PULMONARY EMBOLISM DIZZINESS ANXIETY HEADACHE HYPERCOAGULATION PAIN PAIN IN EXTREMITY Case # 7953167 Case Type EXPEDITED (15-DAY) Product NUVARING CLARITIN Health Professional Y Outcomes HO Role Route S C Manufacturer Control # 2011SP000360 Dosage Text Age 33 YR Duration Sex Female Country USA

Manufacturer

7283316 Date FDA Received

13-Sep-2011 Preferred Term

Case # 7283316

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO,OT Role Route S

Manufacturer Control # 2009-196667-NL Dosage Text

Age 27 YR Duration

Sex Female

Country USA

Manufacturer

CEREBRAL VENOUS THROMBOSIS ABDOMINAL DISCOMFORT ABDOMINAL PAIN AMNESIA CAVERNOUS SINUS THROMBOSIS CEREBRAL HAEMORRHAGE CEREBRAL PALSY CEREBROVASCULAR ACCIDENT COAGULOPATHY COGNITIVE DISORDER DEEP VEIN THROMBOSIS DEHYDRATION DIARRHOEA DISORIENTATION DIZZINESS DRUG DEPENDENCE DRY MOUTH

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 539 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7283316
Preferred Term FACTOR V DEFICIENCY FAECAL INCONTINENCE GASTROENTERITIS GASTROENTERITIS VIRAL GRIMACING HAEMATOCRIT DECREASED HEADACHE HYPOKALAEMIA INTERNATIONAL NORMALISED RATIO INCREASED MIGRAINE NAUSEA SUBARACHNOID HAEMORRHAGE THROMBOSIS URINARY TRACT INFECTION VOMITING WHITE BLOOD CELL COUNT INCREASED Product Role Route Dosage Text Duration Manufacturer

7805214 Date FDA Received

13-Sep-2011 Preferred Term

Case # 7805214

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO,DS,OT Role Route S

Manufacturer Control # 2008-176508-NL Dosage Text 1 DF

Age 25 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS CATHETER SITE HAEMORRHAGE FALL HEAD INJURY HYPERCOAGULATION MAY-THURNER SYNDROME

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 540 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7825115 Date FDA Received
13-Sep-2011 Preferred Term PULMONARY EMBOLISM DEEP VEIN THROMBOSIS OEDEMA PERIPHERAL PAIN IN EXTREMITY MALIGNANT MELANOMA HYPOTHYROIDISM LETHARGY MELANOCYTIC NAEVUS THYROID DISORDER VITAMIN B12 DEFICIENCY WEIGHT DECREASED Case # 7825115 Case Type EXPEDITED (15-DAY) Product NUVARING VITAMINS NOS ASCORBIC ACID VITAMIN B12 FERROUS SULFATE Health Professional Y Outcomes HO,OT Role Route S C C C C Manufacturer Control # 2010SP028269 Dosage Text Age 38 YR Duration Sex Female Country USA

Manufacturer

8048878 Date FDA Received

13-Sep-2011 Preferred Term

Case # 8048878

Case Type EXPEDITED (15-DAY) Product NUVARING FLONASE NASONEX VITAMIN D

Health Professional Y

Outcomes HO,DS,LT,OT Role Route S C C C C VAGINAL

Manufacturer Control # 2011SP031313 Dosage Text QM; VAG, QM; VAG

Age 35 YR Duration

Sex Female

Country USA

Manufacturer

CEREBROVASCULAR ACCIDENT CEREBRAL VENOUS THROMBOSIS INTRACRANIAL VENOUS SINUS THROMBOSIS

PREDNISONE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 541 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7808590 Date FDA Received
14-Sep-2011 Preferred Term PULMONARY EMBOLISM HYPERTENSION MUSCLE SPASMS HEART RATE IRREGULAR ANAEMIA HYPOKALAEMIA PANIC ATTACK ANXIETY BENIGN BREAST NEOPLASM DIARRHOEA EUSTACHIAN TUBE DYSFUNCTION FATIGUE FEELING JITTERY HYPOAESTHESIA INSOMNIA LIMB INJURY MUSCULOSKELETAL CHEST PAIN PALPITATIONS PLEURISY PNEUMONIA PULMONARY INFARCTION SINUSITIS SKIN IRRITATION TEMPOROMANDIBULAR JOINT SYNDROME Case # 7808590 Case Type EXPEDITED (15-DAY) Product NUVARING SYNTHROID PROVENTIL METFORMIN HYDROCHLORIDE ASCORBIC ACID DAILY VITAMINS TYLENOL Health Professional Y Outcomes HO,OT Role Route S C C C C C C Manufacturer Control # 2010SP044540 Dosage Text Age 30 YR Duration Sex Female Country USA

Manufacturer

7114559 Date FDA Received

15-Sep-2011 Preferred Term

Case # 7114559

Case Type EXPEDITED (15-DAY) Product

Health Professional Y

Outcomes HO,DS Role Route

Manufacturer Control # 2009SP017681 Dosage Text

Age 41 YR Duration

Sex Female

Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 542 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7114559
Preferred Term CEREBROVASCULAR ACCIDENT UPPER LIMB FRACTURE APHASIA APRAXIA DEPRESSION UNRESPONSIVE TO STIMULI CEREBRAL INFARCTION ABDOMINAL PAIN ATELECTASIS BLOOD POTASSIUM DECREASED BRAIN STEM HAEMORRHAGE CEREBRAL ARTERY OCCLUSION CHEST PAIN COMPLEX REGIONAL PAIN SYNDROME CYST EXERCISE ELECTROCARDIOGRAM ABNORMAL FALL GRAND MAL CONVULSION HUMERUS FRACTURE INFUSION SITE ERYTHEMA INSOMNIA MENTAL IMPAIRMENT METRORRHAGIA MIGRAINE OSTEOPENIA OSTEOPOROSIS PAIN IN EXTREMITY PELVIC PAIN SINUSITIS SKIN DISORDER Product NUVARING TOPAMAX NASACORT AMITRIPTYLINE HYDROCHLORIDE MAXALT PARAFON FORTE TYLENOL Role Route S C C C C C C VAGINAL Dosage Text 1 DF;QM;VAG Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 543 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7114559
Preferred Term SPINAL COLUMN INJURY URINARY TRACT INFECTION VAGINAL DISCHARGE Product Role Route Dosage Text Duration Manufacturer

7974780 Date FDA Received

16-Sep-2011 Preferred Term

Case # 7974780

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO,OT Role Route S

Manufacturer Control # 2011SP003700 Dosage Text

Age 29 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM ABDOMINAL TENDERNESS ABORTION SPONTANEOUS CARDIAC MURMUR COGNITIVE DISORDER EMOTIONAL DISORDER FIBRIN D DIMER INCREASED HILAR LYMPHADENOPATHY HYPERCOAGULATION MENTAL DISORDER OVARIAN CYST PLEURAL EFFUSION PNEUMONIA PULMONARY INFARCTION SARCOIDOSIS TUBERCULOSIS

8159361 Date FDA Received

16-Sep-2011 Preferred Term SPEECH DISORDER HYPOAESTHESIA VISUAL IMPAIRMENT

Case # 8159361

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO Role Route S

Manufacturer Control # 2011SP043219 Dosage Text

Age 23 YR Duration

Sex Female

Country DEU

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 544 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8161099 Date FDA Received
16-Sep-2011 Preferred Term DEPRESSION INTENTIONAL SELF-INJURY PSYCHOTIC DISORDER SUICIDAL BEHAVIOUR Case # 8161099 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional N Outcomes LT,OT Role Route S Manufacturer Control # 2011SP042488 Dosage Text Duration Age Sex Female Country USA

Manufacturer

8744606 Date FDA Received

16-Sep-2011 Preferred Term

Case # 8744606

Case Type DIRECT Product NUVARING Case Type DIRECT Product NUVARING ARMOUR

Health Professional N

Outcomes HO,LT Role Route S

Manufacturer Control #

Age 27 YR

Sex Female

Country USA

Dosage Text

Duration 9 MTH

Manufacturer

PULMONARY EMBOLISM

8744709 Date FDA Received

16-Sep-2011 Preferred Term PAIN IN EXTREMITY INSOMNIA BURNING SENSATION CHEST PAIN CONTUSION OEDEMA PERIPHERAL

Case # 8744709

Health Professional Y

Outcomes HO Role Route S C VAGINAL

Manufacturer Control #

Age 44 YR

Sex Female

Country USA

Dosage Text 1 RING, PER MONTH, VAG

Duration

Manufacturer SCHERING PLOUGH

7194890 Date FDA Received

19-Sep-2011 Preferred Term

Case # 7194890

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO Role Route S S S C

Manufacturer Control # 2009SP033713 Dosage Text

Age 22 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM PELVIC PAIN BACK PAIN FLANK PAIN

ORTHO TRI CYCLEN LO/OVRAL IBUPROFEN

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 545 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7194890
Preferred Term HYDRONEPHROSIS NEPHROLITHIASIS ABORTION MISSED ANXIETY BLOOD PRESSURE INCREASED CHEST PAIN CORONARY ARTERY INSUFFICIENCY DEEP VEIN THROMBOSIS DEPRESSION DIZZINESS DYSPNOEA HEADACHE HYPERTENSION INSOMNIA JOINT DISLOCATION LIGAMENT SPRAIN LOBAR PNEUMONIA LUNG INFILTRATION MATERNAL EXPOSURE DURING PREGNANCY MENORRHAGIA MITRAL VALVE INCOMPETENCE MUSCLE STRAIN OEDEMA PERIPHERAL PALPITATIONS PELVIC INFLAMMATORY DISEASE PLATELET COUNT INCREASED PLEURAL EFFUSION PNEUMONIA PREGNANCY WITH CONTRACEPTIVE DEVICE PRESYNCOPE ROAD TRAFFIC ACCIDENT Product LOPRESSOR LORTAB Role Route C C Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 546 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7194890
Preferred Term SINUS HEADACHE STREPTOCOCCUS TEST POSITIVE SUPRAVENTRICULAR TACHYCARDIA TRICUSPID VALVE INCOMPETENCE Product Role Route Dosage Text Duration Manufacturer

8744798 Date FDA Received

19-Sep-2011 Preferred Term

Case # 8744798

Case Type DIRECT Product NUVARING

Health Professional Y

Outcomes HO Role Route S

Manufacturer Control #

Age 28 YR

Sex Female

Country USA

Dosage Text

Duration

Manufacturer

BLOOD PRESSURE INCREASED DIZZINESS DYSPNOEA HYPOAESTHESIA PARAESTHESIA

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 547 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7271481 Date FDA Received
20-Sep-2011 Preferred Term PULMONARY EMBOLISM OEDEMA PERIPHERAL PAIN IN EXTREMITY BODY TEMPERATURE INCREASED AMENORRHOEA ASTHMA BODY TEMPERATURE DECREASED CANDIDA TEST POSITIVE CERVICAL DYSPLASIA CHEST DISCOMFORT CHEST PAIN COUGH DEEP VEIN THROMBOSIS DEPRESSION DRUG INEFFECTIVE DYSMENORRHOEA DYSPNOEA ELECTROCARDIOGRAM T WAVE INVERSION GASTROOESOPHAGEAL REFLUX DISEASE HEADACHE JAUNDICE LUNG NEOPLASM MELANOCYTIC NAEVUS MIGRAINE PNEUMONIA TACHYCARDIA WHEEZING Case # 7271481 Case Type EXPEDITED (15-DAY) Product NUVARING DEPO-PROVERA CYMBALTA MULTI-VITAMIN Health Professional Y Outcomes HO,OT Role Route S S C C Manufacturer Control # 2009SP021074 Dosage Text Age 31 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 548 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7792793 Date FDA Received
20-Sep-2011 Preferred Term PULMONARY EMBOLISM ALCOHOL USE ANAEMIA ANTIPHOSPHOLIPID SYNDROME HAEMATEMESIS HYPOAESTHESIA LOSS OF CONSCIOUSNESS MENORRHAGIA PARAESTHESIA PLEURISY VAGINITIS BACTERIAL VIITH NERVE PARALYSIS WEIGHT DECREASED Case # 7792793 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO,OT Role Route S Manufacturer Control # 2011SP000225 Dosage Text Age 19 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 549 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7807490 Date FDA Received
21-Sep-2011 Preferred Term PULMONARY EMBOLISM MULTIPLE INJURIES DEEP VEIN THROMBOSIS THROMBOSIS MIGRAINE MOOD SWINGS ACCIDENT AT WORK LIGAMENT SPRAIN INTERVERTEBRAL DISC PROTRUSION ANXIETY ASTHENIA ASTHMA BRONCHOSPASM CONVERSION DISORDER HEPATIC LESION LEFT VENTRICULAR HYPERTROPHY LUNG INFILTRATION MITRAL VALVE INCOMPETENCE MITRAL VALVE SCLEROSIS PULMONARY ARTERIAL HYPERTENSION PULMONARY HYPERTENSION RENAL CYST RENAL DISORDER SPINAL OSTEOARTHRITIS TRICUSPID VALVE INCOMPETENCE VAGINAL HAEMORRHAGE VOCAL CORD DISORDER Case # 7807490 Case Type EXPEDITED (15-DAY) Product NUVARING NUVARING NUVARING NUVARING NUVARING NUVARING NUVARING NUVARING NUVARING Health Professional Y Outcomes HO,DS,OT Role Route S S S S S S S S S Manufacturer Control # 2010SP053033 Dosage Text Age 35 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 550 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8099712 Date FDA Received
21-Sep-2011 Preferred Term SALPINGO-OOPHORITIS INFECTIOUS PERITONITIS Case # 8099712 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO Role Route S VAGINAL Manufacturer Control # 2011SP036491 Dosage Text VAG Age 18 YR Duration Sex Female Country AUT

Manufacturer

7238541 Date FDA Received

22-Sep-2011

Case # 7238541

Case Type EXPEDITED (15-DAY)

Health Professional Y

Outcomes HO,OT

Manufacturer Control # 2009-198567-NL

Age 21 YR

Sex Female

Country USA

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 551 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7238541
Preferred Term PULMONARY EMBOLISM PYREXIA HEADACHE PARAESTHESIA ADNEXA UTERI CYST AMENORRHOEA BRONCHITIS BRONCHOSPASM DECREASED APPETITE DEEP VEIN THROMBOSIS DEPRESSED MOOD DYSMENORRHOEA DYSPAREUNIA FATIGUE GASTROENTERITIS HYPEREMESIS GRAVIDARUM MATERNAL EXPOSURE DURING PREGNANCY MIGRAINE MYOCARDIAL INFARCTION NAUSEA PELVIC PAIN PERITONEAL NEOPLASM PNEUMONIA PREGNANCY VAGINITIS BACTERIAL VIRAL INFECTION VIRAL UPPER RESPIRATORY TRACT INFECTION VOMITING WEIGHT DECREASED Product NUVARING MIRENA CEPHALEXIN AMITRIPTYLENE Role Route S S C C Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 552 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7826803 Date FDA Received
22-Sep-2011 Preferred Term PULMONARY EMBOLISM ABDOMINAL PAIN ACUTE SINUSITIS AFFECTIVE DISORDER COSTOCHONDRITIS DEPRESSION DIZZINESS EPISTAXIS EXCESSIVE EXERCISE HAEMORRHOIDS HYPERCOAGULATION INTERNATIONAL NORMALISED RATIO INCREASED JOINT DISLOCATION PALPITATIONS PERIPHERAL EMBOLISM POSTPARTUM DISORDER POST-TRAUMATIC STRESS DISORDER PREGNANCY PREMATURE DELIVERY PULMONARY INFARCTION VERTIGO Case # 7826803 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO,DS,OT Role Route S Manufacturer Control # 2010SP041972 Dosage Text Age 30 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 553 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7672933 Date FDA Received
23-Sep-2011 Preferred Term PULMONARY EMBOLISM ANXIETY FIBRIN D DIMER INCREASED HAEMOPTYSIS HEARING IMPAIRED HYPERCOAGULATION LEUKOPENIA MENTAL DISORDER PULMONARY INFARCTION SUPRAVENTRICULAR TACHYCARDIA TACHYCARDIA TEMPERATURE INTOLERANCE THROMBOCYTOPENIA TINNITUS VIRAL INFECTION VISION BLURRED Case # 7672933 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO,OT Role Route S Manufacturer Control # 2010SP019048 Dosage Text Age 24 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 554 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7197918 Date FDA Received
27-Sep-2011 Preferred Term PULMONARY EMBOLISM BRONCHITIS VON WILLEBRAND'S FACTOR ANTIGEN INCREASED ARTHRALGIA ASTHMA CHEST PAIN CONDITION AGGRAVATED GAIT DISTURBANCE INTERNATIONAL NORMALISED RATIO INCREASED PALPITATIONS Case # 7197918 Case Type EXPEDITED (15-DAY) Product NUVARING PREDNISONE DOXYCYCLINE Health Professional Y Outcomes HO Role Route S C C VAGINAL Manufacturer Control # 2009-195834-NL Dosage Text VAG Age 22 YR Duration Sex Female Country USA

Manufacturer

8175130 Date FDA Received

27-Sep-2011 Preferred Term PNEUMOTHORAX

Case # 8175130

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2011SP044476 Dosage Text 1 DF Manufacturer Control #

Age

Sex Female

Country USA

Duration

Manufacturer

8745061 Date FDA Received

27-Sep-2011 Preferred Term

Case # 8745061

Case Type DIRECT Product NUVARING

Health Professional Y

Outcomes HO,OT Role Route S C C VAGINAL

Age 42 YR

Sex Female

Country USA

Dosage Text EVERY 3 WEEKS VAG

Duration

Manufacturer MERCK

PULMONARY EMBOLISM

AMLODIPINE HYDROCHLOROTHIAZIDE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 555 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7826858 Date FDA Received
28-Sep-2011 Preferred Term DEEP VEIN THROMBOSIS ABDOMINAL PAIN BLOOD URINE PRESENT CAESAREAN SECTION CHEST PAIN CHRONIC TONSILLITIS FLANK PAIN HAEMORRHAGE IN PREGNANCY HEADACHE MATERNAL EXPOSURE DURING PREGNANCY MULTIPLE INJURIES PAIN IN EXTREMITY PREGNANCY WITH CONTRACEPTIVE DEVICE PREMATURE DELIVERY PREMATURE RUPTURE OF MEMBRANES PREMATURE SEPARATION OF PLACENTA STREPTOCOCCUS TEST POSITIVE SUBCHORIONIC HAEMORRHAGE THROMBOSIS TONSILLAR HYPERTROPHY UTERINE DISORDER VULVOVAGINAL CANDIDIASIS Case # 7826858 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO,OT Role Route S Manufacturer Control # 2010SP005477 Dosage Text Age 24 YR Duration Sex Female Country USA

Manufacturer

8176208 Date FDA Received

28-Sep-2011 Preferred Term

Case # 8176208

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO Role Route S TRANSPLACENTAL

Manufacturer Control # 2011SP045038 Dosage Text TRPL

Age

Sex Unknown

Country USA

Duration

Manufacturer

MATERNAL DRUGS AFFECTING FOETUS PREMATURE BABY

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 556 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8176230 Date FDA Received
28-Sep-2011 Preferred Term PREGNANCY WITH CONTRACEPTIVE DEVICE MATERNAL EXPOSURE DURING PREGNANCY PREMATURE LABOUR Case # 8176230 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO Role Route S Manufacturer Control # 2011SP044739 Dosage Text 1 DF Duration Age Sex Female Country USA

Manufacturer

8745211 Date FDA Received

28-Sep-2011 Preferred Term

Case # 8745211

Case Type DIRECT Product NUVARING

Health Professional Y

Outcomes LT,OT Role Route S VAGINAL

Manufacturer Control #

Age 18 YR

Sex Female

Country USA

Dosage Text ONE PER MONTH VAG

Duration

Manufacturer

EMOTIONAL DISORDER ANGER MENTAL DISORDER PARANOIA TEARFULNESS

8176191 Date FDA Received

29-Sep-2011 Preferred Term

Case # 8176191

Case Type EXPEDITED (15-DAY) Product NUVARING Case Type DIRECT Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2011SP043674 Dosage Text VAG Manufacturer Control #

Age 25 YR Duration

Sex Female

Country RUS

Manufacturer

GASTROINTESTINAL DISORDER

8745446 Date FDA Received

29-Sep-2011 Preferred Term

Case # 8745446

Health Professional N

Outcomes HO,LT Role Route S VAGINAL

Age 38 YR

Sex Female

Country USA

Dosage Text 1 RING MONTH VAG

Duration

Manufacturer MERCK

PULMONARY EMBOLISM CHOLECYSTECTOMY LOSS OF CONSCIOUSNESS

7153609 Date FDA Received

30-Sep-2011 Preferred Term

Case # 7153609

Case Type EXPEDITED (15-DAY) Product

Health Professional Y

Outcomes DE,HO Role Route

Manufacturer Control # 2009SP028574 Dosage Text

Age 47 YR Duration

Sex Female

Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 557 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7153609
Preferred Term PULMONARY EMBOLISM ABDOMINAL PAIN UPPER ACIDOSIS ACUTE HEPATIC FAILURE ATRIOVENTRICULAR BLOCK COMPLETE BRADYCARDIA CARDIAC ARREST CARDIAC FAILURE CONGESTIVE CERVICAL POLYP DECREASED APPETITE DISSEMINATED INTRAVASCULAR COAGULATION DIZZINESS EXERCISE ELECTROCARDIOGRAM ABNORMAL FAECAL INCONTINENCE FLUID OVERLOAD HAEMOGLOBIN DECREASED HEART RATE IRREGULAR HEPATITIS ACUTE HEPATOMEGALY HYPOTENSION MENORRHAGIA OLIGURIA PLATELET COUNT DECREASED PLEURAL EFFUSION PULMONARY HYPERTENSION PULMONARY OEDEMA RESPIRATORY DISTRESS RESPIRATORY FAILURE RIGHT VENTRICULAR FAILURE THROMBOSIS Product NUVARING Role Route S Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 558 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7153609
Preferred Term URINARY INCONTINENCE UROSEPSIS VENTRICULAR DYSFUNCTION WHITE BLOOD CELL COUNT INCREASED Product Role Route Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 559 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7635670 Date FDA Received
03-Oct-2011 Preferred Term PULMONARY EMBOLISM ABORTION SPONTANEOUS PLEURITIC PAIN DYSPNOEA ABORTION MISSED ABORTION THREATENED ANAEMIA ANXIETY ATELECTASIS CARDIOMEGALY FOETAL DEATH HIATUS HERNIA LEUKOCYTOSIS MATERNAL EXPOSURE BEFORE PREGNANCY MATERNAL EXPOSURE DURING PREGNANCY OVARIAN CYST PLEURAL EFFUSION PNEUMONIA POST STROKE DEPRESSION PULMONARY INFARCTION PYREXIA URINARY TRACT INFECTION UTERINE LEIOMYOMA VULVOVAGINAL MYCOTIC INFECTION Case # 7635670 Case Type EXPEDITED (15-DAY) Product NUVARING UNSPECIFIED INGREDIENT DARVOCET VALIUM Health Professional Y Outcomes HO,LT,OT Role Route S S C C VAGINAL Manufacturer Control # 2010SP026025 Dosage Text VAG Age 29 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 560 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7739607 Date FDA Received
03-Oct-2011 Preferred Term DEEP VEIN THROMBOSIS PULMONARY EMBOLISM ANXIETY DEPRESSION FATIGUE ANAEMIA ARTHRITIS BRONCHITIS CYTOMEGALOVIRUS TEST POSITIVE EPSTEIN-BARR VIRUS ANTIGEN POSITIVE HEART RATE IRREGULAR HYPOKALAEMIA MITRAL VALVE INCOMPETENCE MUSCLE SPASMS OEDEMA PERIPHERAL OVARIAN CYST PELVIC PAIN PHLEBITIS PNEUMONIA PNEUMONITIS PRESYNCOPE PULMONARY VALVE INCOMPETENCE RESTLESS LEGS SYNDROME THROMBOPHLEBITIS TRICUSPID VALVE INCOMPETENCE URINARY TRACT INFECTION VAGINAL DISCHARGE VARICOSE VEIN VIRAL INFECTION Case # 7739607 Case Type EXPEDITED (15-DAY) Product NUVARING NUVARING ASPIRIN MULTI-VITAMIN CLARITIN Health Professional Y Outcomes HO,DS,OT Role Route S S S C C Manufacturer Control # 2010SP020793 Dosage Text Age 34 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 561 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7821726 Date FDA Received
04-Oct-2011 Preferred Term PULMONARY EMBOLISM LUNG INFILTRATION ATELECTASIS PLEURAL EFFUSION PULMONARY INFARCTION ASTHMA DEPRESSION HAEMATURIA NEOPLASM UTERINE HAEMORRHAGE Case # 7821726 Case Type EXPEDITED (15-DAY) Product NUVARING EFFEXOR BUTALBITAL TOPAMAX ADVAIR DISKUS Health Professional Y Outcomes HO,OT Role Route S C C C C Manufacturer Control # 2010SP015869 Dosage Text Age 40 YR Duration Sex Female Country USA

Manufacturer

7340122 Date FDA Received

05-Oct-2011 Preferred Term

Case # 7340122

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO,OT Role Route S

Manufacturer Control # 2009-194884-NL Dosage Text 1 DF;

Age 19 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM HYPERCOAGULATION INTERNATIONAL NORMALISED RATIO INCREASED MUSCLE SPASMS PAIN PROTEIN S DEFICIENCY PRURITUS SWELLING

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 562 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8183563 Date FDA Received
05-Oct-2011 Preferred Term THYROID DISORDER CARBOHYDRATE METABOLISM DISORDER Case # 8183563 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional N Outcomes OT Role Route S VAGINAL Manufacturer Control # 2011SP045717 Dosage Text QM, VAG Age 23 YR Duration Sex Female Country CHL

Manufacturer

7825440 Date FDA Received

06-Oct-2011 Preferred Term ATELECTASIS PLEURAL EFFUSION HEPATIC CYST ANAEMIA

Case # 7825440

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO,OT Role Route S C C

Manufacturer Control # 2009SP040697 Dosage Text

Age 45 YR Duration

Sex Female

Country USA

Manufacturer

MULTI-VITAMIN CALCIUM CARBONATE

ANTIPHOSPHOLIPID SYNDROME DYSFUNCTIONAL UTERINE BLEEDING HAEMANGIOMA OF LIVER HYPERCOAGULATION INTERNATIONAL NORMALISED RATIO INCREASED MENORRHAGIA PNEUMONIA PNEUMOTHORAX PULMONARY EMBOLISM PULMONARY INFARCTION UTERINE POLYP

8188456 Date FDA Received

06-Oct-2011 Preferred Term FALL

Case # 8188456

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2011SP046186 Dosage Text

Age 38 YR Duration

Sex Female

Country UKR

Manufacturer

LOSS OF CONSCIOUSNESS

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 563 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7279217 Date FDA Received
07-Oct-2011 Preferred Term PULMONARY EMBOLISM DEEP VEIN THROMBOSIS PAIN HEADACHE HYPERTENSION HEART RATE IRREGULAR ATELECTASIS ATRIAL FIBRILLATION CITROBACTER INFECTION DERMAL CYST FATIGUE LOSS OF EMPLOYMENT MITRAL VALVE INCOMPETENCE PALPITATIONS PROTHROMBIN TIME SHORTENED PULMONARY HYPERTENSION PULMONARY INFARCTION PULMONARY VALVE INCOMPETENCE RHINITIS ALLERGIC SUPRAVENTRICULAR EXTRASYSTOLES TRICUSPID VALVE INCOMPETENCE URINARY TRACT INFECTION VULVOVAGINITIS TRICHOMONAL Case # 7279217 Case Type EXPEDITED (15-DAY) Product NUVARING ADVIL NORVASC FLONASE DIAZEPAM CELEBREX Health Professional Y Outcomes HO,DS,OT Role Route S C C C C C Manufacturer Control # 2009SP020441 Dosage Text Age 43 YR Duration Sex Female Country USA

Manufacturer

8081774 Date FDA Received

07-Oct-2011 Preferred Term

Case # 8081774

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO,DS,OT Role Route S VAGINAL

Manufacturer Control # 2011SP001056 Dosage Text VAG

Age 51 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 564 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8081774
Preferred Term DEEP VEIN THROMBOSIS AMNESIA ANXIETY ASTHMA BACK PAIN BALANCE DISORDER BLOOD CHOLESTEROL INCREASED DEMYELINATION DEPRESSION DISTURBANCE IN ATTENTION DIVERTICULITIS DIZZINESS EXERCISE TOLERANCE DECREASED FALL FEELING ABNORMAL FOLLICULITIS HAEMORRHOIDS HERPES SIMPLEX HORDEOLUM HYPERCOAGULATION HYPERTENSION HYPOAESTHESIA INSOMNIA IRRITABLE BOWEL SYNDROME MEMORY IMPAIRMENT MICROANGIOPATHY MIGRAINE MULTIPLE ALLERGIES MUSCULOSKELETAL PAIN NECK PAIN Product EFFEXOR XR Role Route S ORAL Dosage Text 37.5 DF;BID;PO, 37.5 DF;BID;PO Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 565 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8081774
Preferred Term NEURALGIA OBSESSIVE-COMPULSIVE DISORDER ORAL HERPES PAIN IN EXTREMITY PARAESTHESIA PRODUCT QUALITY ISSUE PULMONARY INFARCTION RESTLESS LEGS SYNDROME RHINITIS ALLERGIC ROTATOR CUFF SYNDROME SINUS DISORDER SINUS TACHYCARDIA SKIN ULCER SPINAL COLUMN STENOSIS STRESS SYNCOPE VERTIGO CNS ORIGIN Product Role Route Dosage Text Duration Manufacturer

8188716 Date FDA Received

07-Oct-2011 Preferred Term OVARIAN CYST

Case # 8188716

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes HO,OT Role Route S

Manufacturer Control # 2011SP014003 Dosage Text

Age 30 YR Duration

Sex Female

Country NOR

Manufacturer

MENSTRUATION IRREGULAR NAUSEA VULVOVAGINAL PAIN VULVOVAGINAL SWELLING

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 566 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8189218 Date FDA Received
07-Oct-2011 Preferred Term BLIGHTED OVUM ABORTION SPONTANEOUS MATERNAL EXPOSURE DURING PREGNANCY METRORRHAGIA NAUSEA PREGNANCY WITH CONTRACEPTIVE DEVICE VOMITING Case # 8189218 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes OT Role Route S VAGINAL Manufacturer Control # 2011SP046312 Dosage Text QM;VAG, QM;VAG Age 26 YR Duration Sex Female Country MEX

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 567 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7086732 Date FDA Received
11-Oct-2011 Preferred Term INTRACRANIAL VENOUS SINUS THROMBOSIS ANOGENITAL WARTS BLOOD GLUCOSE INCREASED BLOOD PRESSURE DECREASED CEREBRAL THROMBOSIS CEREBROVASCULAR ACCIDENT DEPRESSION DERMATITIS DISTURBANCE IN ATTENTION EMOTIONAL DISORDER HEADACHE INFLUENZA LIKE ILLNESS INITIAL INSOMNIA LOSS OF CONSCIOUSNESS MEMORY IMPAIRMENT MENINGISM METAPLASIA NAUSEA PAIN PAPILLOMA VIRAL INFECTION PHOTOPHOBIA SUBARACHNOID HAEMORRHAGE SUPERIOR SAGITTAL SINUS THROMBOSIS URINARY TRACT INFECTION UTERINE CERVICAL SQUAMOUS METAPLASIA VAGINITIS BACTERIAL VISION BLURRED VOMITING WHITE BLOOD CELL COUNT INCREASED Case # 7086732 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO,OT Role Route S VAGINAL Manufacturer Control # 2009SP017154 Dosage Text 1 DF;QM;VAG Age 23 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 568 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7106010 Date FDA Received
11-Oct-2011 Preferred Term HYSTERECTOMY COAGULOPATHY ACCIDENT ACTIVITIES OF DAILY LIVING IMPAIRED HEADACHE IMPAIRED HEALING LIPOMA LIPOSARCOMA MENORRHAGIA NAIL AVULSION PAIN PARONYCHIA PLANTAR FASCIITIS PULMONARY EMBOLISM SEBORRHOEIC DERMATITIS UTERINE PROLAPSE UTERINE SPASM VENOUS OCCLUSION Case # 7106010 Case Type EXPEDITED (15-DAY) Product NUVARING HYDROCODONE BITARTRATE AND ACETAMINOPHEN Health Professional Y Outcomes HO,OT Role Route S C VAGINAL Manufacturer Control # 2009SP017431 Dosage Text QM, VAG Age 31 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 569 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7277664 Date FDA Received
11-Oct-2011 Preferred Term PULMONARY EMBOLISM UTERINE HAEMORRHAGE ATELECTASIS PLEURAL EFFUSION PULMONARY INFARCTION ABDOMINAL NEOPLASM ASTHMA BLOOD HOMOCYSTEINE DECREASED CHEST PAIN DEPRESSION HAEMATURIA Case # 7277664 Case Type EXPEDITED (15-DAY) Product NUVARING EFFEXOR BUTALBITAL TOPAMAX ADVAIR DISKUS Health Professional Y Outcomes HO,OT Role Route S C C C C Manufacturer Control # 2009SP023520 Dosage Text 1 DF Age 40 YR Duration Sex Female Country USA

Manufacturer

7681476 Date FDA Received

11-Oct-2011 Preferred Term

Case # 7681476

Case Type EXPEDITED (15-DAY) Product NUVARING TYLENOL MOTRIN

Health Professional Y

Outcomes HO,DS,OT Role Route S C C

Manufacturer Control # 2010SP042178 Dosage Text

Age 21 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS PULMONARY EMBOLISM SYSTEMIC LUPUS ERYTHEMATOSUS ABSCESS ACROCHORDON ANAEMIA ANOGENITAL WARTS ANTIPHOSPHOLIPID SYNDROME ARTHROPOD BITE ASTHENIA ATELECTASIS BACK INJURY BACK PAIN BRONCHITIS

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 570 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7681476
Preferred Term CELLULITIS CERVICAL DYSPLASIA CHOKING COAGULOPATHY CONSTIPATION DEHYDRATION DILATATION VENTRICULAR DIZZINESS EXCORIATION EYE DISCHARGE FATIGUE GASTROOESOPHAGEAL REFLUX DISEASE HEADACHE HYPERCOAGULATION HYPERTENSION HYPOMAGNESAEMIA HYPOTENSION HYPOXIA INTERNATIONAL NORMALISED RATIO INCREASED INTERVERTEBRAL DISC PROTRUSION LEFT ATRIAL DILATATION LUNG NEOPLASM MATERNAL EXPOSURE BEFORE PREGNANCY MEDICATION ERROR MENORRHAGIA MIGRAINE MULTIPLE ALLERGIES MUSCLE SPASMS NEUTROPENIA OCULAR HYPERAEMIA Product Role Route Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 571 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7681476
Preferred Term OSTEOARTHRITIS OSTEOPENIA OSTEOPOROSIS OVARIAN CYST PAIN PANCYTOPENIA PLEURAL EFFUSION PLEURISY PORTAL VEIN THROMBOSIS PULMONARY HAEMORRHAGE PULMONARY HYPERTENSION RENAL FAILURE ACUTE SICK SINUS SYNDROME SINUS BRADYCARDIA SINUS HEADACHE SPINAL COMPRESSION FRACTURE TRICUSPID VALVE INCOMPETENCE WART EXCISION WEIGHT INCREASED Product Role Route Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 572 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7723878 Date FDA Received
11-Oct-2011 Preferred Term PULMONARY EMBOLISM ABDOMINAL PAIN ANXIETY CONSTIPATION DEEP VEIN THROMBOSIS DEPRESSION FAMILY STRESS FATIGUE FLANK PAIN HEADACHE LOBAR PNEUMONIA PAIN PANIC ATTACK UTERINE CERVIX STENOSIS VENOUS THROMBOSIS Case # 7723878 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO,OT Role Route S VAGINAL Manufacturer Control # 2010SP051441 Dosage Text VAG Age 36 YR Duration Sex Female Country USA

Manufacturer

7974775 Date FDA Received

11-Oct-2011 Preferred Term

Case # 7974775

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO,OT Role Route S

Manufacturer Control # 2011SP003677 Dosage Text

Age 44 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY THROMBOSIS PNEUMONIA PULMONARY EMBOLISM

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 573 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8176266 Date FDA Received
11-Oct-2011 Preferred Term INSOMNIA FEELING JITTERY ANXIETY Case # 8176266 Case Type DIRECT Product NUVARING PHENERGAN EQ Health Professional Y Outcomes OT Role Route S C ORAL Dosage Text Manufacturer Control # Age 20 YR Duration Sex Female Country USA

Manufacturer

8183808 Date FDA Received

11-Oct-2011 Preferred Term

Case # 8183808

Case Type EXPEDITED (15-DAY) Product NUVARING SPASFON

Health Professional Y

Outcomes

Manufacturer Control # 2011SP033117

Age 29 YR Duration

Sex Female

Country FRA

Role Route S C C

Dosage Text

Manufacturer

PREGNANCY WITH CONTRACEPTIVE DEVICE VULVOVAGINAL DISCOMFORT DEVICE DISLOCATION ABORTION SPONTANEOUS

KETOPROFEN

8191946 Date FDA Received

11-Oct-2011 Preferred Term

Case # 8191946

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO Role Route S

Manufacturer Control # 2011SP046362 Dosage Text

Age 28 YR Duration

Sex Female

Country USA

Manufacturer

HAEMORRHAGIC INFARCTION NO REACTION ON PREVIOUS EXPOSURE TO DRUG TRANSVERSE SINUS THROMBOSIS

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 574 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8192361 Date FDA Received
11-Oct-2011 Preferred Term SYNCOPE DIZZINESS BLOOD CHOLESTEROL INCREASED CONVULSION IMMOBILE MULTIPLE INJURIES PAIN IN EXTREMITY PULMONARY EMBOLISM RESPIRATORY DISORDER THROMBOSIS Case # 8192361 Case Type EXPEDITED (15-DAY) Product NUVARING MARIJUANA Health Professional N Outcomes HO,OT Role Route S C Manufacturer Control # 2010SP056930 Dosage Text Age 25 YR Duration Sex Female Country USA

Manufacturer

8192624 Date FDA Received

11-Oct-2011 Preferred Term

Case # 8192624

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2011SP047010 Dosage Text VAG

Age 35 YR Duration 3 DAY

Sex Female

Country CAN

Manufacturer

APHTHOUS STOMATITIS DYSPNOEA NAUSEA ORAL PAIN PALPITATIONS

8192640 Date FDA Received

11-Oct-2011 Preferred Term

Case # 8192640

Case Type EXPEDITED (15-DAY) Product NUVARING TINZAPARIN

Health Professional N

Outcomes HO,DS,LT,OT Role Route S C C

Manufacturer Control # 2011SP047044 Dosage Text

Age 36 YR Duration 4 YEAR

Sex Female

Country CAN

Manufacturer

PULMONARY EMBOLISM

WARFARIN SODIUM

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 575 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8749842 Date FDA Received
11-Oct-2011 Preferred Term PANIC ATTACK DEPRESSION Case # 8749842 Case Type DIRECT Product NUVARING Health Professional Y Outcomes OT Role Route S VAGINAL Dosage Text 1, EVERY 3 WEEKS, VAG Manufacturer Control # Age 25 YR Duration Sex Female Country USA

Manufacturer SCHERING PLOUGH

7855623 Date FDA Received

13-Oct-2011 Preferred Term

Case # 7855623

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO,OT Role Route S

Manufacturer Control # 2010SP064419 Dosage Text

Age 34 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM ADENOMYOSIS ADJUSTMENT DISORDER WITH DEPRESSED MOOD ALANINE AMINOTRANSFERASE INCREASED AMNESIA ANXIETY ASTHENIA ATELECTASIS BLOOD ALBUMIN DECREASED CARDIOMEGALY CELLULITIS CHEST PAIN CONSTIPATION DIZZINESS DYSPNOEA DYSPNOEA EXERTIONAL EMOTIONAL DISORDER EMOTIONAL DISTRESS ENDOMETRIOSIS FATIGUE FEAR OF DEATH

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 576 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7855623
Preferred Term FEELING ABNORMAL HAEMOPTYSIS HEADACHE HYPERCOAGULATION HYPOAESTHESIA LOCAL SWELLING MALAISE MENTAL DISORDER MENTAL STATUS CHANGES METRORRHAGIA MIGRAINE MULTIPLE INJURIES OEDEMA PERIPHERAL PAIN IN EXTREMITY PALPITATIONS PANIC ATTACK PELVIC PAIN PLEURAL EFFUSION PNEUMONIA POLYCYSTIC OVARIES POST PROCEDURAL HAEMORRHAGE PULMONARY HYPERTENSION RESPIRATORY ALKALOSIS RESPIRATORY DISORDER RESPIRATORY TRACT OEDEMA SINUS DISORDER SINUSITIS SINUS POLYP TOOTH ABSCESS WEIGHT INCREASED Product Role Route Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 577 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8167143 Date FDA Received
13-Oct-2011 Preferred Term NAUSEA BODY TEMPERATURE INCREASED DEHYDRATION DIARRHOEA RED BLOOD CELL COUNT INCREASED VIRAL INFECTION VOMITING Case # 8167143 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes OT Role Route S VAGINAL Manufacturer Control # 2011SP042963 Dosage Text 1 DF;QM;VAG Age 36 YR Duration Sex Female Country USA

Manufacturer

8197928 Date FDA Received

13-Oct-2011 Preferred Term

Case # 8197928

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2011SP047802 Dosage Text QM;VAG

Age 21 YR Duration

Sex Female

Country COL

Manufacturer

PREGNANCY WITH CONTRACEPTIVE DEVICE ABORTION SPONTANEOUS HAEMORRHAGE IN PREGNANCY MATERNAL EXPOSURE DURING PREGNANCY

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 578 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7271456 Date FDA Received
14-Oct-2011 Preferred Term PULMONARY EMBOLISM PALLOR HYPERHIDROSIS ATELECTASIS BARTHOLIN'S CYST CONSTIPATION DYSPNOEA HAEMODYNAMIC INSTABILITY HYPOTENSION LEFT VENTRICULAR DYSFUNCTION PULMONARY HYPERTENSION SYNOVIAL CYST Case # 7271456 Case Type EXPEDITED (15-DAY) Product NUVARING LEVOTHYROXINE SODIUM MAXALT Health Professional Y Outcomes HO Role Route S C C Manufacturer Control # 2009SP023296 Dosage Text 1 DF Age 48 YR Duration Sex Female Country USA

Manufacturer

7911395 Date FDA Received

14-Oct-2011

Case # 7911395

Case Type EXPEDITED (15-DAY)

Health Professional Y

Outcomes HO,OT

Manufacturer Control # 2010SP054431

Age 40 YR

Sex Female

Country USA

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 579 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7911395
Preferred Term DEEP VEIN THROMBOSIS ASTHMA BLOOD GLUCOSE INCREASED BODY TINEA BRONCHIAL HYPERREACTIVITY BRONCHITIS DIABETES MELLITUS FATIGUE FLUID RETENTION GLUCOSE TOLERANCE IMPAIRED GLYCOSYLATED HAEMOGLOBIN INCREASED GROIN PAIN INFLAMMATION INTERNATIONAL NORMALISED RATIO DECREASED LYMPHOEDEMA PAIN PERIPHERAL VASCULAR DISORDER PHLEBITIS PNEUMONIA POSTMENOPAUSAL HAEMORRHAGE POST THROMBOTIC SYNDROME PREMATURE MENOPAUSE SINUSITIS SKIN HYPERPIGMENTATION STASIS DERMATITIS URINARY TRACT INFECTION UTERINE POLYP VASCULAR RUPTURE VENOUS INSUFFICIENCY WHITE BLOOD CELL COUNT DECREASED Product NUVARING Role Route S Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 580 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8181265 Date FDA Received
14-Oct-2011 Preferred Term PULMONARY EMBOLISM DYSPNOEA Case # 8181265 Case Type EXPEDITED (15-DAY) Product GILENYA NUVARING Case # 8181661 Case Type DIRECT Product NUVARING Case Type EXPEDITED (15-DAY) Health Professional Y Health Professional N Health Professional Y Outcomes HO Role Route S S Outcomes HO Role Route S Outcomes HO,DS,OT Dosage Text 1 Ring Manufacturer Control # 2011SP025677 Age 26 YR Sex Female Country USA Manufacturer Control # Age 50 YR Duration Sex Female Country USA ORAL Manufacturer Control # PHHO2009US10239 Dosage Text 0.5 mg, UNK Age 69 YR Duration Sex Female Country USA

Manufacturer

8181661 Date FDA Received

14-Oct-2011 Preferred Term

Manufacturer

PULMONARY THROMBOSIS

8164420 Date FDA Received

17-Oct-2011

Case # 8164420

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 581 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8164420
Preferred Term PULMONARY EMBOLISM MULTIPLE INJURIES URINARY TRACT INFECTION PNEUMONIA ANAEMIA HYPERCOAGULATION INFLUENZA LIKE ILLNESS UPPER RESPIRATORY TRACT INFECTION EMOTIONAL DISORDER ATELECTASIS BACK INJURY BRONCHITIS DEEP VEIN THROMBOSIS DRUG INTOLERANCE FIBRIN D DIMER INCREASED HYPONATRAEMIA MENTAL DISORDER METRORRHAGIA MIGRAINE NAUSEA NECK INJURY OVARIAN CYST PELVIC MASS PLATELET COUNT INCREASED PLEURAL EFFUSION PLEURISY PULMONARY INFARCTION ROAD TRAFFIC ACCIDENT VAGINAL DISCHARGE VOMITING Product NUVARING NUVARING NUVARING NUVARING NUVARING NUVARING NUVARING VICOPROFEN MULTI-VITAMIN Role Route S S S S S S S S C 1 DF; ONCE Dosage Text VAG Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 582 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8183260 Date FDA Received
17-Oct-2011 Preferred Term PREGNANCY ON CONTRACEPTIVE MATERNAL EXPOSURE DURING PREGNANCY Case # 8183260 Case Type DIRECT Product NUVARING Health Professional Y Outcomes OT Role Route S VAGINAL Dosage Text 1 ring Manufacturer Control # Age 30 YR Duration 8 MTH Sex Female Country USA

Manufacturer

7108319 Date FDA Received

18-Oct-2011 Preferred Term

Case # 7108319

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO Role Route S

Manufacturer Control # 2009-200921-NL Dosage Text

Age 26 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM HAEMATOCRIT DECREASED HAEMOGLOBIN DECREASED HAEMORRHAGE HYPOKALAEMIA INTERNATIONAL NORMALISED RATIO INCREASED MATERNAL EXPOSURE BEFORE PREGNANCY MUSCULOSKELETAL CHEST PAIN OVARIAN CYST RUPTURED PERIPHERAL EMBOLISM PREGNANCY PROCEDURAL VOMITING SINUSITIS URINARY TRACT INFECTION URINE OUTPUT DECREASED VAGINITIS BACTERIAL VOMITING WHITE BLOOD CELL COUNT INCREASED

7733155 Date FDA Received

18-Oct-2011 Preferred Term

Case # 7733155

Case Type EXPEDITED (15-DAY) Product

Health Professional Y

Outcomes HO,LT,OT Role Route

Manufacturer Control # 2010SP046931 Dosage Text

Age 27 YR Duration

Sex Female

Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 583 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7733155
Preferred Term DEEP VEIN THROMBOSIS ABDOMINAL PAIN UPPER ALOPECIA ANAEMIA ATELECTASIS ATTENTION DEFICIT/HYPERACTIVITY DISORDER BREAST HAEMATOMA CARDIOMEGALY CHEST PAIN COLLATERAL CIRCULATION CONTUSION DEPRESSION FEAR FUNGAL INFECTION HAEMORRHAGE ILIAC VEIN OCCLUSION INTERNATIONAL NORMALISED RATIO DECREASED INTERNATIONAL NORMALISED RATIO INCREASED MAMMOPLASTY MATERNAL EXPOSURE BEFORE PREGNANCY MAY-THURNER SYNDROME OEDEMA PERIPHERAL PALPITATIONS PHLEBITIS PLATELET COUNT INCREASED POLYCYSTIC OVARIES PREGNANCY THROMBOPHLEBITIS SUPERFICIAL THROMBOSIS Product NUVARING Role Route S Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 584 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7733155
Preferred Term TREATMENT FAILURE VEIN DISORDER VENOUS INSUFFICIENCY VENOUS OCCLUSION VENOUS RECANALISATION WEIGHT INCREASED Product Role Route Dosage Text Duration Manufacturer

8169393 Date FDA Received

18-Oct-2011 Preferred Term

Case # 8169393

Case Type EXPEDITED (15-DAY) Product NUVARING Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO,LT,OT Role Route S VAGINAL

Manufacturer Control # 2011SP018163 Dosage Text QM;VAG Manufacturer Control # 2011SP048188 Dosage Text

Age 22 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM

8212640 Date FDA Received

18-Oct-2011 Preferred Term VERTIGO

Case # 8212640

Health Professional N

Outcomes OT Role Route S

Age 37 YR Duration

Sex Female

Country FRA

Manufacturer

ABDOMINAL DISTENSION HEPATITIS C

8212702 Date FDA Received

18-Oct-2011 Preferred Term ABORTION

Case # 8212702

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2011SP048407 Dosage Text QM;VAG

Age

Sex Female

Country CHL

Duration

Manufacturer

MATERNAL EXPOSURE DURING PREGNANCY PREGNANCY WITH CONTRACEPTIVE DEVICE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 585 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8749752 Date FDA Received
18-Oct-2011 Preferred Term ACUTE MYOCARDIAL INFARCTION CARDIAC ARREST Case # 8749752 Case Type DIRECT Product NUVARING Health Professional Y Outcomes HO,DS,LT Role Route S VAGINAL Dosage Text Q3WKS, VAG Duration Manufacturer Control # Age Sex Female Country USA

Manufacturer

7761065 Date FDA Received

19-Oct-2011 Preferred Term

Case # 7761065

Case Type EXPEDITED (15-DAY) Product NUVARING TYLENOL

Health Professional Y

Outcomes HO,OT Role Route S C

Manufacturer Control # 2009SP033450 Dosage Text

Age 28 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS PULMONARY EMBOLISM ABORTION MISSED ABORTION SPONTANEOUS ANAEMIA BREAST MASS CERVICAL CYST CERVICAL DYSPLASIA CERVICITIS HEADACHE IRON DEFICIENCY ANAEMIA LIGAMENT SPRAIN LIMB INJURY MATERNAL EXPOSURE DURING PREGNANCY PALPITATIONS SMEAR CERVIX ABNORMAL VAGINITIS BACTERIAL

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 586 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8217024 Date FDA Received
19-Oct-2011 Preferred Term HYPOTHYROIDISM ABNORMAL WITHDRAWAL BLEEDING INCORRECT DRUG ADMINISTRATION DURATION PYELONEPHRITIS ACUTE Case # 8217024 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional N Outcomes OT Role Route S VAGINAL Manufacturer Control # 2011SP048412 Dosage Text QM;VAG Age 32 YR Duration Sex Female Country CHL

Manufacturer

8217524 Date FDA Received

19-Oct-2011 Preferred Term EPISTAXIS THROMBOSIS

Case # 8217524

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2011SP048620 Dosage Text VAG

Age 19 YR Duration

Sex Female

Country CAN

Manufacturer

8213427 Date FDA Received

20-Oct-2011 Preferred Term

Case # 8213427

Case Type EXPEDITED (15-DAY) Product NUVARING Case Type DIRECT Product NUVARING IBUPROFEN Case Type EXPEDITED (15-DAY) Product NUVARING ADVIL

Health Professional Y

Outcomes DE Role Route S

Manufacturer Control # 2011SP049010 Dosage Text

Age 33 YR Duration

Sex Female

Country LBN

Manufacturer

CEREBROVASCULAR ACCIDENT

8745372 Date FDA Received

20-Oct-2011 Preferred Term DYSMENORRHOEA

Case # 8745372

Health Professional Y

Outcomes OT Role Route S C

Manufacturer Control #

Age 32 YR

Sex Female

Country USA

Dosage Text

Duration

Manufacturer

TRIGEMINAL NEURALGIA

7156282 Date FDA Received

21-Oct-2011 Preferred Term

Case # 7156282

Health Professional Y

Outcomes HO,DS,OT Role Route S C VAGINAL

Manufacturer Control # 2009SP017429 Dosage Text 1 DF, QM, VAG

Age 48 YR Duration

Sex Female

Country USA

Manufacturer

ARTERIAL THROMBOSIS PAIN

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 587 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7156282
Preferred Term HEADACHE LEG AMPUTATION ARTERIOSCLEROSIS BLADDER OPERATION BREAST CYST CALCULUS URETERIC COMPARTMENT SYNDROME DEPRESSION EAR PAIN EPISTAXIS HYDRONEPHROSIS HYPERCOAGULATION HYPOAESTHESIA INGROWING NAIL INJECTION SITE HAEMATOMA INTERNATIONAL NORMALISED RATIO INCREASED INTERVERTEBRAL DISC DEGENERATION INTERVERTEBRAL DISC PROTRUSION MENORRHAGIA METATARSALGIA NEPHROLITHIASIS OCULAR HYPERAEMIA ONYCHOMYCOSIS OVARIAN CYST PARAESTHESIA PERIPHERAL NERVE INJURY ROAD TRAFFIC ACCIDENT SCIATICA TENDONITIS URINARY TRACT INFECTION Product VIOXX IMODIUM Role Route C C Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 588 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7156282
Preferred Term UTERINE LEIOMYOMA VAGINAL HAEMORRHAGE WEIGHT INCREASED Product Role Route Dosage Text Duration Manufacturer

7727197 Date FDA Received

21-Oct-2011 Preferred Term

Case # 7727197

Case Type EXPEDITED (15-DAY) Product NUVARING CYMBALTA NORVASC RHINOCORT ALLEGRA

Health Professional Y

Outcomes HO,DS,OT Role Route S S S C C C VAGINAL ORAL ORAL

Manufacturer Control # 2010SP028233 Dosage Text VAG 60 MG, BID, QD, PO 10 MG, QD, PO

Age 45 YR Duration

Sex Female

Country USA

Manufacturer

EMOTIONAL DISORDER INJURY LOSS OF EMPLOYMENT METRORRHAGIA DIARRHOEA BRAIN OEDEMA ABDOMINAL PAIN UPPER ALOPECIA EFFLUVIUM ALTERED VISUAL DEPTH PERCEPTION ANXIETY DISORDER BACTERIAL INFECTION BALANCE DISORDER BINOCULAR EYE MOVEMENT DISORDER CAROTID ARTERY ANEURYSM CEREBRAL HAEMORRHAGE CEREBROVASCULAR ARTERIOVENOUS MALFORMATION CHLAMYDIAL INFECTION COGNITIVE DISORDER COITAL BLEEDING CONDITION AGGRAVATED CONTUSION CONVULSION CONVULSIVE THRESHOLD LOWERED

VITAMINS NOS

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 589 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7727197
Preferred Term DYSKINESIA DYSPAREUNIA ENCEPHALOMALACIA EXECUTIVE DYSFUNCTION FALL FATIGUE GONORRHOEA GRAND MAL CONVULSION HAEMANGIOMA OF LIVER HAIR GROWTH ABNORMAL HEADACHE HEPATIC LESION HUMERUS FRACTURE HYPERGLYCAEMIA HYPERTENSION HYPOGONADISM HYPOTENSION INFLUENZA INSOMNIA INTRACRANIAL ANEURYSM IRRITABILITY LIVER FUNCTION TEST ABNORMAL MAJOR DEPRESSION MEMORY IMPAIRMENT MENSTRUATION IRREGULAR MOOD ALTERED MUSCLE TWITCHING MUSCULOSKELETAL PAIN OSTEOPOROSIS PERIODIC LIMB MOVEMENT DISORDER PYREXIA Product Role Route Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 590 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7727197
Preferred Term SHORT-BOWEL SYNDROME SLEEP APNOEA SYNDROME SLEEP DISORDER STRESS AT WORK SUBARACHNOID HAEMORRHAGE SUTURE RELATED COMPLICATION SWELLING TREATMENT NONCOMPLIANCE VARICOSE VEIN VITAMIN B12 DEFICIENCY WOUND DEHISCENCE Product Role Route Dosage Text Duration Manufacturer

8160872 Date FDA Received

21-Oct-2011 Preferred Term

Case # 8160872

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S TRANSPLACENTAL

Manufacturer Control # 2011SP043561 Dosage Text TRPL

Age

Sex

Country USA

210 DAY Female Duration

Manufacturer

MATERNAL DRUGS AFFECTING FOETUS OVARIAN CYST ULTRASOUND ANTENATAL SCREEN ABNORMAL

8193784 Date FDA Received

21-Oct-2011 Preferred Term NAUSEA METRORRHAGIA DYSMENORRHOEA

Case # 8193784

Case Type NON-EXPEDITED Product

Health Professional N

Outcomes

Manufacturer Control # US-TEVA-305466USA

Age 23 YR Duration

Sex Female

Country USA

Role Route S S ORAL VAGINAL

Dosage Text

Manufacturer DURAMED

PLAN B ONE-STEP NUVARING

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 591 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8221161 Date FDA Received
21-Oct-2011 Preferred Term APPENDICITIS ABNORMAL WITHDRAWAL BLEEDING Case # 8221161 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional N Outcomes OT Role Route S VAGINAL Manufacturer Control # 2011SP049207 Dosage Text VAG Duration Age Sex Female Country ESP

Manufacturer

8221358 Date FDA Received

21-Oct-2011 Preferred Term ABDOMINAL PAIN DYSPNOEA FATIGUE

Case # 8221358

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes HO Role Route S

Manufacturer Control # 2011SP049015 Dosage Text

Age 27 YR Duration

Sex Female

Country DEU

Manufacturer

8224950 Date FDA Received

21-Oct-2011 Preferred Term

Case # 8224950

Case Type EXPEDITED (15-DAY) Product NUVARING Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2011SP048662 Dosage Text QM;VAG Manufacturer Control # 2011SP049280 Dosage Text

Age

Sex Female

Country CHL

Duration

Manufacturer

GALLBLADDER OPERATION

8222013 Date FDA Received

24-Oct-2011 Preferred Term

Case # 8222013

Health Professional Y

Outcomes HO Role Route S

Age 28 YR Duration

Sex Female

Country CHE

Manufacturer

SMEAR CERVIX ABNORMAL PAPILLOMA VIRAL INFECTION

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 592 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8228505 Date FDA Received
25-Oct-2011 Preferred Term DEVICE MISUSE ENDOMETRIOSIS GASTROINTESTINAL PAIN INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION Case # 8228505 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional N Outcomes DS,OT Role Route S VAGINAL Manufacturer Control # 2011SP047947 Dosage Text QM;VAG Age 29 YR Duration Sex Female Country CHL

Manufacturer

7808569 Date FDA Received

26-Oct-2011 Preferred Term

Case # 7808569

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO,OT Role Route S C C

Manufacturer Control # 2010SP044535 Dosage Text

Age 28 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM OVARIAN CYST PLEURISY ABDOMINAL PAIN DYSFUNCTIONAL UTERINE BLEEDING DYSPHEMIA HEADACHE HYPOAESTHESIA ORAL HYPOGLYCAEMIA MATERNAL EXPOSURE BEFORE PREGNANCY TREMOR TUNNEL VISION

VITAMIN B COMPLEX GINSENG

8114540 Date FDA Received

26-Oct-2011 Preferred Term

Case # 8114540

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO,OT Role Route S C

Manufacturer Control # 2011SP004362 Dosage Text

Age 36 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS MULTIPLE INJURIES ANXIETY ARTHRALGIA

WOMEN'S ONE A DAY VITAMIN

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 593 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8114540
Preferred Term BACK PAIN BUNDLE BRANCH BLOCK RIGHT CHEST PAIN CONSTIPATION DIZZINESS DYSPNOEA EMOTIONAL DISORDER EUSTACHIAN TUBE DYSFUNCTION GASTRIC DISORDER HEADACHE HEART RATE IRREGULAR HYPERCOAGULATION HYPOAESTHESIA LIGAMENT SPRAIN MENTAL DISORDER MIGRAINE MUSCLE STRAIN MUSCULOSKELETAL PAIN NAUSEA NECK PAIN OPEN WOUND PAIN IN EXTREMITY PHARYNGITIS STREPTOCOCCAL RESPIRATORY DISORDER RHINITIS ALLERGIC SINUSITIS SKIN PAPILLOMA TENSION HEADACHE URINARY TRACT INFECTION Product Role Route Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 594 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8231676 Date FDA Received
26-Oct-2011 Preferred Term HEADACHE HAEMORRHAGE METRORRHAGIA OVARIAN DISORDER Case # 8231676 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional N Outcomes HO Role Route S VAGINAL Manufacturer Control # 2011SP049410 Dosage Text VAG Duration Age Sex Female Country RUS

Manufacturer

6095941 Date FDA Received

27-Oct-2011 Preferred Term

Case # 6095941

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO,OT Role Route S C C C C C C C C VAGINAL

Manufacturer Control # 2006-145229-NL Dosage Text VAG

Age 40 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS BREAST DISCHARGE MITRAL VALVE PROLAPSE AUTONOMIC NERVOUS SYSTEM IMBALANCE ARRHYTHMIA POST THROMBOTIC SYNDROME VENOUS INSUFFICIENCY HYPERCOAGULATION MIGRAINE ABORTION ABORTION INDUCED AMNESIA ANXIETY ARTHRALGIA BREAST HYPERPLASIA CEREBROVASCULAR ACCIDENT CHEST DISCOMFORT CHEST PAIN DEPRESSION DISTURBANCE IN ATTENTION

EFFEXOR XR IMIPRAMINE TYLENOL WITH CODEINE ALLEGRA TYLENOL BENADRYL TOPROL XL CELEXA

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 595 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6095941
Preferred Term DIZZINESS DYSPNOEA EPISTAXIS EYELID PTOSIS FATIGUE GAIT DISTURBANCE GINGIVAL BLEEDING HAEMORRHAGE HEADACHE HYPOAESTHESIA LOSS OF CONSCIOUSNESS MATERNAL EXPOSURE BEFORE PREGNANCY MENORRHAGIA MUSCULOSKELETAL STIFFNESS MYALGIA OVARIAN CYST PAIN IN EXTREMITY PARAESTHESIA SKIN DISCOLOURATION SYNCOPE TRANSIENT ISCHAEMIC ATTACK VISION BLURRED Product Role Route Dosage Text Duration Manufacturer

8141352 Date FDA Received

27-Oct-2011 Preferred Term

Case # 8141352

Case Type EXPEDITED (15-DAY) Product NUVARING SYMBICORT

Health Professional Y

Outcomes HO,OT Role Route S C

Manufacturer Control # 2010SP063660 Dosage Text QM, QM

Age 44 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM MULTIPLE INJURIES ANTIPHOSPHOLIPID ANTIBODIES POSITIVE ARTHRALGIA ASTHMA

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 596 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8141352
Preferred Term BLOOD CHOLESTEROL INCREASED CONTUSION COUGH DEEP VEIN THROMBOSIS DEPRESSION DILATATION VENTRICULAR DIZZINESS ECCHYMOSIS EMOTIONAL DISORDER FIBRIN D DIMER INCREASED FIBROADENOMA OF BREAST GOITRE HYPERGLYCAEMIA HYPERSENSITIVITY HYPERTENSION INSOMNIA LYMPHADENOPATHY MEDIASTINAL MENTAL DISORDER MULTIPLE ALLERGIES MUSCLE HAEMORRHAGE MUSCLE RUPTURE OEDEMA PERIPHERAL PAIN PANIC ATTACK PHLEBITIS PULMONARY HYPERTENSION RIGHT ATRIAL DILATATION TACHYCARDIA TENDONITIS THROMBOSIS TRICUSPID VALVE INCOMPETENCE Product Role Route Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 597 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8233056 Date FDA Received
27-Oct-2011 Preferred Term PANCREATITIS HYPERTRIGLYCERIDAEMIA MATERNAL EXPOSURE BEFORE PREGNANCY PREGNANCY Case # 8233056 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO,DS,LT,OT Role Route S Manufacturer Control # 2011SP049910 Dosage Text 1 DF Age 40 YR Duration Sex Female Country USA

Manufacturer

8140107 Date FDA Received

31-Oct-2011 Preferred Term

Case # 8140107

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2011SP024467 Dosage Text VAG

Age 25 YR Duration

Sex Female

Country BRA

Manufacturer

PREGNANCY WITH CONTRACEPTIVE DEVICE HAEMORRHAGE INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION PREMATURE SEPARATION OF PLACENTA TWIN PREGNANCY

8231109 Date FDA Received

31-Oct-2011 Preferred Term OVARIAN CYST ADNEXA UTERI PAIN

Case # 8231109

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes HO Role Route S

Manufacturer Control # 2011SP049656 Dosage Text ;VAG

Age

Sex Female

Country ESP

Duration

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 598 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8235847 Date FDA Received
31-Oct-2011 Preferred Term ABDOMINAL PAIN UPPER ASTHENIA CHEST PAIN DIZZINESS HEADACHE MALAISE SOMNOLENCE VOMITING Case # 8235847 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional N Outcomes HO Role Route S VAGINAL Manufacturer Control # 2011SP050162 Dosage Text 1.0 DF;VAG Age 45 YR Duration 88 DAY Sex Female Country CAN

Manufacturer

8236164 Date FDA Received

31-Oct-2011 Preferred Term UTERINE LEIOMYOMA ABORTION

Case # 8236164

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2011SP050328 Dosage Text ;VAG

Age 24 YR Duration

Sex Female

Country USA

Manufacturer

ENDOCRINE DISORDER FOETAL EXPOSURE DURING PREGNANCY INFERTILITY FEMALE PANCREATITIS PELVIC INFLAMMATORY DISEASE PREGNANCY WITH CONTRACEPTIVE DEVICE

8141330 Date FDA Received

01-Nov-2011 Preferred Term NEPHROLITHIASIS METRORRHAGIA RENAL COLIC

Case # 8141330

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2011SP022759 Dosage Text ;VAG

Age 39 YR Duration

Sex Female

Country DEU

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 599 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8151210 Date FDA Received
01-Nov-2011 Preferred Term MATERNAL DRUGS AFFECTING FOETUS TWIN PREGNANCY CAESAREAN SECTION LACTOSE INTOLERANCE PREMATURE BABY Case # 8151210 Case Type EXPEDITED (15-DAY) Product NUVARING PROGESTERONE Health Professional N Outcomes OT Role Route S S TRANSPLACENTAL TRANSPLACENTAL Manufacturer Control # 2011SP041650 Dosage Text TRPL TRPL Age Sex Country BRA 121 DAY Female Duration

Manufacturer

8235230 Date FDA Received

01-Nov-2011 Preferred Term PNEUMONIA

Case # 8235230

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes HO,DS,LT,OT Role Route S VAGINAL

Manufacturer Control # 2011SP050670 Dosage Text ;QM;VAG

Age 28 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM

7085876 Date FDA Received

02-Nov-2011 Preferred Term

Case # 7085876

Case Type EXPEDITED (15-DAY) Product NUVARING CELLCEPT

Health Professional Y

Outcomes DE,HO Role Route S S S C C C VAGINAL

Manufacturer Control # 2008-187454-NL Dosage Text 1 DF; QM; VAG

Age 21 YR Duration

Sex Female

Country USA

Manufacturer

MYOCARDIAL INFARCTION HEART TRANSPLANT LEUKOPENIA HYPERTENSION CARDIAC ARREST ARTERIAL THROMBOSIS ATRIOVENTRICULAR BLOCK BRAIN DEATH CARDIAC FAILURE CARDIAC FAILURE CONGESTIVE CARDIAC TAMPONADE CARDIOGENIC SHOCK CONSTIPATION

PREDNISONE METRONIDAZOLE FLUCONAZOLE HUMALOG

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 600 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7085876
Preferred Term CORONARY ARTERY OCCLUSION DIABETES MELLITUS INADEQUATE CONTROL DIABETIC KETOACIDOSIS DYSPHAGIA ENTEROCOCCAL INFECTION HAEMATOCRIT DECREASED HYPOXIC-ISCHAEMIC ENCEPHALOPATHY IMMUNOSUPPRESSION INSOMNIA MEDICAL DEVICE COMPLICATION MYOPATHY NEUROPATHY PERIPHERAL PERIPHERAL ISCHAEMIA PERONEAL NERVE PALSY PULMONARY HYPERTENSION PULSELESS ELECTRICAL ACTIVITY SINUS TACHYCARDIA TRANSPLANT REJECTION UNRESPONSIVE TO STIMULI VENTRICULAR TACHYCARDIA Product Role Route Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 601 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7271493 Date FDA Received
02-Nov-2011 Preferred Term PULMONARY EMBOLISM DEPRESSION BLOOD DISORDER CHILLS CONSTIPATION C-REACTIVE PROTEIN INCREASED DIZZINESS EAR PAIN ECONOMIC PROBLEM GASTROENTERITIS VIRAL GROIN PAIN HAEMORRHOIDS HEADACHE HYPERHIDROSIS HYPOAESTHESIA JOINT EFFUSION MARITAL PROBLEM NAUSEA OVARIAN CYST PYREXIA RECTAL HAEMORRHAGE WEIGHT DECREASED Case # 7271493 Case Type EXPEDITED (15-DAY) Product NUVARING LORTAB Health Professional Y Outcomes HO,OT Role Route S S Manufacturer Control # 2009SP023472 Dosage Text 1 DF Age 24 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 602 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7664569 Date FDA Received
02-Nov-2011 Preferred Term PULMONARY EMBOLISM DEPRESSION ALOPECIA BRONCHIAL HYPERREACTIVITY CAESAREAN SECTION DEVICE EXPULSION DRUG INTOLERANCE GENE MUTATION GENITAL HERPES GESTATIONAL HYPERTENSION HEADACHE HYPERTENSION INTERNATIONAL NORMALISED RATIO DECREASED MENORRHAGIA NAUSEA PNEUMONITIS PREGNANCY SKIN INFECTION SUPERINFECTION URINARY TRACT INFECTION VAGINAL DISCHARGE VAGINITIS BACTERIAL VULVOVAGINAL PAIN Case # 7664569 Case Type EXPEDITED (15-DAY) Product NUVARING CHANTIX Health Professional Y Outcomes HO,OT Role Route S S Manufacturer Control # 2010SP038554 Dosage Text Age 31 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 603 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8025540 Date FDA Received
02-Nov-2011 Preferred Term ANXIETY PNEUMONIA PULMONARY EMBOLISM Case # 8025540 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO Role Route S Manufacturer Control # 2010SP055022 Dosage Text Age 30 YR Duration Sex Female Country USA

Manufacturer

8151153 Date FDA Received

02-Nov-2011 Preferred Term

Case # 8151153

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes HO,OT Role Route S S

Manufacturer Control # 2011SP041628 Dosage Text UNK;TRPL UNK;TRMA

Age

Sex Female

Country BRA

Duration

Manufacturer

FOETAL EXPOSURE DURING PREGNANCY PREMATURE BABY LOW BIRTH WEIGHT BABY

PROGESTERONE

8224739 Date FDA Received

03-Nov-2011 Preferred Term FUNGAL INFECTION

Case # 8224739

Case Type DIRECT Product NUVARING

Health Professional N

Outcomes

Manufacturer Control #

Age 31 YR

Sex Female

Country USA

Role Route S Health Professional N VAGINAL

Dosage Text 1 Manufacturer Control # 2011SP051290 Dosage Text

Duration

Manufacturer

8241003 Date FDA Received

04-Nov-2011 Preferred Term MULTIPLE INJURIES ECONOMIC PROBLEM PAIN

Case # 8241003

Case Type EXPEDITED (15-DAY) Product NUVARING

Outcomes OT Role Route S

Age

Sex Female

Country USA

Duration

Manufacturer

QUALITY OF LIFE DECREASED UNEVALUABLE EVENT

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 604 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7841228 Date FDA Received
07-Nov-2011 Preferred Term DEEP VEIN THROMBOSIS ACTIVATED PARTIAL THROMBOPLASTIN TIME SHORTENED ANAEMIA CERVICAL DYSPLASIA DYSFUNCTIONAL UTERINE BLEEDING EMOTIONAL DISORDER HYPERCOAGULATION INTERNATIONAL NORMALISED RATIO DECREASED IRON DEFICIENCY ANAEMIA MENTAL DISORDER UTERINE LEIOMYOMA VARICOSE VEIN VENOUS INSUFFICIENCY Case # 7841228 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO,OT Role Route S Manufacturer Control # 2011SP004878 Dosage Text 1 DF;QM ; 1 DF;QM Age 42 YR Duration Sex Female Country USA

Manufacturer

7237949 Date FDA Received

08-Nov-2011 Preferred Term

Case # 7237949

Case Type EXPEDITED (15-DAY) Product NUVARING ALLEGRA GYNAZOLE CLINDESSE

Health Professional Y

Outcomes HO,OT Role Route S C C C C C C C C VAGINAL

Manufacturer Control # 2009-198554-NL Dosage Text 1 DF;Q3W;VAG

Age 31 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM PALPITATIONS DIZZINESS SEASONAL ALLERGY CONDITION AGGRAVATED HAEMODYNAMIC INSTABILITY VENTRICULAR HYPERTROPHY DYSMENORRHOEA BLOOD CHOLESTEROL INCREASED

OXYCODONE AND ACETAMINOPHEN PROMETHAZINE GLIMEPIRIDE FEXOFENADINE FLUTICASONE PROPIONATE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 605 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7237949
Preferred Term LOW DENSITY LIPOPROTEIN INCREASED VAGINITIS BACTERIAL OVARIAN CYSTECTOMY ABORTION SPONTANEOUS ANTIBIOTIC RESISTANT STAPHYLOCOCCUS TEST POSITIVE BACTERAEMIA BRONCHIAL HYPERREACTIVITY CERVICAL INCOMPETENCE CHORIOAMNIONITIS DEEP VEIN THROMBOSIS FALL FATIGUE HYPERCHOLESTEROLAEMIA HYPERTENSION INJECTION SITE PHLEBITIS INTERNATIONAL NORMALISED RATIO INCREASED LOSS OF CONSCIOUSNESS MATERNAL EXPOSURE DURING PREGNANCY NAUSEA OVARIAN CYST PELVIC PAIN POST PROCEDURAL INFECTION PREGNANCY WITH CONTRACEPTIVE DEVICE PREMATURE RUPTURE OF MEMBRANES RETAINED PLACENTA OR MEMBRANES SYNCOPE TYPE 2 DIABETES MELLITUS UTERINE LEIOMYOMA Product XOPENEX METRONIDAZOLE ANAPROX DS Role Route C C C Dosage Text Duration Manufacturer

8025487
Date - Time: 02-04-2013 9:43:10 AM EST Note: If the field is blank, there is no data Page: 606 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8025487
FDA Received Date 08-Nov-2011 Preferred Term PULMONARY EMBOLISM MULTIPLE INJURIES ABDOMINAL PAIN UPPER ADNEXA UTERI CYST ANAEMIA ATELECTASIS BREAST MASS CHANGE OF BOWEL HABIT COLITIS DIARRHOEA DIZZINESS DYSPEPSIA ECCHYMOSIS EMOTIONAL DISORDER ENTEROCOLITIS INFECTIOUS GASTROENTERITIS VIRAL HAEMATOMA HYPERCOAGULATION LUNG CONSOLIDATION LUNG INFECTION MENTAL DISORDER MITRAL VALVE INCOMPETENCE NAUSEA PAIN PANIC ATTACK PULMONARY INFARCTION PULMONARY VALVE INCOMPETENCE SALPINGITIS Case # 8025487 Case Type EXPEDITED (15-DAY) Product NUVARING COUMADIN Health Professional Y Outcomes HO,OT Role Route S S Manufacturer Control # 2010SP058603 Dosage Text Age 37 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 607 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8025487
Preferred Term TACHYCARDIA TRICUSPID VALVE INCOMPETENCE UTERINE LEIOMYOMA VAGINAL HAEMORRHAGE VENOUS INSUFFICIENCY VENOUS OCCLUSION VIRAL INFECTION VOMITING WEIGHT DECREASED Product Role Route Dosage Text Duration Manufacturer

8245254 Date FDA Received

08-Nov-2011 Preferred Term

Case # 8245254

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2011SP051277 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

PULMONARY EMBOLISM DEEP VEIN THROMBOSIS

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 608 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8160000 Date FDA Received
10-Nov-2011 Preferred Term OEDEMA PERIPHERAL PULMONARY EMBOLISM ABDOMINAL PAIN ANXIETY ATELECTASIS BLOOD CHOLESTEROL INCREASED BRONCHITIS BRONCHOSPASM CERVICAL DYSPLASIA DEPRESSION DYSLIPIDAEMIA FACTOR V DEFICIENCY FATIGUE HAEMOGLOBIN DECREASED HYPOTHYROIDISM INSULIN RESISTANCE LACERATION LUNG CONSOLIDATION MUSCULOSKELETAL PAIN PLEURISY PULMONARY INFARCTION ROAD TRAFFIC ACCIDENT SKIN PAPILLOMA THROMBOPHLEBITIS SUPERFICIAL TYMPANIC MEMBRANE PERFORATION UPPER RESPIRATORY TRACT INFECTION VAGINAL DISORDER VITAMIN D DEFICIENCY WEIGHT INCREASED Case # 8160000 Case Type EXPEDITED (15-DAY) Product NUVARING PROTONIX Health Professional Y Outcomes HO,OT Role Route S C Manufacturer Control # 2010SP058593 Dosage Text 1 DF;QM Age 32 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 609 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8217227 Date FDA Received
10-Nov-2011 Preferred Term PULMONARY EMBOLISM MUSCLE SPASMS CYST RUPTURE ENDOMETRIOSIS ADENOMYOSIS RENAL DISORDER UTERINE CYST ABDOMINAL DISCOMFORT ACUTE CORONARY SYNDROME ACUTE MYOCARDIAL INFARCTION ADNEXA UTERI PAIN ANXIETY ASTHENIA BLOOD PRESSURE INCREASED BRONCHITIS CORONARY ARTERY DISEASE COSTOCHONDRITIS DEEP VEIN THROMBOSIS DEPRESSION DIASTOLIC DYSFUNCTION FATIGUE GASTROOESOPHAGEAL REFLUX DISEASE HEART RATE INCREASED HEART RATE IRREGULAR HIATUS HERNIA HYPERSOMNIA INFLUENZA LIKE ILLNESS INSOMNIA IRON DEFICIENCY Case # 8217227 Case Type EXPEDITED (15-DAY) Product NUVARING NUVARING TOPAMAX TRICOR ZOMIG ZYRTEC EFFEXOR Health Professional Y Outcomes HO,OT Role Route S S C C C C C Manufacturer Control # 2011SP019411 Dosage Text Age 34 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 610 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8217227
Preferred Term LOSS OF EMPLOYMENT MALAISE MIGRAINE MITRAL VALVE INCOMPETENCE NIGHTMARE OVARIAN CYST PELVIC PAIN PLEURISY PYREXIA RENAL FAILURE SINUSITIS TACHYCARDIA TRICUSPID VALVE INCOMPETENCE UPPER RESPIRATORY TRACT INFECTION VITAMIN B12 DEFICIENCY Product Role Route Dosage Text Duration Manufacturer

7808489 Date FDA Received

14-Nov-2011 Preferred Term

Case # 7808489

Case Type EXPEDITED (15-DAY) Product NUVARING NUVARING ASPIRIN

Health Professional Y

Outcomes HO,DS,OT Role Route S S S C C VAGINAL

Manufacturer Control # 2010SP019254 Dosage Text VAG

Age 34 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS PULMONARY EMBOLISM MULTIPLE INJURIES AORTIC EMBOLUS ANXIETY ABDOMINAL PAIN ANAEMIA ARTHRALGIA ARTHRITIS ASTHENIA BACK PAIN BRONCHITIS

MULTI-VITAMIN CLARITIN

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 611 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7808489
Preferred Term CHRONIC FATIGUE SYNDROME CONSTIPATION CYTOMEGALOVIRUS INFECTION DEPRESSION DIZZINESS EPSTEIN-BARR VIRUS INFECTION ERYTHEMA NODOSUM EYE SWELLING FATIGUE FIBRIN D DIMER INCREASED GENERAL PHYSICAL CONDITION ABNORMAL HAEMATEMESIS HEART RATE IRREGULAR HYPERSENSITIVITY HYPOKALAEMIA INFLUENZA LIKE ILLNESS INTRACARDIAC THROMBUS MITRAL VALVE INCOMPETENCE MUSCLE SPASMS MUSCULOSKELETAL CHEST PAIN NAUSEA NIGHT SWEATS NOCTURIA NODULE OEDEMA OVARIAN CYST PAIN IN EXTREMITY PAPILLOMA VIRAL INFECTION PELVIC PAIN PHLEBITIS PNEUMONIA Product Role Route Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 612 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7808489
Preferred Term PNEUMONIA VIRAL PRESYNCOPE RASH RESTLESS LEGS SYNDROME RHEUMATIC HEART DISEASE SKIN PAPILLOMA SLEEP APNOEA SYNDROME SNORING SUPRAVENTRICULAR EXTRASYSTOLES SWELLING FACE THROMBOPHLEBITIS TRICUSPID VALVE INCOMPETENCE URINARY TRACT INFECTION VAGINAL INFECTION VARICOSE VEIN VENTRICULAR EXTRASYSTOLES VISION BLURRED VOMITING WEIGHT DECREASED WEIGHT INCREASED Product Role Route Dosage Text Duration Manufacturer

7825134 Date FDA Received

14-Nov-2011

Case # 7825134

Case Type EXPEDITED (15-DAY)

Health Professional Y

Outcomes HO,OT

Manufacturer Control # 2010SP009502

Age 25 YR

Sex Female

Country USA

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 613 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7825134
Preferred Term PULMONARY EMBOLISM GALLBLADDER DISORDER PNEUMONIA MIGRAINE TRANSIENT ISCHAEMIC ATTACK NASAL CONGESTION BONE PAIN CERVICAL DYSPLASIA DEEP VEIN THROMBOSIS EATING DISORDER HYPOAESTHESIA INTERNATIONAL NORMALISED RATIO INCREASED LUNG INFILTRATION MITRAL VALVE INCOMPETENCE MITRAL VALVE PROLAPSE MUSCULAR WEAKNESS NAUSEA OVARIAN CYST OXYGEN SATURATION DECREASED PLEURAL EFFUSION PLEURITIC PAIN POST PROCEDURAL COMPLICATION PULMONARY HYPERTENSION PULMONARY INFARCTION PYREXIA SINUS TACHYCARDIA THROMBOSIS UPPER-AIRWAY COUGH SYNDROME WEIGHT DECREASED Product NUVARING LEVAQUIN COUMADIN IMITREX TREXIMET PROZAC Role Route S S S C C C Dosage Text QM 750 MG;QD Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 614 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8048840 Date FDA Received
14-Nov-2011 Preferred Term DEEP VEIN THROMBOSIS IMPAIRED WORK ABILITY CONDITION AGGRAVATED DEPRESSION DRUG ABUSE ENCEPHALITIS FATIGUE HAEMORRHAGE IN PREGNANCY HYPOTENSION MASTOIDITIS MENINGITIS VIRAL MENSTRUATION IRREGULAR MUSCLE TWITCHING PLASMINOGEN ACTIVATOR INHIBITOR INCREASED PLEOCYTOSIS PREGNANCY RED BLOOD CELL COUNT DECREASED STRESS SUICIDAL IDEATION SUPERIOR SAGITTAL SINUS THROMBOSIS TRANSVERSE SINUS THROMBOSIS URINARY TRACT INFECTION Case # 8048840 Case Type EXPEDITED (15-DAY) Product NUVARING NARDIL Health Professional Y Outcomes HO,DS,OT Role Route S S Manufacturer Control # 2011SP014788 Dosage Text QM Age 34 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 615 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8141348 Date FDA Received
14-Nov-2011 Preferred Term PULMONARY EMBOLISM ANGINA PECTORIS ARTHRALGIA ASTHENIA FIBRIN D DIMER INCREASED LIGAMENT RUPTURE NAUSEA PAIN IN EXTREMITY SINUS TACHYCARDIA STOMATITIS VOMITING Case # 8141348 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO,DS Role Route S Manufacturer Control # 2011SP016551 Dosage Text Age 28 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 616 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7063328 Date FDA Received
16-Nov-2011 Preferred Term DIZZINESS HEADACHE BACK PAIN HYPOAESTHESIA PARAESTHESIA CRYING DEHYDRATION HYPERTENSION IRRITABILITY MOOD SWINGS MUSCULOSKELETAL STIFFNESS NAUSEA OBSESSIVE-COMPULSIVE DISORDER TRANSVERSE SINUS THROMBOSIS VARICOSE VEIN VENOUS ANGIOMA OF BRAIN VISION BLURRED VOMITING Case # 7063328 Case Type EXPEDITED (15-DAY) Product NUVARING ALBUTEROL CLARITHROMYCIN AMOXICILLIN PREVACID Health Professional Y Outcomes HO Role Route S C C C C VAGINAL Manufacturer Control # 2009-190394-NL Dosage Text 1 DF;QM;VAG Age 28 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 617 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7826870 Date FDA Received
16-Nov-2011 Preferred Term TRANSIENT ISCHAEMIC ATTACK CEREBROVASCULAR ACCIDENT THYROID DISORDER ATRIAL SEPTAL DEFECT CARDIAC ANEURYSM COGNITIVE DISORDER CONFUSIONAL STATE DYSARTHRIA MIGRAINE MITRAL VALVE INCOMPETENCE SLEEP APNOEA SYNDROME TRICUSPID VALVE INCOMPETENCE VIITH NERVE PARALYSIS Case # 7826870 Case Type EXPEDITED (15-DAY) Product NUVARING SYNTHROID ASPIRIN Health Professional Y Outcomes HO,OT Role Route S C C Manufacturer Control # 2010SP004583 Dosage Text Age 46 YR Duration Sex Female Country USA

Manufacturer

8048827 Date FDA Received

16-Nov-2011 Preferred Term HEADACHE

Case # 8048827

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO,OT Role Route S

Manufacturer Control # 2011SP014624 Dosage Text

Age 40 YR Duration

Sex Female

Country USA

Manufacturer

ABDOMINAL PAIN LOWER BLOOD CHOLESTEROL INCREASED DEPRESSION FATIGUE IMPAIRED WORK ABILITY MUSCLE SPASMS OROPHARYNGEAL PAIN PULMONARY EMBOLISM UPPER RESPIRATORY TRACT CONGESTION

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 618 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8161432 Date FDA Received
16-Nov-2011 Preferred Term PULMONARY EMBOLISM ASTHMA MENTAL DISORDER BIPOLAR DISORDER COGNITIVE DISORDER CONDITION AGGRAVATED DYSPNOEA EMOTIONAL DISORDER FACTOR V LEIDEN MUTATION FLUID INTAKE REDUCED OVARIAN CYST PAIN IN EXTREMITY PULMONARY ARTERIAL HYPERTENSION PULMONARY INFARCTION VARICOSE VEIN Case # 8161432 Case Type EXPEDITED (15-DAY) Product NUVARING LEVOTHYROXINE SODIUM ABILIFY Health Professional Y Outcomes HO,OT Role Route S C C Manufacturer Control # 2010SP055778 Dosage Text Age 22 YR Duration Sex Female Country USA

Manufacturer

8162493 Date FDA Received

16-Nov-2011 Preferred Term OFF LABEL USE APPENDICITIS DEVICE EXPULSION

Case # 8162493

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes HO Role Route S

Manufacturer Control # 2011SP042438 Dosage Text ;UNK;VAG

Age 18 YR Duration

Sex Female

Country BRA

Manufacturer

MENSTRUATION IRREGULAR

8264048 Date FDA Received

16-Nov-2011 Preferred Term AFFECTIVE DISORDER

Case # 8264048

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2011SP052590 Dosage Text VAG

Age

Sex Female

Country USA

Duration

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 619 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8263700 Date FDA Received
17-Nov-2011 Preferred Term OOPHORITIS CYST METRORRHAGIA Case # 8263700 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional N Outcomes HO Role Route S VAGINAL Manufacturer Control # 2011SP053344 Dosage Text ;VAG Duration Age Sex Female Country RUS

Manufacturer

8263715 Date FDA Received

17-Nov-2011 Preferred Term DECIDUAL CAST

Case # 8263715

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2011SP053099 Dosage Text ;VAG Manufacturer Control # 2011SP025834 Dosage Text VAG

Age 26 YR Duration

Sex Female

Country COL

Manufacturer

8007593 Date FDA Received

18-Nov-2011 Preferred Term SEPTIC SHOCK

Case # 8007593

Case Type EXPEDITED (15-DAY) Product NUVARING NASONEX ZYRTEC

Health Professional Y

Outcomes HO,LT Role Route S C C VAGINAL

Age 36 YR Duration

Sex Female

Country USA

Manufacturer

OVARIAN HAEMORRHAGE INFECTIOUS PERITONITIS ANTIBIOTIC RESISTANT STAPHYLOCOCCUS TEST POSITIVE APPENDIX DISORDER ASCITES ATELECTASIS BENIGN HEPATIC NEOPLASM BLOOD IMMUNOGLOBULIN G DECREASED BRAIN NATRIURETIC PEPTIDE INCREASED CARDIOMYOPATHY COLITIS CORONARY ARTERY EMBOLISM FLUID RETENTION FOCAL NODULAR HYPERPLASIA GASTROINTESTINAL OEDEMA

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 620 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8007593
Preferred Term GENERALISED OEDEMA HAEMORRHAGIC ANAEMIA HEPATIC FIBROSIS HEPATITIS INTRA-ABDOMINAL HAEMATOMA INTRA-ABDOMINAL HAEMORRHAGE LEFT VENTRICULAR HYPERTROPHY LEUKOCYTOSIS MESENTERIC HAEMATOMA MYOCARDITIS OEDEMA PERIPHERAL PERITONEAL HAEMORRHAGE PLATELET COUNT INCREASED PLEURAL EFFUSION POST PROCEDURAL MYOCARDIAL INFARCTION RIGHT ATRIAL DILATATION SEROSITIS SMALL INTESTINAL OBSTRUCTION STREPTOCOCCAL SEPSIS TOXIC SHOCK SYNDROME TROPONIN INCREASED VASOSPASM VENTRICULAR HYPOKINESIA Product Role Route Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 621 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7271463 Date FDA Received
21-Nov-2011 Preferred Term PULMONARY EMBOLISM MULTIPLE INJURIES BREAST CELLULITIS BREAST HAEMATOMA BREAST NECROSIS CANDIDIASIS DEEP VEIN THROMBOSIS DRUG HYPERSENSITIVITY HYPERGLOBULINAEMIA HYPOALBUMINAEMIA INTERNATIONAL NORMALISED RATIO DECREASED MASTITIS MIGRAINE OVARIAN CYST PAIN IN EXTREMITY PLATELET COUNT INCREASED PLEURAL EFFUSION PNEUMONIA PULMONARY HYPERTENSION PULMONARY INFARCTION VENOUS OCCLUSION Case # 7271463 Case Type EXPEDITED (15-DAY) Product NUVARING COUMADIN Health Professional Y Outcomes HO,OT Role Route S S VAGINAL Manufacturer Control # 2009SP023496 Dosage Text VAG Age 25 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 622 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7996300 Date FDA Received
21-Nov-2011 Preferred Term PULMONARY EMBOLISM DEEP VEIN THROMBOSIS ABDOMINAL PAIN BLOOD THYROID STIMULATING HORMONE INCREASED CONDITION AGGRAVATED DYSMENORRHOEA HORMONE LEVEL ABNORMAL HYPERCOAGULATION MULTIPLE INJURIES PLANTAR FASCIITIS SINUS TACHYCARDIA Case # 7996300 Case Type EXPEDITED (15-DAY) Product NUVARING LEVOTHYROXINE SODIUM Health Professional Y Outcomes HO,OT Role Route S C Manufacturer Control # 2010SP058760 Dosage Text Age 34 YR Duration Sex Female Country USA

Manufacturer

8115364 Date FDA Received

21-Nov-2011 Preferred Term ABORTION INDUCED ABORTION MISSED DEVICE EXPULSION

Case # 8115364

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO Role Route S VAGINAL

Manufacturer Control # 2011SP036787 Dosage Text VAG

Age 18 YR Duration

Sex Female

Country FIN

Manufacturer

MATERNAL EXPOSURE DURING PREGNANCY PREGNANCY WITH CONTRACEPTIVE DEVICE

8269864 Date FDA Received

21-Nov-2011 Preferred Term

Case # 8269864

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes LT,OT Role Route S

Manufacturer Control # 2011SP053260 Dosage Text

Age

Sex Male

Country FRA Manufacturer

Duration

ANAPHYLACTIC SHOCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 623 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8275631 Date FDA Received
21-Nov-2011 Preferred Term VULVOVAGINAL BURNING SENSATION PELVIC PAIN VAGINISMUS VULVOVAGINAL PAIN Case # 8275631 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes OT Role Route S VAGINAL Manufacturer Control # 2011SP048329 Dosage Text ; QM;VAG Age 26 YR Duration Sex Female Country USA

Manufacturer

6797998 Date FDA Received

22-Nov-2011 Preferred Term

Case # 6797998

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes DE,HO,OT Role Route S VAGINAL

Manufacturer Control # 2008-185204-NL Dosage Text 1 DF;VAG

Age 31 YR Duration

Sex Female

Country USA

Manufacturer

RESPIRATORY FAILURE ABDOMINAL PAIN UPPER ALTERED STATE OF CONSCIOUSNESS ATELECTASIS CARDIOMEGALY CHOLECYSTITIS ACUTE CHOLELITHIASIS COUGH DUODENAL ULCER GASTROOESOPHAGEAL REFLUX DISEASE HAEMATOMA INFECTION HAEMOLYTIC TRANSFUSION REACTION HEPATOMEGALY HIATUS HERNIA HYPERBILIRUBINAEMIA ILEUS LEUKOCYTOSIS LUNG CONSOLIDATION LUNG INFILTRATION PLATELET COUNT INCREASED

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 624 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6797998
Preferred Term PLEURAL EFFUSION PNEUMONIA POSTOPERATIVE ABSCESS POST PROCEDURAL HAEMATOMA PULMONARY CONGESTION PULMONARY EMBOLISM PULMONARY OEDEMA PULMONARY VASCULAR DISORDER PYREXIA RENAL CYST SEPSIS SICKLE CELL ANAEMIA WITH CRISIS UPPER RESPIRATORY TRACT INFECTION Product Role Route Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 625 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7258067 Date FDA Received
22-Nov-2011 Preferred Term DEEP VEIN THROMBOSIS AMENORRHOEA ARTHRALGIA BACK PAIN BLOOD HOMOCYSTEINE INCREASED CARDIOMEGALY CELLULITIS COAGULOPATHY DRUG DOSE OMISSION FIBRIN D DIMER INCREASED HIATUS HERNIA INTERNATIONAL NORMALISED RATIO INCREASED LIGAMENT SPRAIN MENORRHAGIA MENSTRUATION IRREGULAR OEDEMA PERIPHERAL PULMONARY EMBOLISM THROMBOPHLEBITIS VAGINAL DISCHARGE VULVOVAGINAL MYCOTIC INFECTION Case # 7258067 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO,OT Role Route S Manufacturer Control # 2009-201106-NL Dosage Text Age 25 YR Duration Sex Female Country USA

Manufacturer

8258861 Date FDA Received

22-Nov-2011 Preferred Term MIDDLE INSOMNIA

Case # 8258861

Case Type DIRECT Product NUVARING

Health Professional N

Outcomes

Manufacturer Control #

Age 21 YR

Sex Female

Country USA

Role Route S VAGINAL

Dosage Text 1 ring

Duration

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 626 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7271494 Date FDA Received
23-Nov-2011 Preferred Term DEEP VEIN THROMBOSIS ABORTION SPONTANEOUS BREECH PRESENTATION COAGULOPATHY DRUG SCREEN POSITIVE DYSPNOEA FOETAL DEATH MATERNAL EXPOSURE BEFORE PREGNANCY MIGRAINE TRICHOMONIASIS Case # 7271494 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes OT Role Route S Manufacturer Control # 2009SP023477 Dosage Text 1 DF; Age 21 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 627 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7635954 Date FDA Received
23-Nov-2011 Preferred Term DEEP VEIN THROMBOSIS OVARIAN CYST ANOGENITAL WARTS BACTERIAL INFECTION COAGULATION FACTOR VIII LEVEL INCREASED DYSFUNCTIONAL UTERINE BLEEDING ENERGY INCREASED FACTOR V LEIDEN MUTATION GASTROOESOPHAGEAL REFLUX DISEASE HEADACHE INJECTION SITE HAEMATOMA JOINT INJURY PAIN UTERINE LEIOMYOMA WEIGHT INCREASED Case # 7635954 Case Type EXPEDITED (15-DAY) Product NUVARING ACETAMINOPHEN Health Professional Y Outcomes OT Role Route S C VAGINAL Manufacturer Control # 2010SP004918 Dosage Text VAG Age 50 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 628 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8225340 Date FDA Received
25-Nov-2011 Preferred Term ISCHAEMIC STROKE DEPRESSION ADJUSTMENT DISORDER WITH ANXIETY ADJUSTMENT DISORDER WITH DEPRESSED MOOD AMNESIA CAROTID ARTERY DISSECTION DEAFNESS DYSPEPSIA ENCEPHALOMALACIA FALL HYPERLIPIDAEMIA INCREASED APPETITE INSOMNIA MYOSITIS PAIN IN EXTREMITY RHINITIS ALLERGIC SINUS BRADYCARDIA THROMBOSIS Case # 8225340 Case Type EXPEDITED (15-DAY) Product NUVARING SLIM QUICK Health Professional Y Outcomes HO,OT Role Route S C Manufacturer Control # 2011SP019415 Dosage Text Age 36 YR Duration Sex Female Country USA

Manufacturer

8264288 Date FDA Received

28-Nov-2011 Preferred Term WEIGHT INCREASED

Case # 8264288

Case Type DIRECT Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control #

Age 30 YR

Sex Female

Country USA

Dosage Text

Duration

Manufacturer

ABDOMINAL DISTENSION FLUID RETENTION NIPPLE PAIN

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 629 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6179039 Date FDA Received
29-Nov-2011 Preferred Term MYOCARDIAL INFARCTION ANGINA UNSTABLE CARDIAC FLUTTER CARDIOMYOPATHY CORONARY ARTERY DISEASE CORONARY ARTERY STENOSIS DYSLIPIDAEMIA DYSPEPSIA HYPERTENSION LYME DISEASE MITRAL VALVE INCOMPETENCE PAIN PALPITATIONS PRESYNCOPE TREATMENT NONCOMPLIANCE VENTRICULAR TACHYCARDIA Case # 6179039 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO Role Route S Manufacturer Control # 2006-149909-NL Dosage Text Age 44 YR Duration Sex Female Country USA

Manufacturer

7133619 Date FDA Received

29-Nov-2011 Preferred Term

Case # 7133619

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2008-184829-NL Dosage Text VAG

Age 29 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM ATELECTASIS PULMONARY INFARCTION URINARY TRACT INFECTION

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 630 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8277478 Date FDA Received
29-Nov-2011 Preferred Term MENORRHAGIA OVARIAN CYST Case # 8277478 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes OT Role Route S Manufacturer Control # 2011SP054727 Dosage Text Age 18 YR Duration Sex Female Country USA

Manufacturer

8277555 Date FDA Received

29-Nov-2011 Preferred Term INJURY

Case # 8277555

Case Type EXPEDITED (15-DAY) Product NUVARING COUMADIN ZYRTEC LOVENOX FIORICET IBUPROFEN

Health Professional Y

Outcomes HO,OT Role Route S S S S C C

Manufacturer Control # 2011SP014822 Dosage Text

Age 32 YR Duration

Sex Female

Country USA

Manufacturer

PANCREATIC DISORDER PARATHYROID DISORDER THYROID DISORDER ADRENAL DISORDER HYPOTHALAMO-PITUITARY DISORDER CAESAREAN SECTION DEEP VEIN THROMBOSIS HYPERSENSITIVITY HYPOCHROMIC ANAEMIA PULMONARY EMBOLISM THROMBOCYTOPENIA URTICARIA

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 631 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7279199 Date FDA Received
30-Nov-2011 Preferred Term PULMONARY EMBOLISM SCAR BLOOD CHOLESTEROL INCREASED PHLEBITIS LOBAR PNEUMONIA NAUSEA VOMITING ATELECTASIS DEHYDRATION EAR PAIN HAEMATEMESIS HYPERCOAGULATION HYPONATRAEMIA PANIC DISORDER PLEURAL EFFUSION PROTEIN C DEFICIENCY PROTEIN S DEFICIENCY PULMONARY INFARCTION THROMBOCYTOPENIA THROMBOPHLEBITIS SUPERFICIAL VERTIGO Case # 7279199 Case Type EXPEDITED (15-DAY) Product NUVARING NUVARING NUVARING NUVARING DEPO-PROVERA CLARITIN PAXIL Health Professional Y Outcomes HO,OT Role Route S S S S S C C Manufacturer Control # 2009SP021085 Dosage Text Age 27 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 632 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8099589 Date FDA Received
30-Nov-2011 Preferred Term DEEP VEIN THROMBOSIS ANXIETY ASTHMA BACK PAIN BACTERIAL TOXAEMIA BLOOD CHOLESTEROL INCREASED CAESAREAN SECTION DIZZINESS EMOTIONAL DISORDER HEADACHE HYPERTENSION INFLUENZA LIKE ILLNESS INTERNATIONAL NORMALISED RATIO DECREASED MATERNAL EXPOSURE BEFORE PREGNANCY MENTAL DISORDER NAUSEA POSTPARTUM HAEMORRHAGE PRE-ECLAMPSIA STRESS TUBERCULIN TEST POSITIVE VARICOSE VEIN VULVOVAGINAL ERYTHEMA VULVOVAGINAL PRURITUS VULVOVAGINAL SWELLING WEIGHT DECREASED Case # 8099589 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO Role Route S Manufacturer Control # 2011SP002506 Dosage Text Age 30 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 633 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8268520 Date FDA Received
30-Nov-2011 Preferred Term PNEUMONIA LOSS OF CONSCIOUSNESS MUSCLE SPASMS PULMONARY EMBOLISM Case # 8268520 Case Type DIRECT Product NUVARING Health Professional Y Outcomes HO Role Route S VAGINAL Dosage Text Manufacturer Control # Age 16 YR Duration 2 MTH Sex Female Country USA

Manufacturer

8296342 Date FDA Received

30-Nov-2011 Preferred Term

Case # 8296342

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2011SP054872 Dosage Text ;VAG

Age 31 YR Duration

Sex Female

Country USA

Manufacturer

DRUG WITHDRAWAL SYNDROME ABASIA BEDRIDDEN MYALGIA NAUSEA PYREXIA VOMITING

8278012 Date FDA Received

01-Dec-2011 Preferred Term

Case # 8278012

Case Type DIRECT Product NUVARING

Health Professional N

Outcomes HO,OT Role Route S VAGINAL

Manufacturer Control #

Age 39 YR

Sex Female

Country USA

Dosage Text 1/MONTH VAGINAL

Duration

Manufacturer ORGANON

ABDOMINAL DISTENSION DIPLOPIA MIGRAINE PARAESTHESIA

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 634 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8293350 Date FDA Received
01-Dec-2011 Preferred Term INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION METRORRHAGIA HYPERINSULINAEMIA Case # 8293350 Case Type EXPEDITED (15-DAY) Product NUVARING METFORMIN HYDROCHLORIDE Health Professional N Outcomes OT Role Route S C VAGINAL Manufacturer Control # 2011SP054952 Dosage Text QM;VAG Age 26 YR Duration Sex Female Country CHL

Manufacturer

5963740 Date FDA Received

02-Dec-2011 Preferred Term PRURITUS

Case # 5963740

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes HO,OT Role Route S C C C C C C VAGINAL

Manufacturer Control # 2004-121159-NL Dosage Text ;VAG

Age 31 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM THROMBOSIS

ACETAMINOPHEN NEXIUM --/--/2002 - --/--/2010 LEXAPRO --/--/2004 - --/--/2010 BENADRYL PROZAC --/--/1987 - --/--/2009 IBUPROFEN

6784656 Date FDA Received

02-Dec-2011 Preferred Term

Case # 6784656

Case Type NON-EXPEDITED Product NUVARING PROZAC

Health Professional Y

Outcomes HO,OT Role Route S C C VAGINAL

Manufacturer Control # 2008-183726-NL Dosage Text ;VAG

Age 25 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS URINARY TRACT INFECTION CONSTIPATION DEPRESSION PAIN IN EXTREMITY

GLUCOPHAGE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 635 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7000213 Date FDA Received
02-Dec-2011 Preferred Term INTRACRANIAL VENOUS SINUS THROMBOSIS MIGRAINE BRONCHITIS VIRAL INFECTION Case # 7000213 Case Type NON-EXPEDITED Product NUVARING XOPENEX MIDOL EXTENDED RELIEF ACETAMINOPHEN INFLUENZA VACCINE Health Professional Y Outcomes HO Role Route S C C C C Outcomes HO,DS Role Route S C C C C VAGINAL Manufacturer Control # 2009-189973-NL Dosage Text ; VAG Age 33 YR Duration Sex Female Country USA VAGINAL Manufacturer Control # 2009-195833-NL Dosage Text 1 DF;QM;VAG Age 14 YR Duration Sex Female Country USA

Manufacturer

7056876 Date FDA Received

02-Dec-2011 Preferred Term

Case # 7056876

Case Type NON-EXPEDITED Product NUVARING ADVIL

Health Professional Y

Manufacturer

PULMONARY EMBOLISM DEEP VEIN THROMBOSIS PLANTAR FASCIITIS ADVERSE DRUG REACTION FATIGUE ANXIETY DEPRESSION HEADACHE WEIGHT INCREASED

ACETAMINOPHEN LEXAPRO DICYCLOMINE HYDROCHLORIDE

7101649 Date FDA Received

02-Dec-2011 Preferred Term THROMBOSIS MIGRAINE OVARIAN CYST PAIN IN EXTREMITY POLYP

Case # 7101649

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2009SP017659 Dosage Text 1 DF; QM; VAG

Age 25 YR Duration

Sex Female

Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 636 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7271471 Date FDA Received
02-Dec-2011 Preferred Term PULMONARY EMBOLISM DEEP VEIN THROMBOSIS ANAEMIA BRONCHITIS MIGRAINE Case # 7271471 Case Type NON-EXPEDITED Product NUVARING MULTI-VITAMIN PRILOSEC VITAMIN C VITAMIN B COMPLEX ACETAMINOPHEN Health Professional Y Outcomes HO Role Route S C C C C C Outcomes OT Role Route S C C Outcomes HO,OT Role Route S VAGINAL Manufacturer Control # 2009SP024015 Dosage Text QM;VAG Age 21 YR Duration Sex Female Country USA Manufacturer Control # 2009SP021073 Dosage Text Age 46 YR Duration Sex Female Country USA VAGINAL Manufacturer Control # 2009SP023513 Dosage Text VAG Age 45 YR Duration Sex Female Country USA

Manufacturer

7271480 Date FDA Received

02-Dec-2011 Preferred Term

Case # 7271480

Case Type NON-EXPEDITED Product NUVARING ATACAND

Health Professional Y

Manufacturer

DEEP VEIN THROMBOSIS THROMBOPHLEBITIS SUPERFICIAL

FLUOXETINE

7271488 Date FDA Received

02-Dec-2011 Preferred Term

Case # 7271488

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Manufacturer

PULMONARY EMBOLISM ATELECTASIS HEADACHE HYPERVENTILATION MUSCULOSKELETAL CHEST PAIN POISONING PULMONARY INFARCTION URINARY TRACT INFECTION

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 637 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7271491 Date FDA Received
02-Dec-2011 Preferred Term PULMONARY EMBOLISM DYSURIA MICTURITION URGENCY Case # 7271491 Case Type NON-EXPEDITED Product NUVARING MULTI-VITAMIN BEE POLLEN CONJUGATED LIINOLEIC ACID Health Professional Y Outcomes HO Role Route S C C C Outcomes HO,OT Role Route S C C C Manufacturer Control # 2009SP025221 Dosage Text Age 30 YR Duration Sex Female Country USA Manufacturer Control # 2009SP023462 Dosage Text 1 DF Age 36 YR Duration Sex Female Country USA

Manufacturer

7276514 Date FDA Received

02-Dec-2011 Preferred Term

Case # 7276514

Case Type NON-EXPEDITED Product NUVARING CENTRUM EXCEDRIN TYLENOL

Health Professional

Manufacturer

PULMONARY EMBOLISM THROMBOPHLEBITIS PLEURITIC PAIN EXTRASYSTOLES BRADYCARDIA HEADACHE

7276519 Date FDA Received

02-Dec-2011 Preferred Term

Case # 7276519

Case Type NON-EXPEDITED Product NUVARING PROVERA

Health Professional Y

Outcomes HO Role Route S C VAGINAL

Manufacturer Control # 2009SP025227 Dosage Text ;QM; VAG

Age 19 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM ROAD TRAFFIC ACCIDENT ANXIETY ARTHRITIS

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 638 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7277425 Date FDA Received
02-Dec-2011 Preferred Term PULMONARY EMBOLISM ANXIETY BLOOD GLUCOSE INCREASED HEADACHE PAIN STRESS Case # 7277425 Case Type NON-EXPEDITED Product NUVARING Health Professional Y Outcomes HO Role Route S Manufacturer Control # 2009SP028654 Dosage Text Duration Age Sex Unknown Country USA

Manufacturer

7277447 Date FDA Received

02-Dec-2011 Preferred Term

Case # 7277447

Case Type NON-EXPEDITED Product NUVARING COUMADIN

Health Professional Y

Outcomes HO,OT Role Route S S VAGINAL

Manufacturer Control # 2009SP028568 Dosage Text ;QM; VAG

Age 26 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM DEEP VEIN THROMBOSIS ADVERSE EVENT DEPRESSION FATIGUE MENSTRUATION IRREGULAR STRESS

7277482 Date FDA Received

02-Dec-2011 Preferred Term

Case # 7277482

Case Type NON-EXPEDITED Product NUVARING NUVARING

Health Professional

Outcomes HO Role Route S S C C

Manufacturer Control # 2009SP027035 Dosage Text

Age 27 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS URINARY TRACT INFECTION PULMONARY EMBOLISM ANAEMIA

HYDROCODONE BITARTRATE ACETAMINOPHEN

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 639 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7277483 Date FDA Received
02-Dec-2011 Preferred Term DEEP VEIN THROMBOSIS FIBROADENOMA OF BREAST HYPERGLYCAEMIA PULMONARY EMBOLISM VARICOSE VEIN VENOUS INSUFFICIENCY Case # 7277483 Case Type NON-EXPEDITED Product NUVARING PHENTERMINE Health Professional Y Outcomes HO,OT Role Route S C Manufacturer Control # 2009SP026924 Dosage Text Age 33 YR Duration Sex Female Country USA

Manufacturer

7277793 Date FDA Received

02-Dec-2011 Preferred Term

Case # 7277793

Case Type NON-EXPEDITED Product NUVARING EFFEXOR TOPAMAX PERCOCET XANAX

Health Professional Y

Outcomes HO Role Route S C C C C

Manufacturer Control # 2009-199327-NL Dosage Text

Age 24 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 640 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7278753 Date FDA Received
02-Dec-2011 Preferred Term SARCOIDOSIS TEMPERATURE INTOLERANCE ARTHRALGIA BACK PAIN BRONCHITIS CHILLS DEPRESSION FATIGUE HEADACHE MUSCLE STRAIN OBSESSIVE-COMPULSIVE DISORDER PULMONARY EMBOLISM SLEEP PARALYSIS SOMNOLENCE THROMBOSIS VULVOVAGINAL CANDIDIASIS WEIGHT FLUCTUATION Case # 7278753 Case Type NON-EXPEDITED Product NUVARING SYNTHROID FLEXERIL Health Professional Y Outcomes HO,OT Role Route S C C VAGINAL Manufacturer Control # 2009-198050-NL Dosage Text 1 DF;Q3W;VAG Age 25 YR Duration Sex Female Country USA

Manufacturer

7278763 Date FDA Received

02-Dec-2011 Preferred Term

Case # 7278763

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes HO,LT Role Route S C

Manufacturer Control # 2009-197874-NL Dosage Text

Age 36 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS COLPOSCOPY METRORRHAGIA PULMONARY EMBOLISM

ACETAMINOPHEN

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 641 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7278973 Date FDA Received
02-Dec-2011 Preferred Term PULMONARY EMBOLISM DEEP VEIN THROMBOSIS COLITIS ULCERATIVE HYPERTENSION INFECTION THROMBOPHLEBITIS SUPERFICIAL Case # 7278973 Case Type NON-EXPEDITED Product NUVARING SYNTHROID TRICOR METFORMIN HYDROCHLORIDE ASPIRIN AVANDAMET ADVICOR LOFIBRA LEVOTHYROXINE SODIUM Health Professional Y Outcomes HO,OT Role Route S C C C C C C C C Outcomes HO Role Route S Manufacturer Control # 2009SP020323 Dosage Text Age 26 YR Duration Sex Female Country USA VAGINAL Manufacturer Control # 2009-199672-NL Dosage Text VAG Age 44 YR Duration Sex Female Country USA

Manufacturer

7279236 Date FDA Received

02-Dec-2011 Preferred Term

Case # 7279236

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Manufacturer

PULMONARY EMBOLISM CHEST PAIN CYST DEEP VEIN THROMBOSIS HEADACHE

7279334 Date FDA Received

02-Dec-2011 Preferred Term

Case # 7279334

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes HO,OT Role Route S C C C C

Manufacturer Control # 2009SP021522 Dosage Text

Age 32 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS

FEXOFENADINE AZITHROMYCIN PSEUDOVENT BUPROPION HYDROCHLORIDE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 642 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7281011 Date FDA Received
02-Dec-2011 Preferred Term DEEP VEIN THROMBOSIS FOLLICULITIS CALCULUS URINARY EAR INFECTION FUNGAL FUNGAL INFECTION URINARY TRACT INFECTION FUNGAL VAGINAL DISCHARGE Case # 7281011 Case Type NON-EXPEDITED Product NUVARING ONEA A DAY WOMEN'S MULTIVITAMINS VITAMINS MACROBID Health Professional Y Outcomes HO Role Route S C C C Manufacturer Control # 2009SP017663 Dosage Text 1 DF; QM; Age 27 YR Duration Sex Female Country USA

Manufacturer

7281687 Date FDA Received

02-Dec-2011 Preferred Term DEPRESSION

Case # 7281687

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes HO,OT Role Route S

Manufacturer Control # 2008-188731-NL Dosage Text 1 DF;

Age 28 YR Duration

Sex Female

Country USA

Manufacturer

HEART RATE IRREGULAR PULMONARY EMBOLISM THROMBOSIS

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 643 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7281712 Date FDA Received
02-Dec-2011 Preferred Term DEEP VEIN THROMBOSIS HEADACHE PHARYNGITIS IRON DEFICIENCY ANAEMIA THROMBOPHLEBITIS Case # 7281712 Case Type NON-EXPEDITED Product NUVARING AMBIEN FERROUS SULFATE IBUPROFEN VICODIN FOLIC ACID FLAXSEED OIL VITAMINS NOS VITAMIN B COMPLEX Health Professional Y Outcomes HO,DS,OT Role Route S C C C C C C C C Manufacturer Control # 2008-188635-NL Dosage Text Age 33 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 644 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7281737 Date FDA Received
02-Dec-2011 Preferred Term PULMONARY EMBOLISM PULMONARY INFARCTION GALACTORRHOEA DRY EYE CHEST PAIN INSOMNIA LIGAMENT SPRAIN BREAST MASS AMENORRHOEA Case # 7281737 Case Type NON-EXPEDITED Product NUVARING NADOL ATARAX VALIUM DARVOCET CLOBETASOL PROPIONATE FLUTICASONE PROPIONATE ESCITALPRAM OXALATE LORATADINE TRAZODONE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE GUAIFENESIN DM SINGULAIR FLEXERIL KEFLEX ULTRAVATE LEXAPRO PROVERA TRIAMCINOLONE Health Professional Y Outcomes HO,OT Role Route S C C C C C C C C C C C C C C C C C C Manufacturer Control # 2009-189323-NL Dosage Text Age 35 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 645 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7281748 Date FDA Received
02-Dec-2011 Preferred Term PULMONARY EMBOLISM MUSCLE SPASMS Case # 7281748 Case Type NON-EXPEDITED Product NUVARING PROZAC WELLBUTRIN WELLBUTRIN FERROUS SULFATE VITAMINS NOS CALCIUM AND VITAMIN D Health Professional Y Outcomes HO Role Route S C C C C C C Outcomes HO Role Route S C C Manufacturer Control # 2008-188700-NL Dosage Text Age 24 YR Duration Sex Female Country USA Manufacturer Control # 2008-188129-NL Dosage Text Age 49 YR Duration Sex Female Country USA

Manufacturer

7281775 Date FDA Received

02-Dec-2011 Preferred Term

Case # 7281775

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Manufacturer

PULMONARY EMBOLISM VESTIBULITIS

FLUOXETINE --/--/2007 SPIRIVA

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 646 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7281778 Date FDA Received
02-Dec-2011 Preferred Term DEEP VEIN THROMBOSIS SKIN ULCER TENDONITIS UTERINE LEIOMYOMA BREAST MASS CHEST PAIN HEADACHE HYPERCHOLESTEROLAEMIA HYPERCOAGULATION OEDEMA PERIPHERAL PAIN PAIN IN EXTREMITY Case # 7281778 Case Type NON-EXPEDITED Product NUVARING SYNTHROID OMACOR PREVACID Health Professional Y Outcomes HO Role Route S C C C Manufacturer Control # 2009SP017678 Dosage Text 1 DF; QM; Age 50 YR Duration Sex Female Country USA

Manufacturer

7281782 Date FDA Received

02-Dec-2011 Preferred Term

Case # 7281782

Case Type NON-EXPEDITED Product NUVARING ECHINACEA

Health Professional Y

Outcomes HO Role Route S C C C C

Manufacturer Control # 2009SP017680 Dosage Text 1 DF; QM;

Age 26 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM PAIN INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION BACK PAIN HEADACHE

ACETAMINOPHEN IBUPROFEN CELEBREX

7281785 Date FDA Received

02-Dec-2011 Preferred Term

Case # 7281785

Case Type NON-EXPEDITED Product NUVARING VALTREX

Health Professional Y

Outcomes HO Role Route S C VAGINAL

Manufacturer Control # 2009SP017684 Dosage Text 1 DFL QNL VAG

Age 25 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS VAGINAL INFECTION

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 647 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7282092 Date FDA Received
02-Dec-2011 Preferred Term DEEP VEIN THROMBOSIS BREAST CANCER IN SITU BREAST MASS NERVE COMPRESSION SLEEP APNOEA SYNDROME Case # 7282092 Case Type NON-EXPEDITED Product NUVARING METFORMIN HYDROCHLORIDE ATACND LYRICA GLUCOPHAGE HYDROCHLOROTHIAZIDE Health Professional Y Outcomes HO,OT Role Route S C C C C C Outcomes HO Role Route S Manufacturer Control # 2009SP017640 Dosage Text 1 DF; QM; Age 26 YR Duration Sex Female Country USA VAGINAL Manufacturer Control # 2009SP017397 Dosage Text 1 DF; VAG Age 47 YR Duration Sex Female Country USA

Manufacturer

7282112 Date FDA Received

02-Dec-2011 Preferred Term

Case # 7282112

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Manufacturer

DEEP VEIN THROMBOSIS DYSTHYMIC DISORDER HEADACHE PAIN SCAR

7282180 Date FDA Received

02-Dec-2011 Preferred Term EMBOLIC STROKE INFLUENZA VARICOSE VEIN

Case # 7282180

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes HO Role Route S C C C VAGINAL

Manufacturer Control # 2009SP016965 Dosage Text 1 DF; QM; VAG

Age 33 YR Duration

Sex Female

Country USA

Manufacturer

CEPHALEXIN ACETAMINOPHEN IMITREXT

FIBROADENOMA OF BREAST ENCEPHALOMALACIA INTERVERTEBRAL DISC DISORDER MIGRAINE PHLEBITIS WEIGHT DECREASED

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 648 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7282393 Date FDA Received
02-Dec-2011 Preferred Term PULMONARY EMBOLISM DILATATION VENTRICULAR DYSPEPSIA DYSPHONIA ASTHMA INSOMNIA DEPRESSION CANDIDIASIS BRONCHITIS Case # 7282393 Case Type NON-EXPEDITED Product NUVARING BENICAR AZMACORT METFORMIN HYDROCHLORIDE ZANTAC RANITIDINE IBUPROFEN LIPITOR Health Professional Y Outcomes HO,OT Role Route S C C C C C C C VAGINAL Manufacturer Control # 2009SP016968 Dosage Text 1 DF;QM; VAG Age 35 YR Duration Sex Female Country USA

Manufacturer

7284183 Date FDA Received

02-Dec-2011 Preferred Term

Case # 7284183

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2008-186445-NL Dosage Text

Age 24 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS POLLAKIURIA

7284233 Date FDA Received

02-Dec-2011 Preferred Term

Case # 7284233

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes HO,OT Role Route S

Manufacturer Control # 2008-186240-NL Dosage Text 1 DF;

Age 29 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM METRORRHAGIA MIGRAINE MUSCLE SPASMS

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 649 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7284247 Date FDA Received
02-Dec-2011 Preferred Term PULMONARY EMBOLISM BRONCHITIS PAPILLOMA VIRAL INFECTION PULMONARY INFARCTION SECRETION DISCHARGE Case # 7284247 Case Type NON-EXPEDITED Product NUVARING Health Professional Y Outcomes HO Role Route S VAGINAL Manufacturer Control # 2008-186094-NL Dosage Text 1 DF; ;VAG Age 28 YR Duration Sex Female Country USA

Manufacturer

7284667 Date FDA Received

02-Dec-2011 Preferred Term

Case # 7284667

Case Type NON-EXPEDITED Product NUVARING SYNTHROID

Health Professional Y

Outcomes HO,OT Role Route S C C C VAGINAL

Manufacturer Control # 2009-193882-NL Dosage Text ; VAG

Age 35 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS COUGH BRONCHITIS PULMONARY EMBOLISM MENSTRUAL DISORDER

PRENATABS FA METFORMIN HYDROCHLORIDE

7284734 Date FDA Received

02-Dec-2011 Preferred Term

Case # 7284734

Case Type NON-EXPEDITED Product NUVARING COUMADIN

Health Professional Y

Outcomes HO Role Route S S C C C C C C C VAGINAL

Manufacturer Control # 2009-201021-NL Dosage Text 1 DF; QM; VAG

Age 23 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM DEEP VEIN THROMBOSIS PHARYNGITIS DERMATITIS LYMPHADENOPATHY MENSTRUAL DISORDER ACNE PULMONARY INFARCTION BLOOD DISORDER

HYDROCORTISONE METROGEL BENZACLIN LIQUIBID NASONEX ARMODAFINIL AZITHROMYCIN

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 650 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7284738 Date FDA Received
02-Dec-2011 Preferred Term PULMONARY EMBOLISM INFERTILITY FEMALE PYREXIA DYSPNOEA ABDOMINAL PAIN UPPER VOMITING DIARRHOEA Case # 7284738 Case Type NON-EXPEDITED Product NUVARING BUSPAR WELLBUTRIN PAXIL NASACORT ALLEGRA ACETAMINOPHEN PREVACID Health Professional Y Outcomes HO,OT Role Route S C C C C C C C Health Professional Y Outcomes HO Role Route S C C C Health Professional Y Outcomes HO,OT Role Route S C C Manufacturer Control # 2009-198561-NL Dosage Text Age 36 YR Duration Sex Female Country USA Manufacturer Control # 2009-198568-NL Dosage Text Age 33 YR Duration Sex Female Country USA Manufacturer Control # 2009-192816-NL Dosage Text Age 23 YR Duration Sex Female Country USA

Manufacturer

7284780 Date FDA Received

02-Dec-2011 Preferred Term

Case # 7284780

Case Type NON-EXPEDITED Product NUVARING PRILOSEC

Manufacturer

DEEP VEIN THROMBOSIS

DIOVAN HCT MOTRIN

7284783 Date FDA Received

02-Dec-2011 Preferred Term

Case # 7284783

Case Type NON-EXPEDITED Product NUVARING MOTRIN NAPROSYN

Manufacturer

DEEP VEIN THROMBOSIS URINARY TRACT INFECTION WEIGHT INCREASED FATIGUE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 651 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7284816 Date FDA Received
02-Dec-2011 Preferred Term PULMONARY EMBOLISM DEEP VEIN THROMBOSIS Case # 7284816 Case Type NON-EXPEDITED Product NUVARING Health Professional Y Outcomes HO Role Route S Manufacturer Control # 2009-200467-NL Dosage Text Age 22 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 652 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7284852 Date FDA Received
02-Dec-2011 Preferred Term DEEP VEIN THROMBOSIS METRORRHAGIA PULMONARY EMBOLISM Case # 7284852 Case Type NON-EXPEDITED Product NUVARING ESTROGEN NOS ZYRTEC TYLENOL SINUS FLONASE FLAGIL CLARITIN METHYLPREDNISOLONE ACETATE PAROXETINE AZITHROMYCIN TRANSDERM SCOP AZITHROMYCIN ESTRADERM PROVENTIL HFA AVELOX METRONIDAZOLE HYDROCODONE BITARTRATE AND ACETAMINOPHEN TYLENOL COLD ALBUTEROL INHALER AFRIN PRILOSEC DORYX FLUTICASONE PROPIONATE Health Professional Y Outcomes HO,OT Role Route S S C C C C C C C C C C C C C C C C C C C C C Manufacturer Control # 2009-194843-NL Dosage Text 1 DF Age 31 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 653 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7284865 Date FDA Received
02-Dec-2011 Preferred Term PULMONARY EMBOLISM DEEP VEIN THROMBOSIS ANKLE FRACTURE MEDICATION ERROR Case # 7284865 Case Type NON-EXPEDITED Product NUVARING IBUPROFEN Health Professional Y Outcomes HO Role Route S C 1 DF Manufacturer Control # 2009-194846-NL Dosage Text Age 27 YR Duration Sex Female Country USA

Manufacturer

7284869 Date FDA Received

02-Dec-2011 Preferred Term LIGAMENT SPRAIN HERPES SIMPLEX WEIGHT INCREASED HEADACHE

Case # 7284869

Case Type NON-EXPEDITED Product NUVARING IBUPROFEN

Health Professional Y

Outcomes HO Role Route S C C

Manufacturer Control # 2009-194848-NL Dosage Text 1 DF;

Age 24 YR Duration

Sex Female

Country USA

Manufacturer

VITAMINS NOS

PULMONARY EMBOLISM

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 654 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7284896 Date FDA Received
02-Dec-2011 Preferred Term CEREBRAL INFARCTION DEEP VEIN THROMBOSIS UTEROVAGINAL PROLAPSE URINARY INCONTINENCE ADJUSTMENT DISORDER DEPRESSION DYSMENORRHOEA EXTRAOCULAR MUSCLE PARESIS FALL JOINT DISLOCATION MENORRHAGIA METRORRHAGIA PAIN IN EXTREMITY PELVIC PAIN RASH ROTATOR CUFF SYNDROME VAGINAL DISCHARGE Case # 7284896 Case Type NON-EXPEDITED Product NUVARING EXCEDRIN ESTROGENS, CONJUGATED TRIAZOLAM Health Professional Y Outcomes HO,DS Role Route S C C C VAGINAL Manufacturer Control # 2007-153550-NL Dosage Text 1 DF; ;VAG Age 40 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 655 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7285013 Date FDA Received
02-Dec-2011 Preferred Term PULMONARY EMBOLISM ANXIETY DEPRESSION LUNG NEOPLASM METRORRHAGIA NIPPLE PAIN URINARY TRACT INFECTION VARICOSE VEIN Case # 7285013 Case Type NON-EXPEDITED Product NUVARING Health Professional Y Outcomes HO Role Route S Manufacturer Control # 2009-196218-NL Dosage Text Age 40 YR Duration Sex Female Country USA

Manufacturer

7285435 Date FDA Received

02-Dec-2011 Preferred Term

Case # 7285435

Case Type NON-EXPEDITED Product NUVARING IBUPROFEN GARDASIL

Health Professional Y

Outcomes HO Role Route S C C

Manufacturer Control # 2009-195828-NL Dosage Text 1 DF;

Age 19 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS MIGRAINE WITH AURA LIGAMENT SPRAIN

7285437 Date FDA Received

02-Dec-2011 Preferred Term

Case # 7285437

Case Type NON-EXPEDITED Product NUVARING CALCIUM

Health Professional Y

Outcomes HO Role Route S C C VAGINAL

Manufacturer Control # 2009-195830-NL Dosage Text VAG

Age 38 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM HEADACHE

MULTI-VITAMIN

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 656 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7285551 Date FDA Received
02-Dec-2011 Preferred Term PULMONARY EMBOLISM Case # 7285551 Case Type NON-EXPEDITED Product NUVARING DETROL VALIUM Health Professional Y Outcomes HO,DS Role Route S C C Health Professional Y Outcomes HO,DS Role Route S C C VAGINAL Manufacturer Control # 2009SP017696 Dosage Text 1 DF, QM, VAG Age 35 YR Duration Sex Female Country USA Manufacturer Control # 2009-195761-NL Dosage Text 1 DF; Age 24 YR Duration Sex Female Country USA

Manufacturer

7294748 Date FDA Received

02-Dec-2011 Preferred Term

Case # 7294748

Case Type NON-EXPEDITED Product NUVARING

Manufacturer

PULMONARY EMBOLISM MENORRHAGIA LIGAMENT SPRAIN AMNESIA ANXIETY BLEPHARITIS CHALAZION CONTUSION ECCHYMOSIS ERYTHEMA FALL FIBROCYSTIC BREAST DISEASE HORDEOLUM MEIBOMIANITIS NERVE INJURY PAIN IN EXTREMITY PALPITATIONS UPPER RESPIRATORY TRACT INFECTION

TYLENOL WITH CODEINE TRAZODONE HYDROCHLORIDE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 657 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7294756 Date FDA Received
02-Dec-2011 Preferred Term DEEP VEIN THROMBOSIS Case # 7294756 Case Type NON-EXPEDITED Product NUVARING PROMETRIUM Health Professional Y Outcomes HO Role Route S S Outcomes HO,DS Role Route S ;UNK; Manufacturer Control # 2010SP025273 Dosage Text Age 24 YR Duration Sex Female Country USA Manufacturer Control # 2008-181319-NL Dosage Text Age 47 YR Duration Sex Female Country USA

Manufacturer

7805372 Date FDA Received

02-Dec-2011 Preferred Term

Case # 7805372

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Manufacturer

DEEP VEIN THROMBOSIS DEPRESSION MUSCLE STRAIN

7805882 Date FDA Received

02-Dec-2011 Preferred Term

Case # 7805882

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes HO Role Route S

Manufacturer Control # 2010SP052614 Dosage Text

Age 24 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM CHEST PAIN LUNG INFILTRATION PULMONARY INFARCTION

7805915 Date FDA Received

02-Dec-2011 Preferred Term

Case # 7805915

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes HO Role Route S

Manufacturer Control # 2010SP025056 Dosage Text

Age 31 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM CONSTIPATION DEEP VEIN THROMBOSIS LIPODYSTROPHY ACQUIRED SKIN STRIAE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 658 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7805929 Date FDA Received
02-Dec-2011 Preferred Term DEEP VEIN THROMBOSIS ANXIETY PULMONARY EMBOLISM Case # 7805929 Case Type NON-EXPEDITED Product NUVARING IBUPROFEN /00109201/ NAPROXEN Case Type NON-EXPEDITED Product NUVARING Health Professional Y Health Professional Y Outcomes HO Role Route S C C Outcomes HO Role Route S Manufacturer Control # 2010SP025130 Dosage Text Age 27 YR Duration Sex Female Country USA Manufacturer Control # 2010SP025088 Dosage Text Age 25 YR Duration Sex Female Country USA

Manufacturer

7805931 Date FDA Received

02-Dec-2011 Preferred Term

Case # 7805931

Manufacturer

PULMONARY EMBOLISM PULMONARY INFARCTION

7805939 Date FDA Received

02-Dec-2011 Preferred Term

Case # 7805939

Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes HO Role Route S VAGINAL

Manufacturer Control # 2010SP025237 Dosage Text VAG Manufacturer Control # 2010SP020585 Dosage Text

Age 28 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM

7805991 Date FDA Received

02-Dec-2011 Preferred Term

Case # 7805991

Health Professional N

Outcomes OT Role Route S

Age 27 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS ABNORMAL WITHDRAWAL BLEEDING ALOPECIA ANXIETY MOOD ALTERED

7806056 Date FDA Received

02-Dec-2011 Preferred Term

Case # 7806056

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2010SP019463 Dosage Text 1 DF;VAG

Age

Sex Female

Country USA

Duration

Manufacturer

THROMBOPHLEBITIS SUPERFICIAL

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 659 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7806058 Date FDA Received
02-Dec-2011 Preferred Term CEREBROVASCULAR ACCIDENT VISUAL ACUITY REDUCED ATTENTION DEFICIT/HYPERACTIVITY DISORDER Case # 7806058 Case Type NON-EXPEDITED Product NUVARING ADDERALL Health Professional N Outcomes HO,OT Role Route S C VAGINAL Manufacturer Control # 2010SP019147 Dosage Text ; VAG Age 24 YR Duration Sex Female Country USA

Manufacturer

7807495 Date FDA Received

02-Dec-2011 Preferred Term

Case # 7807495

Case Type NON-EXPEDITED Product NUVARING

Health Professional

Outcomes HO Role Route S

Manufacturer Control # 2010SP051468 Dosage Text

Age 26 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM BACK PAIN CARDIOMEGALY DEEP VEIN THROMBOSIS HEADACHE INTERVERTEBRAL DISC PROTRUSION IRON DEFICIENCY ANAEMIA LIMB INJURY MENTAL DISORDER MIGRAINE ROAD TRAFFIC ACCIDENT SUBSTANCE USE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 660 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7807506 Date FDA Received
02-Dec-2011 Preferred Term PULMONARY EMBOLISM BACK PAIN CERVICAL DYSPLASIA DYSURIA PULMONARY INFARCTION Case # 7807506 Case Type NON-EXPEDITED Product NUVARING Health Professional Y Outcomes HO,OT Role Route S Manufacturer Control # 2010SP051451 Dosage Text ;QM; Age 21 YR Duration Sex Female Country USA

Manufacturer

7807517 Date FDA Received

02-Dec-2011 Preferred Term

Case # 7807517

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes HO Role Route S C C C C C C

Manufacturer Control # 2010SP048873 Dosage Text

Age 24 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM HYPERCOAGULATION DRUG HYPERSENSITIVITY HEADACHE DEPRESSION ABDOMINAL PAIN NAUSEA VOMITING

PROPOXYPHENE HYDROCHLORIDE EFFEXOR XR FLEXERIL ALBUTEROL INHALER ACETAMINOPHEN EXCEDRIN MIGRAINE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 661 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7807522 Date FDA Received
02-Dec-2011 Preferred Term DEEP VEIN THROMBOSIS HYPERTENSION CELLULITIS OEDEMA PERIPHERAL SOMNOLENCE URINARY TRACT INFECTION WEIGHT INCREASED Case # 7807522 Case Type NON-EXPEDITED Product NUVARING BACLOFEN Health Professional Outcomes HO,OT Role Route S C Manufacturer Control # 2010SP048853 Dosage Text ;QM Age 46 YR Duration Sex Female Country USA

Manufacturer

7807619 Date FDA Received

02-Dec-2011 Preferred Term

Case # 7807619

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes HO,OT Role Route S

Manufacturer Control # 2010SP046916 Dosage Text

Age 21 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS BREAST MASS FALL JOINT INJURY PULMONARY EMBOLISM

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 662 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7807620 Date FDA Received
02-Dec-2011 Preferred Term PULMONARY EMBOLISM BRONCHITIS CANDIDIASIS PHARYNGITIS EPISTAXIS BACK PAIN DEPRESSION DERMATITIS CONTACT FOLLICULITIS PULMONARY INFARCTION SPINAL DISORDER TINEA INFECTION Case # 7807620 Case Type NON-EXPEDITED Product NUVARING ALBUTEROL ZOLOFT CAFFEINE CITRATE MULTIVITAMIN WITH IRON Health Professional Y Outcomes HO Role Route S C C C C Manufacturer Control # 2009SP029611 Dosage Text Age 26 YR Duration Sex Female Country USA

Manufacturer

7808336 Date FDA Received

02-Dec-2011 Preferred Term

Case # 7808336

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes HO,DS,OT Role Route S

Manufacturer Control # 2010SP004921 Dosage Text

Age 27 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS PULMONARY EMBOLISM

7808346 Date FDA Received

02-Dec-2011 Preferred Term

Case # 7808346

Case Type NON-EXPEDITED Product NUVARING

Health Professional

Outcomes HO Role Route S

Manufacturer Control # 2009SP032655 Dosage Text

Age 22 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM UNINTENDED PREGNANCY

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 663 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7808349 Date FDA Received
02-Dec-2011 Preferred Term PULMONARY EMBOLISM Case # 7808349 Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Health Professional Y Health Professional N Outcomes HO,DS Role Route S Outcomes OT Role Route S Manufacturer Control # 2010SP038534 Dosage Text Age 24 YR Duration Sex Female Country USA Manufacturer Control # 2009SP031151 Dosage Text Age 39 YR Duration Sex Female Country USA

Manufacturer

7808356 Date FDA Received

02-Dec-2011 Preferred Term

Case # 7808356

Manufacturer

TRANSIENT ISCHAEMIC ATTACK CHEST INJURY METRORRHAGIA PAIN

7808434 Date FDA Received

02-Dec-2011 Preferred Term

Case # 7808434

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes HO Role Route S

Manufacturer Control # 2010SP040150 Dosage Text

Age 26 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM PULMONARY INFARCTION

7808448 Date FDA Received

02-Dec-2011 Preferred Term

Case # 7808448

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes HO Role Route S

Manufacturer Control # 2010SP029106 Dosage Text

Age 26 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM CHOLECYSTECTOMY

7808471 Date FDA Received

02-Dec-2011 Preferred Term

Case # 7808471

Case Type NON-EXPEDITED Product NUVARING

Health Professional N

Outcomes HO Role Route S

Manufacturer Control # 2010SP038532 Dosage Text

Age 30 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 664 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7808501 Date FDA Received
02-Dec-2011 Preferred Term PULMONARY EMBOLISM LEUKOCYTOSIS DEHYDRATION HAEMOCONCENTRATION POOR VENOUS ACCESS UPPER RESPIRATORY TRACT INFECTION Case # 7808501 Case Type NON-EXPEDITED Product NUVARING TOPAMAX VITAMINS NOS Health Professional Y Outcomes HO Role Route S C C Manufacturer Control # 2010SP028439 Dosage Text Age 26 YR Duration Sex Female Country USA

Manufacturer

7808527 Date FDA Received

02-Dec-2011 Preferred Term

Case # 7808527

Case Type NON-EXPEDITED Product NUVARING

Health Professional N

Outcomes HO Role Route S VAGINAL

Manufacturer Control # 2010SP019290 Dosage Text VAG

Age 42 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS PULMONARY EMBOLISM

7808529 Date FDA Received

02-Dec-2011 Preferred Term

Case # 7808529

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes HO Role Route S

Manufacturer Control # 2010SP046925 Dosage Text

Age 29 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM ANAEMIA DEEP VEIN THROMBOSIS GASTROOESOPHAGEAL REFLUX DISEASE

7808560 Date FDA Received

02-Dec-2011 Preferred Term

Case # 7808560

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes HO Role Route S

Manufacturer Control # 2010SP044532 Dosage Text

Age 34 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM GOITRE SYSTEMIC LUPUS ERYTHEMATOSUS UTERINE LEIOMYOMA

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 665 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7808593 Date FDA Received
02-Dec-2011 Preferred Term PULMONARY EMBOLISM BRONCHITIS DRUG HYPERSENSITIVITY HYPERVENTILATION SINUS DISORDER Case # 7808593 Case Type NON-EXPEDITED Product NUVARING BENADRYL SYNTHROID Health Professional Y Outcomes HO Role Route S S C VAGINAL Manufacturer Control # 2010SP044541 Dosage Text VAG Age 33 YR Duration Sex Female Country USA

Manufacturer

7808598 Date FDA Received

02-Dec-2011 Preferred Term

Case # 7808598

Case Type NON-EXPEDITED Product NUVARING SYNTHROID

Health Professional Y

Outcomes HO,OT Role Route S C C C C

Manufacturer Control # 2010SP044543 Dosage Text

Age 31 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM PULMONARY INFARCTION HYPERTENSION HERPES SIMPLEX DERMATITIS CONTACT INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION

ROCALTROL PROZAC CALCITRIOL

7808611 Date FDA Received

02-Dec-2011 Preferred Term

Case # 7808611

Case Type NON-EXPEDITED Product NUVARING IBUPROFEN

Health Professional Y

Outcomes HO Role Route S C

Manufacturer Control # 2010SP044544 Dosage Text

Age 25 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS SYNOVIAL CYST GASTROOESOPHAGEAL REFLUX DISEASE HYPERLIPIDAEMIA OBESITY

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 666 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7808627 Date FDA Received
02-Dec-2011 Preferred Term PULMONARY EMBOLISM DEEP VEIN THROMBOSIS INJURY NASOPHARYNGITIS Case # 7808627 Case Type NON-EXPEDITED Product NUVARING Health Professional Y Outcomes HO,OT Role Route S Manufacturer Control # 2010SP046375 Dosage Text Age 26 YR Duration Sex Female Country USA

Manufacturer

7810056 Date FDA Received

02-Dec-2011 Preferred Term

Case # 7810056

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes HO Role Route S C Outcomes HO Role Route S VAGINAL

Manufacturer Control # 2009SP041471 Dosage Text ;VAG

Age 24 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM DEEP VEIN THROMBOSIS

EXCEDRIN MIGRAINE --/--/2003 Case Type NON-EXPEDITED Product NUVARING Health Professional Y Health Professional Y

7810069 Date FDA Received

02-Dec-2011 Preferred Term

Case # 7810069

Manufacturer Control # 2009SP040687 Dosage Text

Age 21 YR Duration

Sex Female

Country USA

Manufacturer

SUPERIOR SAGITTAL SINUS THROMBOSIS

7821304 Date FDA Received

02-Dec-2011 Preferred Term

Case # 7821304

Case Type NON-EXPEDITED Product NUVARING

Outcomes HO,OT Role Route S VAGINAL

Manufacturer Control # 2010SP002239 Dosage Text VAG

Age 24 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM DEPRESSION

7821360 Date FDA Received

02-Dec-2011 Preferred Term

Case # 7821360

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes HO Role Route S C VAGINAL

Manufacturer Control # 2010SP000521 Dosage Text VAG

Age 21 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM CERVICAL DYSPLASIA

METRONIDAZOLE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 667 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7821386 Date FDA Received
02-Dec-2011 Preferred Term CEREBELLAR INFARCTION FATIGUE LEUKOCYTOSIS VULVOVAGINAL DISCOMFORT Case # 7821386 Case Type NON-EXPEDITED Product NUVARING Health Professional Y Outcomes HO,DS,LT Role Route S Manufacturer Control # 2009SP043045 Dosage Text Age 22 YR Duration Sex Female Country USA

Manufacturer

7823106 Date FDA Received

02-Dec-2011 Preferred Term

Case # 7823106

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes HO Role Route S

Manufacturer Control # 2010SP007773 Dosage Text

Age 43 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM ENDOMETRIOSIS FOOT DEFORMITY HEADACHE MENORRHAGIA PELVIC PAIN

7823192 Date FDA Received

02-Dec-2011 Preferred Term

Case # 7823192

Case Type NON-EXPEDITED Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2010SP007404 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

CEREBROVASCULAR ACCIDENT DEEP VEIN THROMBOSIS

7823365 Date FDA Received

02-Dec-2011 Preferred Term

Case # 7823365

Case Type NON-EXPEDITED Product NUVARING MARIJUANA ALBUTEROL

Health Professional Y

Outcomes HO,OT Role Route S C C VAGINAL

Manufacturer Control # 2010SP006324 Dosage Text ; VAG

Age 25 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM HYPERTENSION

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 668 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7823370 Date FDA Received
02-Dec-2011 Preferred Term DEEP VEIN THROMBOSIS SYNOVIAL CYST METRORRHAGIA Case # 7823370 Case Type NON-EXPEDITED Product NUVARING NAPROXEN Health Professional Y Outcomes OT Role Route S C VAGINAL Manufacturer Control # 2010SP006327 Dosage Text ;VAG Age 26 YR Duration Sex Female Country USA

Manufacturer

7825097 Date FDA Received

02-Dec-2011 Preferred Term

Case # 7825097

Case Type NON-EXPEDITED Product NUVARING ADVIL

Health Professional Y

Outcomes HO,OT Role Route S C

Manufacturer Control # 2010SP010757 Dosage Text

Age 22 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM DEEP VEIN THROMBOSIS HAEMATURIA

7825124 Date FDA Received

02-Dec-2011 Preferred Term

Case # 7825124

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes HO Role Route S C Outcomes HO Role Route S C C C

Manufacturer Control # 2010SP028286 Dosage Text

Age 35 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS MIGRAINE

VITAMINS NOS Case # 7825270 Case Type NON-EXPEDITED Product NUVARING FLOVENT FIORICET ALBUTEROL Health Professional Y

7825270 Date FDA Received

02-Dec-2011 Preferred Term

Manufacturer Control # 2010SP028335 Dosage Text

Age 35 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM ANTIPHOSPHOLIPID ANTIBODIES

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 669 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7825357 Date FDA Received
02-Dec-2011 Preferred Term CEREBROVASCULAR ACCIDENT HEAD INJURY POSTPARTUM DEPRESSION TRANSIENT ISCHAEMIC ATTACK Case # 7825357 Case Type NON-EXPEDITED Product NUVARING Health Professional Y Outcomes HO,OT Role Route S Manufacturer Control # 2009SP040689 Dosage Text Age 26 YR Duration Sex Female Country USA

Manufacturer

7825456 Date FDA Received

02-Dec-2011 Preferred Term

Case # 7825456

Case Type NON-EXPEDITED Product NUVARING NORVASC

Health Professional Y

Outcomes HO Role Route S C C C C C C C VAGINAL

Manufacturer Control # 2009SP040437 Dosage Text ;VAG

Age 30 YR Duration

Sex Female

Country USA

Manufacturer

VENA CAVA THROMBOSIS PULMONARY INFARCTION VISUAL IMPAIRMENT MENSTRUAL DISORDER PULMONARY EMBOLISM

PREDNISONE NORVASC FOLIC ACID DARVOCET-N 100 METHOTREXATE ZOLOFT

7825461 Date FDA Received

02-Dec-2011 Preferred Term

Case # 7825461

Case Type NON-EXPEDITED Product NUVARING IRON

Health Professional Y

Outcomes HO,OT Role Route S C

Manufacturer Control # 2009SP040442 Dosage Text

Age 31 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM DEEP VEIN THROMBOSIS MUSCULOSKELETAL PAIN

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 670 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7825523 Date FDA Received
02-Dec-2011 Preferred Term PELVIC VENOUS THROMBOSIS ROAD TRAFFIC ACCIDENT BACK PAIN CYSTITIS DYSPNOEA ELECTROCARDIOGRAM ABNORMAL HEADACHE HYPERLIPIDAEMIA LEUKOCYTOSIS OVARIAN MASS PHARYNGITIS STREPTOCOCCAL TACHYCARDIA THROMBOCYTOSIS THROMBOPHLEBITIS WEIGHT INCREASED Case # 7825523 Case Type NON-EXPEDITED Product NUVARING DIURETIC Health Professional Y Outcomes HO,OT Role Route S C VAGINAL Manufacturer Control # 2009SP037673 Dosage Text 1 DF;Q3W;VAG Age 38 YR Duration Sex Female Country USA

Manufacturer

7825541 Date FDA Received

02-Dec-2011 Preferred Term

Case # 7825541

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes OT Role Route S C C

Manufacturer Control # 2009SP037335 Dosage Text

Age 20 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS FIBROADENOMA OF BREAST SINUS TACHYCARDIA

NORTRIPTYLINE HYDROCHLORIDE DIGESTIVE ADVANTAGE (PROBIOTIC)

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 671 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7826296 Date FDA Received
02-Dec-2011 Preferred Term CEREBROVASCULAR ACCIDENT TRANSIENT ISCHAEMIC ATTACK ADVERSE DRUG REACTION HYPERGLYCAEMIA KIDNEY INFECTION DYSAESTHESIA DRUG HYPERSENSITIVITY URINARY TRACT INFECTION DEPRESSION MIGRAINE UNINTENDED PREGNANCY Case # 7826296 Case Type NON-EXPEDITED Product NUVARING LEVAQUIN ALBUTEROL XOPENEX ZOLOFT DIET PILL ANTIBIOTIC IBUPROFEN ADVAIR DISKUS Health Professional Y Outcomes HO,DS,OT Role Route S S C C C C C C C VAGINAL Manufacturer Control # 2009SP035179 Dosage Text ;VAG Age 34 YR Duration Sex Female Country USA

Manufacturer

7826781 Date FDA Received

02-Dec-2011 Preferred Term

Case # 7826781

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes HO Role Route S VAGINAL

Manufacturer Control # 2009SP033460 Dosage Text ;VAG

Age 17 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS PLATELET COUNT DECREASED

7826793 Date FDA Received

02-Dec-2011 Preferred Term

Case # 7826793

Case Type NON-EXPEDITED Product NUVARING

Health Professional N

Outcomes HO Role Route S

Manufacturer Control # 2009SP032948 Dosage Text

Age 23 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS PULMONARY EMBOLISM

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 672 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7826811 Date FDA Received
02-Dec-2011 Preferred Term SUBCLAVIAN VEIN THROMBOSIS SINUSITIS UPPER RESPIRATORY TRACT INFECTION HYPOTENSION VARICOSE VEIN VENOUS THROMBOSIS Case # 7826811 Case Type NON-EXPEDITED Product NUVARING SYNTHROID PLAN B Health Professional Y Outcomes HO Role Route S C C VAGINAL Manufacturer Control # 2010SP041118 Dosage Text ; VAG Age 18 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 673 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7826814 Date FDA Received
02-Dec-2011 Preferred Term DEEP VEIN THROMBOSIS ABDOMINAL PAIN ANXIETY ARTHRALGIA BUNION COUGH DEPRESSION DIARRHOEA DIVERTICULUM HAEMATURIA HEADACHE HIGH RISK SEXUAL BEHAVIOUR INSOMNIA MAMMOGRAM ABNORMAL MENSTRUATION IRREGULAR MUSCLE SPASMS NAUSEA PAIN IN EXTREMITY RENAL CYST URINARY TRACT INFECTION Case # 7826814 Case Type NON-EXPEDITED Product NUVARING Health Professional Y Outcomes HO Role Route S Manufacturer Control # 2010SP040537 Dosage Text Age 37 YR Duration Sex Female Country USA

Manufacturer

7826816 Date FDA Received

02-Dec-2011 Preferred Term

Case # 7826816

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes HO Role Route S C

Manufacturer Control # 2010SP040358 Dosage Text

Age 21 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM DEEP VEIN THROMBOSIS HEADACHE PYREXIA

ACETAMINOPHEN

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 674 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7826819 Date FDA Received
02-Dec-2011 Preferred Term PULMONARY EMBOLISM ABDOMINAL PAIN BACK PAIN BRADYCARDIA HAEMORRHAGIC ANAEMIA HYPERTENSION MIGRAINE PULMONARY INFARCTION THROMBOSIS UNINTENDED PREGNANCY Case # 7826819 Case Type NON-EXPEDITED Product NUVARING Health Professional Y Outcomes HO,DS,OT Role Route S Manufacturer Control # 2010SP006027 Dosage Text Age 28 YR Duration Sex Female Country USA

Manufacturer

7826820 Date FDA Received

02-Dec-2011 Preferred Term

Case # 7826820

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes HO Role Route S C VAGINAL

Manufacturer Control # 2010SP006041 Dosage Text ;VAG

Age 41 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM DEEP VEIN THROMBOSIS DEPRESSION EMOTIONAL DISORDER HEPATIC MASS MALLORY-WEISS SYNDROME

ACETAMINOPHEN

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 675 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7826846 Date FDA Received
02-Dec-2011 Preferred Term CEREBROVASCULAR ACCIDENT TRANSIENT ISCHAEMIC ATTACK CANDIDA TEST POSITIVE CEREBRAL INFARCTION CONSTIPATION MIGRAINE Case # 7826846 Case Type NON-EXPEDITED Product NUVARING ALBUTEROL Health Professional Y Outcomes DS,OT Role Route S C Manufacturer Control # 2010SP005471 Dosage Text Age 23 YR Duration Sex Female Country USA

Manufacturer

7826854 Date FDA Received

02-Dec-2011 Preferred Term

Case # 7826854

Case Type NON-EXPEDITED Product NUVARING DILAUDID

Health Professional Y

Outcomes HO Role Route S S VAGINAL

Manufacturer Control # 2010SP005474 Dosage Text 1 DF;QM;VAG

Age 31 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM NAUSEA VOMITING

7826866 Date FDA Received

02-Dec-2011 Preferred Term

Case # 7826866

Case Type NON-EXPEDITED Product NUVARING IMITREX

Health Professional Y

Outcomes HO,OT Role Route S C

Manufacturer Control # 2010SP004581 Dosage Text

Age 35 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM DEEP VEIN THROMBOSIS HEADACHE MENSTRUATION IRREGULAR MIGRAINE PHARYNGITIS PLEURISY UMBILICAL HERNIA VERTIGO WEIGHT INCREASED

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 676 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7826876 Date FDA Received
02-Dec-2011 Preferred Term ISCHAEMIC CEREBRAL INFARCTION TRANSIENT ISCHAEMIC ATTACK AORTIC VALVE INCOMPETENCE BREAST PAIN BREAST SWELLING DEPRESSION EMOTIONAL DISORDER IRRITABILITY MENTAL DISORDER MIGRAINE PAPILLOMA VIRAL INFECTION PHARYNGITIS STREPTOCOCCAL Case # 7826876 Case Type NON-EXPEDITED Product NUVARING CLARITIN Health Professional Y Outcomes HO,OT Role Route S C Manufacturer Control # 2010SP004567 Dosage Text Age 30 YR Duration Sex Female Country USA

Manufacturer

7826902 Date FDA Received

02-Dec-2011 Preferred Term

Case # 7826902

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes HO,OT Role Route S C C

Manufacturer Control # 2010SP004278 Dosage Text

Age 23 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM CHLAMYDIA TEST POSITIVE DIARRHOEA MUSCLE SPASMS NAUSEA VOMITING

FEMCON FE (ORAL CONTRACEPTIVE) NSAID

7827172 Date FDA Received

02-Dec-2011 Preferred Term

Case # 7827172

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes HO,OT Role Route S

Manufacturer Control # 2010SP046348 Dosage Text

Age 43 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 677 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7827268 Date FDA Received
02-Dec-2011 Preferred Term DEEP VEIN THROMBOSIS ASPARTATE AMINOTRANSFERASE INCREASED BLOOD CHOLESTEROL INCREASED HYPERTENSION Case # 7827268 Case Type NON-EXPEDITED Product NUVARING Health Professional Y Outcomes OT Role Route S Manufacturer Control # 2010SP045164 Dosage Text Age 25 YR Duration Sex Female Country USA

Manufacturer

7827322 Date FDA Received

02-Dec-2011 Preferred Term

Case # 7827322

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2010SP043234 Dosage Text

Age 26 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS ABDOMINAL PAIN GASTROINTESTINAL DISORDER PULMONARY EMBOLISM

7827370 Date FDA Received

02-Dec-2011 Preferred Term

Case # 7827370

Case Type NON-EXPEDITED Product NUVARING AGGRENOX

Health Professional Y

Outcomes HO,OT Role Route S S C VAGINAL

Manufacturer Control # 2010SP042538 Dosage Text 1 DF; QM; VAG

Age 42 YR Duration

Sex Female

Country USA

Manufacturer

CEREBROVASCULAR ACCIDENT THROMBOSIS HEADACHE ANOGENITAL WARTS DYSPHAGIA HYPERLIPIDAEMIA MENORRHAGIA PAPILLOMA VIRAL INFECTION RHINITIS ALLERGIC VARICOSE VEIN VULVOVAGINITIS

PHENTERMINE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 678 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7827379 Date FDA Received
02-Dec-2011 Preferred Term PULMONARY EMBOLISM BREAST CANCER IN SITU COAGULOPATHY Case # 7827379 Case Type NON-EXPEDITED Product NUVARING VITAMINS NOS Health Professional Y Outcomes HO,LT,OT Role Route S C Manufacturer Control # 2010SP042279 Dosage Text Age 45 YR Duration Sex Female Country USA

Manufacturer

7828753 Date FDA Received

02-Dec-2011 Preferred Term

Case # 7828753

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes HO Role Route S

Manufacturer Control # 2010SP031955 Dosage Text

Age 26 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY INFARCTION ABDOMINAL PAIN NAUSEA PULMONARY EMBOLISM RETROPERITONEUM CYST VOMITING

7828762 Date FDA Received

02-Dec-2011 Preferred Term

Case # 7828762

Case Type NON-EXPEDITED Product NUVARING

Health Professional N

Outcomes HO Role Route S

Manufacturer Control # 2010SP031885 Dosage Text

Age 21 YR Duration

Sex Female

Country USA

Manufacturer

SUPERIOR SAGITTAL SINUS THROMBOSIS INCORRECT DRUG ADMINISTRATION DURATION THROMBOSIS

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 679 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7828776 Date FDA Received
02-Dec-2011 Preferred Term PULMONARY EMBOLISM DEEP VEIN THROMBOSIS LUNG INFILTRATION VAGINITIS BACTERIAL Case # 7828776 Case Type NON-EXPEDITED Product NUVARING Health Professional Y Outcomes HO,OT Role Route S Manufacturer Control # 2010SP031305 Dosage Text Age Sex Country USA < 1 DAY Female Duration

Manufacturer

7846456 Date FDA Received

02-Dec-2011 Preferred Term

Case # 7846456

Case Type NON-EXPEDITED Product NUVARING

Health Professional N

Outcomes HO,LT Role Route S

Manufacturer Control # 2010SP028235 Dosage Text

Age 20 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS HEADACHE MENSTRUAL DISCOMFORT MENTAL DISORDER PULMONARY EMBOLISM

7848491 Date FDA Received

02-Dec-2011 Preferred Term

Case # 7848491

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes HO,OT Role Route S

Manufacturer Control # 2010SP046450 Dosage Text

Age 27 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM HYPERCOAGULATION

7900720 Date FDA Received

02-Dec-2011 Preferred Term

Case # 7900720

Case Type NON-EXPEDITED Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2011SP000809 Dosage Text

Age 26 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 680 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8235156 Date FDA Received
02-Dec-2011 Preferred Term MUSCLE TWITCHING IRRITABILITY VIITH NERVE PARALYSIS Case # 8235156 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes OT Role Route S VAGINAL Manufacturer Control # 2011SP050886 Dosage Text VAG Age 43 YR Duration Sex Female Country USA

Manufacturer

8246462 Date FDA Received

02-Dec-2011 Preferred Term VAGINAL INFECTION

Case # 8246462

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S C

Manufacturer Control # 2011SP020383 Dosage Text

Age 31 YR Duration

Sex Female

Country FRA

Manufacturer

PREGNANCY WITH CONTRACEPTIVE DEVICE BRONCHITIS FUNGAL INFECTION GESTATIONAL DIABETES INFLUENZA VULVOVAGINAL MYCOTIC INFECTION

AMOXICILLIN TRIHYDRATE

8248138 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8248138

Case Type NON-EXPEDITED Product NUVARING SYNTHROID

Health Professional Y

Outcomes HO,OT Role Route S C

Manufacturer Control # 2011SP019417 Dosage Text

Age 36 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM CHEST PAIN ACUTE SINUSITIS ATELECTASIS OBESITY PALPITATIONS TINEA INFECTION

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 681 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8264091 Date FDA Received
02-Dec-2011 Preferred Term DEEP VEIN THROMBOSIS GALLBLADDER DISORDER PAIN Case # 8264091 Case Type NON-EXPEDITED Product NUVARING Health Professional N Outcomes HO,OT Role Route S Manufacturer Control # 2011SP025636 Dosage Text Age 32 YR Duration Sex Female Country USA

Manufacturer

8270261 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8270261

Case Type NON-EXPEDITED Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2011SP014799 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

DEEP VEIN THROMBOSIS PULMONARY EMBOLISM

8272352 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8272352

Case Type DIRECT Product NUVARING

Health Professional Y

Outcomes HO Role Route S VAGINAL

Manufacturer Control #

Age 17 YR

Sex Female

Country USA

Dosage Text

Duration 5 MTH

Manufacturer

INTRACRANIAL VENOUS SINUS THROMBOSIS SINUSITIS

8274428 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8274428

Case Type NON-EXPEDITED Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2011SP016572 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

DEEP VEIN THROMBOSIS PULMONARY EMBOLISM

8276296 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8276296

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes HO Role Route S VAGINAL

Manufacturer Control # 2011SP022381 Dosage Text ;VAG

Age

Sex Female

Country USA

Duration

Manufacturer

DEEP VEIN THROMBOSIS

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 682 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8292994 Date FDA Received
02-Dec-2011 Preferred Term EYELID OEDEMA ABDOMINAL PAIN UPPER DYSPNOEA HAEMORRHAGE HYPERSENSITIVITY SWELLING FACE VULVOVAGINAL DRYNESS Case # 8292994 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO Role Route S VAGINAL Manufacturer Control # 2011SP055046 Dosage Text VAG Age 25 YR Duration Sex Female Country SWE

Manufacturer

8304061 Date FDA Received

02-Dec-2011 Preferred Term SLEEP DISORDER DEVICE EXPULSION EPILEPSY

Case # 8304061

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2011SP055228 Dosage Text QM; VAG

Age 25 YR Duration

Sex Female

Country CHL

Manufacturer

INAPPROPRIATE AFFECT INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION INSULIN RESISTANCE METRORRHAGIA

8335870 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8335870

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes

Manufacturer Control # 2010SP045373

Age

Sex Female

Country USA

Role Route S VAGINAL

Dosage Text VAG

Duration

Manufacturer

MEDICAL DEVICE DISCOMFORT

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 683 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8336768 Date FDA Received
02-Dec-2011 Preferred Term DEEP VEIN THROMBOSIS Case # 8336768 Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING SYNTHROID Case Type NON-EXPEDITED Product NUVARING Health Professional Y Health Professional Y Health Professional N Outcomes HO Role Route S Outcomes HO,LT Role Route S C Outcomes HO Role Route S Manufacturer Control # 2010SP050733 Dosage Text Age 31 YR Duration Sex Female Country USA VAGINAL Manufacturer Control # 2010SP049764 Dosage Text VAG Age 46 YR Duration Sex Female Country USA Manufacturer Control # 2010SP049199 Dosage Text Age 37 YR Duration Sex Female Country USA

Manufacturer

8338330 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8338330

Manufacturer

DEEP VEIN THROMBOSIS PULMONARY EMBOLISM

8338334 Date FDA Received

02-Dec-2011 Preferred Term THROMBOSIS DEPRESSION MIGRAINE

Case # 8338334

Manufacturer

PULMONARY EMBOLISM SLEEP APNOEA SYNDROME WEIGHT INCREASED

8338338 Date FDA Received

02-Dec-2011 Preferred Term THROMBOSIS DEPRESSION

Case # 8338338

Case Type NON-EXPEDITED Product NUVARING ALDOMET

Health Professional Y

Outcomes HO Role Route S C

Manufacturer Control # 2010SP050753 Dosage Text

Age 34 YR Duration

Sex Female

Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 684 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8338342 Date FDA Received
02-Dec-2011 Preferred Term DEEP VEIN THROMBOSIS DYSPNOEA Case # 8338342 Case Type NON-EXPEDITED Product NUVARING Health Professional Y Outcomes HO,DS Role Route S Manufacturer Control # 2010SP051420 Dosage Text Age 25 YR Duration Sex Female Country USA

Manufacturer

8338367 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8338367

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes HO Role Route S

Manufacturer Control # 2010SP032263 Dosage Text 1 DF;QM

Age 24 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM THROMBOSIS

8338734 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8338734

Case Type NON-EXPEDITED Product NUVARING LEVOXYL ALBUTEROL LIPITOR

Health Professional Y

Outcomes HO Role Route S C C C VAGINAL

Manufacturer Control # 2010SP002393 Dosage Text 1 DF;QM;VAG

Age 31 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS VULVOVAGINAL CANDIDIASIS VAGINITIS BACTERIAL

8338798 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8338798

Case Type NON-EXPEDITED Product NUVARING NEURONTIN SOMA PROTONIX NICOTINE

Health Professional Y

Outcomes HO,LT,OT Role Route S C C C C C C

Manufacturer Control # 2011SP026360 Dosage Text

Age 25 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM DEEP VEIN THROMBOSIS

ACETAMINOPHEN COLACE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 685 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8338801 Date FDA Received
02-Dec-2011 Preferred Term PULMONARY EMBOLISM Case # 8338801 Case Type NON-EXPEDITED Product NUVARING ZOLOFT Health Professional Y Outcomes HO,LT Role Route S C Health Professional Y Outcomes HO Role Route S Manufacturer Control # 2011SP025887 Dosage Text 1 DF Duration Age Sex Female Country USA VAGINAL Manufacturer Control # 2011SP026385 Dosage Text 0.120 MG;QM;VAG Age 40 YR Duration Sex Female Country USA

Manufacturer

8338803 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8338803

Case Type NON-EXPEDITED Product NUVARING

Manufacturer

VAGINAL HAEMORRHAGE INCORRECT DRUG ADMINISTRATION DURATION

8338806 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8338806

Case Type NON-EXPEDITED Product NUVARING CELEXA

Health Professional Y

Outcomes HO,LT Role Route S C VAGINAL

Manufacturer Control # 2011SP025613 Dosage Text VAG

Age 31 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM

8338813 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8338813

Case Type NON-EXPEDITED Product NUVARING

Health Professional N

Outcomes HO Role Route S

Manufacturer Control # 2011SP025678 Dosage Text

Age 34 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM DEEP VEIN THROMBOSIS

8338814 Date FDA Received

02-Dec-2011 Preferred Term THROMBOSIS

Case # 8338814

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2011SP025555 Dosage Text 1 DF

Age

Sex Female

Country USA

Duration

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 686 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8338844 Date FDA Received
02-Dec-2011 Preferred Term PULMONARY EMBOLISM DEEP VEIN THROMBOSIS Case # 8338844 Case Type NON-EXPEDITED Product NUVARING Health Professional N Outcomes OT Role Route S Manufacturer Control # 2011SP003706 Dosage Text Duration Age Sex Female Country USA

Manufacturer

8338860 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8338860

Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2011SP003696 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

DEEP VEIN THROMBOSIS

8338880 Date FDA Received

02-Dec-2011 Preferred Term RASH GENERALISED

Case # 8338880

Health Professional Y

Outcomes HO,OT Role Route S VAGINAL

Manufacturer Control # 2011SP028743 Dosage Text VAG Manufacturer Control # 2011SP028093 Dosage Text

Age 21 YR Duration

Sex Female

Country USA

Manufacturer

8338884 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8338884

Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING

Health Professional N

Outcomes OT Role Route S

Age

Sex Female

Country USA

Duration

Manufacturer

CEREBROVASCULAR ACCIDENT

8338885 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8338885

Health Professional Y

Outcomes HO,OT Role Route S

Manufacturer Control # 2011SP003697 Dosage Text

Age 24 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM DEEP VEIN THROMBOSIS DEPRESSION

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 687 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8338886 Date FDA Received
02-Dec-2011 Preferred Term DEEP VEIN THROMBOSIS Case # 8338886 Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Health Professional Y Health Professional N Health Professional Y Health Professional Y Outcomes HO Role Route S Outcomes HO Role Route S Outcomes OT Role Route S Outcomes HO,OT Role Route S Manufacturer Control # 2011SP003682 Dosage Text Age 24 YR Duration Sex Female Country USA Manufacturer Control # 2011SP027508 Dosage Text 1 DF Manufacturer Control # 2011SP027509 Dosage Text 1 DF Manufacturer Control # 2011SP027541 Dosage Text Duration Age Sex Female Country USA Age 30 YR Duration Sex Female Country USA Age 27 YR Duration Sex Female Country USA

Manufacturer

8338888 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8338888

Manufacturer

DEEP VEIN THROMBOSIS

8338896 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8338896

Manufacturer

DEEP VEIN THROMBOSIS

8338899 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8338899

Manufacturer

PULMONARY EMBOLISM ABORTION INDUCED CHLAMYDIA TEST POSITIVE PULMONARY INFARCTION UNINTENDED PREGNANCY

8338903 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8338903

Case Type NON-EXPEDITED Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2011SP027543 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

DEEP VEIN THROMBOSIS

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 688 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8338904 Date FDA Received
02-Dec-2011 Preferred Term FLUID RETENTION Case # 8338904 Case Type NON-EXPEDITED Product NUVARING Case # 8338905 Case Type NON-EXPEDITED Product NUVARING NUVARING Health Professional Y Health Professional N Outcomes OT Role Route S VAGINAL Manufacturer Control # 2011SP027028 Dosage Text VAG Manufacturer Control # 2011SP003660 Dosage Text Age 32 YR Duration Sex Female Country USA Duration Age Sex Female Country USA

Manufacturer

8338905 Date FDA Received

02-Dec-2011 Preferred Term

Outcomes HO,OT Role Route S S

Manufacturer

PULMONARY EMBOLISM

8338909 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8338909

Case Type NON-EXPEDITED Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2011SP026442 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

DEEP VEIN THROMBOSIS PULMONARY EMBOLISM

8338910 Date FDA Received

02-Dec-2011 Preferred Term THROMBOSIS

Case # 8338910

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2011SP002757 Dosage Text VAG Manufacturer Control # 2011SP026444 Dosage Text

Age 36 YR Duration

Sex Female

Country USA

Manufacturer

8338911 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8338911

Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING

Health Professional N

Outcomes HO Role Route S

Age 44 YR Duration

Sex Female

Country USA

Manufacturer

TRANSVERSE SINUS THROMBOSIS

8338913 Date FDA Received

02-Dec-2011 Preferred Term THROMBOSIS

Case # 8338913

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2011SP002270 Dosage Text QM;VAG

Age 18 YR Duration

Sex Female

Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 689 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8338916 Date FDA Received
02-Dec-2011 Preferred Term PULMONARY EMBOLISM Case # 8338916 Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case # 8338932 Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Health Professional Y Health Professional Y Health Professional Y Role Route S VAGINAL Health Professional N Outcomes OT Role Route S Outcomes Manufacturer Control # 2011SP001890 Dosage Text Q3W;VAG Manufacturer Control # 2011SP001433 Dosage Text QD;VAG Manufacturer Control # 2011SP014615 Dosage Text Age 43 YR Duration Sex Female Country USA Duration Age Sex Female Country USA Age 33 YR Duration Sex Female Country USA Manufacturer Control # 2011SP001879 Dosage Text Duration Age Sex Female Country USA

Manufacturer

8338929 Date FDA Received

02-Dec-2011 Preferred Term DEVICE EXPULSION

Case # 8338929

Manufacturer

8338932 Date FDA Received

02-Dec-2011 Preferred Term

Outcomes OT Role Route S VAGINAL

Manufacturer

TOXIC SHOCK SYNDROME

8339063 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8339063

Outcomes HO,OT Role Route S

Manufacturer

PULMONARY EMBOLISM ANTIBODY TEST POSITIVE DEEP VEIN THROMBOSIS FEELING COLD HYDROMETRA HYPOAESTHESIA THYROID DISORDER TREMOR

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 690 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8339068 Date FDA Received
02-Dec-2011 Preferred Term POST-TRAUMATIC STRESS DISORDER PULMONARY EMBOLISM THROMBOSIS Case # 8339068 Case Type NON-EXPEDITED Product NUVARING Health Professional Y Outcomes HO Role Route S Manufacturer Control # 2011SP014622 Dosage Text Age 22 YR Duration Sex Female Country USA

Manufacturer

8339079 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8339079

Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2011SP014051 Dosage Text

Age 16 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS

8339115 Date FDA Received

02-Dec-2011 Preferred Term THROMBOSIS

Case # 8339115

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2010SP053882 Dosage Text

Age 38 YR Duration

Sex Female

Country USA

Manufacturer

8339134 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8339134

Case Type NON-EXPEDITED Product NUVARING

Health Professional N

Outcomes HO Role Route S C

Manufacturer Control # 2010SP053378 Dosage Text

Age 22 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS DEPRESSION DEHYDRATION GASTROINTESTINAL DISORDER

MIDODRINE HYDROCHLORIDE

8339168 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8339168

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2011SP013606 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

PULMONARY EMBOLISM

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 691 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8339172 Date FDA Received
02-Dec-2011 Preferred Term DEEP VEIN THROMBOSIS Case # 8339172 Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING LISINOPRIL AND HYDROCHLOROTHIAZIDE Case # 8339291 Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING IBUPROFEN Case Type NON-EXPEDITED Product NUVARING Health Professional N Health Professional Y Health Professional N Health Professional N Health Professional Y Outcomes OT Role Route S VAGINAL Manufacturer Control # 2011SP012995 Dosage Text VAG Manufacturer Control # 2011SP011851 Dosage Text VAG Age 40 YR Duration Sex Female Country USA Duration Age Sex Female Country USA

Manufacturer

8339269 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8339269

Outcomes OT Role Route S C Outcomes OT Role Route S Outcomes HO Role Route S C Outcomes OT Role Route S VAGINAL VAGINAL

Manufacturer

BLOOD PRESSURE INCREASED MIGRAINE

8339291 Date FDA Received

02-Dec-2011 Preferred Term

Manufacturer Control # 2011SP011690 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

PULMONARY EMBOLISM

8339565 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8339565

Manufacturer Control # 2010SP016729 Dosage Text

Age 27 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM VULVOVAGINAL MYCOTIC INFECTION

8339660 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8339660

Manufacturer Control # 2011SP011658 Dosage Text ;VAG

Age 32 YR Duration

Sex Female

Country USA

Manufacturer

BLOOD PRESSURE INCREASED HEADACHE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 692 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8339661 Date FDA Received
02-Dec-2011 Preferred Term CEREBROVASCULAR ACCIDENT Case # 8339661 Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Health Professional N Health Professional Y Health Professional Y Outcomes HO Role Route S VAGINAL Manufacturer Control # 2011SP011196 Dosage Text VAG Manufacturer Control # 2011SP010890 Dosage Text ;VAG Manufacturer Control # 2011SP010634 Dosage Text ;VAG Age 19 YR Duration Sex Female Country USA Age 24 YR Duration Sex Female Country USA Age 46 YR Duration Sex Female Country USA

Manufacturer

8339681 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8339681

Outcomes OT Role Route S VAGINAL

Manufacturer

PULMONARY EMBOLISM

8339701 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8339701

Outcomes OT Role Route S VAGINAL

Manufacturer

ABNORMAL WITHDRAWAL BLEEDING HYPERSENSITIVITY PAIN

8339706 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8339706

Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes HO,LT Role Route S VAGINAL

Manufacturer Control # 2011SP010052 Dosage Text 0.120 MG, QD, VAG Manufacturer Control # 2009SP23522 Dosage Text 1 DF

Age 50 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS

8339842 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8339842

Health Professional Y

Outcomes HO,OT Role Route S C

Age 31 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS DRUG HYPERSENSITIVITY OLIGOMENORRHOEA PULMONARY EMBOLISM

METFORMIN HYDROCHLORIDE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 693 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8340861 Date FDA Received
02-Dec-2011 Preferred Term PULMONARY EMBOLISM NASOPHARYNGITIS DIARRHOEA FATIGUE FLANK PAIN MIGRAINE Case # 8340861 Case Type NON-EXPEDITED Product NUVARING KLONOPIN Health Professional Y Outcomes HO Role Route S S 1 MG;PRN Manufacturer Control # 2010SP049206 Dosage Text Age 46 YR Duration Sex Female Country USA

Manufacturer

8341083 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8341083

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes OT Role Route S C C

Manufacturer Control # 2010SP020840 Dosage Text

Age 29 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS CHEST PAIN THROMBOPHLEBITIS ABDOMINAL PAIN VAGINAL DISCHARGE

RISPERIDONE ZOLOFT

8341110 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8341110

Case Type NON-EXPEDITED Product NUVARING

Health Professional N

Outcomes HO Role Route S C C C C C

Manufacturer Control # 2009SP040685 Dosage Text

Age 18 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS MIGRAINE FUNGAL INFECTION

ADVAIR DISKUS SINGULAIR ALBUTEROL ULTRAM FLEXERIL

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 694 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8341112 Date FDA Received
02-Dec-2011 Preferred Term DEEP VEIN THROMBOSIS Case # 8341112 Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING ADVAIR DISKUS ALBUTEROL IMITREX EXCEDRIN Health Professional N Health Professional Y Outcomes HO,LT,OT Role Route S VAGINAL Manufacturer Control # 2011SP005990 Dosage Text 1 DF;VAG Manufacturer Control # 2011SP005931 Dosage Text Age 17 YR Duration Sex Female Country USA Age 35 YR Duration Sex Female Country USA

Manufacturer

8341120 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8341120

Outcomes HO Role Route S C C C C

Manufacturer

PULMONARY EMBOLISM DEPRESSION ANXIETY

8341122 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8341122

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes HO Role Route S

Manufacturer Control # 2011SP005937 Dosage Text

Age 29 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM HYPOTHYROIDISM

8341123 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8341123

Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes HO Role Route S VAGINAL

Manufacturer Control # 2011SP024587 Dosage Text ;VAG Manufacturer Control # 2011SP005496 Dosage Text VAG

Age 33 YR Duration

Sex Female

Country USA

Manufacturer

CEREBROVASCULAR ACCIDENT

8341132 Date FDA Received

02-Dec-2011 Preferred Term THROMBOSIS

Case # 8341132

Health Professional N

Outcomes OT Role Route S VAGINAL

Age 31 YR Duration

Sex Female

Country USA

Manufacturer

INCORRECT DRUG ADMINISTRATION DURATION

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 695 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8341139 Date FDA Received
02-Dec-2011 Preferred Term DEEP VEIN THROMBOSIS Case # 8341139 Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Health Professional Y Health Professional N Outcomes OT Role Route S Outcomes HO Role Route S Manufacturer Control # 2011SP004773 Dosage Text Age 20 YR Duration Sex Female Country USA Manufacturer Control # 2011SP005105 Dosage Text Duration Age Sex Female Country USA

Manufacturer

8341140 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8341140

Manufacturer

DEEP VEIN THROMBOSIS DENTAL CARE EMOTIONAL DISORDER MENTAL DISORDER ORAL SURGERY

8341143 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8341143

Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes HO Role Route S VAGINAL

Manufacturer Control # 2011SP004359 Dosage Text VAG Manufacturer Control # 2011SP003954 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

PULMONARY EMBOLISM

8341146 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8341146

Health Professional N

Outcomes HO Role Route S

Age

Sex Female

Country USA

Duration

Manufacturer

PULMONARY EMBOLISM

8341147 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8341147

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2011SP022605 Dosage Text 1 DF;

Age 50 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM DEEP VEIN THROMBOSIS

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 696 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8341148 Date FDA Received
02-Dec-2011 Preferred Term DEEP VEIN THROMBOSIS CHEST PAIN DEPRESSION HEADACHE Case # 8341148 Case Type NON-EXPEDITED Product NUVARING Health Professional Y Outcomes HO,DS Role Route S Manufacturer Control # 2011SP003704 Dosage Text Age 24 YR Duration Sex Female Country USA

Manufacturer

8341150 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8341150

Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes HO Role Route S VAGINAL

Manufacturer Control # 2011SP021630 Dosage Text ;VAG Manufacturer Control # 2011SP021659

Age

Sex Female

Country USA

Duration

Manufacturer

CEREBRAL THROMBOSIS

8341154 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8341154

Health Professional Y

Outcomes LT Role Route S VAGINAL

Age 34 YR Duration

Sex Female

Country USA

Dosage Text ;VAG Manufacturer Control # 2011SP021316 Dosage Text ;QM;VAG

Manufacturer

PULMONARY EMBOLISM

8341165 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8341165

Health Professional Y

Outcomes HO Role Route S VAGINAL

Age 27 YR Duration

Sex Female

Country USA

Manufacturer

CEREBRAL THROMBOSIS CEREBROVASCULAR ACCIDENT MUSCULAR WEAKNESS PARAESTHESIA

8341168 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8341168

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes HO Role Route S VAGINAL

Manufacturer Control # 2011SP020811 Dosage Text 1 DF;QM;VAG

Age 45 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS PULMONARY EMBOLISM

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 697 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8341173 Date FDA Received
02-Dec-2011 Preferred Term DEEP VEIN THROMBOSIS THROMBOSIS WITHDRAWAL BLEED Case # 8341173 Case Type NON-EXPEDITED Product NUVARING SYNTHROID Health Professional Y Outcomes OT Role Route S C VAGINAL Manufacturer Control # 2011SP020783 Dosage Text 1 DF; ;VAG Age 21 YR Duration Sex Female Country USA

Manufacturer

8341188 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8341188

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes HO,OT Role Route S

Manufacturer Control # 2010SP058813 Dosage Text

Age 33 YR Duration

Sex Female

Country USA

Manufacturer

INTRACRANIAL VENOUS SINUS THROMBOSIS HEADACHE HYPERCOAGULATION HYPOKALAEMIA SINUSITIS TYMPANOSCLEROSIS

8341195 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8341195

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes HO Role Route S

Manufacturer Control # 2010SP059078 Dosage Text

Age 23 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM BRONCHITIS DEEP VEIN THROMBOSIS MUSCLE SPASMS OROPHARYNGEAL PAIN RHINORRHOEA

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 698 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8341199 Date FDA Received
02-Dec-2011 Preferred Term DEEP VEIN THROMBOSIS VULVOVAGINAL PRURITUS PAIN IN EXTREMITY Case # 8341199 Case Type NON-EXPEDITED Product NUVARING MOTRIN Health Professional Y Outcomes HO Role Route S C Manufacturer Control # 2010SP059989 Dosage Text Age 25 YR Duration Sex Female Country USA

Manufacturer

8341200 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8341200

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes OT Role Route S C Outcomes HO Role Route S VAGINAL VAGINAL

Manufacturer Control # 2010SP060697 Dosage Text 1 DF; ;VAG

Age 23 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS

ORTHO TRI CYCLEN

8341202 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8341202

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Manufacturer Control # 2011SP020555 Dosage Text VAG

Age 22 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM THROMBOSIS

8341205 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8341205

Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING IMPLANON BENICAR

Health Professional Y

Outcomes HO,DS,LT,OT Role Route S VAGINAL

Manufacturer Control # 2011SP020515 Dosage Text QM;VAG Manufacturer Control # 2010SP060203 Dosage Text 1 DF; ;VAG

Age 40 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY THROMBOSIS

8341206 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8341206

Health Professional Y

Outcomes HO,LT Role Route S C C VAGINAL

Age 29 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 699 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8341207 Date FDA Received
02-Dec-2011 Preferred Term EMBOLISM Case # 8341207 Case Type NON-EXPEDITED Product NUVARING Case # 8341209 Case Type NON-EXPEDITED Product NUVARING SYNTHROID Case # 8341219 Case Type NON-EXPEDITED Product NUVARING Case # 8341220 Case Type NON-EXPEDITED Product NUVARING Health Professional Y Health Professional N Health Professional Y Health Professional Y Outcomes OT Role Route S VAGINAL Manufacturer Control # 2011SP020428 Dosage Text VAG Manufacturer Control # 2010SP059901 Dosage Text Age 31 YR Duration Sex Female Country USA Duration Age Sex Female Country USA

Manufacturer

8341209 Date FDA Received

02-Dec-2011 Preferred Term

Outcomes HO,LT,OT Role Route S C Outcomes OT Role Route S VAGINAL

Manufacturer

PULMONARY EMBOLISM MIGRAINE

8341219 Date FDA Received

02-Dec-2011 Preferred Term THROMBOSIS

Manufacturer Control # 2010SP058790 Dosage Text 1 DF;QM;VAG Manufacturer Control # 2011SP019418 Dosage Text

Age 19 YR Duration

Sex Female

Country USA

Manufacturer

8341220 Date FDA Received

02-Dec-2011 Preferred Term

Outcomes HO,DS Role Route S

Age 40 YR Duration

Sex Female

Country USA

Manufacturer

CEREBROVASCULAR ACCIDENT DYSLIPIDAEMIA MENTAL DISORDER

8341228 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8341228

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2010SP058149 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

DEEP VEIN THROMBOSIS

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 700 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8341231 Date FDA Received
02-Dec-2011 Preferred Term PULMONARY EMBOLISM Case # 8341231 Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Health Professional Y Health Professional Y Health Professional N Outcomes OT Role Route S Outcomes OT Role Route S Outcomes HO,DS Role Route S Manufacturer Control # 2011SP017862 Dosage Text Age 31 YR Duration Sex Female Country USA Manufacturer Control # 2010SP058153 Dosage Text Duration Age Sex Female Country USA Manufacturer Control # 2011SP019155 Dosage Text Duration Age Sex Female Country USA

Manufacturer

8341232 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8341232

Manufacturer

DEEP VEIN THROMBOSIS

8341235 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8341235

Manufacturer

PULMONARY EMBOLISM EMOTIONAL DISORDER MENTAL DISORDER UNINTENDED PREGNANCY

8341242 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8341242

Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING

Health Professional N

Outcomes HO Role Route S VAGINAL

Manufacturer Control # 2010SP060871 Dosage Text 1 DF; ;VAG Manufacturer Control # 2010SP055008 Dosage Text 1 DF;QM;VAG

Age

Sex Female

Country USA

Duration

Manufacturer

CEREBROVASCULAR ACCIDENT

8341314 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8341314

Health Professional Y

Outcomes HO Role Route S VAGINAL

Age 19 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS THROMBOSIS

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 701 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8341348 Date FDA Received
02-Dec-2011 Preferred Term CEREBROVASCULAR ACCIDENT Case # 8341348 Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Health Professional Y Health Professional N Health Professional Y Outcomes HO,LT,OT Role Route S VAGINAL Manufacturer Control # 2010SP056178 Dosage Text ;VAG Manufacturer Control # 2011SP046462 Dosage Text Duration Age Sex Female Country USA Age 20 YR Duration Sex Female Country USA

Manufacturer

8341352 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8341352

Outcomes OT Role Route S Outcomes HO Role Route S

Manufacturer

PULMONARY EMBOLISM

8341356 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8341356

Manufacturer Control # 2010SP055017 Dosage Text

Age 21 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM COGNITIVE DISORDER DEEP VEIN THROMBOSIS DEPRESSION EMOTIONAL DISORDER MENTAL DISORDER SCIATICA URINARY TRACT INFECTION

8341359 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8341359

Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2011SP046465 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

DEEP VEIN THROMBOSIS

8341367 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8341367

Health Professional Y

Outcomes HO,LT,OT Role Route S VAGINAL

Manufacturer Control # 2010SP058103 Dosage Text 1 DF; ;VAG

Age 24 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 702 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8341375 Date FDA Received
02-Dec-2011 Preferred Term PULMONARY EMBOLISM Case # 8341375 Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Health Professional Y Health Professional N Health Professional N Health Professional N Outcomes OT Role Route S Outcomes OT Role Route S Outcomes OT Role Route S Outcomes OT Role Route S Manufacturer Control # 2010SP057201 Dosage Text 1 DF; Age 40 YR Duration Sex Female Country USA Manufacturer Control # 2011SP046642 Dosage Text Duration Age Sex Female Country USA Manufacturer Control # 2011SP046641 Dosage Text Duration Age Sex Female Country USA Manufacturer Control # 2011SP046640 Dosage Text Duration Age Sex Female Country USA

Manufacturer

8341382 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8341382

Manufacturer

CEREBROVASCULAR ACCIDENT

8341386 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8341386

Manufacturer

PULMONARY EMBOLISM

8341388 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8341388

Manufacturer

DEEP VEIN THROMBOSIS THROMBOSIS

8341394 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8341394

Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING

Health Professional N

Outcomes HO Role Route S

Manufacturer Control # 2010SP056798 Dosage Text

Age 20 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS

8341395 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8341395

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2011SP046646 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

CEREBROVASCULAR ACCIDENT

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 703 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8341414 Date FDA Received
02-Dec-2011 Preferred Term PHLEBITIS PAIN Case # 8341414 Case Type NON-EXPEDITED Product NUVARING Health Professional Y Outcomes OT Role Route S VAGINAL Manufacturer Control # 2010SP056782 Dosage Text ;VAG Duration Age Sex Female Country USA

Manufacturer

8341418 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8341418

Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2011SP017556 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

PULMONARY EMBOLISM

8341423 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8341423

Health Professional Y

Outcomes HO Role Route S C VAGINAL

Manufacturer Control # 2010SP056683 Dosage Text 1 DF; ;VAG

Age 17 YR Duration

Sex Female

Country USA

Manufacturer

BLOOD PRESSURE INCREASED ANGER AGITATION

PHENTERMINE

8341424 Date FDA Received

02-Dec-2011 Preferred Term HYPERTENSION DIZZINESS PRESYNCOPE

Case # 8341424

Case Type NON-EXPEDITED Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2011SP017493 Dosage Text VAG

Age 41 YR Duration

Sex Female

Country USA

Manufacturer

8341425 Date FDA Received

02-Dec-2011 Preferred Term MIGRAINE

Case # 8341425

Case Type NON-EXPEDITED Product NUVARING

Health Professional N

Outcomes HO Role Route S VAGINAL

Manufacturer Control # 2010SP055703 Dosage Text ;VAG

Age 18 YR Duration

Sex Female

Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 704 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8341427 Date FDA Received
02-Dec-2011 Preferred Term PULMONARY EMBOLISM Case # 8341427 Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Health Professional Y Health Professional Y Health Professional Y Outcomes HO,DS Role Route S VAGINAL Manufacturer Control # 2011SP017272 Dosage Text VAG Manufacturer Control # 2011SP017277 Dosage Text 1 DF Manufacturer Control # 2010SP054128 Dosage Text 1 DF;QD;VAG Age 26 YR Duration Sex Female Country USA Duration Age Sex Female Country USA Age 29 YR Duration Sex Female Country USA

Manufacturer

8341428 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8341428

Outcomes OT Role Route S Outcomes HO,LT,OT Role Route S VAGINAL

Manufacturer

PULMONARY EMBOLISM

8341432 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8341432

Manufacturer

PULMONARY EMBOLISM INCORRECT DRUG ADMINISTRATION DURATION

8341439 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8341439

Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2011SP017278 Dosage Text 1 DF Manufacturer Control # 2011SP017280 Dosage Text 1 DF Manufacturer Control # 2011SP017282 Dosage Text 1 DF

Age

Sex Female

Country USA

Duration

Manufacturer

PULMONARY EMBOLISM

8341469 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8341469

Health Professional Y

Outcomes OT Role Route S

Age

Sex Female

Country USA

Duration

Manufacturer

PULMONARY EMBOLISM

8341500 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8341500

Health Professional Y

Outcomes OT Role Route S

Age

Sex Female

Country USA

Duration

Manufacturer

PULMONARY EMBOLISM

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 705 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8341506 Date FDA Received
02-Dec-2011 Preferred Term PULMONARY EMBOLISM Case # 8341506 Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING CENTRUM CITALOPRAM HYDROBROMIDE Health Professional Y Health Professional N Health Professional N Health Professional Y Outcomes OT Role Route S Outcomes OT Role Route S Outcomes OT Role Route S Outcomes HO,LT,OT Role Route S C C Outcomes HO,LT,OT Role Route S C VAGINAL Manufacturer Control # 2011SP037534 Dosage Text ;VAG Age 52 YR Duration Sex Female Country USA VAGINAL Manufacturer Control # 2011SP034061 Dosage Text 1 DF; QM; VAG Age 31 YR Duration Sex Female Country USA Manufacturer Control # 2011SP040945 Dosage Text Duration Age Sex Female Country USA Manufacturer Control # 2011SP017284 Dosage Text 1 DF Manufacturer Control # 2011SP016557 Dosage Text Age 27 YR Duration Sex Female Country USA Duration Age Sex Female Country USA

Manufacturer

8341507 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8341507

Manufacturer

PULMONARY EMBOLISM

8341606 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8341606

Manufacturer

DEEP VEIN THROMBOSIS

8341611 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8341611

Manufacturer

PULMONARY EMBOLISM

8341613 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8341613

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Manufacturer

PULMONARY EMBOLISM

METHOTREXATE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 706 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8341630 Date FDA Received
02-Dec-2011 Preferred Term PULMONARY EMBOLISM DEEP VEIN THROMBOSIS Case # 8341630 Case Type NON-EXPEDITED Product NUVARING Health Professional N Outcomes HO Role Route S Manufacturer Control # 2011SP032589 Dosage Text Age 27 YR Duration Sex Female Country USA

Manufacturer

8341633 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8341633

Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING COUMADIN

Health Professional N

Outcomes HO,DS,LT,OT Role Route S VAGINAL

Manufacturer Control # 2011SP039431 Dosage Text ;VAG;VAG Manufacturer Control # 2011SP032317 Dosage Text VAG Manufacturer Control # 2011SP031789 Dosage Text

Age 40 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM

8341643 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8341643

Health Professional N

Outcomes HO,LT Role Route S VAGINAL

Age 20 YR Duration

Sex Female

Country USA

Manufacturer

CEREBROVASCULAR ACCIDENT

8341673 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8341673

Health Professional N

Outcomes HO Role Route S

Age 48 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS

8341680 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8341680

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2011SP040391 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

PULMONARY EMBOLISM

8341685 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8341685

Health Professional Y

Outcomes HO Role Route S C VAGINAL

Manufacturer Control # 2011SP038475 Dosage Text ;VAG

Age

Sex Female

Country USA

Duration

Manufacturer

DEEP VEIN THROMBOSIS

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 707 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8341690 Date FDA Received
02-Dec-2011 Preferred Term PULMONARY EMBOLISM OEDEMA PERIPHERAL Case # 8341690 Case Type NON-EXPEDITED Product NUVARING Health Professional N Outcomes HO Role Route S Manufacturer Control # 2011SP031790 Dosage Text Age 37 YR Duration Sex Female Country USA

Manufacturer

8341694 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8341694

Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2011SP039038 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

PULMONARY EMBOLISM

8341696 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8341696

Health Professional N

Outcomes HO Role Route S

Manufacturer Control # 2011SP031366 Dosage Text

Age 28 YR Duration

Sex Female

Country USA

Manufacturer

CEREBRAL ARTERY OCCLUSION CEREBROVASCULAR ACCIDENT

8341709 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8341709

Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes HO,LT Role Route S

Manufacturer Control # 2011SP031097 Dosage Text 1 DF Manufacturer Control # 2011SP031110 Dosage Text

Age 47 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM

8341721 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8341721

Health Professional N

Outcomes HO Role Route S

Age 27 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM

8341792 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8341792

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2011SP034315 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

PULMONARY EMBOLISM

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 708 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8341802 Date FDA Received
02-Dec-2011 Preferred Term PULMONARY EMBOLISM Case # 8341802 Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case # 8341846 Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Health Professional N Health Professional N Health Professional Y Health Professional N Health Professional N Health Professional N Outcomes OT Role Route S Outcomes OT Role Route S Outcomes OT Role Route S Outcomes HO Role Route S VAGINAL Manufacturer Control # 2011SP030644 Dosage Text VAG Manufacturer Control # 2011SP030646 Dosage Text Age 48 YR Duration Sex Female Country USA Age 16 YR Duration Sex Female Country USA Manufacturer Control # 2011SP031112 Dosage Text Duration Age Sex Female Country USA Manufacturer Control # 2010SP065525 Dosage Text Duration Age Sex Female Country USA Manufacturer Control # 2011SP031111 Dosage Text Duration Age Sex Female Country USA

Manufacturer

8341823 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8341823

Manufacturer

PULMONARY EMBOLISM

8341825 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8341825

Manufacturer

CEREBROVASCULAR ACCIDENT

8341828 Date FDA Received

02-Dec-2011 Preferred Term THROMBOSIS

Case # 8341828

Manufacturer

8341846 Date FDA Received

02-Dec-2011 Preferred Term

Outcomes HO Role Route S Outcomes HO Role Route S

Manufacturer

PULMONARY EMBOLISM

8341864 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8341864

Manufacturer Control # 2011SP030649 Dosage Text

Age 23 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 709 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8341985 Date FDA Received
02-Dec-2011 Preferred Term PULMONARY EMBOLISM BRONCHITIS CYSTOSCOPY DEEP VEIN THROMBOSIS JOINT INJURY UPPER RESPIRATORY TRACT INFECTION Case # 8341985 Case Type NON-EXPEDITED Product NUVARING Health Professional Y Outcomes HO Role Route S Manufacturer Control # 2010SP065540 Dosage Text Age 44 YR Duration Sex Female Country USA

Manufacturer

8341988 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8341988

Case Type NON-EXPEDITED Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2011SP030603 Dosage Text

Age 31 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS ACNE ALOPECIA ANGIOPATHY STRESS

8342012 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8342012

Case Type NON-EXPEDITED Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2010SP063652 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

DEEP VEIN THROMBOSIS

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 710 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8342018 Date FDA Received
02-Dec-2011 Preferred Term DEEP VEIN THROMBOSIS ANTIPHOSPHOLIPID ANTIBODIES POSITIVE ANXIETY BREAST MASS BREAST TENDERNESS INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION MENISCUS LESION PULMONARY INFARCTION Case # 8342018 Case Type NON-EXPEDITED Product NUVARING Health Professional Y Outcomes HO Role Route S Manufacturer Control # 2011SP016571 Dosage Text Age 45 YR Duration Sex Female Country USA

Manufacturer

8342040 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8342040

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes HO Role Route S

Manufacturer Control # 2010SP063643 Dosage Text

Age 31 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM NASOPHARYNGITIS STRESS

8342068 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8342068

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2010SP063436 Dosage Text 1DF; VAG

Age 46 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS DEHYDRATION GASTROINTESTINAL INFECTION

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 711 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8342070 Date FDA Received
02-Dec-2011 Preferred Term DEEP VEIN THROMBOSIS THROMBOPHLEBITIS MENTAL DISORDER HYPERTENSION CONTUSION EMOTIONAL DISORDER Case # 8342070 Case Type NON-EXPEDITED Product NUVARING HERBAL TEA MOMETASONE FUROATE MONOHYDRATE PATANASE 04/05/2009 Health Professional Y Outcomes OT Role Route S C C C VAGINAL Manufacturer Control # 2011SP016577 Dosage Text 1 DF;QM;VAG Age 47 YR Duration Sex Female Country USA

Manufacturer

8342074 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8342074

Case Type NON-EXPEDITED Product NUVARING

Health Professional N

Outcomes HO Role Route S

Manufacturer Control # 2011SP030608 Dosage Text

Age 27 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM HYPERSENSITIVITY MENTAL DISORDER

8342093 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8342093

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2010SP062533 Dosage Text

Age 26 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 712 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8342095 Date FDA Received
02-Dec-2011 Preferred Term PULMONARY EMBOLISM SYSTEMIC LUPUS ERYTHEMATOSUS ARTHRITIS ATELECTASIS DEPRESSION VAGINAL DISCHARGE ABDOMINAL PAIN NAUSEA OEDEMA PERIPHERAL PRURITUS Case # 8342095 Case Type NON-EXPEDITED Product NUVARING MULTI-VITAMIN PREDNISONE 06/--/2009 07/20/2009 CLARITIN ALBUTEROL FLEXERIL Health Professional Y Outcomes HO,DS,OT Role Route S C C C C C Manufacturer Control # 2011SP016071 Dosage Text Age 27 YR Duration Sex Female Country USA

Manufacturer

8342098 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8342098

Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING

Health Professional N

Outcomes HO Role Route S

Manufacturer Control # 2011SP030613 Dosage Text

Age 33 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS

8342103 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8342103

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2011SP030615 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

DEEP VEIN THROMBOSIS PULMONARY EMBOLISM

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 713 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8342104 Date FDA Received
02-Dec-2011 Preferred Term DEEP VEIN THROMBOSIS ANXIETY ARTHROPATHY DIZZINESS HEADACHE HEPATIC ENZYME INCREASED HYPOTENSION IRRITABLE BOWEL SYNDROME NAUSEA Case # 8342104 Case Type NON-EXPEDITED Product NUVARING Health Professional Y Outcomes HO,DS,OT Role Route S Manufacturer Control # 2010SP062528 Dosage Text Age 36 YR Duration Sex Female Country USA

Manufacturer

8342106 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8342106

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes HO,OT Role Route S C

Manufacturer Control # 2011SP016073 Dosage Text

Age 39 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM DEEP VEIN THROMBOSIS BACK PAIN DYSPEPSIA DYSURIA HEADACHE THROMBOPHLEBITIS SUPERFICIAL

EXCEDRIN MIGRAINE

8342110 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8342110

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes HO,LT,OT Role Route S VAGINAL

Manufacturer Control # 2011SP029476 Dosage Text ;QM;VAG

Age

Sex Female

Country USA

Duration

Manufacturer

CEREBRAL THROMBOSIS

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 714 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8342116 Date FDA Received
02-Dec-2011 Preferred Term GENERALISED OEDEMA PAIN IN EXTREMITY WEIGHT INCREASED Case # 8342116 Case Type NON-EXPEDITED Product NUVARING Health Professional N Outcomes OT Role Route S VAGINAL Manufacturer Control # 2011SP014969 Dosage Text ;VAG Age 31 YR Duration Sex Female Country USA

Manufacturer

8342118 Date FDA Received

02-Dec-2011 Preferred Term ANGIOEDEMA PAIN IN EXTREMITY ARTHRALGIA

Case # 8342118

Case Type NON-EXPEDITED Product NUVARING CINRYZE

Health Professional N

Outcomes OT Role Route S S INTRAVENOUS

Manufacturer Control # 2010SP062307 Dosage Text 1000 IU; IV, 1000 IU; QOD; IV

Age 20 YR Duration

Sex Female

Country USA

Manufacturer

8342119 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8342119

Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes HO,DS,LT Role Route S VAGINAL

Manufacturer Control # 2011SP029270 Dosage Text ;VAG Manufacturer Control # 2010SP060919 Dosage Text 0.12 MG; VAG

Age 20 YR Duration

Sex Female

Country USA

Manufacturer

CEREBROVASCULAR ACCIDENT

8342126 Date FDA Received

02-Dec-2011 Preferred Term HYPERTENSION HEADACHE

Case # 8342126

Health Professional Y

Outcomes OT Role Route S VAGINAL

Age 50 YR Duration

Sex Female

Country USA

Manufacturer

INCORRECT DRUG ADMINISTRATION DURATION

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 715 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8342131 Date FDA Received
02-Dec-2011 Preferred Term DEEP VEIN THROMBOSIS Case # 8342131 Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING RITALIN Case # 8342139 Case Type NON-EXPEDITED Product NUVARING HERBAL SUPPLEMENT DIPHENHYDRAMINE HYDROCHLORIDE Health Professional N Health Professional Y Health Professional Y Outcomes OT Role Route S VAGINAL Manufacturer Control # 2011SP029020 Dosage Text ;QM;VAG Manufacturer Control # 2010SP060921 Dosage Text 1 DF; QD; VAG Age 50 YR Duration Sex Female Country USA Age 32 YR Duration Sex Female Country USA

Manufacturer

8342138 Date FDA Received

02-Dec-2011 Preferred Term HYPERTENSION HEADACHE

Case # 8342138

Outcomes OT Role Route S C Outcomes HO,OT Role Route S C C Outcomes OT Role Route S C C Outcomes OT Role Route S VAGINAL

Manufacturer

8342139 Date FDA Received

02-Dec-2011 Preferred Term

Manufacturer Control # 2011SP030596 Dosage Text

Age 41 YR Duration

Sex Female

Country USA

Manufacturer

THROMBOSIS MESENTERIC VESSEL GALLBLADDER DISORDER

8342152 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8342152

Case Type NON-EXPEDITED Product NUVARING ZANTAC

Health Professional Y

Manufacturer Control # 2011SP015784 Dosage Text 1 DF;

Age 24 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM

GLUCOPHAGE

8342162 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8342162

Case Type NON-EXPEDITED Product NUVARING

Health Professional N

Manufacturer Control # 2011SP009617 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

PULMONARY EMBOLISM

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 716 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8342164 Date FDA Received
02-Dec-2011 Preferred Term DEEP VEIN THROMBOSIS Case # 8342164 Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING MICARDIS GARDASIL Health Professional Y Health Professional N Outcomes OT Role Route S Outcomes OT Role Route S C C Health Professional N Outcomes HO Role Route S Manufacturer Control # 2011SP030599 Dosage Text Age 26 YR Duration Sex Female Country USA Manufacturer Control # 2011SP009525 Dosage Text Age 23 YR Duration Sex Female Country USA Manufacturer Control # 2011SP015133 Dosage Text Duration Age Sex Female Country USA

Manufacturer

8342172 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8342172

Manufacturer

BLOOD PRESSURE INCREASED RASH PRURITIC

8342173 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8342173

Case Type NON-EXPEDITED Product NUVARING

Manufacturer

PULMONARY EMBOLISM BACK PAIN

8342201 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8342201

Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2011SP008602 Dosage Text ; VAG Manufacturer Control # 2011SP008124 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

HEPATIC ENZYME INCREASED

8342219 Date FDA Received

02-Dec-2011 Preferred Term THROMBOSIS

Case # 8342219

Health Professional Y

Outcomes HO Role Route S

Age 33 YR Duration

Sex Female

Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 717 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8342224 Date FDA Received
02-Dec-2011 Preferred Term DEEP VEIN THROMBOSIS PULMONARY EMBOLISM Case # 8342224 Case Type NON-EXPEDITED Product NUVARING Health Professional N Outcomes HO Role Route S Manufacturer Control # 2011SP007680 Dosage Text Age 24 YR Duration Sex Female Country USA

Manufacturer

8342246 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8342246

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2011SP006889 Dosage Text

Age 17 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM CEREBROVASCULAR ACCIDENT

8342255 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8342255

Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2011SP039039 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

PULMONARY EMBOLISM

8342265 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8342265

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2011SP006895 Dosage Text

Age 24 YR Duration

Sex Unknown

Country USA

Manufacturer

PULMONARY EMBOLISM CEREBROVASCULAR ACCIDENT

8342281 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8342281

Case Type NON-EXPEDITED Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2011SP037380 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

PULMONARY EMBOLISM

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 718 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8342289 Date FDA Received
02-Dec-2011 Preferred Term PULMONARY EMBOLISM OEDEMA PERIPHERAL ANXIETY DYSPEPSIA ELECTROCARDIOGRAM ABNORMAL HYPERTENSION INSOMNIA LIGAMENT SPRAIN PLANTAR FASCIITIS URINARY TRACT INFECTION Case # 8342289 Case Type NON-EXPEDITED Product NUVARING MELOXICAM Health Professional Y Outcomes HO Role Route S C Manufacturer Control # 2011SP006195 Dosage Text Age 51 YR Duration Sex Female Country USA

Manufacturer

8342314 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8342314

Case Type NON-EXPEDITED Product NUVARING

Health Professional N

Outcomes HO Role Route S

Manufacturer Control # 2011SP006199 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

DEEP VEIN THROMBOSIS PULMONARY EMBOLISM

8342420 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8342420

Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2011SP037382 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

CEREBROVASCULAR ACCIDENT

8342425 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8342425

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2011SP037383 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

PULMONARY EMBOLISM DEEP VEIN THROMBOSIS

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 719 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8342430 Date FDA Received
02-Dec-2011 Preferred Term DEEP VEIN THROMBOSIS Case # 8342430 Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Health Professional Y Health Professional N Health Professional Y Outcomes OT Role Route S VAGINAL Manufacturer Control # 2011SP036549 Dosage Text VAG Manufacturer Control # 2011SP035856 Dosage Text Duration Age Sex Female Country USA Age 20 YR Duration Sex Female Country USA

Manufacturer

8342433 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8342433

Outcomes OT Role Route S Outcomes OT Role Route S

Manufacturer

THROMBOPHLEBITIS SUPERFICIAL

8342469 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8342469

Manufacturer Control # 2011SP001283 Dosage Text

Age 23 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS PAPILLOMA VIRAL INFECTION VAGINAL DISCHARGE

8342473 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8342473

Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2011SP001291 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

CEREBROVASCULAR ACCIDENT

8342475 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8342475

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2011SP000802 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

DEEP VEIN THROMBOSIS

8342493 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8342493

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2011SP000363 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

PULMONARY EMBOLISM

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 720 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8342521 Date FDA Received
02-Dec-2011 Preferred Term THROMBOSIS PULMONARY EMBOLISM ANXIETY STRESS DEPRESSION MIGRAINE Case # 8342521 Case Type NON-EXPEDITED Product NUVARING XANAX LEXAPRO ABILIFY Health Professional N Outcomes HO,LT,OT Role Route S C C C Manufacturer Control # 2011SP000376 Dosage Text QM Age 30 YR Duration Sex Female Country USA

Manufacturer

8342522 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8342522

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2011SP000349 Dosage Text

Age 35 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS LIGAMENT SPRAIN

8342543 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8342543

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes HO,LT Role Route S C VAGINAL

Manufacturer Control # 2011SP000305 Dosage Text VAG

Age 45 YR Duration

Sex Female

Country USA

Manufacturer

CEREBROVASCULAR ACCIDENT

LEVOTHROID

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 721 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8342549 Date FDA Received
02-Dec-2011 Preferred Term DEEP VEIN THROMBOSIS BLOOD DISORDER BURSITIS HYPERCOAGULATION MIGRAINE PLANTAR FASCIITIS TONSILLECTOMY WEIGHT INCREASED Case # 8342549 Case Type NON-EXPEDITED Product NUVARING Health Professional Y Outcomes OT Role Route S Manufacturer Control # 2010SP065553 Dosage Text Age 22 YR Duration Sex Female Country USA

Manufacturer

8342886 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8342886

Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2011SP043796 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

DEEP VEIN THROMBOSIS

8342888 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8342888

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2011SP043683 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

PULMONARY EMBOLISM

8342889 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8342889

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2011SP043080 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

PULMONARY EMBOLISM

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 722 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8342891 Date FDA Received
02-Dec-2011 Preferred Term TRANSIENT ISCHAEMIC ATTACK HEADACHE Case # 8342891 Case Type NON-EXPEDITED Product NUVARING METFORMIN HYDROCHLORIDE Case # 8342896 Case Type NON-EXPEDITED Product NUVARING Case # 8342905 Case Type NON-EXPEDITED Product NUVARING Health Professional Y Health Professional Y Health Professional Y Outcomes OT Role Route S C Outcomes OT Role Route S VAGINAL Manufacturer Control # 2011SP042944 Dosage Text 1 DF; VAG Manufacturer Control # 2011SP042947 Dosage Text 1D; VAG Duration Age Sex Female Country USA Duration Age Sex Female Country USA Manufacturer Control # 2011SP042921 Dosage Text Age 38 YR Duration Sex Female Country USA

Manufacturer

8342896 Date FDA Received

02-Dec-2011 Preferred Term VENOUS THROMBOSIS

Manufacturer

8342905 Date FDA Received

02-Dec-2011 Preferred Term

Outcomes OT Role Route S VAGINAL

Manufacturer

PULMONARY EMBOLISM THROMBOSIS

8342908 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8342908

Case Type NON-EXPEDITED Product NUVARING IBUPROFEN

Health Professional Y

Outcomes HO,LT Role Route S C VAGINAL

Manufacturer Control # 2011SP042752 Dosage Text 1 DF; VAG

Age 26 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM C-REACTIVE PROTEIN INCREASED PULMONARY INFARCTION

8342915 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8342915

Case Type NON-EXPEDITED Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2011SP042221 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

PULMONARY EMBOLISM

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 723 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8342939 Date FDA Received
02-Dec-2011 Preferred Term PULMONARY EMBOLISM DEEP VEIN THROMBOSIS Case # 8342939 Case Type NON-EXPEDITED Product NUVARING Health Professional N Outcomes HO,OT Role Route S Manufacturer Control # 2011SP041922 Dosage Text Duration Age Sex Female Country USA

Manufacturer

8342947 Date FDA Received

02-Dec-2011 Preferred Term THROMBOSIS

Case # 8342947

Case Type NON-EXPEDITED Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2011SP042073 Dosage Text

Age 27 YR Duration

Sex Female

Country USA

Manufacturer

8342950 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8342950

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes HO Role Route S C Outcomes OT Role Route S

Manufacturer Control # 2011SP041131 Dosage Text

Age 20 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM

DEPO-PROVERA

8342956 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8342956

Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING

Health Professional N

Manufacturer Control # 2011SP040933 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

CEREBRAL VENOUS THROMBOSIS

8342958 Date FDA Received

02-Dec-2011 Preferred Term THROMBOSIS

Case # 8342958

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2011SP035862 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

8342975 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8342975

Case Type NON-EXPEDITED Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2011SP035863 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

PULMONARY EMBOLISM

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 724 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8342980 Date FDA Received
02-Dec-2011 Preferred Term PULMONARY EMBOLISM DEEP VEIN THROMBOSIS Case # 8342980 Case Type NON-EXPEDITED Product NUVARING Health Professional N Outcomes OT Role Route S Manufacturer Control # 2011SP035865 Dosage Text Duration Age Sex Female Country USA

Manufacturer

8342990 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8342990

Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2011SP040936 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

PULMONARY EMBOLISM

8342992 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8342992

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2011SP040937 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

PULMONARY EMBOLISM

8342994 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8342994

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2011SP040939 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

DEEP VEIN THROMBOSIS

8342997 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8342997

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2011SP035574 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

PULMONARY EMBOLISM

8343004 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8343004

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2011SP035575 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

DEEP VEIN THROMBOSIS PULMONARY EMBOLISM

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 725 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8343007 Date FDA Received
02-Dec-2011 Preferred Term DEEP VEIN THROMBOSIS Case # 8343007 Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Health Professional N Health Professional N Health Professional N Outcomes OT Role Route S Outcomes OT Role Route S Outcomes OT Role Route S Manufacturer Control # 2011SP046042 Dosage Text Duration Age Sex Female Country USA Manufacturer Control # 2011SP046648 Dosage Text Duration Age Sex Female Country USA Manufacturer Control # 2011SP034942 Dosage Text Duration Age Sex Female Country USA

Manufacturer

8343025 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8343025

Manufacturer

CEREBROVASCULAR ACCIDENT

8343131 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8343131

Manufacturer

PULMONARY EMBOLISM DEEP VEIN THROMBOSIS

8343167 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8343167

Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2011SP045292 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

PULMONARY EMBOLISM

8343228 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8343228

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2011SP044319 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

DEEP VEIN THROMBOSIS

8343235 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8343235

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2011SP043793 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

PULMONARY EMBOLISM DEEP VEIN THROMBOSIS

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 726 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8344023 Date FDA Received
02-Dec-2011 Preferred Term CEREBROVASCULAR ACCIDENT ISCHAEMIC STROKE MIGRAINE Case # 8344023 Case Type NON-EXPEDITED Product NUVARING Health Professional Y Outcomes HO,DS Role Route S Manufacturer Control # 2011SP000372 Dosage Text Age 47 YR Duration Sex Female Country USA

Manufacturer

8344093 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8344093

Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes LT,OT Role Route S VAGINAL

Manufacturer Control # 2010SP062557 Dosage Text VAG Manufacturer Control # 2011SP008651 Dosage Text

Age 51 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM

8344949 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8344949

Health Professional N

Outcomes HO Role Route S

Age 39 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM

8344987 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8344987

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2011SP042784 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

PULMONARY EMBOLISM

8346081 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8346081

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2011PS046467 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

PULMONARY EMBOLISM DEEP VEIN THROMBOSIS

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 727 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8346088 Date FDA Received
02-Dec-2011 Preferred Term DEEP VEIN THROMBOSIS PULMONARY EMBOLISM Case # 8346088 Case Type NON-EXPEDITED Product NUVARING Health Professional N Outcomes OT Role Route S Manufacturer Control # 2011SP04637 Dosage Text Duration Age Sex Female Country USA

Manufacturer

8346254 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8346254

Case Type NON-EXPEDITED Product NUVARING

Health Professional Y

Outcomes HO Role Route S C Outcomes OT Role Route S VAGINAL VAGINAL

Manufacturer Control # 2011SP039930 Dosage Text 1 DF; ;VAG

Age 22 YR Duration

Sex Female

Country USA

Manufacturer

CEREBROVASCULAR ACCIDENT

SEASONIQUE 06/--/2007 - 12/--/ 2007

8346307 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8346307

Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING Case Type NON-EXPEDITED Product NUVARING FLONASE

Health Professional Y

Manufacturer Control # 2011SP019594 Dosage Text QM;VAG Manufacturer Control # 2011SP046654 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

PHLEBITIS SUPERFICIAL

8346477 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8346477

Health Professional N

Outcomes OT Role Route S

Age

Sex Female

Country USA

Duration

Manufacturer

DEEP VEIN THROMBOSIS

8346517 Date FDA Received

02-Dec-2011 Preferred Term

Case # 8346517

Health Professional Y

Outcomes HO Role Route S C C

Manufacturer Control # 2011SP043971 Dosage Text

Age 46 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM

SUDAFED 12 HOUR

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 728 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8346555 Date FDA Received
02-Dec-2011 Preferred Term PULMONARY EMBOLISM DEEP VEIN THROMBOSIS Case # 8346555 Case Type NON-EXPEDITED Product NUVARING Health Professional N Outcomes HO Role Route S Manufacturer Control # 2011AP037379 Dosage Text Age 29 YR Duration Sex Female Country USA

Manufacturer

7271468 Date FDA Received

05-Dec-2011 Preferred Term

Case # 7271468

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO,OT Role Route S

Manufacturer Control # 2009SP023508 Dosage Text

Age 34 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM ARTHRALGIA ASTHMA BACK PAIN CATHETER SITE RELATED REACTION FALL HERNIA JOINT INJURY LIGAMENT RUPTURE MACULAR DEGENERATION MALAISE MIGRAINE NAUSEA OEDEMA PERIPHERAL ROTATOR CUFF SYNDROME SLEEP APNOEA SYNDROME SNORING SOMNOLENCE TENOSYNOVITIS VOMITING

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 729 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7826881 Date FDA Received
05-Dec-2011 Preferred Term PULMONARY EMBOLISM ABDOMINAL PAIN ABORTION SPONTANEOUS BACK PAIN CHEST PAIN CONDITION AGGRAVATED COSTOCHONDRITIS DEPRESSION DIARRHOEA DIZZINESS DYSPNOEA FALL HEAD INJURY HYPERTENSION IMPAIRED WORK ABILITY INFLUENZA MIGRAINE NAUSEA PAIN IN EXTREMITY PANIC ATTACK PHOTOPHOBIA PREGNANCY RECTAL HAEMORRHAGE TENSION HEADACHE THROMBOSIS VAGINAL HAEMORRHAGE VAGINITIS BACTERIAL VOMITING WEIGHT INCREASED Case # 7826881 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO,OT Role Route S VAGINAL Manufacturer Control # 2010SP004262 Dosage Text VAG Age 22 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 730 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8274887 Date FDA Received
05-Dec-2011 Preferred Term SUICIDAL IDEATION DEPRESSION APATHY DECREASED APPETITE FATIGUE HYPOAESTHESIA SELF ESTEEM DECREASED Case # 8274887 Case Type DIRECT Product NUVARING NUVARING Health Professional N Outcomes OT Role Route S C VAGINAL VAGINAL Dosage Text 0.015 mg released daily 0.015 mg released daily ORGANON Manufacturer Control # Age 20 YR Duration Sex Female Country USA

Manufacturer

8293349 Date FDA Received

05-Dec-2011 Preferred Term

Case # 8293349

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S TRANSPLACENTAL

Manufacturer Control # 2011SP055275 Dosage Text ;TRPL

Age

Sex Male

Country ESP Manufacturer

Duration

VENTRICULAR EXTRASYSTOLES MATERNAL DRUGS AFFECTING FOETUS PREGNANCY WITH CONTRACEPTIVE DEVICE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 731 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7823250 Date FDA Received
06-Dec-2011 Preferred Term DEEP VEIN THROMBOSIS ADJUSTMENT DISORDER WITH DEPRESSED MOOD ARTHRALGIA HAEMORRHOIDS HYPOAESTHESIA INFLUENZA LIKE ILLNESS ONYCHOMYCOSIS PARAESTHESIA SMEAR CERVIX ABNORMAL TENDONITIS UPPER RESPIRATORY TRACT INFECTION Case # 7823250 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes OT Role Route S VAGINAL Manufacturer Control # 2010SP007300 Dosage Text 1 DF;VAG Age 27 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 732 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7931675 Date FDA Received
06-Dec-2011 Preferred Term PULMONARY EMBOLISM ABORTION SPONTANEOUS ACTIVITIES OF DAILY LIVING IMPAIRED BLOOD URINE PRESENT CONFUSIONAL STATE DEEP VEIN THROMBOSIS FLANK PAIN HEADACHE HYPOAESTHESIA IMPAIRED WORK ABILITY INTERNATIONAL NORMALISED RATIO DECREASED MUSCULOSKELETAL CHEST PAIN NEPHROLITHIASIS PARAESTHESIA PREGNANCY THROMBOPHLEBITIS SUPERFICIAL UPPER RESPIRATORY TRACT INFECTION Case # 7931675 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO,DS,OT Role Route S Manufacturer Control # 2011SP000367 Dosage Text Age 26 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 733 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7974220 Date FDA Received
06-Dec-2011 Preferred Term PULMONARY EMBOLISM THROMBOPHLEBITIS SUPERFICIAL ABDOMINAL PAIN ABORTION INCOMPLETE BACK PAIN BREAST MASS CALCULUS BLADDER CERVICAL DYSPLASIA CHOLELITHIASIS DEPRESSION EYE SWELLING FACTOR V LEIDEN MUTATION FATIGUE FEMALE STERILISATION GASTRIC BYPASS HEADACHE MYALGIA NAUSEA NEPHROLITHIASIS PHARYNGITIS STREPTOCOCCAL SLEEP APNOEA SYNDROME SYNCOPE Case # 7974220 Case Type EXPEDITED (15-DAY) Product NUVARING ZOLOFT Health Professional Y Outcomes HO,OT Role Route S C Manufacturer Control # 2010SP062381 Dosage Text Age 33 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 734 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8020409 Date FDA Received
06-Dec-2011 Preferred Term MEASLES MENSTRUATION IRREGULAR INJURY NAIL INFECTION Case # 8020409 Case Type EXPEDITED (15-DAY) Product NUVARING AMOXICILLIN Health Professional N Outcomes HO Role Route S C VAGINAL Manufacturer Control # 2011SP027846 Dosage Text VAG Age 24 YR Duration Sex Female Country BRA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 735 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8296517 Date FDA Received
06-Dec-2011 Preferred Term PULMONARY EMBOLISM ABORTION SPONTANEOUS BACK PAIN BACTERIAL TEST POSITIVE BLOOD URINE PRESENT BRONCHITIS CONNECTIVE TISSUE DISORDER HAEMATOCRIT DECREASED HAEMOGLOBIN DECREASED HYPOAESTHESIA HYPOALBUMINAEMIA IMPAIRED WORK ABILITY MUSCULOSKELETAL PAIN NAUSEA PLATELET COUNT INCREASED PLEURAL EFFUSION PLEURISY PNEUMONIA BACTERIAL PNEUMONIA VIRAL PREGNANCY PROTEIN URINE PRESENT PYREXIA TACHYCARDIA TOXICOLOGIC TEST ABNORMAL UPPER RESPIRATORY TRACT INFECTION Case # 8296517 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO Role Route S Manufacturer Control # 2011SP005798 Dosage Text Age 25 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 736 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8056380 Date FDA Received
07-Dec-2011 Preferred Term INJURY CEREBROVASCULAR ACCIDENT JOINT INJURY ABDOMINAL PAIN UPPER ANAEMIA ARTHRALGIA BLOOD CHOLESTEROL INCREASED BRAIN INJURY BRONCHITIS CAROTID ARTERY STENOSIS CAROTID ARTERY THROMBOSIS CEREBRAL INFARCTION DRUG DEPENDENCE DYSARTHRIA DYSPNOEA GENERAL PHYSICAL CONDITION ABNORMAL HYPERLIPIDAEMIA HYPERTRIGLYCERIDAEMIA MUSCULOSKELETAL PAIN OVERWEIGHT PERIPHERAL VASCULAR DISORDER PETECHIAE RECTAL HAEMORRHAGE SINUSITIS THROMBOSIS Case # 8056380 Case Type EXPEDITED (15-DAY) Product NUVARING OMEPRAZOLE MARIJUANA Health Professional Y Outcomes HO,DS,OT Role Route S C C VAGINAL Manufacturer Control # 2009SP040884 Dosage Text VAG Age 36 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 737 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8277895 Date FDA Received
07-Dec-2011 Preferred Term THROMBOSIS Case # 8277895 Case Type DIRECT Product NUVARING Case # 8279983 Case Type DIRECT Product NUVARING Case Type EXPEDITED (15-DAY) Product NUVARING CHLOROQUINE IBUPROFEN Health Professional Y Health Professional Y Health Professional N Outcomes HO,LT Role Route S VAGINAL Dosage Text 1 Manufacturer Control # Manufacturer Control # Age 27 YR Duration 1 YEAR Age 21 YR Dosage Text Duration Sex Female Country USA Sex Female Country USA

Manufacturer

8279983 Date FDA Received

08-Dec-2011 Preferred Term

Outcomes HO,LT Role Route S VAGINAL

Manufacturer

PULMONARY EMBOLISM

7196232 Date FDA Received

12-Dec-2011 Preferred Term

Case # 7196232

Outcomes HO,LT,OT Role Route S C C VAGINAL

Manufacturer Control # 2009-198042-NL Dosage Text 1 DF;QM;VAG

Age 22 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS PULMONARY EMBOLISM VARICOSE VEIN ABDOMINAL DISCOMFORT ABDOMINAL PAIN ABDOMINAL PAIN LOWER CHLAMYDIA TEST POSITIVE DEPRESSION GENITAL PAIN MENORRHAGIA MUSCLE STRAIN MUSCULOSKELETAL CHEST PAIN NERVOUSNESS OVARIAN CYST STRESS TELANGIECTASIA TREMOR VENOUS INSUFFICIENCY

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 738 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7277716 Date FDA Received
12-Dec-2011 Preferred Term PULMONARY EMBOLISM BACK PAIN BREAST CYST BREAST FIBROMA BRONCHITIS CERVICAL DYSPLASIA CERVICITIS HEADACHE HYPOAESTHESIA MATERNAL EXPOSURE DURING PREGNANCY MENORRHAGIA MUSCLE SPASMS MUSCLE STRAIN PAIN PARAESTHESIA PLEURITIC PAIN PREGNANCY STRESS THROMBOSIS TREATMENT NONCOMPLIANCE Case # 7277716 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO,OT Role Route S Manufacturer Control # 2009SP023433 Dosage Text Age 27 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 739 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7461431 Date FDA Received
12-Dec-2011 Preferred Term SUBARACHNOID HAEMORRHAGE MENTAL STATUS CHANGES CONVULSION CEREBRAL VENOUS THROMBOSIS LIGAMENT SPRAIN ANAEMIA ACINETOBACTER INFECTION BACTERIAL SEPSIS BRONCHOPNEUMONIA CNS VENTRICULITIS ENTEROCOCCUS TEST POSITIVE HYPOXIC-ISCHAEMIC ENCEPHALOPATHY INTRACRANIAL HYPOTENSION MENINGITIS PERITONEAL ABSCESS PHARYNGEAL ABSCESS POSTOPERATIVE WOUND INFECTION PSEUDOMONAS INFECTION SERRATIA INFECTION TACHYCARDIA Case # 7461431 Case Type EXPEDITED (15-DAY) Product NUVARING DOXYCYCLINE HYCLATE RETIN-A TRIAMCINOLONE CLEOCIN HYDROCHLORIDE KETOCONAZOLE Health Professional Y Outcomes DE,HO,DS,OT Role Route S C C C C C Manufacturer Control # 2010SP034645 Dosage Text Age 27 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 740 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8188430 Date FDA Received
12-Dec-2011 Preferred Term ECTOPIC PREGNANCY WITH INTRAUTERINE DEVICE INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION INCORRECT DRUG ADMINISTRATION DURATION MATERNAL EXPOSURE DURING PREGNANCY RUPTURED ECTOPIC PREGNANCY Case # 8188430 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO Role Route S Manufacturer Control # 2011SP044698 Dosage Text Age 23 YR Duration Sex Female Country FRA

Manufacturer

8284309 Date FDA Received

12-Dec-2011 Preferred Term HIATUS HERNIA

Case # 8284309

Case Type DIRECT Product NUVARING

Health Professional N

Outcomes HO,LT Role Route S VAGINAL

Manufacturer Control #

Age 33 YR

Sex Female

Country USA

Dosage Text one ring

Duration

Manufacturer

DEEP VEIN THROMBOSIS PULMONARY EMBOLISM

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 741 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7278972 Date FDA Received
13-Dec-2011 Preferred Term PULMONARY EMBOLISM THROMBOPHLEBITIS SUPERFICIAL FATIGUE ATAXIA CHEST DISCOMFORT COMPLEX REGIONAL PAIN SYNDROME DEEP VEIN THROMBOSIS DEPRESSION DYSPHAGIA DYSPNOEA EXERTIONAL ECCHYMOSIS GALLBLADDER DISORDER HEART RATE DECREASED LIGAMENT SPRAIN LOCAL SWELLING LOSS OF CONSCIOUSNESS ORTHOSTATIC HYPERTENSION PALPITATIONS PRESYNCOPE PULMONARY HYPERTENSION SENSORY LOSS STRESS FRACTURE SYNCOPE TRIGGER FINGER TUNNEL VISION URINARY RETENTION VENTRICULAR EXTRASYSTOLES VISION BLURRED Case # 7278972 Case Type EXPEDITED (15-DAY) Product NUVARING LEXAPRO PROPRANOLOL Health Professional Y Outcomes HO,OT Role Route S C C Manufacturer Control # 2009-199669-NL Dosage Text 1 DF Age 43 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 742 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8305649 Date FDA Received
13-Dec-2011 Preferred Term PULMONARY EMBOLISM STRESS ECHOCARDIOGRAM ABNORMAL Case # 8305649 Case Type EXPEDITED (15-DAY) Product NUVARING ASPIRIN Health Professional Y Health Professional Y Outcomes LT Role Route S C Outcomes HO,OT Role Route S Manufacturer Control # 2010SP056522 Dosage Text Age 27 YR Duration Sex Female Country USA Manufacturer Control # 2011SP056984 Dosage Text AM;IU Age 47 YR Duration Sex Female Country AUS

Manufacturer

7703616 Date FDA Received

14-Dec-2011 Preferred Term

Case # 7703616

Case Type EXPEDITED (15-DAY) Product NUVARING

Manufacturer

CEREBELLAR HAEMORRHAGE AFFECT LABILITY ALOPECIA ANGINA PECTORIS ANXIETY ARTHRALGIA BENIGN INTRACRANIAL HYPERTENSION BLINDNESS TRANSIENT BREAST MASS CARDIAC FAILURE CONGESTIVE CENTRAL PAIN SYNDROME CEREBRAL ATROPHY CEREBRAL INFARCTION CEREBRAL VENOUS THROMBOSIS CEREBROVASCULAR ACCIDENT DEAFNESS DEPRESSION DERMAL CYST DERMATITIS DIARRHOEA DIZZINESS DRUG DEPENDENCE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 743 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7703616
Preferred Term EMOTIONAL DISORDER ENCEPHALOMALACIA ENLARGED CLITORIS FUNGAL INFECTION FURUNCLE GASTROINTESTINAL HAEMORRHAGE HEADACHE HEART RATE IRREGULAR HYPERCOAGULATION HYPOAESTHESIA INFLUENZA INTRACRANIAL VENOUS SINUS THROMBOSIS IRRITABILITY LIMB INJURY MALABSORPTION MENTAL DISORDER MULTIPLE INJURIES MUSCLE TWITCHING NASOPHARYNGITIS NAUSEA NECK PAIN OEDEMA PERIPHERAL OPTIC DISC DISORDER OVARIAN CYST PAIN PAPILLOMA VIRAL INFECTION PHOTOPHOBIA PSORIASIS RECTAL HAEMORRHAGE SLEEP APNOEA SYNDROME SUBARACHNOID HAEMORRHAGE Product Role Route Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 744 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7703616
Preferred Term THALAMIC INFARCTION TRANSVERSE SINUS THROMBOSIS VARICOSE VEIN VIITH NERVE PARALYSIS VOMITING WEIGHT DECREASED Product Role Route Dosage Text Duration Manufacturer

7865805 Date FDA Received

14-Dec-2011 Preferred Term

Case # 7865805

Case Type EXPEDITED (15-DAY) Product NUVARING ASPIRIN

Health Professional Y

Outcomes HO,OT Role Route S C VAGINAL

Manufacturer Control # 2010SP056526 Dosage Text 1 DF;QM;VAG

Age 28 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM DEEP VEIN THROMBOSIS BACTERIAL TEST HAEMOGLOBIN DECREASED HYPERCOAGULATION PAIN PNEUMONIA

8148458 Date FDA Received

14-Dec-2011 Preferred Term

Case # 8148458

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2011SP041866 Dosage Text

Age 33 YR Duration

Sex Female

Country DEU

Manufacturer

CERVIX CARCINOMA STAGE 0

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 745 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8309513 Date FDA Received
14-Dec-2011 Preferred Term HEADACHE MUSCLE SPASMS HAEMORRHAGE APHASIA DIPLOPIA HYPOAESTHESIA WEIGHT INCREASED Case # 8309513 Case Type EXPEDITED (15-DAY) Product NUVARING SYNTHROID RITALIN Health Professional N Outcomes HO,LT Role Route S C C VAGINAL Manufacturer Control # 2011SP057413 Dosage Text QM;VAG Age 42 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 746 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7271472 Date FDA Received
15-Dec-2011 Preferred Term DEEP VEIN THROMBOSIS ABDOMINAL PAIN UPPER ABORTION INDUCED ABSCESS NECK BLOOD PRESSURE INCREASED DYSPNOEA EXPOSURE TO COMMUNICABLE DISEASE FIBRIN D DIMER INCREASED FLANK PAIN HAEMORRHAGE HYPOKALAEMIA INCORRECT DRUG ADMINISTRATION DURATION MATERNAL EXPOSURE BEFORE PREGNANCY PELVIC PAIN PREGNANCY PULMONARY EMBOLISM VULVOVAGINAL CANDIDIASIS Case # 7271472 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO,OT Role Route S Manufacturer Control # 2009SP023519 Dosage Text Age 29 YR Duration Sex Female Country USA

Manufacturer

8292671 Date FDA Received

15-Dec-2011 Preferred Term THROMBOSIS WEIGHT INCREASED

Case # 8292671

Case Type DIRECT Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control #

Age 45 YR

Sex Female

Country USA

Dosage Text

Duration

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 747 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8308919 Date FDA Received
15-Dec-2011 Preferred Term ANKLE FRACTURE Case # 8308919 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional N Outcomes HO Role Route S Manufacturer Control # 2011SP057560 Dosage Text Age 24 YR Duration Sex Female Country DEU

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 748 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7586982 Date FDA Received
16-Dec-2011 Preferred Term PULMONARY EMBOLISM PULMONARY INFARCTION ACCIDENT AT WORK ATELECTASIS BLOOD CHOLESTEROL INCREASED BODY TEMPERATURE INCREASED BRONCHITIS CANDIDIASIS CERVICAL DYSPLASIA COLITIS ULCERATIVE DEPRESSION DYSTHYMIC DISORDER GASTROOESOPHAGEAL REFLUX DISEASE HEADACHE JAUNDICE LUNG NEOPLASM MUSCULOSKELETAL CHEST PAIN OEDEMA PERIPHERAL OROPHARYNGEAL PAIN PAIN IN EXTREMITY PAPILLOMA VIRAL INFECTION POSTPARTUM STRESS DISORDER RHINITIS ALLERGIC SLEEP DISORDER SUICIDAL IDEATION UPPER LIMB FRACTURE VICTIM OF SEXUAL ABUSE Case # 7586982 Case Type EXPEDITED (15-DAY) Product NUVARING UNSPECIFIED INGREDIENT Health Professional Y Outcomes HO,OT Role Route S S VAGINAL Manufacturer Control # 2009SP043080 Dosage Text ;VAG Age 25 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 749 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7797012 Date FDA Received
16-Dec-2011 Preferred Term INTRACRANIAL ANEURYSM DIZZINESS ANAEMIA BLOOD TRIGLYCERIDES INCREASED HYPERTENSION BLOOD PRESSURE INADEQUATELY CONTROLLED CAROTID ARTERY ANEURYSM CEREBRAL INFARCTION CULTURE POSITIVE DIABETES MELLITUS INADEQUATE CONTROL ENTEROCOCCUS TEST POSITIVE HYPERTENSIVE CRISIS LEFT VENTRICULAR HYPERTROPHY NAUSEA OTITIS MEDIA PNEUMOCEPHALUS PYREXIA SWELLING FACE TREATMENT NONCOMPLIANCE VERTIGO Case # 7797012 Case Type EXPEDITED (15-DAY) Product NUVARING METFORMIN HYDROCHLORIDE GLIPIZIDE METOPROLOL TARTRATE LISINOPRIL HYDROCHLOROTHIAZIDE Health Professional Y Outcomes HO,OT Role Route S C C C C C VAGINAL Manufacturer Control # 2011SP000219 Dosage Text ;VAG Age 46 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 750 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8007806 Date FDA Received
16-Dec-2011 Preferred Term DEEP VEIN THROMBOSIS PSORIASIS ABDOMINAL PAIN ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED ANXIETY BREAST DISCHARGE CHEST PAIN DEPRESSION FALL FOOT FRACTURE HAEMATOCHEZIA HAEMORRHOIDAL HAEMORRHAGE HYPERCOAGULATION HYPERLIPIDAEMIA INTERNATIONAL NORMALISED RATIO INCREASED IRRITABLE BOWEL SYNDROME MENOMETRORRHAGIA MUSCULOSKELETAL PAIN NAUSEA NECK PAIN OVARIAN CYST PROTHROMBIN TIME PROLONGED TEMPERATURE INTOLERANCE UTERINE LEIOMYOMA Case # 8007806 Case Type EXPEDITED (15-DAY) Product NUVARING SYNTHROID Health Professional Y Outcomes HO,OT Role Route S C Manufacturer Control # 2011SP005927 Dosage Text Age 33 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 751 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8231251 Date FDA Received
16-Dec-2011 Preferred Term HEADACHE ABDOMINAL PAIN URETHRAL HAEMORRHAGE URINARY TRACT INFECTION Case # 8231251 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes OT Role Route S Manufacturer Control # 2011SP049776 Dosage Text Age 43 YR Duration Sex Female Country DEU

Manufacturer

8295740 Date FDA Received

16-Dec-2011

Case # 8295740

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # US-BRISTOL-MYERS SQUIBB COMPANY-15967375

Age

Sex Female

Country USA

Preferred Term DRUG INEFFECTIVE

Product ABILIFY NUVARING XANAX

Role Route S S S Health Professional N Outcomes OT Role Route S

Dosage Text

Duration

Manufacturer

8313520 Date FDA Received

16-Dec-2011 Preferred Term INJURY BRAIN INJURY CARDIAC ARREST

Case # 8313520

Case Type EXPEDITED (15-DAY) Product NUVARING

Manufacturer Control # 2011SP058196 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

PULMONARY EMBOLISM

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 752 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8268379 Date FDA Received
19-Dec-2011 Preferred Term DEEP VEIN THROMBOSIS CERVICAL DYSPLASIA MATERNAL EXPOSURE BEFORE PREGNANCY PREGNANCY THROMBOSIS Case # 8268379 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO,OT Role Route S Manufacturer Control # 2011SP014803 Dosage Text Age 21 YR Duration Sex Female Country USA

Manufacturer

8294046 Date FDA Received

19-Dec-2011 Preferred Term ECZEMA

Case # 8294046

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes DS,OT Role Route S VAGINAL

Manufacturer Control # 2011SP051467 Dosage Text 15 MCG/120 MCG/245 HEURES, SYSTEME DE DIFFUSION VAGINAL (NUVARING / 01603301/)

Age 20 YR Duration

Sex Female

Country FRA

Manufacturer

DEPRESSION DYSTONIA MIGRAINE WITH AURA NERVOUS SYSTEM DISORDER

8315997 Date FDA Received

19-Dec-2011 Preferred Term

Case # 8315997

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2011SP054332 Dosage Text QM, VAG

Age 35 YR Duration

Sex Female

Country CHL

Manufacturer

INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION ABORTION SPONTANEOUS PREGNANCY WITH CONTRACEPTIVE DEVICE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 753 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7953486 Date FDA Received
20-Dec-2011 Preferred Term PULMONARY EMBOLISM INJURY ANXIETY BONE PAIN BUNDLE BRANCH BLOCK RIGHT CARDIOMEGALY DEPRESSION DIPLOPIA DIZZINESS ELECTROCARDIOGRAM T WAVE ABNORMAL GESTATIONAL DIABETES GROIN PAIN HEPATIC STEATOSIS HYPOTHYROIDISM INTERNATIONAL NORMALISED RATIO INCREASED LUNG NEOPLASM MATERNAL EXPOSURE DURING PREGNANCY OVARIAN CYST PAIN PAIN IN EXTREMITY PLEURISY PREGNANCY TRICUSPID VALVE INCOMPETENCE UPPER RESPIRATORY TRACT INFECTION VERTIGO Case # 7953486 Case Type EXPEDITED (15-DAY) Product NUVARING ADVIL Health Professional Y Outcomes HO,OT Role Route S C Manufacturer Control # 2010SP065562 Dosage Text Age 27 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 754 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8274514 Date FDA Received
20-Dec-2011 Preferred Term PULMONARY EMBOLISM ANTIPHOSPHOLIPID SYNDROME EMOTIONAL DISORDER IMPAIRED WORK ABILITY MIGRAINE PSYCHOLOGICAL TRAUMA Case # 8274514 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO,DS Role Route S Manufacturer Control # 2011SP023177 Dosage Text Age 26 YR Duration Sex Female Country USA

Manufacturer

8302844 Date FDA Received

20-Dec-2011 Preferred Term

Case # 8302844

Case Type DIRECT Product NUVARING

Health Professional N

Outcomes

Manufacturer Control #

Age 22 YR

Sex Female

Country USA

Role Route S VAGINAL

Dosage Text 1 vaginal ring

Duration

Manufacturer

DRUG DISPENSING ERROR ANXIETY EXPIRED DRUG ADMINISTERED STRESS

8322172 Date FDA Received

21-Dec-2011 Preferred Term

Case # 8322172

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO,LT Role Route S C C VAGINAL

Manufacturer Control # 2011SP058682 Dosage Text VAG

Age 46 YR Duration

Sex Female

Country DEU

Manufacturer

HEMIANOPIA HOMONYMOUS CEREBRAL INFARCTION HAEMORRHAGIC CEREBRAL INFARCTION

AMLODIPINE RAMIPRIL Health Professional Y

8322178 Date FDA Received

21-Dec-2011 Preferred Term

Case # 8322178

Case Type EXPEDITED (15-DAY) Product NUVARING

Outcomes HO Role Route S

Manufacturer Control # 2011SP045405 Dosage Text

Age 26 YR Duration

Sex Female

Country DEU

Manufacturer

INTRACRANIAL VENOUS SINUS THROMBOSIS BRAIN OEDEMA EPILEPSY

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 755 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8322633 Date FDA Received
21-Dec-2011 Preferred Term PITUITARY TUMOUR Case # 8322633 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional N Outcomes OT Role Route S Manufacturer Control # 2011SP057715 Dosage Text Age 22 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 756 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8018277 Date FDA Received
23-Dec-2011 Preferred Term PULMONARY EMBOLISM CHEST PAIN ARTHROPOD BITE ATELECTASIS BILIARY COLIC BILIARY DYSKINESIA BLOOD LACTATE DEHYDROGENASE INCREASED CONDITION AGGRAVATED DYSMENORRHOEA GASTROOESOPHAGEAL REFLUX DISEASE HELICOBACTER GASTRITIS HYPERCOAGULATION HYPERLIPIDAEMIA MAMMOPLASTY MENTAL DISORDER NECK PAIN NEPHROLITHIASIS NIGHT SWEATS OROPHARYNGEAL PAIN PAIN IN EXTREMITY PLEURITIC PAIN POST PROCEDURAL HAEMATOMA RASH MACULO-PAPULAR URTICARIA VACCINATION SITE SWELLING VOMITING Case # 8018277 Case Type EXPEDITED (15-DAY) Product NUVARING PREDNISONE Health Professional Y Outcomes HO,OT Role Route S C VAGINAL Manufacturer Control # 2010SP053353 Dosage Text 1 DF, QM, VAG Age 32 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 757 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8235350 Date FDA Received
23-Dec-2011 Preferred Term PULMONARY EMBOLISM ABDOMINAL PAIN HYPERCOAGULATION WITHDRAWAL BLEED ANXIETY DISORDER FLANK PAIN PANIC ATTACK SPLENOMEGALY Case # 8235350 Case Type EXPEDITED (15-DAY) Product NUVARING VYVANSE LORAZEPAM SERTRALINE HYDROCHLORIDE Health Professional Y Outcomes HO Role Route S C C C VAGINAL Manufacturer Control # 2011SP017555 Dosage Text QM;VAG Age 17 YR Duration Sex Female Country USA

Manufacturer

7396584 Date FDA Received

28-Dec-2011 Preferred Term

Case # 7396584

Case Type EXPEDITED (15-DAY) Product NUVARING FLEXERIL

Health Professional Y

Outcomes HO,OT Role Route S C

Manufacturer Control # 2010SP009673 Dosage Text 1 DF

Age 41 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS THROMBOSIS ABDOMINAL PAIN ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED ACTIVITIES OF DAILY LIVING IMPAIRED ANXIETY BACK PAIN BREAST PAIN CHEST PAIN CONTUSION COSTOCHONDRITIS DEPRESSION DIARRHOEA DUODENITIS HAEMORRHOIDS HIATUS HERNIA

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 758 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7396584
Preferred Term HYPERCOAGULATION HYPOAESTHESIA INJURY INTERNATIONAL NORMALISED RATIO DECREASED IRON DEFICIENCY ANAEMIA LIPOMA LOSS OF CONTROL OF LEGS LYMPHADENOPATHY LYMPHADENOPATHY MEDIASTINAL MENOMETRORRHAGIA MENORRHAGIA MICROCYTIC ANAEMIA MUSCLE STRAIN OVARIAN CYST PAIN PANIC DISORDER POST THROMBOTIC SYNDROME PROCTITIS RESTLESS LEGS SYNDROME STRESS SWELLING SYNCOPE TOOTH ABSCESS UPPER RESPIRATORY TRACT INFECTION UTERINE LEIOMYOMA VITAMIN B12 DEFICIENCY VOMITING WEIGHT INCREASED Product Role Route Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 759 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7271452 Date FDA Received
03-Jan-2012 Preferred Term PULMONARY EMBOLISM DEEP VEIN THROMBOSIS CARDIAC DISORDER CARDIAC FAILURE ACUTE CATARACT CERVICAL DYSPLASIA DEPRESSION DILATATION VENTRICULAR GASTROOESOPHAGEAL REFLUX DISEASE HERPES VIRUS INFECTION HYPERHOMOCYSTEINAEMIA HYPERTENSION IRON DEFICIENCY ANAEMIA MIGRAINE OESOPHAGEAL ACHALASIA OSTEOARTHRITIS REFRACTIVE AMBLYOPIA RENAL CYST RHEUMATOID ARTHRITIS SLEEP APNOEA SYNDROME STRABISMUS TENDONITIS UVEITIS Case # 7271452 Case Type EXPEDITED (15-DAY) Product NUVARING ACETAMINOPHEN Health Professional Y Outcomes HO,OT Role Route S C Manufacturer Control # 2009SP023301 Dosage Text Age 31 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 760 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7808469 Date FDA Received
03-Jan-2012 Preferred Term PULMONARY EMBOLISM ABDOMINAL PAIN UPPER AGORAPHOBIA ANEURYSM ANXIETY CONTUSION DIARRHOEA FEAR OF DEATH GASTRITIS HEAD INJURY OESOPHAGEAL STENOSIS OESOPHAGEAL ULCER PALPITATIONS POST-TRAUMATIC STRESS DISORDER PUPILS UNEQUAL SYNCOPE VISION BLURRED Case # 7808469 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO,OT Role Route S Manufacturer Control # 2010SP038530 Dosage Text Age 38 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 761 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8095659 Date FDA Received
03-Jan-2012 Preferred Term PULMONARY EMBOLISM INFECTION ANXIETY ASTHMA CHALAZION CHEST DISCOMFORT CYSTITIS INTERSTITIAL DERMATOMYOSITIS DYSURIA EMOTIONAL DISORDER FATIGUE HEART RATE INCREASED HEPATIC STEATOSIS HYPERCOAGULATION INSOMNIA MENTAL DISORDER PAIN IN EXTREMITY PALPITATIONS POLYMYOSITIS PRODUCT QUALITY ISSUE RESPIRATORY DISORDER STRESS TACHYPHRENIA TROPONIN INCREASED URINARY TRACT INFECTION VAGINITIS BACTERIAL VULVOVAGINAL CANDIDIASIS VULVOVAGINAL DISCOMFORT Case # 8095659 Case Type EXPEDITED (15-DAY) Product NUVARING PHENTERMINE Health Professional Y Outcomes HO,OT Role Route S C Manufacturer Control # 2010SP063657 Dosage Text Age 32 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 762 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8316013 Date FDA Received
03-Jan-2012 Preferred Term TONSILLECTOMY AMENORRHOEA Case # 8316013 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional N Outcomes HO Role Route S VAGINAL Manufacturer Control # 2011SP057992 Dosage Text VAG Age 32 YR Duration Sex Female Country ESP

Manufacturer

7031567 Date FDA Received

04-Jan-2012 Preferred Term

Case # 7031567

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO,DS,OT Role Route S S C C C C C C C

Manufacturer Control # 2009-198049-NL Dosage Text

Age 29 YR Duration

Sex Female

Country USA

Manufacturer

INTRACRANIAL VENOUS SINUS THROMBOSIS FALL VOMITING DEPRESSION VERTIGO POSITIONAL SUBDURAL HAEMATOMA

COPPER-CONTAINING INTRAUTERINE DEVICE (IUD) ACETAMINOPHEN IMITREX GUAIFENESIN SUDAFED 12 HOUR ALBUTEROL PULMICORT FLEXHALER ADVAIR DISKUS

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 763 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7806010 Date FDA Received
04-Jan-2012 Preferred Term PULMONARY EMBOLISM DEEP VEIN THROMBOSIS COAGULATION FACTOR VIII LEVEL INCREASED COAGULOPATHY FATIGUE FIBRIN D DIMER INCREASED IRON DEFICIENCY MULTIPLE INJURIES ROAD TRAFFIC ACCIDENT TONSILLAR HYPERTROPHY Case # 7806010 Case Type EXPEDITED (15-DAY) Product NUVARING DORYX Health Professional Y Outcomes HO,OT Role Route S C Manufacturer Control # 2010SP020510 Dosage Text ;QM; Age 28 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 764 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7826798 Date FDA Received
04-Jan-2012 Preferred Term DEEP VEIN THROMBOSIS ABDOMINAL PAIN ACNE ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED ALCOHOL POISONING ANGINA PECTORIS ANXIETY ATELECTASIS BLOOD DISORDER BRONCHITIS CELLULITIS COAGULOPATHY DEPRESSION DEVICE BREAKAGE FACTOR V LEIDEN MUTATION FEAR HAEMOGLOBIN DECREASED HYPERSOMNIA INSOMNIA INTERNATIONAL NORMALISED RATIO DECREASED MIGRAINE PNEUMONIA PULMONARY EMBOLISM PULMONARY INFARCTION ROAD TRAFFIC ACCIDENT Case # 7826798 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO Role Route S Manufacturer Control # 2010SP041957 Dosage Text Age 23 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 765 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8158375 Date FDA Received
04-Jan-2012 Preferred Term PYREXIA ABDOMINAL PAIN ABORTION SPONTANEOUS MATERNAL EXPOSURE DURING PREGNANCY OOPHORITIS OVARIAN CYST PREGNANCY WITH CONTRACEPTIVE DEVICE Case # 8158375 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO,OT Role Route S VAGINAL Manufacturer Control # 2011SP040567 Dosage Text VAG Age 31 YR Duration Sex Female Country BRA

Manufacturer

7805906 Date FDA Received

05-Jan-2012 Preferred Term

Case # 7805906

Case Type EXPEDITED (15-DAY) Product NUVARING COUMADIN SYNTHROID

Health Professional Y

Outcomes HO,OT Role Route S S C VAGINAL

Manufacturer Control # 2010SP052983 Dosage Text VAG

Age 27 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM DEEP VEIN THROMBOSIS JOINT INJURY ARTHRALGIA ARTHROFIBROSIS ARTHROPATHY CARDIOVASCULAR DISORDER DIARRHOEA GASTROINTESTINAL DISORDER HAEMATOCHEZIA HEADACHE LIGAMENT RUPTURE PHLEBITIS PULMONARY HYPERTENSION TRICUSPID VALVE INCOMPETENCE VOMITING

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 766 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8087513 Date FDA Received
05-Jan-2012 Preferred Term Peripheral artery thrombosis PERIPHERAL ISCHAEMIA HAEMATOMA VOMITING Case # 8087513 Case Type EXPEDITED (15-DAY) Product NUVARING UNSPECIFIED INGREDIENT PREDNISONE Health Professional Y Outcomes HO,DS,OT Role Route S S S Manufacturer Control # 2011SP015421 Dosage Text Age 27 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 767 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8141360 Date FDA Received
05-Jan-2012 Preferred Term PULMONARY EMBOLISM ANAEMIA ARRHYTHMIA DEEP VEIN THROMBOSIS EMOTIONAL DISORDER FATIGUE HUMAN PAPILLOMA VIRUS TEST POSITIVE INFARCTION INFLAMMATION MENSTRUATION IRREGULAR MENTAL DISORDER MICTURITION URGENCY MUSCLE SPASMS OEDEMA PERIPHERAL PELVIC PAIN PLEURISY PNEUMONIA SMEAR CERVIX ABNORMAL TRICUSPID VALVE INCOMPETENCE UPPER RESPIRATORY TRACT INFECTION URINARY RETENTION VAGINITIS BACTERIAL Case # 8141360 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO,OT Role Route S Manufacturer Control # 2011SP012497 Dosage Text 1 DF, QM Age 26 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 768 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8238831 Date FDA Received
05-Jan-2012 Preferred Term PULMONARY EMBOLISM ECONOMIC PROBLEM MENTAL DISORDER COGNITIVE DISORDER ALANINE AMINOTRANSFERASE INCREASED ASPARTATE AMINOTRANSFERASE INCREASED BLOOD ALKALINE PHOSPHATASE INCREASED EMOTIONAL DISORDER EMPHYSEMA INFUSION SITE PHLEBITIS INTERNATIONAL NORMALISED RATIO DECREASED PULMONARY INFARCTION STAPHYLOCOCCAL INFECTION Case # 8238831 Case Type EXPEDITED (15-DAY) Product NUVARING OXYCODONE HYDROCHLORIDE VALACYCLOVIR HYDROCHLORIDE RANITIDINE Health Professional Y Outcomes HO,OT Role Route S C C C Manufacturer Control # 2011SP014602 Dosage Text Age 46 YR Duration Sex Female Country USA

Manufacturer

8339910 Date FDA Received

05-Jan-2012 Preferred Term PANCREATITIS

Case # 8339910

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2012SP000135 Dosage Text ;VAG

Age 31 YR Duration

Sex Female

Country DEU

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 769 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6022890 Date FDA Received
06-Jan-2012 Preferred Term BODY TEMPERATURE DECREASED MATERNAL EXPOSURE BEFORE PREGNANCY ABORTION MISSED ATELECTASIS ATRIAL FIBRILLATION BODY TEMPERATURE INCREASED CEREBROVASCULAR ACCIDENT CHEST DISCOMFORT DEHYDRATION DIZZINESS FIBROADENOMA OF BREAST GASTROOESOPHAGEAL REFLUX DISEASE HEADACHE JAUNDICE MUSCULOSKELETAL CHEST PAIN NAUSEA PARALYSIS TRANSIENT ISCHAEMIC ATTACK VERTIGO VISION BLURRED VOMITING Case # 6022890 Case Type EXPEDITED (15-DAY) Product NUVARING ACETAMINOPHEN Health Professional Y Outcomes HO Role Route S C VAGINAL Manufacturer Control # 2006-137976-NL Dosage Text VAG Age 38 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 770 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7698679 Date FDA Received
06-Jan-2012 Preferred Term PULMONARY EMBOLISM ANAEMIA ATELECTASIS BLOOD PRESSURE INCREASED DERMATITIS HEADACHE LOBAR PNEUMONIA MATERNAL EXPOSURE BEFORE PREGNANCY MIGRAINE PHOTOPHOBIA SINUSITIS Case # 7698679 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO,OT Role Route S Manufacturer Control # 2010SP044933 Dosage Text Age 31 YR Duration Sex Female Country USA

Manufacturer

7707819 Date FDA Received

06-Jan-2012 Preferred Term OVARIAN INFECTION COLITIS ARRHYTHMIA RENAL DISORDER ABDOMINAL PAIN

Case # 7707819

Case Type EXPEDITED (15-DAY) Product NUVARING COUMADIN HEPARIN LOVENOX

Health Professional Y

Outcomes HO,DS,OT Role Route S S S S

Manufacturer Control # 2010SP042224 Dosage Text

Age 30 YR Duration

Sex Female

Country USA

Manufacturer

ABDOMINAL PAIN UPPER ADNEXA UTERI PAIN ALOPECIA ANGINA PECTORIS ARTHRALGIA ATELECTASIS BACK PAIN BRADYCARDIA BROAD LIGAMENT HAEMATOMA

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 771 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7707819
Preferred Term CERVICITIS CHEST PAIN CHOLECYSTITIS CHRONIC CHOLELITHIASIS CONDITION AGGRAVATED DEPRESSION DRUG DEPENDENCE DYSTHYMIC DISORDER FATIGUE FIBROMYALGIA GASTRITIS GENERALISED ANXIETY DISORDER HAEMORRHAGIC DISORDER HEADACHE HEPATIC CALCIFICATION HIATUS HERNIA HYDRONEPHROSIS IMPATIENCE INGROWING NAIL INSOMNIA LUNG DISORDER MEMORY IMPAIRMENT MIGRAINE MOUTH ULCERATION MUSCULOSKELETAL PAIN MYOSITIS NAUSEA NEPHROLITHIASIS OVARIAN CYST OVARIAN DISORDER PAIN Product Role Route Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 772 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7707819
Preferred Term PALPITATIONS PELVIC FLUID COLLECTION PELVIC PAIN PELVIC VENOUS THROMBOSIS PRURITUS PULMONARY ARTERIAL HYPERTENSION RENAL CYST SKIN PAPILLOMA STRESS SYSTEMIC LUPUS ERYTHEMATOSUS THROMBOPHLEBITIS THROMBOSIS UNEVALUABLE EVENT VOMITING WEIGHT INCREASED WHITE BLOOD CELL COUNT DECREASED Product Role Route Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 773 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7808335 Date FDA Received
06-Jan-2012 Preferred Term PULMONARY EMBOLISM BONE PAIN BREAST MASS CONDITION AGGRAVATED CONTUSION DEEP VEIN THROMBOSIS FUNGAL INFECTION IMPAIRED WORK ABILITY INTERVERTEBRAL DISC DEGENERATION INTERVERTEBRAL DISC PROTRUSION MEDIAL TIBIAL STRESS SYNDROME MENISCUS LESION MIGRAINE MYALGIA PAIN PAIN IN EXTREMITY POST PROCEDURAL COMPLICATION VARICOSE VEIN WEIGHT INCREASED WRIST SURGERY Case # 7808335 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes OT Role Route S Manufacturer Control # 2010SP004901 Dosage Text Age 23 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 774 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7882868 Date FDA Received
06-Jan-2012 Preferred Term CEREBROVASCULAR ACCIDENT CARDIAC DISORDER CARDIOMYOPATHY CONDUCTION DISORDER DEPRESSION ECCHYMOSIS EMBOLIC STROKE EMBOLISM HEART RATE IRREGULAR HEMIPARESIS HYPERCOAGULATION HYPOKINESIA LACUNAR INFARCTION MITRAL VALVE INCOMPETENCE MYOCARDIAL INFARCTION PALPITATIONS PULMONARY VALVE INCOMPETENCE SLEEP APNOEA SYNDROME STRESS SYSTOLIC DYSFUNCTION TRANSIENT ISCHAEMIC ATTACK TRICUSPID VALVE INCOMPETENCE VENTRICULAR FIBRILLATION VENTRICULAR TACHYCARDIA Case # 7882868 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO,DS,OT Role Route S Manufacturer Control # 2010SP062548 Dosage Text Age 27 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 775 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7284827 Date FDA Received
09-Jan-2012 Preferred Term MATERNAL EXPOSURE BEFORE PREGNANCY CAESAREAN SECTION CHOLECYSTITIS CHRONIC CHOLELITHIASIS DEEP VEIN THROMBOSIS PULMONARY EMBOLISM THROMBOPHLEBITIS SUPERFICIAL Case # 7284827 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes OT Role Route S Manufacturer Control # 2009-200154-NL Dosage Text Age 31 YR Duration Sex Female Country USA

Manufacturer

7511253 Date FDA Received

09-Jan-2012 Preferred Term

Case # 7511253

Case Type EXPEDITED (15-DAY) Product NUVARING ALBUTEROL

Health Professional Y

Outcomes DE,OT Role Route S C VAGINAL

Manufacturer Control # 2010SP038538 Dosage Text ;VAG

Age 43 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM THROMBOSIS FOCAL NODULAR HYPERPLASIA OVARIAN CYST PULMONARY CONGESTION PULMONARY THROMBOSIS RENAL ATROPHY SPLEEN DISORDER TENDONITIS

8161102 Date FDA Received

09-Jan-2012 Preferred Term

Case # 8161102

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO,OT Role Route S

Manufacturer Control # 2011SP025635 Dosage Text

Age 23 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM ADENOTONSILLECTOMY ANGER ANXIETY

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 776 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8161102
Preferred Term BENIGN INTRACRANIAL HYPERTENSION BODY TEMPERATURE INCREASED CERVICITIS CONSTIPATION DEEP VEIN THROMBOSIS DEPRESSED MOOD DEPRESSION DIARRHOEA DILATATION VENTRICULAR DRUG INEFFECTIVE DYSMENORRHOEA HAEMATOCHEZIA HEPATIC STEATOSIS HYPERCOAGULATION INJURY IRRITABILITY JAUNDICE JOINT CREPITATION MIGRAINE MOOD ALTERED MUSCLE SPASMS OEDEMA OEDEMA PERIPHERAL PAIN IN EXTREMITY PANIC ATTACK PNEUMONIA POLYCYSTIC OVARIES PULMONARY HYPERTENSION RASH THROMBOSIS URINARY TRACT INFECTION Product Role Route Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 777 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8161102
Preferred Term VULVOVAGINITIS Product Role Route Dosage Text Duration Manufacturer

8216922 Date FDA Received

09-Jan-2012 Preferred Term

Case # 8216922

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO,OT Role Route S

Manufacturer Control # 2011SP019413 Dosage Text

Age 31 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS ANTIPHOSPHOLIPID ANTIBODIES POSITIVE ANXIETY BACK PAIN DRUG ABUSE FEMALE STERILISATION HAEMOPTYSIS HEART RATE DECREASED HYPERCOAGULATION MAJOR DEPRESSION MATERNAL EXPOSURE DURING PREGNANCY MENSTRUAL DISORDER NIGHT SWEATS PHARYNGITIS PREGNANCY WITH CONTRACEPTIVE DEVICE PSYCHOTIC DISORDER PULMONARY EMBOLISM SINUS TACHYCARDIA SKIN LESION STAPHYLOCOCCAL INFECTION STRESS URINARY TRACT INFECTION VAGINAL HAEMORRHAGE VIRAL INFECTION WEIGHT DECREASED

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 778 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8270505 Date FDA Received
09-Jan-2012 Preferred Term PULMONARY EMBOLISM ANAEMIA ASTHENIA BACK PAIN DEEP VEIN THROMBOSIS DERMATITIS ATOPIC DIVERTICULUM INTESTINAL DYSPHAGIA FIBROADENOMA OF BREAST HAEMATURIA HEART RATE IRREGULAR LEIOMYOMA MIGRAINE PALPITATIONS PERIPHERAL NERVE LESION PLEURAL EFFUSION PNEUMONIA UTERINE LEIOMYOMA VARICOSE VEIN Case # 8270505 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO,OT Role Route S Manufacturer Control # 2011SP035868 Dosage Text Age 53 YR Duration Sex Female Country USA

Manufacturer

8295043 Date FDA Received

11-Jan-2012 Preferred Term

Case # 8295043

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO,OT Role Route S

Manufacturer Control # 2011SP026441 Dosage Text

Age 30 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM ADNEXA UTERI PAIN AMNESIA ANGINA PECTORIS ANXIETY

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 779 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8295043
Preferred Term ARTHRITIS BLOOD CHOLESTEROL INCREASED BREAST PAIN BREAST TENDERNESS COSTOCHONDRITIS C-REACTIVE PROTEIN INCREASED DEEP VEIN THROMBOSIS DEPRESSION FIBROADENOMA OF BREAST FIBROMYALGIA GASTRITIS EROSIVE GASTROOESOPHAGEAL REFLUX DISEASE GESTATIONAL HYPERTENSION HEADACHE HYPERCOAGULATION HYPOAESTHESIA INTERVERTEBRAL DISC DEGENERATION INTERVERTEBRAL DISC DISORDER IRRITABLE BOWEL SYNDROME LIGAMENT SPRAIN METRORRHAGIA MUSCULAR WEAKNESS NIGHT SWEATS PHLEBITIS SUPERFICIAL PLANTAR FASCIITIS PREGNANCY PULMONARY OEDEMA SINUSITIS SPINAL OSTEOARTHRITIS SPORTS INJURY SURGERY Product Role Route Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 780 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8295043
Preferred Term THIRST VERTEBRAL FORAMINAL STENOSIS VULVOVAGINAL DRYNESS WEIGHT DECREASED WEIGHT INCREASED Product Role Route Dosage Text Duration Manufacturer

8333397 Date FDA Received

11-Jan-2012 Preferred Term MOOD SWINGS AFFECT LABILITY FALL

Case # 8333397

Case Type DIRECT Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control #

Age 35 YR

Sex Female

Country USA

Dosage Text

Duration

Manufacturer

8354789 Date FDA Received

12-Jan-2012 Preferred Term ANIMAL BITE

Case # 8354789

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes HO Role Route S VAGINAL

Manufacturer Control # 2012SP000799 Dosage Text QM; VAG

Age 22 YR Duration

Sex Female

Country CHL

Manufacturer

INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 781 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8355532 Date FDA Received
12-Jan-2012 Preferred Term HEADACHE APHASIA BLOOD CHOLESTEROL INCREASED BLOOD TRIGLYCERIDES INCREASED CAROTID ARTERY DISSECTION CAROTID ARTERY OCCLUSION CLUMSINESS HYPERCOAGULATION HYPOAESTHESIA Case # 8355532 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO Role Route S Manufacturer Control # 2012SP001209 Dosage Text Age 27 YR Duration Sex Female Country USA

Manufacturer

8355639 Date FDA Received

12-Jan-2012 Preferred Term CHOLECYSTECTOMY

Case # 8355639

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO Role Route S VAGINAL

Manufacturer Control # 2012SP001206 Dosage Text VAG

Age

Sex Female

Country USA

Duration

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 782 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7196228 Date FDA Received
13-Jan-2012 Preferred Term DYSPNOEA PULMONARY EMBOLISM PAIN HEADACHE MELAENA ABDOMINAL PAIN ASTHENIA ATRIOVENTRICULAR BLOCK FIRST DEGREE DIARRHOEA DIZZINESS INSOMNIA LIGAMENT SPRAIN MUSCLE SPASMS NAUSEA NO THERAPEUTIC RESPONSE PNEUMOMEDIASTINUM SINUS BRADYCARDIA STRESS VAGINITIS BACTERIAL Case # 7196228 Case Type EXPEDITED (15-DAY) Product NUVARING ZOLOFT ALEVE ACETAMINOPHEN Health Professional Y Outcomes HO,OT Role Route S C C C VAGINAL Manufacturer Control # 2009SP020314 Dosage Text 1 DF;QM;VAG Age 26 YR Duration Sex Female Country USA

Manufacturer

7806023 Date FDA Received

17-Jan-2012 Preferred Term

Case # 7806023

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO,OT Role Route S C C C C

Manufacturer Control # 2010SP019823 Dosage Text

Age 30 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM HYPOTHYROIDISM DYSPNOEA CHEST PAIN THROMBOSIS

VITAMINS NOS LEVOXYL DIPHENOXYLATE ACETAMINOPHEN

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 783 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7806023
Preferred Term ABDOMINAL PAIN ANXIETY ASTHENIA BLOOD CHOLESTEROL INCREASED BREAST DISCHARGE BREAST HAEMORRHAGE BREAST PAIN CONSTIPATION CYSTITIS INTERSTITIAL DEHYDRATION DIARRHOEA DIZZINESS DYSPNOEA EXERTIONAL FIBROMYALGIA INTERNATIONAL NORMALISED RATIO INCREASED LOW DENSITY LIPOPROTEIN INCREASED MAMMARY DUCT ECTASIA MENSTRUATION IRREGULAR MIGRAINE OVARIAN CYST PAIN IN EXTREMITY PELVIC INFLAMMATORY DISEASE PELVIC PAIN PRURITUS PULMONARY HYPERTENSION VAGINAL INFECTION VERTIGO VOMITING Product Role Route Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 784 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8193506 Date FDA Received
17-Jan-2012 Preferred Term PULMONARY EMBOLISM ATELECTASIS BACK PAIN BONE PAIN COAGULATION FACTOR VIII LEVEL INCREASED CONTUSION FALL INTERNATIONAL NORMALISED RATIO INCREASED JOINT INJURY LIGAMENT SPRAIN PNEUMONIA PULMONARY INFARCTION SYNOVIAL CYST Case # 8193506 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO,OT Role Route S Manufacturer Control # 2011SP005795 Dosage Text Age 38 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 785 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8117945 Date FDA Received
18-Jan-2012 Preferred Term UNRESPONSIVE TO STIMULI BLOOD PH DECREASED BUNDLE BRANCH BLOCK BILATERAL CARDIAC ARREST CARDIOVASCULAR DISORDER DILATATION VENTRICULAR FALL HAEMATOCRIT DECREASED HAEMOGLOBIN DECREASED OBSTETRICAL PULMONARY EMBOLISM POSTPARTUM DISORDER RIGHT ATRIAL DILATATION SINUS TACHYCARDIA TRICUSPID VALVE INCOMPETENCE VENTRICULAR HYPOKINESIA WHITE BLOOD CELL COUNT INCREASED Case # 8117945 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes DE,HO Role Route S VAGINAL Manufacturer Control # 2011SP038550 Dosage Text 1 DF;QM;VAG Age 28 YR Duration Sex Female Country USA

Manufacturer

7072161 Date FDA Received

19-Jan-2012 Preferred Term

Case # 7072161

Case Type EXPEDITED (15-DAY) Product NUVARING LEXAPRO

Health Professional Y

Outcomes HO Role Route S C

Manufacturer Control # 2009-200919-NL Dosage Text

Age 32 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM PNEUMONIA ANXIETY DYSPEPSIA HELICOBACTER TEST POSITIVE HYPERTENSION MIGRAINE TREMOR

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 786 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7362093 Date FDA Received
19-Jan-2012 Preferred Term PULMONARY EMBOLISM BLOOD THYROID STIMULATING HORMONE DECREASED MENORRHAGIA FALL HEAD INJURY FRACTURED COCCYX AUTOIMMUNE THYROIDITIS BREAST PAIN BREAST SWELLING DEPRESSION EMOTIONAL DISORDER GOITRE HEADACHE INTERVERTEBRAL DISC DEGENERATION MENTAL DISORDER Case # 7362093 Case Type EXPEDITED (15-DAY) Product NUVARING MEDROXYPROGESTERONE ACETATE SYNTHROID TOBRADEX CEPHALEXIN HYDROCODONE BITARTRATE AND ACETAMINOPHEN Health Professional Y Outcomes HO,OT Role Route S S C C C C VAGINAL Manufacturer Control # 2010SP009716 Dosage Text VAG Age 30 YR Duration Sex Female Country USA

Manufacturer

8294749 Date FDA Received

19-Jan-2012 Preferred Term

Case # 8294749

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO Role Route S

Manufacturer Control # 2011SP055484 Dosage Text

Age

Sex Female

Country SVN

Duration

Manufacturer

PULMONARY EMBOLISM MENTAL DISORDER PSYCHOTIC DISORDER

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 787 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8344018 Date FDA Received
20-Jan-2012 Preferred Term PREGNANCY WITH CONTRACEPTIVE DEVICE ABORTION SPONTANEOUS INCOMPLETE MATERNAL EXPOSURE DURING PREGNANCY Case # 8344018 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO Role Route S Manufacturer Control # 2011SP059404 Dosage Text Age 30 YR Duration Sex Female Country CHE

Manufacturer

8389019 Date FDA Received

20-Jan-2012 Preferred Term ANKLE FRACTURE HAEMORRHAGE

Case # 8389019

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes HO Role Route S VAGINAL

Manufacturer Control # 2012SP002261 Dosage Text VAG

Age

Sex Female

Country ESP

Duration

Manufacturer

7827223 Date FDA Received

23-Jan-2012 Preferred Term

Case # 7827223

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO,DS,OT Role Route S

Manufacturer Control # 2010SP045172 Dosage Text

Age 46 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM ANXIETY ELECTROCARDIOGRAM Q WAVES ELECTROCARDIOGRAM ST SEGMENT ABNORMAL FATIGUE HEADACHE HEPATIC CYST IMPAIRED WORK ABILITY LUNG NEOPLASM PALPITATIONS SINUS TACHYCARDIA STRESS

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 788 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7233282 Date FDA Received
24-Jan-2012 Preferred Term THROMBOTIC STROKE ACUTE MYOCARDIAL INFARCTION ANKLE FRACTURE ANTIPHOSPHOLIPID SYNDROME ANXIETY ATRIAL FIBRILLATION CARDIO-RESPIRATORY ARREST CYANOSIS EPILEPSY FIBULA FRACTURE GRAND MAL CONVULSION INTERNATIONAL NORMALISED RATIO DECREASED LIGAMENT SPRAIN MUSCLE SPASMS OBESITY PULMONARY EMBOLISM RESPIRATORY DISTRESS ROAD TRAFFIC ACCIDENT SKELETAL INJURY SYNCOPE TRANSVERSE SINUS THROMBOSIS UNRESPONSIVE TO STIMULI Case # 7233282 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes DE,HO,OT Role Route S VAGINAL Manufacturer Control # 2008-178179-NL Dosage Text 1 DF, VAG Age 29 YR Duration Sex Female Country USA

Manufacturer

8344126 Date FDA Received

24-Jan-2012 Preferred Term

Case # 8344126

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO Role Route S

Manufacturer Control # 2011SP056471 Dosage Text

Age 32 YR Duration

Sex Female

Country CHE

Manufacturer

PREGNANCY WITH CONTRACEPTIVE DEVICE

7546590
Date - Time: 02-04-2013 9:43:10 AM EST Note: If the field is blank, there is no data Page: 789 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7546590
FDA Received Date 25-Jan-2012 Preferred Term PULMONARY HYPERTENSION DEEP VEIN THROMBOSIS PULMONARY EMBOLISM SCAR IMPAIRED WORK ABILITY OVARIAN CYST ACNE AMENORRHOEA ANXIETY ARTHRALGIA BLOOD GLUCOSE INCREASED BODY TEMPERATURE INCREASED CARDIAC FAILURE CONGESTIVE CARDIOMEGALY DERMATITIS DEVICE BREAKAGE DIABETES MELLITUS INADEQUATE CONTROL GOUT HAEMORRHAGIC OVARIAN CYST HEADACHE HIRSUTISM HYPERTENSION HYPOKALAEMIA INTERNATIONAL NORMALISED RATIO DECREASED JAUNDICE MENORRHAGIA OBESITY Case # 7546590 Case Type EXPEDITED (15-DAY) Product NUVARING HERBALIFE METFORMIN HYDROCHLORIDE HYDROCHLOROTHIAZIDE ASPIRIN POTASSIUM CHLORIDE Health Professional Y Outcomes HO,DS,OT Role Route S C C C C C Manufacturer Control # 2010SP042477 Dosage Text Age 31 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 790 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7546590
Preferred Term OSTEOARTHRITIS PAIN IN JAW PERITONEAL HAEMORRHAGE PLEURAL EFFUSION PROCEDURAL COMPLICATION RASH PRURITIC RENAL FAILURE SLEEP APNOEA SYNDROME SYNCOPE TREATMENT NONCOMPLIANCE URINARY RETENTION WEIGHT DECREASED Product Role Route Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 791 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8254282 Date FDA Received
25-Jan-2012 Preferred Term PULMONARY EMBOLISM MENTAL DISORDER ANXIETY CARPAL TUNNEL SYNDROME CEREBROVASCULAR ACCIDENT COAGULOPATHY DEEP VEIN THROMBOSIS DEPRESSION DYSFUNCTIONAL UTERINE BLEEDING EMOTIONAL DISORDER INTERVERTEBRAL DISC PROTRUSION MUSCLE SPASMS NIGHT SWEATS SOCIAL PHOBIA URINARY TRACT INFECTION WEIGHT INCREASED Case # 8254282 Case Type EXPEDITED (15-DAY) Product NUVARING CIPROFLOXACIN Health Professional Y Outcomes HO,OT Role Route S S Manufacturer Control # 2011SP030601 Dosage Text Age 35 YR Duration Sex Female Country USA

Manufacturer

8270275 Date FDA Received

25-Jan-2012 Preferred Term

Case # 8270275

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO,OT Role Route S

Manufacturer Control # 2011SP035870 Dosage Text

Age 23 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED ASTHMA BACK INJURY BEDRIDDEN CARDIOVASCULAR DISORDER CHOLELITHIASIS DEEP VEIN THROMBOSIS

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 792 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8270275
Preferred Term DEPRESSION DISCOMFORT DIZZINESS EAR DISORDER EJECTION FRACTION DECREASED HAEMANGIOMA OF LIVER HYPERPLASTIC CHOLECYSTOPATHY HYPOAESTHESIA ORAL MIGRAINE MITRAL VALVE INCOMPETENCE MUSCLE SPASMS NASAL SEPTUM DEVIATION NERVE INJURY OVARIAN CYST PAIN IN EXTREMITY PARAESTHESIA ORAL PROTEUS TEST POSITIVE PULMONARY INFARCTION RENAL DISORDER SINUS DISORDER SLEEP APNOEA SYNDROME TONSILLITIS TRICUSPID VALVE INCOMPETENCE VAGINAL HAEMORRHAGE VERTIGO VISION BLURRED Product Role Route Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 793 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8382332 Date FDA Received
25-Jan-2012 Preferred Term MEDICATION ERROR DRUG PRESCRIBING ERROR INTERCEPTED MEDICATION ERROR Case # 8382332 Case Type DIRECT Product NUVARING ESTRING Role Route S S Dosage Text Duration Health Professional Outcomes Manufacturer Control # Age Sex Unknown Country USA

Manufacturer

8396873 Date FDA Received

26-Jan-2012 Preferred Term

Case # 8396873

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S C C C C C C C C C C C

Manufacturer Control # 2012SP003619 Dosage Text 1 DF

Age 44 YR Duration

Sex Female

Country USA

Manufacturer

LUNG NEOPLASM MALIGNANT

MEPERIDINE HCL NORMODYNE APRESOLINE HYDROCHLORIDE PROVENTIL NARCAN COLACE LOVENOX TORADOL AMBIEN NORCO ONDANSETRON

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 794 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7276504 Date FDA Received
27-Jan-2012 Preferred Term PULMONARY EMBOLISM DEEP VEIN THROMBOSIS SUICIDE ATTEMPT SINUS CONGESTION ABDOMINAL PAIN LOWER ANAEMIA ANXIETY ASCITES DEPRESSION DIZZINESS HYPOKALAEMIA HYPOTENSION MATERNAL EXPOSURE TIMING UNSPECIFIED MUSCULOSKELETAL PAIN NAUSEA PELVIC HAEMATOMA PERITONEAL HAEMORRHAGE PREGNANCY WITH CONTRACEPTIVE DEVICE RETROPERITONEAL HAEMATOMA RHINITIS ALLERGIC VOMITING Case # 7276504 Case Type EXPEDITED (15-DAY) Product NUVARING ACETAMINOPHEN IBUPROFEN PAXIL Health Professional Y Outcomes HO,OT Role Route S C C C Manufacturer Control # 2009SP026627 Dosage Text Age 26 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 795 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8296257 Date FDA Received
27-Jan-2012 Preferred Term PULMONARY EMBOLISM ABDOMINOPLASTY DEEP VEIN THROMBOSIS FLATULENCE HYPERCOAGULATION LEUKOCYTOSIS LUNG CONSOLIDATION POST CONCUSSION SYNDROME PULMONARY INFARCTION ROAD TRAFFIC ACCIDENT SINUSITIS TACHYCARDIA TOOTH ABSCESS Case # 8296257 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO Role Route S Manufacturer Control # 2011SP022677 Dosage Text Age 30 YR Duration Sex Female Country USA

Manufacturer

7125252 Date FDA Received

30-Jan-2012 Preferred Term

Case # 7125252

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO Role Route S

Manufacturer Control # 2009SP023611 Dosage Text

Age 19 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS ABORTION INDUCED ANAEMIA ANXIETY EXTRINSIC ILIAC VEIN COMPRESSION MATERNAL EXPOSURE DURING PREGNANCY PHLEBITIS PREGNANCY WITH CONTRACEPTIVE DEVICE UTERINE SYNECHIAE VAGINAL HAEMORRHAGE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 796 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8342441 Date FDA Received
30-Jan-2012 Preferred Term ABORTION THREATENED DEEP VEIN THROMBOSIS HAEMOGLOBINAEMIA HAEMOGLOBINURIA HEPATIC ENZYME INCREASED HYPERCHROMIC ANAEMIA MATERNAL EXPOSURE TIMING UNSPECIFIED MICROCYTIC ANAEMIA PREGNANCY Case # 8342441 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO Role Route S VAGINAL Manufacturer Control # 2011SP035858 Dosage Text VAG Age 21 YR Duration Sex Female Country USA

Manufacturer

8397815 Date FDA Received

30-Jan-2012 Preferred Term

Case # 8397815

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2012SP003681 Dosage Text 1 DF

Age 30 YR Duration

Sex Female

Country EST

Manufacturer

PREGNANCY WITH CONTRACEPTIVE DEVICE ECTOPIC PREGNANCY MATERNAL EXPOSURE DURING PREGNANCY

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 797 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8099713 Date FDA Received
31-Jan-2012 Preferred Term DEEP VEIN THROMBOSIS ANURIA ANXIETY CARDIAC ARREST CONVULSION FALL INJURY LOSS OF CONSCIOUSNESS MIGRAINE PETECHIAE PLEURAL ADHESION PULMONARY EMBOLISM PULSELESS ELECTRICAL ACTIVITY TORSADE DE POINTES UNRESPONSIVE TO STIMULI VENTRICULAR FIBRILLATION VISCERAL CONGESTION VISCERAL OEDEMA Case # 8099713 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes DE,HO Role Route S Manufacturer Control # 2011SP037140 Dosage Text Age 29 YR Duration Sex Female Country USA

Manufacturer

8375062 Date FDA Received

31-Jan-2012 Preferred Term DIARRHOEA DIZZINESS SWELLING FACE VIRAL INFECTION

Case # 8375062

Case Type DIRECT Product NUVARING

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control #

Age 27 YR

Sex Female

Country USA

Dosage Text

Duration

Manufacturer

7944824 Date FDA Received

01-Feb-2012

Case # 7944824

Case Type EXPEDITED (15-DAY)

Health Professional Y

Outcomes HO,OT

Manufacturer Control # 2010SP056520

Age 24 YR

Sex Female

Country USA

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 798 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7944824
Preferred Term SUPERIOR SAGITTAL SINUS THROMBOSIS ANTIPHOSPHOLIPID ANTIBODIES POSITIVE ANXIETY BENIGN INTRACRANIAL HYPERTENSION BLOOD PRESSURE INCREASED CEREBRAL INFARCTION COAGULATION FACTOR VIII LEVEL INCREASED COMPLICATED MIGRAINE DISORIENTATION DIZZINESS DRUG INEFFECTIVE DYSKINESIA DYSPNOEA EXERTIONAL ELECTROENCEPHALOGRAM ABNORMAL EPILEPSY EPISTAXIS FALL FEELING ABNORMAL GRAND MAL CONVULSION HEADACHE HYPERCOAGULATION HYPERGLYCAEMIA HYPOAESTHESIA INTERNATIONAL NORMALISED RATIO DECREASED LOSS OF CONSCIOUSNESS MENORRHAGIA MENTAL DISORDER MIGRAINE MOANING MULTIPLE INJURIES Product NUVARING Role Route S Dosage Text ;QM; Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 799 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7944824
Preferred Term NASAL CONGESTION NAUSEA OVERWEIGHT PAIN PALPITATIONS PANIC ATTACK PARAESTHESIA PLATELET COUNT INCREASED PNEUMONIA PRESYNCOPE REFRACTION DISORDER SCOTOMA SINUS DISORDER SINUS TACHYCARDIA SOMNOLENCE STRESS SYNCOPE TREMOR UPPER-AIRWAY COUGH SYNDROME URINARY TRACT INFECTION VOMITING WHITE BLOOD CELL COUNT INCREASED Product Role Route Dosage Text Duration Manufacturer

8146231 Date FDA Received

01-Feb-2012

Case # 8146231

Case Type EXPEDITED (15-DAY)

Health Professional Y

Outcomes HO,DS,OT

Manufacturer Control # 2011SP012499

Age 28 YR

Sex Female

Country USA

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 800 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8146231
Preferred Term DEEP VEIN THROMBOSIS PLEURISY OEDEMA ANKLE FRACTURE ANXIETY AUTOIMMUNE THYROIDITIS CENTRAL OBESITY DEPRESSIVE SYMPTOM DERMATITIS DEVICE EXPULSION DIZZINESS DRUG HYPERSENSITIVITY ECZEMA EMOTIONAL DISORDER FIBROUS HISTIOCYTOMA GASTROOESOPHAGEAL REFLUX DISEASE HYPERCOAGULATION INTERNATIONAL NORMALISED RATIO DECREASED MENTAL DISORDER MYOFASCIAL PAIN SYNDROME ORAL HERPES RESPIRATORY DISTRESS SELF-MEDICATION SINUS ARRHYTHMIA SKIN INFECTION TENSION HEADACHE TREATMENT NONCOMPLIANCE VESTIBULAR DISORDER WEIGHT INCREASED Product NUVARING SYNTHROID HYDROXYCUT Role Route S C C Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 801 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7826799 Date FDA Received
02-Feb-2012 Preferred Term MIGRAINE HEADACHE DRUG EFFECT DECREASED ABDOMINAL PAIN ABDOMINAL DISCOMFORT CENTRAL NERVOUS SYSTEM LESION CEREBRAL HAEMOSIDERIN DEPOSITION CONSTIPATION COUGH DRUG ADMINISTRATION ERROR DRUG HYPERSENSITIVITY ENCEPHALOMALACIA FALL FOOT FRACTURE GASTROENTERITIS VIRAL GRAND MAL CONVULSION HAEMORRHAGIC CEREBRAL INFARCTION ILEUS NAUSEA OTITIS MEDIA ACUTE POSTICTAL STATE PROTHROMBIN LEVEL INCREASED STAPHYLOCOCCAL INFECTION SUPERIOR SAGITTAL SINUS THROMBOSIS THYROID DISORDER TONSILLAR DISORDER VARICELLA VOMITING Case # 7826799 Case Type EXPEDITED (15-DAY) Product NUVARING NAPROSYN VICODIN ANAPROX Health Professional Y Outcomes HO,OT Role Route S S C C Manufacturer Control # 2010SP041962 Dosage Text Age 30 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 802 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8384860 Date FDA Received
02-Feb-2012 Preferred Term CONGENITAL CLEFT HAND ADACTYLY MATERNAL DRUGS AFFECTING FOETUS MATERNAL EXPOSURE BEFORE PREGNANCY SYNDACTYLY Case # 8384860 Case Type DIRECT Product NUVARING Health Professional N Outcomes CA Role Route S VAGINAL Dosage Text 1 ring Manufacturer Control # Age Sex Country USA Manufacturer < 1 DAY Male Duration

8401986 Date FDA Received

02-Feb-2012 Preferred Term

Case # 8401986

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2012SP005041 Dosage Text ;;VAG

Age

Sex Female

Country BRA

Duration

Manufacturer

MATERNAL EXPOSURE DURING PREGNANCY ABORTION SPONTANEOUS HYPOMENORRHOEA PREGNANCY WITH CONTRACEPTIVE DEVICE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 803 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7400191 Date FDA Received
03-Feb-2012 Preferred Term DIPLOPIA HUMAN PAPILLOMA VIRUS TEST POSITIVE HYPERTRICHOSIS STRESS ANTIPHOSPHOLIPID ANTIBODIES POSITIVE ABORTION SPONTANEOUS CEREBRAL THROMBOSIS CEREBRAL VENOUS THROMBOSIS CEREBROVASCULAR ACCIDENT CONSTIPATION ELECTROCARDIOGRAM T WAVE INVERSION HYPERCOAGULATION INTRACRANIAL VENOUS SINUS THROMBOSIS MATERNAL EXPOSURE DURING PREGNANCY MUSCLE SPASMS NO THERAPEUTIC RESPONSE PLEURAL EFFUSION PNEUMONIA BACTERIAL SUPERIOR SAGITTAL SINUS THROMBOSIS VISUAL FIELD DEFECT Case # 7400191 Case Type EXPEDITED (15-DAY) Product NUVARING DILAUDID MORPHINE OXYCONTIN OXYCODONE HYDROCHLORIDE Health Professional Y Outcomes HO Role Route S S S S S Manufacturer Control # 2009SP028413 Dosage Text Age 23 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 804 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7687435 Date FDA Received
03-Feb-2012 Preferred Term ASTHMA INFLUENZA DISEASE RECURRENCE METRORRHAGIA SINUSITIS Case # 7687435 Case Type EXPEDITED (15-DAY) Product NUVARING ALOE VERA Health Professional N Outcomes OT Role Route S C VAGINAL Manufacturer Control # 2010SP057119 Dosage Text QM;VAG Age 34 YR Duration Sex Female Country CHL

Manufacturer

8409784 Date FDA Received

03-Feb-2012 Preferred Term

Case # 8409784

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2012SP004858 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

PREGNANCY TEST FALSE POSITIVE ABDOMINAL DISTENSION ABDOMINAL PAIN BREAST PAIN BREAST TENDERNESS FATIGUE MENSTRUAL DISORDER NAUSEA VAGINAL DISCHARGE

7546203 Date FDA Received

06-Feb-2012 Preferred Term

Case # 7546203

Case Type EXPEDITED (15-DAY) Product NUVARING IBUPROFEN LISINOPRIL ZITHROMAX ACIPHEX

Health Professional Y

Outcomes HO,DS,OT Role Route S C C C C C

Manufacturer Control # 2009SP036873 Dosage Text

Age 47 YR Duration

Sex Female

Country USA

Manufacturer

CEREBROVASCULAR ACCIDENT HAEMORRHAGIC STROKE RESPIRATORY FAILURE COMA DEEP VEIN THROMBOSIS PROTEIN S DEFICIENCY

HYDROCODONE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 805 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7546203
Preferred Term SUPERIOR SAGITTAL SINUS THROMBOSIS TRANSVERSE SINUS THROMBOSIS ANEURYSM BLISTER BLOOD GLUCOSE INCREASED BRONCHITIS CERVICAL DYSPLASIA COAGULOPATHY COGNITIVE DISORDER COUGH DEHYDRATION DEPRESSION DIZZINESS EAR PAIN GAIT DISTURBANCE HAEMANGIOMA OF LIVER HAEMORRHAGE HEADACHE HEMIANOPIA HYPERCOAGULATION HYPERTENSION IMPAIRED DRIVING ABILITY INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION IRON DEFICIENCY ANAEMIA LETHARGY LEUKOCYTOSIS MEMORY IMPAIRMENT MENORRHAGIA MOBILITY DECREASED OXYGEN SATURATION DECREASED Product ANCEF PHENYLEPHRINE Role Route C C Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 806 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7546203
Preferred Term PHARYNGITIS RENAL CELL CARCINOMA RHINITIS ALLERGIC SINUSITIS SYNCOPE TEARFULNESS TINNITUS UPPER RESPIRATORY TRACT INFECTION UTERINE LEIOMYOMA UTERINE POLYP VENA CAVA THROMBOSIS VERTIGO VISUAL FIELD DEFECT VOMITING Product Role Route Dosage Text Duration Manufacturer

7778994 Date FDA Received

06-Feb-2012 Preferred Term TWIN PREGNANCY ATELECTASIS EMBOLISM HAEMOPTYSIS HEADACHE LUNG INFILTRATION

Case # 7778994

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO,OT Role Route S

Manufacturer Control # 2010SP042947 Dosage Text

Age 24 YR Duration

Sex Female

Country USA

Manufacturer

MATERNAL EXPOSURE DURING PREGNANCY NASAL CONGESTION NAUSEA PULMONARY EMBOLISM SEASONAL ALLERGY THROAT IRRITATION

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 807 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7984168 Date FDA Received
06-Feb-2012 Preferred Term PULMONARY EMBOLISM ARTHRALGIA BRONCHIAL WALL THICKENING BRONCHOSPASM CHEST DISCOMFORT CHRONIC SINUSITIS COUGH DEEP VEIN THROMBOSIS DYSPNOEA ELECTROCARDIOGRAM ABNORMAL FATIGUE HEADACHE HYPERCHOLESTEROLAEMIA IMPAIRED WORK ABILITY INTERNATIONAL NORMALISED RATIO ABNORMAL MALAISE MUSCULOSKELETAL PAIN PULMONARY CONGESTION UNEVALUABLE EVENT WEIGHT INCREASED Case # 7984168 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO,DS,OT Role Route S VAGINAL Manufacturer Control # 2010SP018678 Dosage Text 1 DF;QM;VAG Age 36 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 808 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8093316 Date FDA Received
06-Feb-2012 Preferred Term CHEST PAIN ABSCESS LIMB ARTHRALGIA ARTHROPOD BITE ATELECTASIS BLOOD CHOLESTEROL INCREASED CELLULITIS DIABETES MELLITUS EMOTIONAL DISORDER GASTROOESOPHAGEAL REFLUX DISEASE HYPERCOAGULATION JOINT INJURY MENTAL DISORDER MUSCLE SPASMS OBESITY OROPHARYNGEAL PAIN PLEURISY PLEURITIC PAIN PULMONARY EMBOLISM PULMONARY VALVE INCOMPETENCE SINUS TACHYCARDIA UPPER RESPIRATORY TRACT INFECTION URINARY TRACT INFECTION Case # 8093316 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO,OT Role Route S Manufacturer Control # 2011SP016578 Dosage Text Age 24 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 809 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8141778 Date FDA Received
06-Feb-2012 Preferred Term PULMONARY EMBOLISM INJURY ANXIETY ARRESTED LABOUR BACK PAIN CAESAREAN SECTION COAGULOPATHY DEEP VEIN THROMBOSIS DRUG DEPENDENCE DYSMENORRHOEA HAEMATOCRIT DECREASED HAEMOGLOBIN DECREASED HEADACHE HUMAN PAPILLOMA VIRUS TEST POSITIVE MATERNAL EXPOSURE DURING PREGNANCY MYALGIA OVARIAN CYST PLACENTAL INFARCTION PLEURITIC PAIN PULMONARY INFARCTION Case # 8141778 Case Type EXPEDITED (15-DAY) Product NUVARING ADVIL Health Professional Y Outcomes HO,DS,OT Role Route S C VAGINAL Manufacturer Control # 2010SP065508 Dosage Text VAG Age 20 YR Duration Sex Female Country USA

Manufacturer

8410895 Date FDA Received

06-Feb-2012 Preferred Term PENILE ULCERATION

Case # 8410895

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S C

Manufacturer Control # 2012SP001406 Dosage Text

Age 32 YR Duration

Sex Male

Country FRA Manufacturer

LANSOPRAZOLE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 810 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7953115 Date FDA Received
07-Feb-2012 Preferred Term DEEP VEIN THROMBOSIS ACTIVITIES OF DAILY LIVING IMPAIRED ANAEMIA DYSPNOEA HAEMORRHAGIC CYST IMPAIRED WORK ABILITY OVARIAN ADHESION OVARIAN CYST OVARIAN MASS OVARIAN NEOPLASM OVARIAN TORSION PELVIC PAIN PROTHROMBIN TIME PROLONGED SALPINGITIS UTERINE LEIOMYOMA Case # 7953115 Case Type EXPEDITED (15-DAY) Product NUVARING COUMADIN Health Professional Y Outcomes HO Role Route S S Manufacturer Control # 2011SP000218 Dosage Text Age 35 YR Duration Sex Female Country USA

Manufacturer

8307729 Date FDA Received

07-Feb-2012 Preferred Term

Case # 8307729

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO,OT Role Route S

Manufacturer Control # 2011SP030612 Dosage Text

Age 28 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM ACTIVITIES OF DAILY LIVING IMPAIRED ANXIETY APHASIA ARTERY DISSECTION ATAXIA BALANCE DISORDER BLOOD CHOLESTEROL INCREASED CARDIOVASCULAR DISORDER CEREBELLAR INFARCTION

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 811 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8307729
Preferred Term CHOLECYSTECTOMY CHOLELITHIASIS COGNITIVE DISORDER DEEP VEIN THROMBOSIS DEPRESSION DIARRHOEA DIZZINESS DYSPNOEA EMOTIONAL DISORDER FEELING ABNORMAL GALLBLADDER DISORDER HEADACHE HORMONE LEVEL ABNORMAL INJURY LIMB INJURY MENTAL DISORDER MIGRAINE MUSCULOSKELETAL DISCOMFORT NAUSEA NECK PAIN NYSTAGMUS PARANOIA POLYMENORRHOEA SPEECH DISORDER TRANSIENT ISCHAEMIC ATTACK VISION BLURRED Product Role Route Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 812 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8169086 Date FDA Received
08-Feb-2012 Preferred Term MAY-THURNER SYNDROME PULMONARY EMBOLISM AMENORRHOEA ARACHNOID CYST BRONCHITIS CEREBRAL CYST DEEP VEIN THROMBOSIS HEADACHE LOSS OF EMPLOYMENT SINUSITIS THROMBOPHLEBITIS SUPERFICIAL THROMBOSIS IN DEVICE THYROID DISORDER UPPER RESPIRATORY TRACT INFECTION URINARY TRACT INFECTION UTERINE LEIOMYOMA Case # 8169086 Case Type EXPEDITED (15-DAY) Product NUVARING SYNTHROID Health Professional Y Outcomes HO,OT Role Route S C Manufacturer Control # 2010SP056217 Dosage Text Age 39 YR Duration Sex Female Country USA

Manufacturer

8399698 Date FDA Received

08-Feb-2012 Preferred Term URINARY RETENTION

Case # 8399698

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO Role Route S VAGINAL

Manufacturer Control # 2012SP004322 Dosage Text QM;VAG

Age 26 YR Duration

Sex Female

Country FIN

Manufacturer

PREGNANCY WITH CONTRACEPTIVE DEVICE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 813 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7704081 Date FDA Received
09-Feb-2012 Preferred Term THROMBOPHLEBITIS ASTHMA ATELECTASIS CELLULITIS COCCYDYNIA DEEP VEIN THROMBOSIS GASTROENTERITIS HYPERGLYCAEMIA MENORRHAGIA MULTIPLE INJURIES OVARIAN CYST PELVIC PAIN PULMONARY EMBOLISM RESPIRATORY FAILURE SINUS TACHYCARDIA STRIDOR SWELLING VOCAL CORD DISORDER Case # 7704081 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO,OT Role Route S Manufacturer Control # 2010SP010746 Dosage Text Age 25 YR Duration Sex Female Country USA

Manufacturer

8094462 Date FDA Received

09-Feb-2012 Preferred Term

Case # 8094462

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2011SP016575 Dosage Text

Age 37 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS ACUTE SINUSITIS ALOPECIA ARTHRALGIA ARTHROPOD BITE ASTHMA BRONCHOPNEUMONIA

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 814 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8094462
Preferred Term CARDIAC MURMUR CONSTIPATION COUGH DIARRHOEA DYSFUNCTIONAL UTERINE BLEEDING ENDOMETRIAL HYPERPLASIA FATIGUE GASTROOESOPHAGEAL REFLUX DISEASE HEADACHE IMPAIRED WORK ABILITY INCORRECT DOSE ADMINISTERED LIBIDO DECREASED MENORRHAGIA MOOD SWINGS MUSCLE SPASMS NASOPHARYNGITIS NAUSEA PERIARTHRITIS PERNICIOUS ANAEMIA POST PROCEDURAL COMPLICATION PULMONARY EMBOLISM RASH RHINORRHOEA TREATMENT NONCOMPLIANCE UTERINE LEIOMYOMA VAGINAL DISCHARGE VARICOSE VEIN VIRAL UPPER RESPIRATORY TRACT INFECTION VISUAL IMPAIRMENT VITAMIN B12 DEFICIENCY Product Role Route Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 815 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8094462
Preferred Term VOMITING VULVOVAGINAL DRYNESS Product Role Route Dosage Text Duration Manufacturer

8237652 Date FDA Received

09-Feb-2012 Preferred Term

Case # 8237652

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO,OT Role Route S

Manufacturer Control # 2011SP025614 Dosage Text

Age 31 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS ABDOMINAL PAIN CARPAL TUNNEL SYNDROME CROHN'S DISEASE GASTROOESOPHAGEAL REFLUX DISEASE INJECTION SITE PAIN INJECTION SITE SWELLING LEUKOPENIA MYALGIA NAUSEA PARAESTHESIA PULMONARY EMBOLISM VOMITING

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 816 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7667838 Date FDA Received
10-Feb-2012 Preferred Term DEEP VEIN THROMBOSIS PYELONEPHRITIS ABORTION INDUCED ASTHMA EAR INFECTION MATERNAL DRUGS AFFECTING FOETUS PREGNANCY WITH CONTRACEPTIVE DEVICE THROMBOPHLEBITIS WEIGHT INCREASED WITHDRAWAL BLEED Case # 7667838 Case Type EXPEDITED (15-DAY) Product NUVARING ADVIL Health Professional Y Outcomes HO,OT Role Route S C VAGINAL Manufacturer Control # 2010SP028485 Dosage Text VAG Age 20 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 817 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8169002 Date FDA Received
10-Feb-2012 Preferred Term PULMONARY EMBOLISM PLANTAR FASCIITIS BLOOD CHOLESTEROL INCREASED MENTAL DISORDER ANXIETY HYPERCOAGULATION PNEUMONIA DEPRESSION BARTHOLIN'S CYST DIABETES MELLITUS HEPATIC STEATOSIS IRRITABLE BOWEL SYNDROME LIGAMENT RUPTURE MENISCUS LESION MYOCARDIAL INFARCTION MYOCARDIAL ISCHAEMIA OEDEMA PERIPHERAL PSORIASIS SYNOVITIS Case # 8169002 Case Type EXPEDITED (15-DAY) Product NUVARING PROPRANOLOL LEVOTHYROXINE SODIUM SEROQUEL MIRTAZAPINE ZYPREXA DIAZEPAM LYRICA Health Professional Y Outcomes HO,OT Role Route S C C C C C C C VAGINAL Manufacturer Control # 2011SP001281 Dosage Text ; VAG Age 43 YR Duration Sex Female Country USA

Manufacturer

8421093 Date FDA Received

10-Feb-2012 Preferred Term HYPERTENSION HEADACHE MALAISE PHOTOPHOBIA

Case # 8421093

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2011SP013539 Dosage Text

Age 35 YR Duration

Sex Female

Country FRA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 818 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8423145 Date FDA Received
10-Feb-2012 Preferred Term FOETAL GROWTH RESTRICTION ARRHYTHMIA NEONATAL CAESAREAN SECTION MATERNAL DRUGS AFFECTING FOETUS UMBILICAL CORD AROUND NECK Case # 8423145 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes OT Role Route S TRANSPLACENTAL Manufacturer Control # 2012SP006578 Dosage Text TRPL Duration Age Sex Female Country FRA

Manufacturer

8423329 Date FDA Received

10-Feb-2012 Preferred Term ECTOPIC PREGNANCY

Case # 8423329

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2012SP006795 Dosage Text

Age

Sex Female

Country FRA

Duration

Manufacturer

PREGNANCY WITH CONTRACEPTIVE DEVICE

8222284 Date FDA Received

13-Feb-2012 Preferred Term DYSPAREUNIA CERVICAL DYSPLASIA

Case # 8222284

Case Type EXPEDITED (15-DAY) Product NUVARING CONCERTA

Health Professional Y

Outcomes HO Role Route S C

Manufacturer Control # 2011SP049388 Dosage Text

Age 30 YR Duration

Sex Female

Country CHE

Manufacturer

8403720 Date FDA Received

13-Feb-2012 Preferred Term VAGINAL DISCHARGE MENORRHAGIA DISCOMFORT

Case # 8403720

Case Type DIRECT Product NUVARING CYMBALTA LYRICA SEROQUEL DIAZEPAM

Health Professional N

Outcomes

Manufacturer Control #

Age 34 YR

Sex Female

Country USA

Role Route S C C C C VAGINAL

Dosage Text

Duration

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 819 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8241007 Date FDA Received
14-Feb-2012 Preferred Term PULMONARY EMBOLISM INJURY DEPRESSION PAIN IN EXTREMITY ANXIETY DYSPNOEA DYSPNOEA EXERTIONAL ELECTROCARDIOGRAM QT PROLONGED INSOMNIA PALPITATIONS SINUS TACHYCARDIA SLEEP DISORDER Case # 8241007 Case Type EXPEDITED (15-DAY) Product NUVARING WELLBUTRIN PROZAC AMBIEN Health Professional Y Outcomes HO Role Route S C C C Manufacturer Control # 2011SP025638 Dosage Text Age 42 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 820 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7114521 Date FDA Received
15-Feb-2012 Preferred Term PALPITATIONS SYNCOPE PULMONARY EMBOLISM PULMONARY ARTERY THROMBOSIS HIATUS HERNIA NAUSEA ADENOMA BENIGN ARTERIOSCLEROSIS CHOLECYSTITIS CHOLELITHIASIS CHOLESTEROSIS COLONIC POLYP CONVULSION DIASTOLIC DYSFUNCTION GASTROOESOPHAGEAL REFLUX DISEASE MIGRAINE MITRAL VALVE INCOMPETENCE OCCULT BLOOD POSITIVE UTERINE LEIOMYOMA Case # 7114521 Case Type EXPEDITED (15-DAY) Product NUVARING MIDRIN ENTEX LQ VALTREX OXYCODONE HYDROCHLORIDE DAYQUIL Health Professional Y Outcomes HO,OT Role Route S C C C C C Manufacturer Control # 2009SP018943 Dosage Text Age 46 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 821 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8341653 Date FDA Received
15-Feb-2012 Preferred Term PULMONARY EMBOLISM LUNG DISORDER CONDITION AGGRAVATED ANXIETY ACNE COGNITIVE DISORDER CYST DEPRESSION EMOTIONAL DISORDER EXERCISE TOLERANCE DECREASED MENOPAUSAL SYMPTOMS MENTAL DISORDER MIGRAINE NAUSEA PLEURAL EFFUSION PULMONARY INFARCTION SALPINGITIS STRESS VOMITING Case # 8341653 Case Type EXPEDITED (15-DAY) Product NUVARING YAZ VALTREX IMITREX Health Professional Y Outcomes HO Role Route S C C C Manufacturer Control # 2011SP040942 Dosage Text Age 38 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 822 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8096434 Date FDA Received
16-Feb-2012 Preferred Term PULMONARY EMBOLISM OLIGOMENORRHOEA UPPER RESPIRATORY TRACT INFECTION BRONCHITIS ANXIETY ASTHMA BACK PAIN CHLAMYDIA TEST POSITIVE DRUG LEVEL BELOW THERAPEUTIC DYSFUNCTIONAL UTERINE BLEEDING FATIGUE HEPATIC STEATOSIS MYOCARDIAL ISCHAEMIA NASOPHARYNGITIS PHARYNGITIS PRESYNCOPE WEIGHT INCREASED Case # 8096434 Case Type EXPEDITED (15-DAY) Product NUVARING WELLBUTRIN PHENTERMINE TRAZODONE HYDROCHLORIDE CITALOPRAM HYDROBROMIDE Health Professional Y Outcomes HO,OT Role Route S S S C C Manufacturer Control # 2011SP019419 Dosage Text Age 18 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 823 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7110457 Date FDA Received
17-Feb-2012 Preferred Term NEPHROLITHIASIS ATELECTASIS CAESAREAN SECTION CARDIAC SEPTAL DEFECT CARDIOGENIC SHOCK CATHETER SITE SWELLING CONTUSION DEEP VEIN THROMBOSIS ECCHYMOSIS HELLP SYNDROME HEPARIN-INDUCED THROMBOCYTOPENIA MATERNAL EXPOSURE DURING PREGNANCY PULMONARY EMBOLISM RETROPERITONEAL HAEMATOMA RIGHT VENTRICULAR FAILURE SUPRAVENTRICULAR TACHYCARDIA Case # 7110457 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO,OT Role Route S Manufacturer Control # 2009SP020292 Dosage Text Age 29 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 824 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7284811 Date FDA Received
17-Feb-2012 Preferred Term PULMONARY EMBOLISM PHARYNGITIS STREPTOCOCCAL ANXIETY RECTAL HAEMORRHAGE HYPOKALAEMIA BACK PAIN ACUTE SINUSITIS SYNCOPE DEPRESSION HYPOAESTHESIA INJURY INSOMNIA IRRITABLE BOWEL SYNDROME MENORRHAGIA MIGRAINE MUSCULAR WEAKNESS PAIN IN EXTREMITY PARAESTHESIA PELVIC PAIN POLLAKIURIA Case # 7284811 Case Type EXPEDITED (15-DAY) Product NUVARING XANAX ADVIL SKELAXIN AMOXICILLIN BACLOFEN LEXAPRO NORCO Health Professional Y Outcomes HO,OT Role Route S C C C C C C C Manufacturer Control # 2009-200464-NL Dosage Text 1 DF Age 30 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 825 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8411072 Date FDA Received
17-Feb-2012 Preferred Term PREGNANCY WITH CONTRACEPTIVE DEVICE DRUG INEFFECTIVE ECTOPIC PREGNANCY MATERNAL EXPOSURE DURING PREGNANCY PRESYNCOPE Case # 8411072 Case Type DIRECT Product NUVARING Health Professional N Outcomes HO Role Route S VAGINAL Dosage Text one regular dose Manufacturer Control # Age 27 YR Duration Sex Female Country USA

Manufacturer

8418829 Date FDA Received

21-Feb-2012 Preferred Term

Case # 8418829

Case Type DIRECT Product NUVARING

Health Professional N

Outcomes HO,LT Role Route S VAGINAL

Manufacturer Control #

Age 26 YR

Sex Female

Country USA

Dosage Text 1 ring

Duration

Manufacturer

SKIN DISCOLOURATION CARDIOMEGALY PULMONARY EMBOLISM

8443667 Date FDA Received

27-Feb-2012 Preferred Term

Case # 8443667

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2012SP009593 Dosage Text QM;VAG

Age

Sex Female

Country MEX

Duration

Manufacturer

ABORTION SPONTANEOUS MATERNAL EXPOSURE DURING PREGNANCY PREGNANCY WITH CONTRACEPTIVE DEVICE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 826 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7825274 Date FDA Received
28-Feb-2012 Preferred Term PULMONARY EMBOLISM BACK PAIN ANAEMIA ANGINA PECTORIS ATELECTASIS DEHYDRATION HEPATIC CYST HYPERCOAGULATION LOSS OF EMPLOYMENT LUNG CONSOLIDATION MUSCLE SPASMS PLEURAL EFFUSION PNEUMONIA PNEUMOTHORAX RHABDOMYOLYSIS Case # 7825274 Case Type EXPEDITED (15-DAY) Product NUVARING CODEINE SULFATE Health Professional Y Outcomes HO,DS Role Route S C Manufacturer Control # 2010SP028345 Dosage Text Age 33 YR Duration Sex Female Country USA

Manufacturer

8316045 Date FDA Received

28-Feb-2012 Preferred Term ECTOPIC PREGNANCY

Case # 8316045

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO Role Route S

Manufacturer Control # 2011SP057875 Dosage Text

Age 23 YR Duration

Sex Female

Country DEU

Manufacturer

ABORTION SPONTANEOUS

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 827 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8445435 Date FDA Received
28-Feb-2012 Preferred Term SOMNOLENCE ANXIETY CHILLS LIBIDO DECREASED MENSTRUAL DISORDER SEXUAL DYSFUNCTION VULVOVAGINAL DRYNESS Case # 8445435 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional N Outcomes HO Role Route S VAGINAL Manufacturer Control # 2012SP010162 Dosage Text VAG Duration Age Sex Female Country BRA

Manufacturer

7395089 Date FDA Received

29-Feb-2012 Preferred Term

Case # 7395089

Case Type EXPEDITED (15-DAY) Product NUVARING MOTRIN FISH OIL

Health Professional Y

Outcomes HO Role Route S C C C C VAGINAL

Manufacturer Control # 2010SP003339 Dosage Text ;QM;VAG

Age 23 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS PULMONARY EMBOLISM CARDIAC MURMUR WEIGHT DECREASED ANXIETY URINARY SEDIMENT PRESENT

VITAMINS NOS CELEXA

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 828 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8071898 Date FDA Received
29-Feb-2012 Preferred Term PULMONARY EMBOLISM DEEP VEIN THROMBOSIS ANXIETY ARTHROPOD BITE ASSISTED DELIVERY BACK PAIN BALANCE DISORDER CERVICITIS TRICHOMONAL DEPRESSION DIZZINESS FACE INJURY FALL FLUSHING FUNGAL INFECTION HORDEOLUM HYPERCOAGULATION HYPERGLYCAEMIA LABOUR INDUCTION MATERNAL EXPOSURE BEFORE PREGNANCY NEPHROLITHIASIS NORMOCHROMIC NORMOCYTIC ANAEMIA PERICARDIAL EFFUSION PERINEAL LACERATION PYELONEPHRITIS RENAL CYST RENAL TUBULAR ACIDOSIS URINARY TRACT INFECTION VULVAL ABSCESS WHEEZING Case # 8071898 Case Type EXPEDITED (15-DAY) Product NUVARING VITAMINS NOS Health Professional Y Outcomes HO,DS,OT Role Route S C VAGINAL Manufacturer Control # 2010SP054733 Dosage Text QM;VAG Age 29 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 829 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8342977 Date FDA Received
29-Feb-2012 Preferred Term PULMONARY EMBOLISM DEEP VEIN THROMBOSIS DISTURBANCE IN ATTENTION HEART RATE INCREASED HYPERCOAGULATION HYPERTENSION HYPERVENTILATION INFECTION TEARFULNESS Case # 8342977 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO Role Route S Manufacturer Control # 2011SP040935 Dosage Text Age 42 YR Duration Sex Female Country USA

Manufacturer

8446718 Date FDA Received

29-Feb-2012 Preferred Term

Case # 8446718

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2012SP004208 Dosage Text QM;VAG

Age 34 YR Duration

Sex Female

Country USA

Manufacturer

ABORTION SPONTANEOUS MATERNAL EXPOSURE DURING PREGNANCY PREGNANCY WITH CONTRACEPTIVE DEVICE

6898098 Date FDA Received

01-Mar-2012 Preferred Term NAUSEA ANAEMIA ANEURYSM

Case # 6898098

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO,OT Role Route S

Manufacturer Control # 2008-180467-NL Dosage Text 1 DF;

Age 44 YR Duration

Sex Female

Country USA

Manufacturer

BLOOD FOLLICLE STIMULATING HORMONE INCREASED BLOOD LUTEINISING HORMONE INCREASED BLOOD PROLACTIN INCREASED COGNITIVE DISORDER DEPRESSION

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 830 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6898098
Preferred Term FRUSTRATION GASTROOESOPHAGEAL REFLUX DISEASE GRAND MAL CONVULSION HAEMATOMA HEADACHE HEPATIC STEATOSIS HUMAN CHORIONIC GONADOTROPIN INCREASED HYDRONEPHROSIS HYPERCOAGULATION HYPERTENSION HYPOTHALAMO-PITUITARY DISORDER HYPOTHYROIDISM INTERNATIONAL NORMALISED RATIO DECREASED INTRAOCULAR PRESSURE INCREASED LACRIMATION INCREASED NECK MASS NEPHROLITHIASIS PAIN IN EXTREMITY PARAESTHESIA PNEUMONIA SUBDURAL HAEMATOMA SUPERIOR SAGITTAL SINUS THROMBOSIS TENDONITIS URINARY TRACT INFECTION UTERINE LEIOMYOMA VAGINAL HAEMORRHAGE VISUAL IMPAIRMENT VOMITING Product Role Route Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 831 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7826908 Date FDA Received
01-Mar-2012 Preferred Term PULMONARY EMBOLISM THROMBOSIS PREGNANCY MATERNAL EXPOSURE DURING PREGNANCY GALLBLADDER DISORDER ROAD TRAFFIC ACCIDENT PNEUMONIA SINUS TACHYCARDIA DYSFUNCTIONAL UTERINE BLEEDING COCCYDYNIA BACK PAIN CALCULUS URETERIC CHOLECYSTITIS ACUTE CHOLELITHIASIS MENOMETRORRHAGIA OVARIAN CYST Case # 7826908 Case Type EXPEDITED (15-DAY) Product NUVARING NAPROXEN CLARITIN PAXIL SYNTHROID BUSPAR HYDROCHLOROTHIAZIDE PREVACID IRON SUPER B COMPLEX Health Professional N Outcomes HO,OT Role Route S C C C C C C C C C Manufacturer Control # 2010SP004039 Dosage Text Age 21 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 832 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8224972 Date FDA Received
01-Mar-2012 Preferred Term DEEP VEIN THROMBOSIS ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED ANAEMIA CHOLECYSTITIS CHOLELITHIASIS DEPRESSION FACTOR II DEFICIENCY INFLUENZA INTERNATIONAL NORMALISED RATIO INCREASED LOBAR PNEUMONIA MITRAL VALVE INCOMPETENCE MUSCULOSKELETAL CHEST PAIN MUSCULOSKELETAL PAIN PELVIC VENOUS THROMBOSIS PULMONARY EMBOLISM PULMONARY INFARCTION SCAR STRESS TRICUSPID VALVE INCOMPETENCE UTERINE LEIOMYOMA Case # 8224972 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO,DS,OT Role Route S Manufacturer Control # 2011SP027264 Dosage Text Age 43 YR Duration Sex Female Country USA

Manufacturer

8452469 Date FDA Received

01-Mar-2012 Preferred Term

Case # 8452469

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO,LT,OT Role Route S S VAGINAL ORAL

Manufacturer Control # 2011SP048230 Dosage Text 1 DF; VAG 300 MG;QPM;PO, 400 MG;QPM;PO

Age 45 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM CHRONIC OBSTRUCTIVE PULMONARY DISEASE

SEROQUEL XR

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 833 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8452469
Preferred Term OVARIAN CYST DEPRESSION BIPOLAR DISORDER PAIN IMPAIRED WORK ABILITY GASTROOESOPHAGEAL REFLUX DISEASE DIABETES MELLITUS DYSLIPIDAEMIA RESTLESS LEGS SYNDROME CONDITION AGGRAVATED HIGH DENSITY LIPOPROTEIN DECREASED MYALGIA SUICIDAL IDEATION VAGINAL HAEMORRHAGE ACUTE SINUSITIS AMNESIA ANGER CHILLS CONSTIPATION DIARRHOEA DYSGEUSIA FIBROMYALGIA FLANK PAIN HYPERHIDROSIS IRREGULAR SLEEP PHASE LOWER RESPIRATORY TRACT INFECTION NARCOLEPSY OVERDOSE PAIN IN EXTREMITY PELVIC PAIN PNEUMONIA Product MORPHINE ASMANEX SPIRIVA FENTANYL NIASPAN WELLBUTRIN XL MIRAPEX TRAMADOL HYDROCHLORIDE LUNESTA PRISTIQ EXTENDED RELEASE CORTISPORIN MAGNESIUM POTASSIUM TYLENOL WITH CODEINE Role Route S C C C C C C C C C C C C C Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 834 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8452469
Preferred Term PRODUCT TASTE ABNORMAL PULMONARY ARTERIAL PRESSURE INCREASED RHINITIS TACHYCARDIA VULVOVAGINITIS Product Role Route Dosage Text Duration Manufacturer

8451664 Date FDA Received

02-Mar-2012 Preferred Term

Case # 8451664

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2012SP009889 Dosage Text 1 DF

Age

Sex Female

Country USA

Duration

Manufacturer

PREGNANCY WITH CONTRACEPTIVE DEVICE ABORTION MATERNAL DRUGS AFFECTING FOETUS

8455141 Date FDA Received

02-Mar-2012 Preferred Term

Case # 8455141

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2012SP005774 Dosage Text

Age 28 YR Duration

Sex Female

Country EGY

Manufacturer

UTERINE CERVICAL EROSION METRORRHAGIA

7154819 Date FDA Received

05-Mar-2012 Preferred Term HUMERUS FRACTURE MIGRAINE

Case # 7154819

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO,OT Role Route S C VAGINAL

Manufacturer Control # 2009SP020705 Dosage Text VAG

Age 20 YR Duration

Sex Female

Country USA

Manufacturer

ACETAMINOPHEN

ABDOMINAL DISCOMFORT ABDOMINAL PAIN ABORTION SPONTANEOUS ACUTE SINUSITIS ARTHRALGIA

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 835 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7154819
Preferred Term ASTHMA BACK PAIN BRONCHITIS CAESAREAN SECTION CERVICAL DYSPLASIA CERVICITIS CHEST PAIN CONJUNCTIVITIS CONTUSION DEEP VEIN THROMBOSIS DERMATITIS CONTACT DYSPNOEA FALL FATIGUE FUNGAL INFECTION HERPES SIMPLEX HYPERCHOLESTEROLAEMIA INCISION SITE PAIN INFLUENZA LIKE ILLNESS INFUSION SITE CYST INFUSION SITE SWELLING LACERATION LIMB INJURY MATERNAL EXPOSURE DURING PREGNANCY MENORRHAGIA MENSTRUATION IRREGULAR MUSCLE STRAIN MUSCULOSKELETAL PAIN NAUSEA NECK INJURY NECK PAIN Product Role Route Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 836 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7154819
Preferred Term NO THERAPEUTIC RESPONSE PELVIC ADHESIONS PELVIC PAIN PHARYNGITIS PLEURAL DISORDER PREGNANCY WITH CONTRACEPTIVE DEVICE PULMONARY EMBOLISM ROAD TRAFFIC ACCIDENT SINUS BRADYCARDIA TEMPERATURE INTOLERANCE TENSION HEADACHE TINEA CRURIS UPPER RESPIRATORY TRACT INFECTION URINARY TRACT INFECTION VAGINAL DISORDER VAGINAL ODOUR VAGINITIS BACTERIAL VULVOVAGINITIS TRICHOMONAL WEIGHT INCREASED Product Role Route Dosage Text Duration Manufacturer

8455471 Date FDA Received

05-Mar-2012 Preferred Term

Case # 8455471

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO Role Route S VAGINAL

Manufacturer Control # 2012SP010145 Dosage Text QM;VAG

Age 29 YR Duration

Sex Female

Country IRL

Manufacturer

Peripheral artery thrombosis BREAST ENLARGEMENT PAGET-SCHROETTER SYNDROME POST THROMBOTIC SYNDROME THERAPEUTIC RESPONSE DECREASED

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 837 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8456028 Date FDA Received
06-Mar-2012 Preferred Term BARTHOLINITIS Case # 8456028 Case Type EXPEDITED (15-DAY) Product NUVARING Case # 8456666 Case Type EXPEDITED (15-DAY) Product NUVARING Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Health Professional Y Health Professional Y Outcomes HO Role Route S Outcomes OT Role Route S Outcomes HO,OT Role Route S VAGINAL Manufacturer Control # 2012SP010683 Dosage Text ;UNK;UNK Manufacturer Control # 2011SP005792 Dosage Text 1 DF;QM;VAG Age 27 YR Duration Sex Female Country USA Duration Age Sex Female Country RUS Manufacturer Control # 2012SP009663 Dosage Text Age 36 YR Duration Sex Female Country FRA

Manufacturer

8456666 Date FDA Received

07-Mar-2012 Preferred Term

Manufacturer

ANAPHYLACTIC SHOCK

8006157 Date FDA Received

08-Mar-2012 Preferred Term

Case # 8006157

Manufacturer

TRANSIENT ISCHAEMIC ATTACK ACARODERMATITIS ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED DRUG HYPERSENSITIVITY ENDOMETRIOSIS GASTROOESOPHAGEAL REFLUX DISEASE HUMAN PAPILLOMA VIRUS TEST POSITIVE HYPERCOAGULATION INFECTION LIPOPROTEIN (A) INCREASED LOWER RESPIRATORY TRACT INFECTION MIGRAINE MITRAL VALVE INCOMPETENCE MULTIPLE ALLERGIES NECK PAIN NEOPLASM MALIGNANT NEUROPATHY PERIPHERAL

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 838 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8006157
Preferred Term NORMOCHROMIC NORMOCYTIC ANAEMIA OVARIAN CYST PELVIC PAIN PHOTOSENSITIVITY REACTION POLLAKIURIA PULMONARY VALVE INCOMPETENCE RESPIRATORY DISTRESS RHINITIS ALLERGIC SINUSITIS SMEAR CERVIX ABNORMAL TENSION HEADACHE TREATMENT NONCOMPLIANCE TRICUSPID VALVE INCOMPETENCE VULVOVAGINITIS TRICHOMONAL Product Role Route Dosage Text Duration Manufacturer

8082688 Date FDA Received

08-Mar-2012 Preferred Term

Case # 8082688

Case Type EXPEDITED (15-DAY) Product NUVARING VITAMINS

Health Professional Y

Outcomes HO,OT Role Route S C

Manufacturer Control # 2010SP064697 Dosage Text

Age 20 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM MULTIPLE INJURIES ACNE ACQUIRED DIAPHRAGMATIC EVENTRATION AGGRESSION AGITATION ANXIETY ATELECTASIS BONE FRAGMENTATION CHEST PAIN CHLAMYDIAL INFECTION COMPLICATION OF DEVICE INSERTION CONCUSSION

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 839 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8082688
Preferred Term DYSPNOEA ECCHYMOSIS FIBRIN D DIMER INCREASED FOREIGN BODY HEADACHE HIRSUTISM HORMONE LEVEL ABNORMAL HYPERCOAGULATION JOINT EFFUSION LACERATION LEUKOCYTOSIS LIPOMA MUSCLE SPASMS NASOPHARYNGITIS OBESITY OROPHARYNGEAL PAIN PAIN PAIN IN EXTREMITY PATELLOFEMORAL PAIN SYNDROME PHARYNGITIS PLATELET COUNT INCREASED PLEURAL EFFUSION POLYCYSTIC OVARIES POST PROCEDURAL HAEMORRHAGE PROTEIN S DECREASED PULMONARY INFARCTION PULMONARY NECROSIS PYREXIA ROAD TRAFFIC ACCIDENT SINUS TACHYCARDIA STREPTOCOCCUS TEST POSITIVE Product Role Route Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 840 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8082688
Preferred Term STRESS TENDON DISORDER TENDONITIS UPPER LIMB FRACTURE UPPER RESPIRATORY TRACT INFECTION URINARY TRACT INFECTION VOMITING Product Role Route Dosage Text Duration Manufacturer

8460166 Date FDA Received

08-Mar-2012 Preferred Term

Case # 8460166

Case Type EXPEDITED (15-DAY) Product NUVARING Case Type EXPEDITED (15-DAY) Product NUVARING Case Type EXPEDITED (15-DAY) Product NUVARING Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2012SP010881 Dosage Text

Age 31 YR Duration

Sex Female

Country PRT

Manufacturer

URINARY TRACT INFECTION

8461120 Date FDA Received

08-Mar-2012 Preferred Term

Case # 8461120

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2012SP010880 Dosage Text

Age

Sex Female

Country RUS

Duration

Manufacturer

ANAPHYLACTIC SHOCK

8461158 Date FDA Received

08-Mar-2012 Preferred Term

Case # 8461158

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2012SP010882 Dosage Text

Age

Sex Female

Country RUS

Duration

Manufacturer

ANAPHYLACTIC SHOCK

8462550 Date FDA Received

08-Mar-2012 Preferred Term

Case # 8462550

Health Professional N

Outcomes HO,DS,LT Role Route S VAGINAL

Manufacturer Control # 2012SP011841 Dosage Text VAG

Age 46 YR Duration

Sex Female

Country USA

Manufacturer

CEREBROVASCULAR ACCIDENT DYSARTHRIA MEMORY IMPAIRMENT

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 841 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8236073 Date FDA Received
09-Mar-2012 Preferred Term PULMONARY EMBOLISM MIGRAINE Case # 8236073 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional N Outcomes DE Role Route S Manufacturer Control # 2011SP050707 Dosage Text Age 22 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 842 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8276109 Date FDA Received
09-Mar-2012 Preferred Term PULMONARY EMBOLISM CONCUSSION CONTUSION CRANIOCEREBRAL INJURY DECREASED APPETITE DEEP VEIN THROMBOSIS DIZZINESS GENITAL DISCHARGE HEADACHE HYPERCOAGULATION LABYRINTHITIS LIGAMENT SPRAIN MOBILITY DECREASED MULTIPLE INJURIES MUSCULOSKELETAL PAIN NIGHT SWEATS OVARIAN CYST PALPITATIONS PELVIC PAIN POST-TRAUMATIC NECK SYNDROME PROTHROMBIN TIME PROLONGED PULMONARY INFARCTION SYNCOPE TACHYCARDIA UPPER RESPIRATORY TRACT INFECTION Case # 8276109 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO,OT Role Route S Manufacturer Control # 2011SP012083 Dosage Text Age 25 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 843 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8462824 Date FDA Received
09-Mar-2012 Preferred Term APPENDICITIS Case # 8462824 Case Type EXPEDITED (15-DAY) Product NUVARING Case # 8454449 Case Type DIRECT Product NUVARING NUVARING Health Professional N Health Professional N Outcomes HO Role Route S VAGINAL Manufacturer Control # 2012SP011816 Dosage Text VAG Manufacturer Control # Age 29 YR Role Route S C Dosage Text Duration Sex Female Country USA Age 39 YR Duration Sex Female Country DEU

Manufacturer

8454449 Date FDA Received

12-Mar-2012 Preferred Term

Outcomes LT

Manufacturer

DEEP VEIN THROMBOSIS PULMONARY EMBOLISM

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 844 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7258113 Date FDA Received
15-Mar-2012 Preferred Term PULMONARY EMBOLISM THROMBOSIS ARRHYTHMIA UPPER RESPIRATORY TRACT INFECTION NAIL INJURY LUNG CONSOLIDATION ABDOMINAL PAIN ABDOMINAL PAIN LOWER AMENORRHOEA FALL GASTROENTERITIS HEADACHE INFECTIOUS MONONUCLEOSIS INFLUENZA LIKE ILLNESS JAW DISORDER MELANOCYTIC NAEVUS NECK PAIN PAIN IN JAW PLEURAL EFFUSION PNEUMONIA POST CONCUSSION SYNDROME PULMONARY INFARCTION RASH ROAD TRAFFIC ACCIDENT SIALOADENITIS SPINAL CORD INJURY CERVICAL VERTIGO VIRAL INFECTION Case # 7258113 Case Type EXPEDITED (15-DAY) Product NUVARING CARISOPRODOL CLONAZEPAM IBUPROFEN HYDROCODONE LORTAB Health Professional Y Outcomes HO,OT Role Route S C C C C C Manufacturer Control # 2009SP028418 Dosage Text 1 DF;QM; Age 23 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 845 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7271461 Date FDA Received
15-Mar-2012 Preferred Term PAIN BRAIN INJURY ALCOHOL USE CEREBRAL INFARCTION CEREBROVASCULAR ACCIDENT CERVICAL DYSPLASIA CHEST PAIN CONVULSION EMBOLISM GASTROINTESTINAL DISORDER HAEMORRHAGE INTRACRANIAL HEADACHE LOSS OF CONSCIOUSNESS MIGRAINE MULTIPLE INJURIES OEDEMA PERIPHERAL VASCULAR DISORDER SUBDURAL HAEMATOMA TACHYCARDIA THROMBOSIS VASCULITIS Case # 7271461 Case Type EXPEDITED (15-DAY) Product NUVARING COCAINE Health Professional Y Outcomes HO,DS,OT Role Route S S Manufacturer Control # 2009SP023491 Dosage Text Age 21 YR Duration Sex Female Country USA

Manufacturer

7271499 Date FDA Received

15-Mar-2012 Preferred Term

Case # 7271499

Case Type EXPEDITED (15-DAY) Product NUVARING PAXIL CR NEXIUM

Health Professional Y

Outcomes HO,LT Role Route S C C

Manufacturer Control # 2009SP023478 Dosage Text

Age 33 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM VENOUS THROMBOSIS HEADACHE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 846 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8217918 Date FDA Received
15-Mar-2012 Preferred Term PULMONARY EMBOLISM BLOOD GLUCOSE INCREASED DEEP VEIN THROMBOSIS DIZZINESS FATIGUE HEADACHE HEPATIC STEATOSIS HYPERCOAGULATION PULMONARY HYPERTENSION PULMONARY INFARCTION REFUSAL OF TREATMENT BY PATIENT SLEEP APNOEA SYNDROME Case # 8217918 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO Role Route S Manufacturer Control # 2011SP005797 Dosage Text Age 30 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 847 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8224701 Date FDA Received
15-Mar-2012 Preferred Term SPLENIC VEIN THROMBOSIS BLOOD PRESSURE INCREASED CALCINOSIS CONSTIPATION DECREASED APPETITE HEPATIC STEATOSIS IMPAIRED WORK ABILITY MULTIPLE INJURIES NEPHROLITHIASIS OVARIAN CYST RUPTURED PORTAL VEIN THROMBOSIS THROMBOSIS UTERINE LEIOMYOMA Case # 8224701 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO,DS,OT Role Route S Manufacturer Control # 2011SP027540 Dosage Text Age 43 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 848 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7102605 Date FDA Received
16-Mar-2012 Preferred Term PULMONARY EMBOLISM DEEP VEIN THROMBOSIS PULMONARY HYPERTENSION DIASTOLIC DYSFUNCTION ACIDOSIS CARDIOMEGALY CERVICOBRACHIAL SYNDROME CHEST PAIN DYSSOMNIA ELECTROCARDIOGRAM ABNORMAL HEPATIC CYST HYPERTENSION INTERNATIONAL NORMALISED RATIO DECREASED PLEURAL EFFUSION PLEURAL FIBROSIS RASH PAPULAR RASH PRURITIC SINUS TACHYCARDIA THROMBOPHLEBITIS SUPERFICIAL TREATMENT NONCOMPLIANCE UTERINE DILATION AND CURETTAGE UTERINE OPERATION Case # 7102605 Case Type EXPEDITED (15-DAY) Product NUVARING TETRACYCLINE DIOVAN HCT WELLBUTRIN Health Professional Y Outcomes HO,OT Role Route S C C C Manufacturer Control # 2009SP017682 Dosage Text Age 52 YR Duration Sex Female Country USA

Manufacturer

7578722 Date FDA Received

16-Mar-2012 Preferred Term

Case # 7578722

Case Type EXPEDITED (15-DAY) Product NUVARING LORTAB

Health Professional Y

Outcomes OT Role Route S S

Manufacturer Control # 2009SP038965 Dosage Text

Age 20 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM VULVOVAGINAL PRURITUS

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 849 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7578722
Preferred Term VULVOVAGINAL BURNING SENSATION PANIC ATTACK AMENORRHOEA ABDOMINAL PAIN UPPER ANHEDONIA ANXIETY APATHY ASTHENIA ASTHMA BACK PAIN BACTERIAL PYELONEPHRITIS CERVICAL DYSPLASIA CHEST PAIN CHLAMYDIAL INFECTION CONDITION AGGRAVATED CONSTIPATION COUGH CYSTITIS BACTERIAL DECREASED APPETITE DECREASED INTEREST DEEP VEIN THROMBOSIS DEPRESSION DIARRHOEA DISTURBANCE IN ATTENTION DYSPNOEA DYSURIA ESCHERICHIA URINARY TRACT INFECTION FEELING OF DESPAIR GASTRITIS GONORRHOEA HAEMORRHOIDS Product IBUPROFEN EXCEDRIN MIGRAINE ALBUTEROL Role Route C C C Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 850 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7578722
Preferred Term HEADACHE HYPERCOAGULATION INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION INTERNATIONAL NORMALISED RATIO INCREASED IRRITABILITY LOWER RESPIRATORY TRACT INFECTION MATERNAL EXPOSURE BEFORE PREGNANCY MENSTRUAL DISORDER MIGRAINE MULTIPLE INJURIES NAUSEA OVARIAN CYST RUPTURED PAROTITIS PNEUMONIA POOR QUALITY SLEEP PREGNANCY PROCEDURAL PAIN PROCTALGIA PROTEIN C DEFICIENCY PROTEIN URINE PRESENT RECTAL HAEMORRHAGE RHINITIS ALLERGIC SINUSITIS SUICIDAL IDEATION THIRST TREATMENT NONCOMPLIANCE URINE KETONE BODY PRESENT VENOUS THROMBOSIS VULVOVAGINAL CANDIDIASIS Product Role Route Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 851 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7578722
Preferred Term WEIGHT DECREASED Product Role Route Dosage Text Duration Manufacturer

8274265 Date FDA Received

19-Mar-2012 Preferred Term

Case # 8274265

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO,DS,OT Role Route S

Manufacturer Control # 2011SP025679 Dosage Text

Age 31 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM ABDOMINAL PAIN ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED BRONCHITIS CYST HYPERCOAGULATION HYPERHIDROSIS HYPERVENTILATION IMPAIRED WORK ABILITY INSOMNIA INTERNATIONAL NORMALISED RATIO DECREASED LUNG NEOPLASM MULTIPLE INJURIES OVARIAN CYST PAIN PHARYNGITIS STREPTOCOCCAL PULMONARY HAEMATOMA PULMONARY HAEMORRHAGE SINUS HEADACHE TEARFULNESS THROMBOSIS VIRAL INFECTION

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 852 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8479634 Date FDA Received
19-Mar-2012 Preferred Term PULMONARY EMBOLISM ANKLE FRACTURE DEEP VEIN THROMBOSIS HYPERINSULINAEMIA MULTIPLE INJURIES POLYCYSTIC OVARIES PULMONARY INFARCTION RIGHT VENTRICULAR FAILURE VAGINAL HAEMORRHAGE Case # 8479634 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO,DS Role Route S Manufacturer Control # 2011SP00056415 Dosage Text Age 28 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 853 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7827327 Date FDA Received
20-Mar-2012 Preferred Term WISDOM TEETH REMOVAL OVARIAN CYST MIGRAINE LOSS OF EMPLOYMENT ANXIETY ABORTION ALCOHOL USE BIOPSY VULVA ABNORMAL CARDIAC DISORDER CHILLS CONTUSION DEHYDRATION DEMYELINATION DIARRHOEA FISTULA HYPOAESTHESIA INFECTION INTERVERTEBRAL DISC PROTRUSION LUMBAR RADICULOPATHY MATERNAL EXPOSURE DURING PREGNANCY MUSCULAR WEAKNESS NEUROPATHY PERIPHERAL PARANASAL SINUS MUCOSAL HYPERTROPHY PREGNANCY WITH CONTRACEPTIVE DEVICE SCOLIOSIS SENSORY LOSS THYROID DISORDER TOBACCO USER UPPER-AIRWAY COUGH SYNDROME Case # 7827327 Case Type EXPEDITED (15-DAY) Product NUVARING NUVARING NUVARING NUVARING COUMADIN Health Professional Y Outcomes HO Role Route S S S S S Manufacturer Control # 2010SP043244 Dosage Text Age 22 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 854 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7634320 Date FDA Received
22-Mar-2012 Preferred Term PULMONARY EMBOLISM DEEP VEIN THROMBOSIS FALL Case # 7634320 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes DE Role Route S Manufacturer Control # 2010SP051502 Dosage Text Age 22 YR Duration Sex Female Country USA

Manufacturer

7635649 Date FDA Received

22-Mar-2012 Preferred Term

Case # 7635649

Case Type EXPEDITED (15-DAY) Product NUVARING NUVARING

Health Professional Y

Outcomes HO,DS Role Route S S

Manufacturer Control # 2010SP004876 Dosage Text

Age 28 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM DEEP VEIN THROMBOSIS CHEST PAIN COAGULATION FACTOR VIII LEVEL INCREASED COITAL BLEEDING DIZZINESS DYSPAREUNIA HEADACHE HERPES SIMPLEX HYPERTENSION MIGRAINE RASH UPPER RESPIRATORY TRACT INFECTION

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 855 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7865567 Date FDA Received
22-Mar-2012 Preferred Term INJURY AORTIC VALVE INCOMPETENCE CHOLECYSTITIS CHOLELITHIASIS CLAUSTROPHOBIA ENDOMETRIOSIS GASTRITIS HEART RATE IRREGULAR MULTIPLE INJURIES OVARIAN CYST PAIN PALPITATIONS PULMONARY EMBOLISM TACHYCARDIA THROMBOSIS TRICUSPID VALVE INCOMPETENCE Case # 7865567 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO,OT Role Route S Manufacturer Control # 2010SP057664 Dosage Text Age 28 YR Duration Sex Female Country USA

Manufacturer

8001708 Date FDA Received

22-Mar-2012 Preferred Term

Case # 8001708

Case Type EXPEDITED (15-DAY) Product NUVARING COUMADIN

Health Professional Y

Outcomes HO,OT Role Route S S C C

Manufacturer Control # 2010SP064933 Dosage Text

Age 39 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS PULMONARY EMBOLISM MULTIPLE INJURIES MAY-THURNER SYNDROME ABDOMINAL PAIN ABDOMINAL PAIN UPPER ALTERED STATE OF CONSCIOUSNESS AMNESIA ANASTOMOTIC ULCER PERFORATION

VITAMIN B COMPLEX NSAID'S

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 856 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8001708
Preferred Term ANGINA PECTORIS ANTIPHOSPHOLIPID ANTIBODIES POSITIVE ARTHRALGIA BACK PAIN BLOOD URINE PRESENT CEREBROVASCULAR ACCIDENT CERVICAL DYSPLASIA COLONIC POLYP CONFUSIONAL STATE CONVULSION DEVICE EXPULSION DYSPEPSIA EPISTAXIS FIBRIN D DIMER INCREASED FLANK PAIN HAEMORRHOIDS HEART RATE IRREGULAR HUMAN PAPILLOMA VIRUS TEST POSITIVE HYDRONEPHROSIS HYPERCOAGULATION HYPERTENSION ILIAC VEIN OCCLUSION INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION INFECTIOUS PERITONITIS INTERNATIONAL NORMALISED RATIO INCREASED INTESTINAL PERFORATION LACERATION LEFT ATRIAL DILATATION MEDICAL DEVICE PAIN Product Role Route Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 857 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8001708
Preferred Term MEMORY IMPAIRMENT MIDDLE INSOMNIA MITRAL VALVE INCOMPETENCE MUSCLE RUPTURE MUSCLE STRAIN MUSCULOSKELETAL CHEST PAIN MUSCULOSKELETAL STIFFNESS MYALGIA OEDEMA PERIPHERAL OVARIAN CYST PALPITATIONS PULMONARY HYPERTENSION RECTAL HAEMORRHAGE RHINITIS STRESS TACHYCARDIA THROMBOPHLEBITIS SUPERFICIAL THROMBOSIS TRICUSPID VALVE INCOMPETENCE URINARY TRACT INFECTION BACTERIAL UTERINE CERVICAL SQUAMOUS METAPLASIA VERTEBRAL ARTERY HYPOPLASIA WEIGHT INCREASED Product Role Route Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 858 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8083546 Date FDA Received
22-Mar-2012 Preferred Term SUPERIOR SAGITTAL SINUS THROMBOSIS INJURY BACK PAIN BLOOD DISORDER CEREBRAL VENOUS THROMBOSIS CEREBROVASCULAR ACCIDENT CONVULSION DEEP VEIN THROMBOSIS DEHYDRATION DIZZINESS FIBROMYALGIA HEADACHE HYPOAESTHESIA MIGRAINE NAUSEA OEDEMA OVARIAN CYST PARAESTHESIA THROMBOSIS TREMOR VARICOSE VEIN VOMITING Case # 8083546 Case Type EXPEDITED (15-DAY) Product NUVARING HYDROMORPHONE HYDROCHLORIDE Health Professional N Outcomes HO,DS,OT Role Route S S Manufacturer Control # 2010SP058866 Dosage Text Age 34 YR Duration Sex Female Country USA

Manufacturer

8481701 Date FDA Received

22-Mar-2012 Preferred Term ABORTION

Case # 8481701

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2012SP013450 Dosage Text VAG

Age

Sex Female

Country NLD

Duration

Manufacturer

PREGNANCY WITH CONTRACEPTIVE DEVICE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 859 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8481708 Date FDA Received
22-Mar-2012 Preferred Term PULMONARY EMBOLISM PREGNANCY MATERNAL EXPOSURE BEFORE PREGNANCY ATELECTASIS BRONCHITIS LUNG NEOPLASM PAIN IN EXTREMITY PLEURAL EFFUSION THROMBOSIS Case # 8481708 Case Type EXPEDITED (15-DAY) Product NUVARING MULTI-VITAMIN CALCIUM AND VITAMIN D Health Professional Y Outcomes HO Role Route S C C VAGINAL Manufacturer Control # 2011SP049920 Dosage Text ;VAG Age 25 YR Duration Sex Female Country USA

Manufacturer

8483695 Date FDA Received

22-Mar-2012 Preferred Term

Case # 8483695

Case Type EXPEDITED (15-DAY) Product NUVARING Case Type EXPEDITED (15-DAY)

Health Professional Y

Outcomes HO,DS,LT Role Route S VAGINAL

Manufacturer Control # 2012SP013819 Dosage Text VAG Manufacturer Control # 2011SP035872

Age

Sex Female

Country USA

Duration

Manufacturer

PULMONARY EMBOLISM

8274469 Date FDA Received

26-Mar-2012

Case # 8274469

Health Professional Y

Outcomes HO,DS,OT

Age 42 YR

Sex Female

Country USA

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 860 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8274469
Preferred Term THROMBOSIS ANXIETY ARTHROPOD STING BEREAVEMENT BLOOD CHOLESTEROL INCREASED CELLULITIS CONDITION AGGRAVATED DEPRESSION DIZZINESS EAR PAIN EXOSTOSIS FOOT FRACTURE HEPATIC CYST HERPES ZOSTER HYPERTENSION HYPOAESTHESIA HYPOAESTHESIA ORAL INSOMNIA JOINT SWELLING MENORRHAGIA MIGRAINE NAUSEA NEPHROLITHIASIS NERVE INJURY PARAESTHESIA PRURITUS RASH RESPIRATORY TRACT INFECTION SINUS DISORDER STRESS AT WORK VERTIGO Product NUVARING Role Route S Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 861 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8339573 Date FDA Received
26-Mar-2012 Preferred Term INJURY PULMONARY EMBOLISM BACK PAIN ATELECTASIS BLOOD HOMOCYSTEINE INCREASED CHEST PAIN DEEP VEIN THROMBOSIS ELECTROCARDIOGRAM ST-T CHANGE EROSIVE OESOPHAGITIS GASTRIC POLYPS GASTRIC ULCER GASTRITIS GASTROOESOPHAGEAL REFLUX DISEASE HYPERCOAGULATION NECK PAIN PLEURAL EFFUSION SINUS TACHYCARDIA Case # 8339573 Case Type EXPEDITED (15-DAY) Product NUVARING SERTRALINE HYDROCHLORIDE ZANTAC Health Professional Y Outcomes HO Role Route S C C Manufacturer Control # 2011SP045027 Dosage Text Age 30 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 862 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8341650 Date FDA Received
26-Mar-2012 Preferred Term DEEP VEIN THROMBOSIS BACK PAIN CHLAMYDIA TEST POSITIVE FACTOR V DEFICIENCY HAEMATOMA HAEMORRHAGIC ANAEMIA HYPERCOAGULATION INTERNATIONAL NORMALISED RATIO DECREASED PULMONARY EMBOLISM Case # 8341650 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO,DS Role Route S Manufacturer Control # 2011SP040941 Dosage Text Age 22 YR Duration Sex Female Country USA

Manufacturer

8485074 Date FDA Received

26-Mar-2012 Preferred Term

Case # 8485074

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO Role Route S TRANSPLACENTAL

Manufacturer Control # 2012SP015175 Dosage Text TRPL

Age

Sex Female

Country USA

Duration

Manufacturer

BREECH PRESENTATION CAESAREAN SECTION MATERNAL DRUGS AFFECTING FOETUS NEONATAL RESPIRATORY DISTRESS SYNDROME OLIGOHYDRAMNIOS ORAL NEOPLASM PREMATURE BABY SEPSIS NEONATAL

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 863 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8487434 Date FDA Received
26-Mar-2012 Preferred Term BLIGHTED OVUM ABORTION SPONTANEOUS MATERNAL DRUGS AFFECTING FOETUS OVARIAN CYST PREGNANCY WITH CONTRACEPTIVE DEVICE Case # 8487434 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes OT Role Route S Manufacturer Control # 2012SP007680 Dosage Text Age 34 YR Duration Sex Female Country CAN

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 864 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7975623 Date FDA Received
27-Mar-2012 Preferred Term PULMONARY EMBOLISM ABORTION SPONTANEOUS ACCIDENTAL DEATH ANXIETY CARDIO-RESPIRATORY ARREST CYANOSIS DEEP VEIN THROMBOSIS ENDOMETRIAL HYPERTROPHY FALL GAIT DISTURBANCE HYPERHIDROSIS JOINT SWELLING LIMB INJURY MATERNAL EXPOSURE DURING PREGNANCY OBESITY OVARIAN CYST PAIN IN EXTREMITY PALLOR PREGNANCY WITH CONTRACEPTIVE DEVICE PULMONARY ARTERIAL HYPERTENSION PUPIL FIXED RETAINED PRODUCTS OF CONCEPTION WHITE BLOOD CELL COUNT INCREASED Case # 7975623 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes DE Role Route S Manufacturer Control # 2011SP021427 Dosage Text Age 26 YR Duration Sex Female Country USA

Manufacturer

8331023 Date FDA Received

27-Mar-2012 Preferred Term THROMBOSIS

Case # 8331023

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes DE Role Route S

Manufacturer Control # 2011SP059318 Dosage Text

Age 27 YR Duration

Sex Female

Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 865 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8442368 Date FDA Received
27-Mar-2012 Preferred Term PULMONARY EMBOLISM Case # 8442368 Case Type EXPEDITED (15-DAY) Product NUVARING Case Type EXPEDITED (15-DAY) Product NUVARING CELEXA Health Professional Y Health Professional N Outcomes DE Role Route S VAGINAL Manufacturer Control # 2012SP008464 Dosage Text VAG Manufacturer Control # 2010SP006056 Dosage Text Age 32 YR Duration Sex Female Country USA Age 24 YR Duration Sex Female Country USA

Manufacturer

7538895 Date FDA Received

28-Mar-2012 Preferred Term

Case # 7538895

Outcomes HO,OT Role Route S C

Manufacturer

PULMONARY EMBOLISM UPPER RESPIRATORY TRACT INFECTION ATELECTASIS DERMOID CYST INTERNATIONAL NORMALISED RATIO INCREASED OVARIAN CYST PLEURAL EFFUSION SINUSITIS SINUS TACHYCARDIA

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 866 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8408723 Date FDA Received
30-Mar-2012 Preferred Term BLINDNESS UNILATERAL GLARE PAIN OPTIC NEURITIS INTERVERTEBRAL DISC DEGENERATION PALPITATIONS CHEST PAIN ANXIETY ARTHRALGIA BLOOD IMMUNOGLOBULIN G INCREASED CLINICALLY ISOLATED SYNDROME DYSMENORRHOEA IRRITABILITY MENSTRUAL DISORDER METRORRHAGIA MOOD SWINGS RASH STRESS VITAMIN B12 DEFICIENCY Case # 8408723 Case Type EXPEDITED (15-DAY) Product NUVARING PAXIL OMEPRAZOLE PRILOSEC ASCORBIC ACID VITAMIN B COMPLEX KLONOPIN Health Professional Y Outcomes DS Role Route S C C C C C C VAGINAL Manufacturer Control # 2012SP005291 Dosage Text 1 DF, QM, VAG Age 37 YR Duration Sex Female Country USA

Manufacturer

8485007 Date FDA Received

30-Mar-2012 Preferred Term ALOPECIA

Case # 8485007

Case Type DIRECT Product NUVARING

Health Professional N

Outcomes

Manufacturer Control #

Age 29 YR

Sex Female

Country USA

Role Route S

Dosage Text

Duration

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 867 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8496694 Date FDA Received
30-Mar-2012 Preferred Term SUICIDE ATTEMPT OVERDOSE Case # 8496694 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes OT Role Route S VAGINAL Manufacturer Control # 2012SP015827 Dosage Text VAG Age 26 YR Duration Sex Female Country GBR

Manufacturer

6079919 Date FDA Received

02-Apr-2012 Preferred Term

Case # 6079919

Case Type EXPEDITED (15-DAY) Product NUVARING MEDROL KEFLEX

Health Professional Y

Outcomes DE Role Route S C C VAGINAL

Manufacturer Control # 2006-144385-NL Dosage Text ;VAG

Age 40 YR Duration

Sex Female

Country USA

Manufacturer

GRAND MAL CONVULSION PULSELESS ELECTRICAL ACTIVITY CARDIAC ARREST BLOOD PRESSURE IMMEASURABLE CYANOSIS DEEP VEIN THROMBOSIS PULMONARY EMBOLISM RESPIRATORY ARREST

7279261 Date FDA Received

02-Apr-2012

Case # 7279261

Case Type EXPEDITED (15-DAY)

Health Professional Y

Outcomes HO,OT

Manufacturer Control # 2009SP023137

Age 24 YR

Sex Female

Country USA

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 868 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7279261
Preferred Term HEADACHE ASTHENIA HYPOAESTHESIA ATRIAL SEPTAL DEFECT BLOOD THYROID STIMULATING HORMONE INCREASED BRONCHITIS CARDIAC MURMUR CEREBRAL INFARCTION CHEST PAIN DIZZINESS ELECTROCARDIOGRAM ABNORMAL ELECTROCARDIOGRAM QT PROLONGED FALL HEART RATE IRREGULAR INFECTION MIGRAINE NAUSEA PALPITATIONS PHONOPHOBIA PHOTOPHOBIA PINEAL GLAND CYST PRESYNCOPE SINUS BRADYCARDIA SINUSITIS SKELETAL INJURY SPEECH DISORDER TRICUSPID VALVE INCOMPETENCE UPPER RESPIRATORY TRACT INFECTION VENTRICULAR EXTRASYSTOLES VISION BLURRED Product NUVARING LEVOTHYROXINE SODIUM TYLENOL Role Route S C C VAGINAL Dosage Text 1 DF, QM, VAG Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 869 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8487102 Date FDA Received
02-Apr-2012 Preferred Term PREGNANCY WITH CONTRACEPTIVE DEVICE MATERNAL EXPOSURE DURING PREGNANCY Case # 8487102 Case Type DIRECT Product NUVARING Health Professional N Role Route S VAGINAL Dosage Text 1 ring Outcomes Manufacturer Control # Age 21 YR Duration 6 MTH Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 870 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7891772 Date FDA Received
03-Apr-2012 Preferred Term PULMONARY EMBOLISM INJURY ABDOMINAL PAIN LOWER ASTHENIA FATIGUE HEADACHE HYPERCOAGULATION HYPERHIDROSIS HYPOAESTHESIA INSOMNIA INTERNATIONAL NORMALISED RATIO INCREASED MIGRAINE MUSCLE SPASMS MUSCULOSKELETAL PAIN NAUSEA NECK PAIN PARAESTHESIA PELVIC PAIN POST-TRAUMATIC STRESS DISORDER PULMONARY INFARCTION VIRAL INFECTION VOMITING Case # 7891772 Case Type EXPEDITED (15-DAY) Product NUVARING ADDERALL XR Health Professional Y Outcomes HO,DS,LT,OT Role Route S C VAGINAL Manufacturer Control # 2010SP054450 Dosage Text 1 DF;Q3W;VAG Age 26 YR Duration Sex Female Country USA

Manufacturer

8499820 Date FDA Received

03-Apr-2012 Preferred Term PNEUMONIA

Case # 8499820

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO Role Route S VAGINAL

Manufacturer Control # 2012SP016617 Dosage Text ;VAG

Age 25 YR Duration

Sex Female

Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 871 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8502541 Date FDA Received
03-Apr-2012 Preferred Term CONVULSION CEREBROVASCULAR DISORDER Case # 8502541 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional N Outcomes HO Role Route S Manufacturer Control # 2012SP016444 Dosage Text Age 22 YR Duration Sex Female Country ISR

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 872 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7277690 Date FDA Received
04-Apr-2012 Preferred Term PULMONARY EMBOLISM ABDOMINAL MASS AORTIC ANEURYSM AORTIC DISSECTION ATELECTASIS BLOOD URINE PRESENT BRAIN STEM STROKE COUGH CRYING DEEP VEIN THROMBOSIS DEPRESSION DIPLOPIA DYSPHAGIA DYSPHONIA EMOTIONAL DISORDER FATIGUE HYPERCOAGULATION HYPERHIDROSIS HYPERTENSION HYPOXIC-ISCHAEMIC ENCEPHALOPATHY LUNG CONSOLIDATION MULTIPLE INJURIES MYASTHENIA GRAVIS OPHTHALMOPLEGIA PLEURAL EFFUSION PSEUDOBULBAR PALSY VISUAL IMPAIRMENT VOCAL CORD PARALYSIS Case # 7277690 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO,DS,OT Role Route S Manufacturer Control # 2009SP023403 Dosage Text Age 44 YR Duration Sex Female Country USA

Manufacturer

7980761
Date - Time: 02-04-2013 9:43:10 AM EST Note: If the field is blank, there is no data Page: 873 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7980761
FDA Received Date 04-Apr-2012 Preferred Term PORTAL VEIN THROMBOSIS ABDOMINAL PAIN ABDOMINAL PAIN LOWER ACCIDENT AT WORK ARTHRALGIA BLOOD CHOLESTEROL INCREASED BURNS THIRD DEGREE COLLATERAL CIRCULATION CONSTIPATION DEVICE EXTRUSION DIZZINESS DYSPEPSIA DYSPNOEA FLANK PAIN GASTRIC DISORDER GASTRITIS HAEMORRHOIDS HEADACHE HEPATIC CYST HEPATIC MASS HEPATIC NECROSIS LIVER DISORDER LIVER FUNCTION TEST ABNORMAL NEPHROLITHIASIS PALPITATIONS PELVIC DISCOMFORT PLATELET COUNT INCREASED PORTAL VEIN OCCLUSION Case # 7980761 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes OT Role Route S Manufacturer Control # 2010SP062584 Dosage Text Age 35 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 874 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7980761
Preferred Term PRESYNCOPE RENAL CYST SCAR SLEEP DISORDER TRICHOMONIASIS UTERINE LEIOMYOMA VAGINAL DISCHARGE VAGINAL HAEMORRHAGE Product Role Route Dosage Text Duration Manufacturer

8494168 Date FDA Received

04-Apr-2012

Case # 8494168

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes HO

Manufacturer Control # USGLAXOSMITHKLINEA0971488A Dosage Text 300MG At night

Age 48 YR

Sex Female

Country USA

Preferred Term MENTAL DISORDER SUICIDAL IDEATION DEPRESSION DRUG INTERACTION ANTICONVULSANT DRUG LEVEL DECREASED

Product LAMICTAL NUVARING TOPAMAX KLONOPIN

Role Route S S C C ORAL

Duration

Manufacturer GLAXOSMITHKLINE GLAXOSMITHKLINE GLAXOSMITHKLINE

7368538 Date FDA Received

05-Apr-2012

Case # 7368538

Case Type EXPEDITED (15-DAY)

Health Professional Y

Outcomes HO,OT

Manufacturer Control # 2010SP006052

Age 24 YR

Sex Female

Country USA

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 875 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7368538
Preferred Term PULMONARY EMBOLISM FLANK PAIN DYSURIA ANXIETY BACK PAIN BLOOD GLUCOSE INCREASED BRONCHITIS BURSITIS CELLULITIS CONTUSION DIZZINESS DYSMENORRHOEA DYSPAREUNIA FEELING ABNORMAL FIBROCYSTIC BREAST DISEASE HERPES ZOSTER HYPOAESTHESIA INFLUENZA KIDNEY INFECTION MENSTRUATION IRREGULAR MIGRAINE MUSCLE SPASMS MUSCULOSKELETAL CHEST PAIN NEPHROLITHIASIS OVARIAN CYST PANIC ATTACK PELVIC INFLAMMATORY DISEASE PLEURAL EFFUSION PLEURISY PULMONARY INFARCTION THROMBOPHLEBITIS SUPERFICIAL Product NUVARING ZOLOFT ATIVAN Role Route S C C VAGINAL Dosage Text 1 DF, QM, VAG Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 876 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7555354 Date FDA Received
05-Apr-2012 Preferred Term PULMONARY EMBOLISM PULMONARY HYPERTENSION TREATMENT NONCOMPLIANCE MENORRHAGIA UTERINE LEIOMYOMA ANAEMIA DIABETES MELLITUS INADEQUATE CONTROL Case # 7555354 Case Type EXPEDITED (15-DAY) Product NUVARING ACTOS LISINOPRIL MULTI-VITAMIN TYLENOL Health Professional Y Outcomes HO Role Route S C C C C VAGINAL Manufacturer Control # 2010SP026815 Dosage Text ;QM;VAG Age 31 YR Duration Sex Female Country USA

Manufacturer

7658409 Date FDA Received

05-Apr-2012 Preferred Term THROMBOSIS HYPERCOAGULATION

Case # 7658409

Case Type EXPEDITED (15-DAY) Product NUVARING DARVOCET CODEINE

Health Professional Y

Outcomes HO,OT Role Route S S S

Manufacturer Control # 2010SP053045 Dosage Text

Age 32 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM ANXIETY DEEP VEIN THROMBOSIS FALL OBSTRUCTIVE AIRWAYS DISORDER PNEUMONIA SYNCOPE VARICOSE VEIN

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 877 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7805405 Date FDA Received
05-Apr-2012 Preferred Term UTERINE LEIOMYOMA MENORRHAGIA ANAEMIA PULMONARY EMBOLISM PULMONARY HYPERTENSION BLOOD GLUCOSE INCREASED DILATATION VENTRICULAR HYPOTENSION TREATMENT NONCOMPLIANCE Case # 7805405 Case Type EXPEDITED (15-DAY) Product NUVARING ACTOS LISINOPRIL TYLENOL MULTI-VITAMIN Health Professional Y Outcomes HO Role Route S C C C C VAGINAL Manufacturer Control # 2010SP020858 Dosage Text ;QM;VAG Age 31 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 878 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7821614 Date FDA Received
05-Apr-2012 Preferred Term CEREBROVASCULAR ACCIDENT BREAST PROSTHESIS USER MIGRAINE HYPERTENSION PHYTOTHERAPY STRESS ANXIETY URINARY TRACT INFECTION ABDOMINAL DISTENSION CERVICAL DYSPLASIA CONTUSION HAEMORRHAGIC ANAEMIA MENORRHAGIA NAUSEA PHONOPHOBIA PYREXIA RETROPERITONEAL HAEMATOMA RETROPERITONEAL HAEMORRHAGE UTERINE HAEMORRHAGE VAGINAL DISCHARGE VENTRICULAR TACHYCARDIA VULVOVAGINAL PAIN Case # 7821614 Case Type EXPEDITED (15-DAY) Product NUVARING ENOXAPARIN CLOPIDOGREL ASPIRIN TYLENOL ADVIL NAPROXEN SUMATRIPTAN Health Professional Y Outcomes HO,OT Role Route S S S S C C C C Manufacturer Control # 2010SP015904 Dosage Text Age 25 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 879 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7314526 Date FDA Received
06-Apr-2012 Preferred Term HEADACHE HYPOAESTHESIA BALANCE DISORDER CARDIAC ANEURYSM DIARRHOEA DROOLING DYSARTHRIA FALL FEELING ABNORMAL HYPERTENSION ISCHAEMIC CEREBRAL INFARCTION LEFT ATRIAL DILATATION MALAISE MYOKYMIA OEDEMA PERIPHERAL SKIN DISCOLOURATION TRICUSPID VALVE INCOMPETENCE VERTIGO VESTIBULAR DISORDER Case # 7314526 Case Type EXPEDITED (15-DAY) Product NUVARING TOPROL XL MULTI-VITAMIN Health Professional Y Outcomes HO,OT Role Route S S C VAGINAL Manufacturer Control # 2010SP003964 Dosage Text VAG Age 43 YR Duration Sex Female Country USA

Manufacturer

8513351 Date FDA Received

06-Apr-2012 Preferred Term

Case # 8513351

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2012SP017566 Dosage Text

Age 22 YR Duration

Sex Female

Country BEL

Manufacturer

PREGNANCY ON CONTRACEPTIVE ABORTION MATERNAL EXPOSURE DURING PREGNANCY

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 880 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7277684 Date FDA Received
09-Apr-2012 Preferred Term PULMONARY EMBOLISM SYNCOPE PALPITATIONS CHEST PAIN COR PULMONALE DEHYDRATION DIASTOLIC HYPERTENSION ERYTHEMA FACTOR V DEFICIENCY HYPERGLYCAEMIA HYPOVOLAEMIA JOINT SWELLING MICROCYTIC ANAEMIA NAUSEA OEDEMA PERIPHERAL PAIN IN EXTREMITY PHLEBITIS SUPERFICIAL TACHYCARDIA Case # 7277684 Case Type EXPEDITED (15-DAY) Product NUVARING PROVENTIL SINGULAIR ALLEGRA D-12 HOUR Health Professional Y Outcomes HO,OT Role Route S C C C Manufacturer Control # 2009SP023526 Dosage Text Age 33 YR Duration Sex Female Country USA

Manufacturer

7284884 Date FDA Received

09-Apr-2012 Preferred Term

Case # 7284884

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO Role Route S VAGINAL

Manufacturer Control # 2008-178512-NL Dosage Text VAG

Age 25 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM ATELECTASIS DEEP VEIN THROMBOSIS HYPERCOAGULATION PNEUMONIA PULMONARY INFARCTION

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 881 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8500155 Date FDA Received
09-Apr-2012 Preferred Term DEPRESSION DISTURBANCE IN ATTENTION FATIGUE FEELINGS OF WORTHLESSNESS IMPAIRED WORK ABILITY IRRITABILITY MIDDLE INSOMNIA SUICIDAL IDEATION Case # 8500155 Case Type DIRECT Product NUVARING Health Professional N Outcomes OT Role Route S VAGINAL Dosage Text 0.015mg Manufacturer Control # Age 37 YR Duration Sex Female Country USA

Manufacturer

8341666 Date FDA Received

10-Apr-2012 Preferred Term

Case # 8341666

Case Type EXPEDITED (15-DAY) Product NUVARING COMPAZINE IMITREX

Health Professional Y

Outcomes HO Role Route S S S C

Manufacturer Control # 2011SP040947 Dosage Text

Age 21 YR Duration

Sex Female

Country USA

Manufacturer

RASH ERYTHEMATOUS PAIN IN EXTREMITY MUSCLE SPASMS PAIN ABDOMINAL DISCOMFORT ALCOHOL ABUSE BIPOLAR DISORDER CHEST PAIN CONJUNCTIVITIS INFECTIVE CONTUSION DEPRESSION DIZZINESS DRUG INEFFECTIVE DRUG SCREEN POSITIVE DYSFUNCTIONAL UTERINE BLEEDING DYSMENORRHOEA

ALBUTEROL NIHALER

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 882 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8341666
Preferred Term DYSPNOEA EPIGASTRIC DISCOMFORT ERYTHEMA FOREIGN BODY GASTRITIS GUN SHOT WOUND HEAD INJURY INSOMNIA INTENTIONAL SELF-INJURY LACERATION MENOMETRORRHAGIA MIGRAINE MULTIPLE DRUG OVERDOSE INTENTIONAL NAUSEA OVARIAN CYST RUPTURED PALPITATIONS PANIC ATTACK PELVIC INFLAMMATORY DISEASE PHYSICAL ASSAULT POISONING POLLAKIURIA RESTLESS LEGS SYNDROME SUICIDAL BEHAVIOUR SWELLING THROMBOPHLEBITIS SUPERFICIAL UTERINE MALPOSITION VAGINAL HAEMORRHAGE VOMITING VULVOVAGINITIS TRICHOMONAL Product Role Route Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 883 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7344074 Date FDA Received
11-Apr-2012 Preferred Term MULTIPLE INJURIES PULMONARY EMBOLISM DEEP VEIN THROMBOSIS PAIN MIGRAINE ABORTION INDUCED BREAST CYST CAESAREAN SECTION CARDIAC DISORDER CONTUSION DIZZINESS DRUG HYPERSENSITIVITY ECCHYMOSIS GASTROOESOPHAGEAL REFLUX DISEASE HYPERCOAGULATION HYPOCHROMIC ANAEMIA MATERNAL EXPOSURE BEFORE PREGNANCY PULMONARY INFARCTION RESPIRATORY FAILURE THROMBOCYTOPENIA VENTRICULAR HYPOKINESIA Case # 7344074 Case Type EXPEDITED (15-DAY) Product NUVARING COUMADIN ZYRTEC LOVENOX FIORICET IBUPROFEN Health Professional Y Outcomes HO,OT Role Route S S S S C C Manufacturer Control # 2010SP014822 Dosage Text Age 32 YR Duration Sex Female Country USA

Manufacturer

7538868 Date FDA Received

11-Apr-2012 Preferred Term

Case # 7538868

Case Type EXPEDITED (15-DAY) Product NUVARING LUPRON

Health Professional Y

Outcomes HO,OT Role Route S C VAGINAL

Manufacturer Control # 2010SP031284 Dosage Text VAG

Age 32 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY INFARCTION POST-TRAUMATIC STRESS DISORDER ANAEMIA ANTINUCLEAR ANTIBODY POSITIVE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 884 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7538868
Preferred Term ANXIETY ARTHRALGIA BACK PAIN BRONCHITIS CHEST DISCOMFORT CHRONIC OBSTRUCTIVE PULMONARY DISEASE COAGULOPATHY COMPLEX REGIONAL PAIN SYNDROME CONVULSION DIZZINESS DRUG INTOLERANCE DYSPEPSIA FATIGUE FIBROMYALGIA HAEMOPTYSIS HEADACHE HYPOAESTHESIA INCISION SITE CELLULITIS INTERNATIONAL NORMALISED RATIO INCREASED MUSCULOSKELETAL STIFFNESS OEDEMA PERIPHERAL PLATELET COUNT INCREASED PLEURISY PNEUMONIA POST PROCEDURAL CONSTIPATION PRESYNCOPE PULMONARY EMBOLISM RAYNAUD'S PHENOMENON RESPIRATORY FAILURE Product Role Route Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 885 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7538868
Preferred Term SCAR SOMNOLENCE STRESS SYSTEMIC LUPUS ERYTHEMATOSUS TACHYCARDIA TRICUSPID VALVE INCOMPETENCE Product Role Route Dosage Text Duration Manufacturer

7827333 Date FDA Received

11-Apr-2012 Preferred Term

Case # 7827333

Case Type EXPEDITED (15-DAY) Product NUVARING NEXIUM

Health Professional Y

Outcomes HO Role Route S C

Manufacturer Control # 2010SP043248 Dosage Text

Age 31 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM PNEUMONIA ABDOMINAL PAIN BIPOLAR DISORDER BLOOD DISORDER CARDIAC MURMUR CLOSTRIDIUM DIFFICILE COLITIS DEHYDRATION DEPENDENT PERSONALITY DISORDER DEPRESSION DIARRHOEA DRUG HYPERSENSITIVITY DYSFUNCTIONAL UTERINE BLEEDING DYSMENORRHOEA GASTROENTERITIS GASTROOESOPHAGEAL REFLUX DISEASE GENERALISED ANXIETY DISORDER HAEMATOCRIT DECREASED HAEMOGLOBIN DECREASED HEPATIC CYST HYPOKALAEMIA

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 886 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7827333
Preferred Term HYPONATRAEMIA IMPAIRED WORK ABILITY IRRITABLE BOWEL SYNDROME LIVER DISORDER NAUSEA PELVIC INFLAMMATORY DISEASE PLATELET COUNT INCREASED PLEURAL EFFUSION PULMONARY ARTERY ANEURYSM PULMONARY INFARCTION RHINITIS ALLERGIC STRESS THROMBOSIS TREATMENT NONCOMPLIANCE VOMITING WEIGHT DECREASED WHITE BLOOD CELL COUNT INCREASED Product Role Route Dosage Text Duration Manufacturer

8504057 Date FDA Received

11-Apr-2012 Preferred Term NAUSEA ABDOMINAL PAIN

Case # 8504057

Case Type DIRECT Product NUVARING

Health Professional N

Outcomes HO Role Route S VAGINAL

Manufacturer Control #

Age 35 YR

Sex Female

Country USA

Dosage Text 1 ring

Duration

Manufacturer

DECREASED APPETITE DIARRHOEA DIZZINESS GASTROENTERITIS VIRAL HEADACHE PANIC ATTACK PYREXIA SYNCOPE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 887 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7271477 Date FDA Received
13-Apr-2012 Preferred Term PULMONARY EMBOLISM NEOPLASM MALIGNANT THROMBOSIS CERUMEN IMPACTION CONSTIPATION DIASTOLIC DYSFUNCTION DYSPNOEA HEPATIC CYST HYPERCOAGULATION HYPOKALAEMIA HYPOTHYROIDISM INFECTION OCCULT BLOOD POSITIVE OVARIAN CYST PELVIC PAIN PULMONARY HYPERTENSION RENAL DISORDER RESPIRATORY ALKALOSIS SINUS TACHYCARDIA TRICUSPID VALVE INCOMPETENCE UTERINE LEIOMYOMA WEIGHT DECREASED Case # 7271477 Case Type EXPEDITED (15-DAY) Product NUVARING SYNTHROID COSOPT Health Professional Y Outcomes HO,OT Role Route S C C Manufacturer Control # 2009SP021064 Dosage Text Age 48 YR Duration Sex Female Country USA

Manufacturer

7438013 Date FDA Received

13-Apr-2012 Preferred Term NASOPHARYNGITIS

Case # 7438013

Case Type EXPEDITED (15-DAY) Product NUVARING FENTANYL TRILEPTAL

Health Professional Y

Outcomes HO,DS,OT Role Route S S C VAGINAL INTRAVENOUS

Manufacturer Control # 2010SP031888 Dosage Text 1 DF;QM;VAG IV

Age 21 YR Duration

Sex Female

Country USA

Manufacturer

RESPIRATORY TRACT INFECTION Atypical pneumonia

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 888 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7438013
Preferred Term DIZZINESS ABORTION INDUCED ACUTE SINUSITIS ANTINUCLEAR ANTIBODY POSITIVE ANTIPHOSPHOLIPID ANTIBODIES POSITIVE ANXIETY ASTHMA BRONCHITIS CERVICAL DYSPLASIA COGNITIVE DISORDER CONJUNCTIVITIS CONVULSION CULTURE WOUND POSITIVE DERMAL CYST ECZEMA EMOTIONAL DISORDER EXCORIATION FALL HEADACHE HEARING IMPAIRED HYPERCOAGULATION HYPOAESTHESIA HYPOTENSION INFLAMMATION INTERNATIONAL NORMALISED RATIO DECREASED KIDNEY INFECTION LIGAMENT SPRAIN LIMB INJURY LOSS OF CONSCIOUSNESS MAJOR DEPRESSION Product ZOLOFT Role Route C Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 889 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7438013
Preferred Term MATERNAL EXPOSURE DURING PREGNANCY MENSTRUATION DELAYED MENTAL DISORDER MULTIPLE ALLERGIES NASAL CONGESTION NEURALGIA PANIC DISORDER PARAESTHESIA PERICARDIAL EFFUSION PHARYNGITIS PHOTOPHOBIA PNEUMONIA POST-TRAUMATIC STRESS DISORDER PULMONARY EMBOLISM PULMONARY INFARCTION SINUS TACHYCARDIA STREPTOCOCCAL INFECTION SYNCOPE TACHYCARDIA THERMAL BURN VENA CAVA INJURY Product Role Route Dosage Text Duration Manufacturer

8263934 Date FDA Received

16-Apr-2012 Preferred Term

Case # 8263934

Case Type EXPEDITED (15-DAY) Product NUVARING ZOLOFT

Health Professional Y

Outcomes HO,OT Role Route S C C

Manufacturer Control # 2011SP041921 Dosage Text

Age 23 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM SLEEP DISORDER INJURY ALCOHOL POISONING ANAEMIA ASTHENIA

TRAZODONE HYDROCHLORIDE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 890 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8263934
Preferred Term ATTENTION DEFICIT/HYPERACTIVITY DISORDER CONSTIPATION ECONOMIC PROBLEM EDUCATIONAL PROBLEM EMOTIONAL DISORDER EXCORIATION FIBRIN D DIMER INCREASED GASTROOESOPHAGEAL REFLUX DISEASE GENERALISED ANXIETY DISORDER HAEMATOCHEZIA INTENTIONAL SELF-INJURY LYMPHADENOPATHY MAJOR DEPRESSION OVARIAN CYST PAIN PALPITATIONS PELVIC PAIN PHARYNGEAL CYST STRESS SUICIDE ATTEMPT SUPRAVENTRICULAR EXTRASYSTOLES TEARFULNESS THYROGLOSSAL CYST INFECTION VAGINAL DISCHARGE VENTRICULAR EXTRASYSTOLES VULVOVAGINAL PRURITUS Product Role Route Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 891 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8481706 Date FDA Received
17-Apr-2012 Preferred Term MATERNAL DRUGS AFFECTING FOETUS LIMB REDUCTION DEFECT Case # 8481706 Case Type EXPEDITED (15-DAY) Product NUVARING ELEVIT Case Type EXPEDITED (15-DAY) Product NUVARING REGLAN Health Professional Y Health Professional Y Outcomes CA Role Route S C Outcomes HO,OT Role Route S S Manufacturer Control # 2010SP045138 Dosage Text Age 23 YR Duration Sex Female Country USA TRANSPLACENTAL Manufacturer Control # 2012SP014508 Dosage Text TRPL Age 1 DAY Duration Sex Female Country LVA

Manufacturer

7827274 Date FDA Received

18-Apr-2012 Preferred Term

Case # 7827274

Manufacturer

PULMONARY EMBOLISM THROMBOSIS ABDOMINAL MASS ABDOMINAL PAIN ABDOMINAL PAIN UPPER ALANINE AMINOTRANSFERASE INCREASED ASPARTATE AMINOTRANSFERASE INCREASED BAND NEUTROPHIL COUNT INCREASED BLOOD ALBUMIN DECREASED COUGH DEEP VEIN THROMBOSIS DRUG HYPERSENSITIVITY DYSMENORRHOEA DYSTONIA ENDOMETRIAL HYPERPLASIA EXTRAPYRAMIDAL DISORDER GOITRE HAEMATOCHEZIA HAEMOPTYSIS INFLAMMATORY BOWEL DISEASE LIPASE INCREASED LUNG INFILTRATION

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 892 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7827274
Preferred Term LUNG NEOPLASM MENORRHAGIA MUSCLE SPASMS MUSCULOSKELETAL CHEST PAIN OVARIAN CYST PNEUMONIA PROTEIN S DEFICIENCY PROTHROMBIN TIME PROLONGED PULMONARY INFARCTION PYREXIA RECTAL POLYP SIMPLEX VIRUS TEST POSITIVE SPEECH DISORDER THYROID NEOPLASM URINARY TRACT INFECTION UTERINE POLYP VAGINITIS BACTERIAL Product Role Route Dosage Text Duration Manufacturer

8228524 Date FDA Received

18-Apr-2012 Preferred Term

Case # 8228524

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO Role Route S

Manufacturer Control # 2011SP030602 Dosage Text QM

Age 31 YR Duration

Sex Female

Country USA

Manufacturer

TRANSVERSE SINUS THROMBOSIS ANEURYSM DENTAL OPERATION HEADACHE JUGULAR VEIN THROMBOSIS MIDDLE INSOMNIA MUSCULOSKELETAL STIFFNESS PARAESTHESIA SUBARACHNOID HAEMORRHAGE TOOTH INFECTION

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 893 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8520669 Date FDA Received
18-Apr-2012 Preferred Term HEADACHE MIGRAINE Case # 8520669 Case Type DIRECT Product NUVARING Health Professional N Role Route S VAGINAL Dosage Text single ring Outcomes Manufacturer Control # Age 30 YR Duration Sex Female Country USA

Manufacturer

8533584 Date FDA Received

18-Apr-2012 Preferred Term

Case # 8533584

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2012SP017109 Dosage Text

Age 34 YR Duration

Sex Female

Country BEL

Manufacturer

ABORTION SPONTANEOUS MATERNAL EXPOSURE DURING PREGNANCY PREGNANCY WITH CONTRACEPTIVE DEVICE

8536960 Date FDA Received

18-Apr-2012 Preferred Term DEHYDRATION

Case # 8536960

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes DS Role Route S VAGINAL

Manufacturer Control # 2012SP019178 Dosage Text UNK;VAG

Age 38 YR Duration

Sex Female

Country KAZ

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 894 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6762507 Date FDA Received
20-Apr-2012 Preferred Term PAIN SWELLING ABSCESS ASTHENIA BURNING SENSATION CELLULITIS CELLULITIS GANGRENOUS GROIN ABSCESS METABOLIC ACIDOSIS MULTI-ORGAN FAILURE PLEURAL EFFUSION PULMONARY HYPERTENSION PULMONARY OEDEMA RENAL FAILURE ACUTE RESPIRATORY DISTRESS RESPIRATORY FAILURE SEPSIS STREPTOCOCCAL INFECTION TOXIC SHOCK SYNDROME TRICUSPID VALVE INCOMPETENCE Case # 6762507 Case Type EXPEDITED (15-DAY) Product NUVARING ORTHO EVRA Health Professional Y Outcomes DE,HO Role Route S C VAGINAL Manufacturer Control # 2008-182753-NL Dosage Text 1 DF, QM, VAG Age 25 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 895 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8165140 Date FDA Received
20-Apr-2012 Preferred Term ACUTE RESPIRATORY FAILURE ASTHMA CARPAL TUNNEL SYNDROME COGNITIVE DISORDER COSTOCHONDRITIS DEEP VEIN THROMBOSIS EMOTIONAL DISORDER FIBROMYALGIA IMPAIRED WORK ABILITY INJURY INTERSTITIAL LUNG DISEASE LUNG INFILTRATION MENTAL DISORDER METRORRHAGIA MIGRAINE MUSCULAR WEAKNESS NEUROPATHY PERIPHERAL OEDEMA PERIPHERAL PAIN PAIN IN EXTREMITY PULMONARY EMBOLISM PULMONARY GRANULOMA PULMONARY INFARCTION RESPIRATORY ALKALOSIS SPIDER VEIN Case # 8165140 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO,OT Role Route S Manufacturer Control # 2011SP025675 Dosage Text Age 47 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 896 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8197916 Date FDA Received
20-Apr-2012 Preferred Term TINNITUS PREMENSTRUAL SYNDROME HEADACHE NAUSEA DIZZINESS TRIGEMINAL NEURALGIA VAGINAL DISCHARGE VERTIGO Case # 8197916 Case Type EXPEDITED (15-DAY) Product NUVARING IBUPROFEN KETOPROFEN TRIMEBUTINA Health Professional N Outcomes OT Role Route S C C C VAGINAL Manufacturer Control # 2011SP039756 Dosage Text QM;VAG Age 41 YR Duration Sex Female Country CHL

Manufacturer

8482016 Date FDA Received

20-Apr-2012 Preferred Term

Case # 8482016

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO,OT Role Route S

Manufacturer Control # 2011SP056190 Dosage Text

Age 36 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM ABDOMINAL PAIN LOWER ANAEMIA BACK PAIN DYSMENORRHOEA DYSPAREUNIA GENERALISED OEDEMA HYPERCHOLESTEROLAEMIA HYPERTENSION INJURY JOINT SWELLING LUPUS NEPHRITIS OEDEMA PERIPHERAL RENAL DISORDER RENAL VEIN THROMBOSIS THROMBOSIS

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 897 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8523559 Date FDA Received
20-Apr-2012 Preferred Term PRODUCT QUALITY ISSUE Case # 8523559 Case Type DIRECT Product NUVARING Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Health Professional Y Role Route S Outcomes HO,OT Role Route S VAGINAL Manufacturer Control # 2012SP019424 Dosage Text ONCE, VAG Age 22 YR Duration Sex Female Country CHE Dosage Text Outcomes Manufacturer Control # Age 25 YR Duration Sex Female Country USA

Manufacturer

8535956 Date FDA Received

20-Apr-2012 Preferred Term

Case # 8535956

Manufacturer

CEREBRAL VENOUS THROMBOSIS EPILEPSY HEADACHE TRANSVERSE SINUS THROMBOSIS VOMITING

8537596 Date FDA Received

20-Apr-2012 Preferred Term

Case # 8537596

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO,DS,LT Role Route S

Manufacturer Control # 2011SP056189 Dosage Text

Age 32 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM BRONCHITIS BRONCHOSPASM DEEP VEIN THROMBOSIS PNEUMONIA RESTLESSNESS

7035295 Date FDA Received

23-Apr-2012

Case # 7035295

Case Type EXPEDITED (15-DAY)

Health Professional Y

Outcomes HO,OT

Manufacturer Control # 2009-190754-NL

Age 27 YR

Sex Female

Country USA

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 898 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7035295
Preferred Term ARTHRALGIA PULMONARY EMBOLISM ACUTE SINUSITIS ANTIPHOSPHOLIPID ANTIBODIES POSITIVE BREAST HYPERPLASIA CONDITION AGGRAVATED COSTOCHONDRITIS FIBRIN D DIMER INCREASED FIBROCYSTIC BREAST DISEASE FLANK PAIN FOLLICULITIS HILAR LYMPHADENOPATHY LUNG CONSOLIDATION LUNG NEOPLASM LYMPHADENOPATHY MEDIASTINAL METASTASES TO BONE MICROMASTIA MYALGIA OPPORTUNISTIC INFECTION OSTEOARTHRITIS PHARYNGITIS PLEURAL EFFUSION PLEURISY PNEUMONIA PROCEDURAL PAIN PULMONARY FIBROSIS PULMONARY SARCOIDOSIS RHEUMATOID ARTHRITIS STAPHYLOCOCCAL INFECTION SYSTEMIC LUPUS ERYTHEMATOSUS Product NUVARING PEPCID Role Route S C Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 899 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8540320 Date FDA Received
24-Apr-2012 Preferred Term SUICIDAL IDEATION Case # 8540320 Case Type EXPEDITED (15-DAY) Product NUVARING Case # 6091165 Case Type EXPEDITED (15-DAY) Product NUVARING COUMADIN NOREL SR AMOXICILLIN ACETAMINOPHEN AND CODEINE PHOSPHATE AZITHROMYCIN CIPRODEX RPOPRANOLOL TYLENOL WITH CODEINE NEURONTIN Health Professional Y Health Professional Y Outcomes LT Role Route S VAGINAL Manufacturer Control # 2012SP020740 Dosage Text VAG Manufacturer Control # 2006-144661-NL Dosage Text QM;VAGINAL 600 Age 25 YR Duration Sex Female Country USA Duration Age Sex Female Country USA

Manufacturer

6091165 Date FDA Received

25-Apr-2012 Preferred Term

Outcomes HO,OT Role Route S S C C C C C C C C VAGINAL

Manufacturer

CEREBROVASCULAR ACCIDENT CEREBRAL THROMBOSIS AMENORRHOEA TYMPANIC MEMBRANE DISORDER INFLAMMATION TREATMENT NONCOMPLIANCE SUBARACHNOID HAEMORRHAGE TRANSVERSE SINUS THROMBOSIS HYPOACUSIS EAR INFECTION ASTHENIA BACK PAIN BACTERIAL TEST POSITIVE BLOOD CHOLESTEROL INCREASED BLOOD PRESSURE INCREASED BLOOD TRIGLYCERIDES INCREASED CEREBRAL INFARCTION CHEST PAIN COUGH CYSTITIS HAEMORRHAGIC DIARRHOEA DISEASE RECURRENCE DYSPNOEA

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 900 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6091165
Preferred Term EFFUSION ERYTHEMA HAEMATURIA HYDRONEPHROSIS HYPERHIDROSIS LOW DENSITY LIPOPROTEIN INCREASED MENORRHAGIA MUSCLE SPASMS NAUSEA NEPHROLITHIASIS OROPHARYNGEAL PAIN OVARIAN CYST RECTAL HAEMORRHAGE RHINORRHOEA SACROILIITIS SCLERAL HAEMORRHAGE TREMOR URINARY TRACT INFECTION VOMITING Product Role Route Dosage Text Duration Manufacturer

8531625 Date FDA Received

26-Apr-2012 Preferred Term WEIGHT INCREASED

Case # 8531625

Case Type DIRECT Product NUVARING NUVARING

Health Professional N

Outcomes

Manufacturer Control #

Age 21 YR

Sex Female

Country USA

Role Route S C Health Professional Y Outcomes HO,OT Role Route S VAGINAL

Dosage Text

Duration

Manufacturer

7730476 Date FDA Received

27-Apr-2012 Preferred Term EMBOLISM VENOUS

Case # 7730476

Case Type EXPEDITED (15-DAY) Product NUVARING

Manufacturer Control # 2010SP026331 Dosage Text

Age 31 YR Duration

Sex Female

Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 901 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7730476
Preferred Term DEEP VEIN THROMBOSIS ABDOMINAL PAIN AFFECTIVE DISORDER ARTHRALGIA BIPOLAR DISORDER CALCULUS URETERIC CHRONIC SINUSITIS CONDITION AGGRAVATED CONTUSION COUGH DIABETES MELLITUS DRUG ABUSE DYSPEPSIA FALL FEELING ABNORMAL FLANK PAIN GLYCOSYLATED HAEMOGLOBIN INCREASED HYDRONEPHROSIS HYPERGLYCAEMIA JOINT SWELLING LUNG CONSOLIDATION MAJOR DEPRESSION NASAL DISORDER NASAL SEPTUM DEVIATION NASAL TURBINATE HYPERTROPHY NAUSEA NEPHROLITHIASIS OEDEMA PERIPHERAL PLEURITIC PAIN POLLAKIURIA PREGNANCY WITH CONTRACEPTIVE DEVICE Product SEROQUEL Role Route S Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 902 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7730476
Preferred Term PULMONARY EMBOLISM PULMONARY INFARCTION ROAD TRAFFIC ACCIDENT SEASONAL ALLERGY SINUS POLYP SINUS TACHYCARDIA SLEEP DISORDER SMEAR CERVIX ABNORMAL SNORING STAPHYLOCOCCAL INFECTION TREMOR URINARY TRACT INFECTION VOMITING Product Role Route Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 903 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8342257 Date FDA Received
27-Apr-2012 Preferred Term PULMONARY EMBOLISM THROMBOSIS ADENOMYOSIS BRONCHITIS DIZZINESS DYSLIPIDAEMIA ELECTROCARDIOGRAM ST-T CHANGE HYPERHIDROSIS INFLUENZA JOINT EFFUSION MUSCLE STRAIN PAIN IN EXTREMITY PARAESTHESIA PULMONARY OEDEMA UTERINE LEIOMYOMA Case # 8342257 Case Type EXPEDITED (15-DAY) Product NUVARING MOBIC Health Professional Y Outcomes HO,DS Role Route S C Manufacturer Control # 2011SP037378 Dosage Text Age 39 YR Duration Sex Female Country USA

Manufacturer

8478812 Date FDA Received

27-Apr-2012 Preferred Term

Case # 8478812

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S C VAGINAL

Manufacturer Control # 2012SP004343 Dosage Text ;VAG

Age 37 YR Duration

Sex Female

Country DEU

Manufacturer

ABORTION SPONTANEOUS PREGNANCY WITH CONTRACEPTIVE DEVICE

CITALOPRAM HYDROBROMIDE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 904 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7239537 Date FDA Received
30-Apr-2012 Preferred Term HEPATIC STEATOSIS PULMONARY EMBOLISM LEFT VENTRICULAR HYPERTROPHY BLOOD GLUCOSE INCREASED BODY TINEA CARDIAC FLUTTER COUGH HAEMATOCHEZIA HEADACHE HYPERCHOLESTEROLAEMIA HYPERTENSION HYPOAESTHESIA INJECTION SITE PAIN MITRAL VALVE INCOMPETENCE MULTIPLE INJURIES MUSCLE SPASMS MUSCULOSKELETAL DISCOMFORT MUSCULOSKELETAL PAIN NASOPHARYNGITIS OEDEMA PERIPHERAL OROPHARYNGEAL PAIN OSTEOARTHRITIS PAIN IN EXTREMITY PALPITATIONS PARAESTHESIA PRURITUS PULMONARY INFARCTION TRICUSPID VALVE INCOMPETENCE URINARY TRACT INFECTION Case # 7239537 Case Type EXPEDITED (15-DAY) Product NUVARING VITAMINS NOS VITAMIN B12 Health Professional Y Outcomes HO,OT Role Route S C C VAGINAL Manufacturer Control # 2009-193180-NL Dosage Text Q3W;VAG Age 37 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 905 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8484283 Date FDA Received
30-Apr-2012 Preferred Term WRONG TECHNIQUE IN DRUG USAGE PROCESS INCORRECT DRUG ADMINISTRATION DURATION ABNORMAL WITHDRAWAL BLEEDING HYPOMENORRHOEA INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION INSULIN RESISTANCE SYNDROME OVERWEIGHT BLOOD GLUCOSE ABNORMAL HEPATIC STEATOSIS Case # 8484283 Case Type EXPEDITED (15-DAY) Product NUVARING LANSOPRAZOLE CLARIMAX AMOXICILLIN BURTEN OMEPRAZOLE IDON Health Professional N Outcomes HO Role Route S C C C C C C VAGINAL Manufacturer Control # 2012SP005090 Dosage Text QM;VAG Duration Age Sex Female Country CHL

Manufacturer

7282124 Date FDA Received

02-May-2012 Preferred Term

Case # 7282124

Case Type EXPEDITED (15-DAY) Product NUVARING DIFLUCAN

Health Professional Y

Outcomes HO,OT Role Route S C C C C VAGINAL

Manufacturer Control # 2009SP016952 Dosage Text 1 DF;QM;VAG

Age 26 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM CHRONIC SINUSITIS RHINITIS ALLERGIC NASAL TURBINATE HYPERTROPHY HYPOTENSION ASTHENIA CONJUNCTIVITIS COUGH HAEMORRHOIDS HYPOAESTHESIA NAUSEA

BENEFIBER /01648102/ CLOTRIMAZOLE /00212501/ PREMARIN

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 906 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8551630 Date FDA Received
02-May-2012 Preferred Term PANCREATITIS Case # 8551630 Case Type EXPEDITED (15-DAY) Product NUVARING Case # 8462759 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Health Professional Y Outcomes DE,LT Role Route S VAGINAL Manufacturer Control # 2012SP022064 Dosage Text VAG Manufacturer Control # 2011SP051273 Dosage Text Age 27 YR Duration Sex Female Country USA Age 28 YR Duration Sex Female Country USA

Manufacturer

8462759 Date FDA Received

04-May-2012 Preferred Term

Outcomes HO Role Route S

Manufacturer

PULMONARY EMBOLISM APPENDICITIS CHEST DISCOMFORT CHOLECYSTITIS CHOLELITHIASIS DEEP VEIN THROMBOSIS DEPRESSION DYSPNOEA HEPATIC STEATOSIS HEPATITIS MESENTERIC VEIN THROMBOSIS NAUSEA PREGNANCY WITH CONTRACEPTIVE DEVICE SPLENOMEGALY URINARY TRACT INFECTION WEIGHT DECREASED

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 907 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8547235 Date FDA Received
04-May-2012 Preferred Term WEIGHT INCREASED ABASIA ACNE ALOPECIA DIZZINESS DYSSTASIA FALL VERTIGO Case # 8547235 Case Type DIRECT Product NUVARING Health Professional N Role Route S Dosage Text Outcomes Manufacturer Control # Age 26 YR Duration Sex Female Country USA

Manufacturer

8556358 Date FDA Received

04-May-2012 Preferred Term

Case # 8556358

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes DE Role Route S

Manufacturer Control # 2012SP023090 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

MENTAL STATUS CHANGES ABDOMINAL PAIN PULMONARY EMBOLISM UNRESPONSIVE TO STIMULI

8559658 Date FDA Received

07-May-2012 Preferred Term

Case # 8559658

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes HO Role Route S VAGINAL

Manufacturer Control # 2012SP022345 Dosage Text QM, VAG

Age

Sex Female

Country USA

Duration

Manufacturer

GALLBLADDER DISORDER

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 908 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8342166 Date FDA Received
08-May-2012 Preferred Term PULMONARY EMBOLISM ALOPECIA AMENORRHOEA ANAEMIA ASTHENIA BACK PAIN CHEST PAIN DEEP VEIN THROMBOSIS DEVICE EXPULSION DEVICE FAILURE DRUG DOSE OMISSION DRUG LEVEL BELOW THERAPEUTIC GROIN PAIN MALAISE MUSCLE SPASMS MUSCULOSKELETAL PAIN NAUSEA PAIN PAIN IN EXTREMITY PELVIC INFLAMMATORY DISEASE PLEURISY RENAL PAIN ROAD TRAFFIC ACCIDENT SURGICAL FAILURE URINARY TRACT INFECTION WEIGHT INCREASED Case # 8342166 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO Role Route S Manufacturer Control # 2011SP030598 Dosage Text Age 21 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 909 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8343008 Date FDA Received
08-May-2012 Preferred Term PLEURAL EFFUSION NEPHROLITHIASIS STREPTOCOCCUS TEST POSITIVE UPPER RESPIRATORY TRACT INFECTION Case # 8343008 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO Role Route S Manufacturer Control # 2011SP034943 Dosage Text Age 38 YR Duration Sex Female Country USA

Manufacturer

8261755 Date FDA Received

09-May-2012 Preferred Term

Case # 8261755

Case Type EXPEDITED (15-DAY) Product NUVARING SYNTHROID

Health Professional Y

Outcomes HO,OT Role Route S C

Manufacturer Control # 2011SP019412 Dosage Text

Age 36 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM EPILEPSY AMNESIA BACTERIURIA BLOOD CHOLESTEROL INCREASED BLOOD THYROID STIMULATING HORMONE INCREASED DEAFNESS HEART RATE INCREASED HYPERLIPIDAEMIA IMPAIRED WORK ABILITY LOW DENSITY LIPOPROTEIN INCREASED PARTIAL SEIZURES POST STROKE DEPRESSION THROMBOTIC CEREBRAL INFARCTION

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 910 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8338959 Date FDA Received
10-May-2012 Preferred Term MIGRAINE HEADACHE CORONARY ARTERY DISEASE ACUTE MYOCARDIAL INFARCTION BREAST CALCIFICATIONS BRONCHIOLITIS BUNION OPERATION MATERNAL EXPOSURE BEFORE PREGNANCY PREGNANCY Case # 8338959 Case Type EXPEDITED (15-DAY) Product NUVARING NITROGLYCERIN ELAVIL Health Professional Y Outcomes HO Role Route S S C Manufacturer Control # 2012SP000258 Dosage Text Age 41 YR Duration Sex Female Country USA

Manufacturer

8523222 Date FDA Received

10-May-2012 Preferred Term

Case # 8523222

Case Type EXPEDITED (15-DAY) Product NUVARING BENICAR

Health Professional Y

Outcomes DE,HO,DS,LT Role Route S C VAGINAL

Manufacturer Control # 2012SP018692 Dosage Text 1 DF;VAG

Age 51 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 911 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7281769 Date FDA Received
11-May-2012 Preferred Term PULMONARY EMBOLISM VOMITING CHEST DISCOMFORT ACQUIRED DIAPHRAGMATIC EVENTRATION HEADACHE LUNG INFILTRATION MATERNAL EXPOSURE BEFORE PREGNANCY MIGRAINE MUSCULOSKELETAL PAIN NASAL SEPTUM DEVIATION PLEURAL EFFUSION PREGNANCY PULMONARY INFARCTION TRICUSPID VALVE INCOMPETENCE UPPER RESPIRATORY TRACT INFECTION Case # 7281769 Case Type EXPEDITED (15-DAY) Product NUVARING LORTAB CEFZIL Health Professional Y Outcomes HO,OT Role Route S C C VAGINAL Manufacturer Control # 2008-187739-NL Dosage Text VAG Age 21 YR Duration Sex Female Country USA

Manufacturer

8192244 Date FDA Received

11-May-2012 Preferred Term

Case # 8192244

Case Type EXPEDITED (15-DAY) Product NUVARING LEXAPRO REGLAN COUMADIN

Health Professional Y

Outcomes HO,DS,OT Role Route S S S S

Manufacturer Control # 2010SP063654 Dosage Text

Age 36 YR Duration

Sex Female

Country USA

Manufacturer

TREATMENT NONCOMPLIANCE DYSURIA MICTURITION URGENCY PULMONARY EMBOLISM ABDOMINAL DISTENSION ACCIDENT AT WORK ACUTE SINUSITIS ADNEXA UTERI MASS ANGER APATHY

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 912 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8192244
Preferred Term ARTHRALGIA ARTHRITIS ASTHENIA BACK PAIN BIPOLAR DISORDER BLOOD 1,25-DIHYDROXYCHOLECALCIFEROL DECREASED BLOOD HOMOCYSTEINE INCREASED BRADYKINESIA BRUXISM CENTRAL NERVOUS SYSTEM LESION CEREBELLAR HAEMORRHAGE CHEST DISCOMFORT CONSTIPATION DIPLOPIA DIZZINESS DRUG INEFFECTIVE DRUG INTOLERANCE DRY EYE DYSGEUSIA DYSMENORRHOEA DYSPNOEA EPSTEIN-BARR VIRUS INFECTION EYE INJURY EYE PAIN FATIGUE FEELING JITTERY FIBROMYALGIA FLATULENCE FOLATE DEFICIENCY GASTRITIS Product Role Route Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 913 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8192244
Preferred Term GENITAL DISCHARGE HEADACHE HERPES DERMATITIS HOT FLUSH HYPERCOAGULATION HYPERHIDROSIS HYPERSENSITIVITY HYPOTENSION IMPAIRED WORK ABILITY INFECTIOUS MONONUCLEOSIS INFLUENZA LIKE ILLNESS INSOMNIA INTERNATIONAL NORMALISED RATIO DECREASED INTERNATIONAL NORMALISED RATIO INCREASED IRITIS IRON DEFICIENCY ANAEMIA IRRITABLE BOWEL SYNDROME JOINT SWELLING LABYRINTHITIS LISTLESS LOSS OF LIBIDO LOWER RESPIRATORY TRACT INFECTION VIRAL LYMPHADENOPATHY LYMPHOEDEMA MAJOR DEPRESSION MALAISE MASTOPTOSIS MEMORY IMPAIRMENT MENIERE'S DISEASE Product Role Route Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 914 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8192244
Preferred Term MENORRHAGIA METRORRHAGIA MIGRAINE MIGRAINE WITH AURA MOOD SWINGS MULTIPLE INJURIES MUSCLE SPASMS MUSCLE STRAIN MUSCULOSKELETAL CHEST PAIN MYOSITIS NAUSEA NECK PAIN NIGHTMARE OEDEMA PERIPHERAL ONYCHOCLASIS OSTEOARTHRITIS OVARIAN CYST PAIN PAIN IN EXTREMITY PARAESTHESIA PELVIC PAIN PHARYNGITIS POLLAKIURIA PREMENSTRUAL SYNDROME PROCTALGIA PROTEIN C DECREASED RASH SEDATION SLEEP APNOEA SYNDROME SLEEP DISORDER SNORING Product Role Route Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 915 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8192244
Preferred Term SOMNOLENCE SUICIDAL IDEATION SYSTEMIC LUPUS ERYTHEMATOSUS TENSION HEADACHE THROMBOSIS TINNITUS TRICUSPID VALVE INCOMPETENCE URINARY TRACT INFECTION UTERINE LEIOMYOMA VAGINITIS BACTERIAL VERTIGO POSITIONAL VIRAL INFECTION VITAMIN B12 DEFICIENCY VITAMIN D DEFICIENCY VOMITING VULVOVAGINAL MYCOTIC INFECTION WEIGHT DECREASED WEIGHT INCREASED Product Role Route Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 916 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8495508 Date FDA Received
14-May-2012 Preferred Term VOMITING BLOOD TRIGLYCERIDES INCREASED DRUG-INDUCED LIVER INJURY FATIGUE LEUKOCYTOSIS LOW DENSITY LIPOPROTEIN INCREASED MIGRAINE POLYCYTHAEMIA TRANSAMINASES INCREASED WEIGHT DECREASED Case # 8495508 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes OT Role Route S Manufacturer Control # 2012SP014866 Dosage Text Age 23 YR Duration Sex Female Country FRA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 917 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8567123 Date FDA Received
14-May-2012 Preferred Term COUGH CHEST DISCOMFORT CHILLS DIZZINESS DYSPNOEA FALL FEELING ABNORMAL FEELING COLD FEELING HOT HEADACHE HYPERHIDROSIS HYPOAESTHESIA PAIN IN EXTREMITY SKIN IRRITATION THROAT IRRITATION URTICARIA Case # 8567123 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional N Outcomes HO Role Route S Manufacturer Control # 2012SP024229 Dosage Text ;QM; Age 24 YR Duration Sex Female Country USA

Manufacturer

7612367 Date FDA Received

16-May-2012 Preferred Term CHEST PAIN DIZZINESS

Case # 7612367

Case Type EXPEDITED (15-DAY) Product NUVARING ALBUTEROL FLOVENT

Health Professional Y

Outcomes HO,OT Role Route S C C C VAGINAL

Manufacturer Control # 2010SP005950 Dosage Text ;VAG

Age 30 YR Duration

Sex Female

Country USA

Manufacturer

BLOOD GLUCOSE DECREASED POST GASTRIC SURGERY SYNDROME ABNORMAL LOSS OF WEIGHT ARTHRALGIA BACK PAIN CARDIAC MURMUR

METOPROLOL TARTRATE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 918 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7612367
Preferred Term CHEST DISCOMFORT CONDITION AGGRAVATED COSTOCHONDRITIS DEEP VEIN THROMBOSIS DYSMENORRHOEA DYSPHAGIA DYSPNOEA EYE SWELLING FALL FIBRIN D DIMER INCREASED GAIT DISTURBANCE GASTROINTESTINAL DISORDER GASTROOESOPHAGEAL REFLUX DISEASE HYPERTENSION HYPOAESTHESIA INTERNATIONAL NORMALISED RATIO DECREASED IRON DEFICIENCY ANAEMIA LOSS OF CONSCIOUSNESS LOSS OF EMPLOYMENT MICROCYTIC ANAEMIA MUSCULOSKELETAL CHEST PAIN PAIN IN JAW PANIC ATTACK PERICARDITIS PERNICIOUS ANAEMIA PLATELET COUNT INCREASED PULMONARY EMBOLISM REFUSAL OF TREATMENT BY PATIENT SCOLIOSIS SPINAL OSTEOARTHRITIS Product Role Route Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 919 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7612367
Preferred Term STRESS THROMBOSIS VARICOSE VEIN VENOUS INSUFFICIENCY VITAMIN D DEFICIENCY Product Role Route Dosage Text Duration Manufacturer

8397839 Date FDA Received

16-May-2012 Preferred Term PAIN IN EXTREMITY ALLODYNIA DRUG INEFFECTIVE HYPERAESTHESIA MALAISE POLYNEUROPATHY

Case # 8397839

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO Role Route S

Manufacturer Control # 2012SP003615 Dosage Text 1 DF;QD

Age 34 YR Duration

Sex Female

Country FRA

Manufacturer

8596129 Date FDA Received

16-May-2012 Preferred Term

Case # 8596129

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO,DS Role Route S

Manufacturer Control # 2012SP024606 Dosage Text

Age 30 YR Duration

Sex Female

Country DNK

Manufacturer

PULMONARY EMBOLISM THROMBOSIS VON WILLEBRAND'S FACTOR ACTIVITY INCREASED

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 920 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8596286 Date FDA Received
16-May-2012 Preferred Term ENCEPHALITIS HEMIPLEGIA Case # 8596286 Case Type EXPEDITED (15-DAY) Product NUVARING AZATHIOPRINE ESCITALOPRAM OXALATE PREDNISONE Health Professional N Outcomes HO,OT Role Route S C C C Outcomes HO,OT Role Route S C C C C C C C C VAGINAL Manufacturer Control # 2009SP016958 Dosage Text QM;VAG Age 39 YR Duration Sex Female Country USA VAGINAL Manufacturer Control # 2012SP024355 Dosage Text VAG ; VAG Age 26 YR Duration Sex Female Country DEU

Manufacturer

7116103 Date FDA Received

17-May-2012 Preferred Term

Case # 7116103

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Manufacturer

PULMONARY EMBOLISM PRESYNCOPE DEEP VEIN THROMBOSIS CHEST DISCOMFORT TRICUSPID VALVE INCOMPETENCE LEFT VENTRICULAR HYPERTROPHY MITRAL VALVE INCOMPETENCE PULMONARY VALVE INCOMPETENCE ADNEXA UTERI CYST CERVICAL DYSPLASIA CHOLELITHIASIS DILATATION VENTRICULAR DYSFUNCTIONAL UTERINE BLEEDING ENDOMETRIAL HYPERPLASIA HEPATIC STEATOSIS LUNG NEOPLASM RENAL CYST SALPINGITIS VENTRICULAR HYPOKINESIA

ATACAND HCT METHOTREXATE FOLIC ACID PREDNISONE DYAZIDE CEFADROZIL CLOTRIMAZOLE CLARINEX

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 921 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8341616 Date FDA Received
17-May-2012 Preferred Term PULMONARY EMBOLISM DEEP VEIN THROMBOSIS MULTIPLE INJURIES THROMBOSIS LOSS OF CONSCIOUSNESS ABORTION SPONTANEOUS AMENORRHOEA ARTHRALGIA ASTHMA BACTERIAL TEST POSITIVE GESTATIONAL DIABETES HAEMOGLOBIN DECREASED HYPERCOAGULATION HYPERTENSION HYPOKALAEMIA INTERNATIONAL NORMALISED RATIO INCREASED LEUKOCYTOSIS LYMPHADENOPATHY MATERNAL EXPOSURE BEFORE PREGNANCY MUSCLE SPASMS NERVE COMPRESSION PRE-ECLAMPSIA PREGNANCY RASH TREATMENT NONCOMPLIANCE URINARY TRACT INFECTION URTICARIA Case # 8341616 Case Type EXPEDITED (15-DAY) Product NUVARING NITROFURANTOIN PHENAZOPYRIDINE HYDROCHLORIDE MEDROL ALBUTEROL Health Professional Y Outcomes HO,DS Role Route S S S S C Manufacturer Control # 2011SP033361 Dosage Text Age 24 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 922 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7102937 Date FDA Received
21-May-2012 Preferred Term HEADACHE EMOTIONAL DISORDER ASTHENIA BRAIN HERNIATION DIZZINESS HYPOAESTHESIA NAUSEA OEDEMA PARAESTHESIA PHOTOPHOBIA SPEECH DISORDER SUBDURAL HAEMORRHAGE TRANSVERSE SINUS THROMBOSIS VOMITING Case # 7102937 Case Type EXPEDITED (15-DAY) Product NUVARING NEXIUM Health Professional Y Outcomes HO Role Route S C Manufacturer Control # 2009-190267-NL Dosage Text Age 31 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 923 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7107776 Date FDA Received
21-May-2012 Preferred Term PULMONARY EMBOLISM DEEP VEIN THROMBOSIS PAIN IN EXTREMITY CHILLS ABORTION INDUCED ADENOMYOSIS ALANINE AMINOTRANSFERASE INCREASED ASPARTATE AMINOTRANSFERASE INCREASED CONSTIPATION LOSS OF CONSCIOUSNESS LYMPHADENOPATHY MENSTRUATION IRREGULAR NAUSEA ORTHOSTATIC HYPOTENSION OVARIAN CYST URINARY TRACT INFECTION UTERINE LEIOMYOMA Case # 7107776 Case Type EXPEDITED (15-DAY) Product NUVARING UNSPECIFIED INGREDIENT DEPO-PROVERA IBUPROFEN Health Professional Y Outcomes HO,OT Role Route S S S C VAGINAL Manufacturer Control # 2006-150706-NL Dosage Text 1 DF, VAG Age 26 YR Duration Sex Female Country USA

Manufacturer

7885427 Date FDA Received

21-May-2012

Case # 7885427

Case Type EXPEDITED (15-DAY)

Health Professional Y

Outcomes HO,OT

Manufacturer Control # 2010SP062564

Age 28 YR

Sex Female

Country USA

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 924 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7885427
Preferred Term DEEP VEIN THROMBOSIS ABDOMINAL PAIN LOWER ANXIETY BRONCHITIS COGNITIVE DISORDER DERMATITIS CONTACT DERMOID CYST EMOTIONAL DISORDER HYPERHIDROSIS HYPOAESTHESIA HYPOTHYROIDISM IRRITABLE BOWEL SYNDROME LABORATORY TEST ABNORMAL MEMORY IMPAIRMENT MENTAL DISORDER MIGRAINE MUSCLE TWITCHING OSTEOARTHRITIS OTITIS MEDIA OVARIAN CYST PNEUMONIA PULMONARY EMBOLISM SINUSITIS SINUS TACHYCARDIA SLEEP APNOEA SYNDROME SUICIDAL IDEATION TENSION HEADACHE TINEA PEDIS UTERINE ENLARGEMENT UTERINE LEIOMYOMA VERTIGO Product NUVARING Role Route S Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 925 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8276051 Date FDA Received
21-May-2012 Preferred Term PULMONARY EMBOLISM MEDICAL DEVICE COMPLICATION PRE-ECLAMPSIA ABORTION MISSED ABORTION SPONTANEOUS ABORTION THREATENED ATELECTASIS CHEST PAIN CONSTIPATION DEEP VEIN THROMBOSIS DIZZINESS ECTOPIC PREGNANCY FIBRIN D DIMER INCREASED HAEMATOCRIT DECREASED HAEMOGLOBIN DECREASED MATERNAL EXPOSURE DURING PREGNANCY NAUSEA PAIN PARAESTHESIA PLEURAL EFFUSION PLEURISY PNEUMONIA POSTPARTUM DISORDER PREGNANCY WITH CONTRACEPTIVE DEVICE PYELONEPHRITIS RENAL COLIC THROMBOSIS URINARY TRACT INFECTION VULVOVAGINAL PAIN Case # 8276051 Case Type EXPEDITED (15-DAY) Product NUVARING SEROQUEL AMBIEN Health Professional Y Outcomes HO,OT Role Route S C C Manufacturer Control # 2011SP019410 Dosage Text Age 26 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 926 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7912458 Date FDA Received
22-May-2012 Preferred Term PULMONARY EMBOLISM HYPERTENSION ABDOMINAL PAIN ABDOMINAL PAIN UPPER ABORTION INDUCED APPENDICITIS BRONCHITIS CARDIO-RESPIRATORY ARREST CERVICITIS TRICHOMONAL CIRCULATORY COLLAPSE DEEP VEIN THROMBOSIS DERMATITIS GOITRE HEART RATE IRREGULAR HYPERCOAGULATION MATERNAL EXPOSURE DURING PREGNANCY NEPHROLITHIASIS PELVIC PAIN PHARYNGITIS PREGNANCY PULSE ABSENT PULSELESS ELECTRICAL ACTIVITY RESPIRATORY TRACT INFECTION UTERINE LEIOMYOMA Case # 7912458 Case Type EXPEDITED (15-DAY) Product NUVARING CINNAMON TABLET Health Professional Y Outcomes DE Role Route S C Manufacturer Control # 2011SP013905 Dosage Text Age 34 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 927 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8587738 Date FDA Received
23-May-2012 Preferred Term ABORTION SPONTANEOUS INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION MATERNAL EXPOSURE DURING PREGNANCY UNINTENDED PREGNANCY Case # 8587738 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional N Outcomes OT Role Route S VAGINAL Manufacturer Control # 2012SP025269 Dosage Text VAG Age 28 YR Duration Sex Female Country NLD

Manufacturer

8588742 Date FDA Received

23-May-2012 Preferred Term

Case # 8588742

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S VAGINAL

Manufacturer Control # 2012SP025972 Dosage Text VAG

Age

Sex Female

Country USA

Duration

Manufacturer

ABORTION SPONTANEOUS PREGNANCY WITH CONTRACEPTIVE DEVICE

8213874 Date FDA Received

24-May-2012 Preferred Term

Case # 8213874

Case Type EXPEDITED (15-DAY) Product NUVARING NUVARING NUVARING

Health Professional Y

Outcomes HO,DS Role Route S S S

Manufacturer Control # 2011SP048232 Dosage Text

Age 32 YR Duration

Sex Female

Country USA

Manufacturer

ACUTE MYOCARDIAL INFARCTION INTRACARDIAC THROMBUS IMPAIRED WORK ABILITY CARDIAC FAILURE CARDIAC FAILURE CONGESTIVE CONGESTIVE CARDIOMYOPATHY DRUG HYPERSENSITIVITY HYPERLIPIDAEMIA HYPERTENSION HYPOKALAEMIA OBESITY SLEEP APNOEA SYNDROME

7886052
Date - Time: 02-04-2013 9:43:10 AM EST Note: If the field is blank, there is no data Page: 928 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7886052
FDA Received Date 29-May-2012 Preferred Term ORTHOSTATIC HYPOTENSION PRESYNCOPE ABDOMINAL DISCOMFORT ACCIDENT AT WORK ALOPECIA AMNESIA ANAEMIA ANAPHYLACTIC SHOCK ANXIETY ARTHRALGIA ASTHMA AUTONOMIC NERVOUS SYSTEM IMBALANCE BACK INJURY BACK PAIN BLOOD PRESSURE SYSTOLIC INCREASED BREAST CYST BUNION OPERATION CEREBROVASCULAR ACCIDENT COGNITIVE DISORDER DEPRESSION DIARRHOEA DIZZINESS DRUG HYPERSENSITIVITY DRUG INEFFECTIVE DYSPEPSIA EMOTIONAL DISORDER FALL FATIGUE Case # 7886052 Case Type EXPEDITED (15-DAY) Product NUVARING IMIPRAMINE Health Professional Y Outcomes HO,OT Role Route S S Manufacturer Control # 2010SP062574 Dosage Text Age 42 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 929 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7886052
Preferred Term FEAR FEELING HOT GASTROINTESTINAL VIRAL INFECTION HAEMATOCRIT DECREASED HAEMOGLOBIN DECREASED HYPERTENSION HYPOAESTHESIA IMPAIRED WORK ABILITY INTERVERTEBRAL DISC DEGENERATION LIGAMENT SPRAIN LIPIDS INCREASED LIPOSUCTION LOSS OF CONSCIOUSNESS MENTAL DISORDER MIGRAINE MITRAL VALVE INCOMPETENCE MULTIPLE INJURIES MUSCULOSKELETAL PAIN NAUSEA NECK PAIN NEUROLOGICAL SYMPTOM PAIN OF SKIN PALPITATIONS RED BLOOD CELL SEDIMENTATION RATE INCREASED RHEUMATOID FACTOR INCREASED SOMNAMBULISM SPINAL VASCULAR DISORDER SYNCOPE TRANSIENT ISCHAEMIC ATTACK TRICUSPID VALVE INCOMPETENCE Product Role Route Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 930 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7886052
Preferred Term UTERINE POLYP VAGINAL DISCHARGE VOMITING WEIGHT INCREASED Product Role Route Dosage Text Duration Manufacturer

8601567 Date FDA Received

29-May-2012 Preferred Term

Case # 8601567

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO Role Route S

Manufacturer Control # 2011SP048209 Dosage Text

Age 26 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM ANAEMIA ATELECTASIS BACK PAIN DEHYDRATION HEART RATE IRREGULAR LEFT VENTRICULAR HYPERTROPHY MUSCLE STRAIN PALPITATIONS PULMONARY INFARCTION SINUS ARRHYTHMIA TACHYCARDIA TRICUSPID VALVE INCOMPETENCE URINARY TRACT INFECTION

8603310 Date FDA Received

29-May-2012 Preferred Term DRUG INTERACTION

Case # 8603310

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO Role Route S S VAGINAL

Manufacturer Control # 2012SP026696 Dosage Text VAG

Age 43 YR Duration

Sex Female

Country DEU

Manufacturer

URINARY TRACT OPERATION METRORRHAGIA

CIPROFLOXACIN

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 931 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8603605 Date FDA Received
30-May-2012 Preferred Term LIBIDO DECREASED Case # 8603605 Case Type DIRECT Product NUVARING Case # 8342451 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Health Professional N Outcomes DS Role Route S Outcomes HO,OT Role Route S Manufacturer Control # 2011SP035860 Dosage Text Age 25 YR Duration Sex Female Country USA Dosage Text Duration Manufacturer Control # Age Sex Female Country USA

Manufacturer

8342451 Date FDA Received

31-May-2012 Preferred Term

Manufacturer

PULMONARY EMBOLISM ANTICOAGULATION DRUG LEVEL BELOW THERAPEUTIC CHOLELITHIASIS CONSTIPATION DEEP VEIN THROMBOSIS LEUKOCYTOSIS

8588170 Date FDA Received

31-May-2012 Preferred Term

Case # 8588170

Case Type NON-EXPEDITED Product

Health Professional N

Outcomes

Manufacturer Control # US-TEVA-340332USA

Age 27 YR Duration

Sex Female

Country USA

Role Route S S C C C Outcomes HO,DS Role Route S ORAL VAGINAL

Dosage Text 1.5 Milligram;

Manufacturer DURAMED

MENSTRUATION IRREGULAR PREGNANCY

PLAN B ONE-STEP NUVARING PROZAC EFFEXOR PROPRANOLOL

8588851 Date FDA Received

31-May-2012 Preferred Term

Case # 8588851

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Manufacturer Control # 2012SP000252 Dosage Text

Age 25 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM ADRENAL DISORDER AMENORRHOEA

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 932 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8588851
Preferred Term ANAL FISSURE ANTINUCLEAR ANTIBODY POSITIVE ASTHMA BRONCHITIS CHOLECYSTITIS CHRONIC CLOSTRIDIUM DIFFICILE COLITIS COLITIS COLONIC POLYP CONSTIPATION FALL FOCAL NODULAR HYPERPLASIA GASTROINTESTINAL DISORDER GASTROINTESTINAL HAEMORRHAGE HAEMORRHOIDS HISTOPLASMOSIS IMPAIRED WORK ABILITY INFECTIOUS MONONUCLEOSIS KIDNEY INFECTION METASTASES TO LIVER MIGRAINE OEDEMA PERIPHERAL OESOPHAGEAL ULCER OVARIAN CYST PRESYNCOPE PULMONARY INFARCTION PYELONEPHRITIS SCIATICA SEASONAL ALLERGY SMEAR CERVIX ABNORMAL UPPER RESPIRATORY TRACT INFECTION Product Role Route Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 933 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7953275 Date FDA Received
01-Jun-2012 Preferred Term PULMONARY EMBOLISM ADNEXA UTERI CYST ANXIETY BRADYCARDIA DEEP VEIN THROMBOSIS DEVICE DISLOCATION EXERCISE TOLERANCE DECREASED LOCALISED INTRAABDOMINAL FLUID COLLECTION MENORRHAGIA MUSCLE SPASMS NAUSEA PLEURITIC PAIN PULMONARY INFARCTION TACHYCARDIA VENOUS STENOSIS Case # 7953275 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO,DS Role Route S Manufacturer Control # 2010SP058340 Dosage Text Age 28 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 934 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7063334 Date FDA Received
04-Jun-2012 Preferred Term ARRHYTHMIA DYSPNOEA CHEST PAIN LIVER DISORDER CROHN'S DISEASE MUSCULOSKELETAL PAIN OEDEMA PERIPHERAL PAIN IN EXTREMITY INTERVERTEBRAL DISC DEGENERATION INTERVERTEBRAL DISC PROTRUSION MIGRAINE PALPITATIONS OROPHARYNGEAL PAIN EAR PAIN MULTIPLE ALLERGIES APHONIA DRUG INEFFECTIVE HEPATIC STEATOSIS LARYNGITIS MUSCLE SPASMS NAUSEA NECK PAIN PAIN POST-TRAUMATIC PAIN VOMITING Case # 7063334 Case Type EXPEDITED (15-DAY) Product NUVARING DROSPIRENONE\ETHINYL ESTRADIOL ACETAMINOPHEN NAPROXEN MAXALT FIORICET AMITRIPTYLINE HYDROCHLORIDE MOMETASONE FUROATE PROPRANOLOL HYDROCHLORIDE SERTRALINE HYDROCHLORIDE AZELASTINE HYDROCHLORIDE ELETRIPTAN HYDROBROMIDE HYDROCODONE BITARTRATE & ACETAMINOPHEN FROVA ERYTHROMYCIN Health Professional Y Outcomes DS,OT Role Route S S C C C C C C C C C C C C C Manufacturer Control # 2009-200158-NL Dosage Text Age 32 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 935 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8629838 Date FDA Received
05-Jun-2012 Preferred Term DEEP VEIN THROMBOSIS GROIN PAIN ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED CYST Heparin-induced thrombocytopenia HYPERCOAGULATION INTERNATIONAL NORMALISED RATIO INCREASED IRON DEFICIENCY ANAEMIA LUNG NEOPLASM MAY-THURNER SYNDROME PHLEBITIS THROMBOCYTOSIS URINARY TRACT INFECTION Case # 8629838 Case Type EXPEDITED (15-DAY) Product NUVARING HEPARIN Health Professional Y Outcomes HO Role Route S S Manufacturer Control # 2011SP050833 Dosage Text Age 23 YR Duration Sex Female Country USA

Manufacturer

8632029 Date FDA Received

06-Jun-2012 Preferred Term ECTOPIC PREGNANCY

Case # 8632029

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO Role Route S

Manufacturer Control # 2012SP029526 Dosage Text ;QM;

Age 43 YR Duration

Sex Female

Country ISR

Manufacturer

MATERNAL EXPOSURE DURING PREGNANCY PREGNANCY WITH CONTRACEPTIVE DEVICE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 936 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7583730 Date FDA Received
07-Jun-2012 Preferred Term PULMONARY EMBOLISM FALL HEAD INJURY CEREBRAL THROMBOSIS SUBDURAL HAEMATOMA Case # 7583730 Case Type EXPEDITED (15-DAY) Product NUVARING AVONEX LISINOPRIL VITAMIN D CALCIUM Case Type EXPEDITED (15-DAY) Product IMPLANON NUVARING IRON PROAIR HFA MULTIPLE VITAMINS ASCORBIC ACID MINERALS NOS Health Professional Y Health Professional Y Outcomes HO,LT,OT Role Route S C C C C Outcomes HO Role Route S S C C C C C SUBDERMAL VAGINAL Manufacturer Control # 2012SP019550 Dosage Text SBDE VAG Age 22 YR Duration Sex Female Country USA VAGINAL Manufacturer Control # 2010SP041567 Dosage Text ;VAG Age 51 YR Duration Sex Female Country USA

Manufacturer

8628751 Date FDA Received

07-Jun-2012 Preferred Term MENORRHAGIA THROMBOSIS

Case # 8628751

Manufacturer

DYSFUNCTIONAL UTERINE BLEEDING POLYP HYPERPLASIA NEOPLASM MALIGNANT UTERINE LEIOMYOMA DYSMENORRHOEA MENSTRUATION IRREGULAR METRORRHAGIA VAGINAL HAEMORRHAGE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 937 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7746521 Date FDA Received
08-Jun-2012 Preferred Term MULTIPLE INJURIES BLOOD CHOLESTEROL INCREASED CEREBRAL THROMBOSIS CEREBROVASCULAR ACCIDENT CHOLECYSTITIS CHRONIC CONDITION AGGRAVATED GASTROOESOPHAGEAL REFLUX DISEASE HYPERCOAGULATION HYPERLIPIDAEMIA MATERNAL EXPOSURE BEFORE PREGNANCY METRORRHAGIA PREGNANCY SUBSTANCE USE UMBILICAL HERNIA Case # 7746521 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO,OT Role Route S Manufacturer Control # 2010SP038548 Dosage Text Age 28 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 938 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8211515 Date FDA Received
08-Jun-2012 Preferred Term CEREBROVASCULAR ACCIDENT CEREBRAL INFARCTION ABDOMINAL PAIN LOWER ABORTION SPONTANEOUS CONVULSION DIABETES MELLITUS DISORIENTATION DIZZINESS FALL HYPERTENSION INGROWING NAIL INTRACRANIAL ANEURYSM LOSS OF CONSCIOUSNESS MATERNAL EXPOSURE DURING PREGNANCY MENTAL DISORDER MYALGIA PAIN IN EXTREMITY SPEECH DISORDER THROMBOSIS TONGUE BITING Case # 8211515 Case Type EXPEDITED (15-DAY) Product NUVARING NUVARING Health Professional Y Outcomes HO,OT Role Route S S Manufacturer Control # 2011SP030611 Dosage Text Age 30 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 939 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8629442 Date FDA Received
08-Jun-2012 Preferred Term PULMONARY EMBOLISM DEEP VEIN THROMBOSIS BLOOD CHOLESTEROL INCREASED ANXIETY MENTAL DISORDER EMOTIONAL DISORDER ARTHRITIS BEDRIDDEN CARDIOMEGALY DIABETES MELLITUS EAR PAIN FATIGUE LOWER RESPIRATORY TRACT INFECTION LUNG NEOPLASM PNEUMONIA PNEUMONITIS RENAL FAILURE ACUTE SINUS TACHYCARDIA SNORING SUBSTANCE USE Case # 8629442 Case Type EXPEDITED (15-DAY) Product NUVARING NUVARING NUVARING ALEVE HUMIRA LASIX Health Professional Y Outcomes HO Role Route S S S C C C VAGINAL Manufacturer Control # 2012SP014011 Dosage Text VAG Age 41 YR Duration Sex Female Country USA

Manufacturer

8627777 Date FDA Received

11-Jun-2012 Preferred Term

Case # 8627777

Case Type DIRECT Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control #

Age 18 YR

Sex Female

Country USA

Dosage Text

Duration

Manufacturer

URINARY TRACT INFECTION AMENORRHOEA

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 940 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8630425 Date FDA Received
11-Jun-2012 Preferred Term PALPITATIONS RESPIRATORY DISORDER DEEP VEIN THROMBOSIS PULMONARY EMBOLISM MYOCARDIAL INFARCTION Case # 8630425 Case Type DIRECT Product TOPAMAX NUVARING LOVENOX COUMADIN WARFARIN SODIUM Case Type EXPEDITED (15-DAY) Product NUVARING PIROXICAM Health Professional Y Health Professional N Outcomes HO,LT Role Route S S C C C Outcomes HO,OT Role Route S C Manufacturer Control # 2012SP009068 Dosage Text Age 42 YR Duration Sex Female Country BEL ORAL VAGINAL Dosage Text TOPAMAX 125MG PER PAY PO NUVARING KEPT ON FOR 3 WKS VAG Manufacturer Control # Age 33 YR Duration 3 MTH 6 WEEK Sex Female Country USA

Manufacturer

8445461 Date FDA Received

12-Jun-2012 Preferred Term

Case # 8445461

Manufacturer

VAGINAL INFLAMMATION SEPTIC SHOCK ABDOMINAL PAIN UPPER ASCITES BACK PAIN DISSEMINATED INTRAVASCULAR COAGULATION PAIN IN EXTREMITY STREPTOCOCCAL SEPSIS UROSEPSIS

8635179 Date FDA Received

12-Jun-2012 Preferred Term

Case # 8635179

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO Role Route S TRANSPLACENTAL

Manufacturer Control # 2012SP029818 Dosage Text TRPL

Age

Sex Female

Country FRA

Duration

Manufacturer

PREGNANCY WITH CONTRACEPTIVE DEVICE ANAEMIA NEONATAL MATERNAL DRUGS AFFECTING FOETUS

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 941 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8636770 Date FDA Received
12-Jun-2012 Preferred Term UNINTENDED PREGNANCY ABORTION HORMONE LEVEL ABNORMAL MATERNAL EXPOSURE DURING PREGNANCY PREGNANCY WITH CONTRACEPTIVE DEVICE Case # 8636770 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes OT Role Route S VAGINAL Manufacturer Control # 2012SP030965 Dosage Text QM; VAG Duration Age Sex Female Country CHL

Manufacturer

8614133 Date FDA Received

14-Jun-2012

Case # 8614133

Case Type EXPEDITED (15-DAY)

Health Professional Y

Outcomes OT

Manufacturer Control # US-PFIZER INC-2012140659 Dosage Text UNK UNK

Age 25 YR

Sex Female

Country USA

Preferred Term GRAND MAL CONVULSION DEJA VU PANIC DISORDER HYPERHIDROSIS NAUSEA

Product EFFEXOR XR EFFEXOR XR NUVARING

Role Route S S S ORAL

Duration

Manufacturer PFIZER PFIZER

8633584 Date FDA Received

14-Jun-2012 Preferred Term

Case # 8633584

Case Type DIRECT Product NUVARING

Health Professional Y

Outcomes OT Role Route S VAGINAL

Manufacturer Control #

Age 27 YR

Sex Female

Country USA

Dosage Text 1RING 3 WEEKS OF 4 VAG

Duration 6 MTH

Manufacturer ORGANON

PREGNANCY WITH CONTRACEPTIVE DEVICE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 942 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8638695 Date FDA Received
14-Jun-2012 Preferred Term PULMONARY EMBOLISM CARDIAC DISORDER DEEP VEIN THROMBOSIS DILATATION VENTRICULAR GLYCOSYLATED HAEMOGLOBIN INCREASED HYPERTENSION LEFT VENTRICULAR HYPERTROPHY PALPITATIONS PULMONARY INFARCTION TACHYCARDIA TRICUSPID VALVE INCOMPETENCE Case # 8638695 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO Role Route S Manufacturer Control # 2012SP053027 Dosage Text Age 42 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 943 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7284787 Date FDA Received
15-Jun-2012 Preferred Term DEEP VEIN THROMBOSIS PULMONARY EMBOLISM FALL ANKLE FRACTURE ATTENTION DEFICIT/HYPERACTIVITY DISORDER CONTUSION DEPRESSION DYSPEPSIA FATIGUE GASTROOESOPHAGEAL REFLUX DISEASE HEADACHE HYPERCOAGULATION INTERNATIONAL NORMALISED RATIO DECREASED INTERNATIONAL NORMALISED RATIO INCREASED LOWER LIMB FRACTURE PAIN PROTHROMBIN TIME PROLONGED PULMONARY HYPERTENSION SYNCOPE TACHYCARDIA TRANSAMINASES INCREASED WEIGHT INCREASED Case # 7284787 Case Type EXPEDITED (15-DAY) Product NUVARING TYLENOL PM CALCIUM Health Professional Y Outcomes HO,LT Role Route S C C VAGINAL Manufacturer Control # 2009-198388-NL Dosage Text QM;VAG Age 29 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 944 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8643662 Date FDA Received
15-Jun-2012 Preferred Term SENSORY DISTURBANCE DISORIENTATION FACIAL PARESIS Case # 8643662 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes OT Role Route S VAGINAL Manufacturer Control # 2012SP031359 Dosage Text VAG Duration Age Sex Female Country DEU

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 945 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7329594 Date FDA Received
18-Jun-2012 Preferred Term CEREBRAL HAEMORRHAGE CEREBRAL VENOUS THROMBOSIS PAIN ASTHMA GRAND MAL CONVULSION APHASIA BALANCE DISORDER CEREBRAL INFARCTION CHOKING DYSKINESIA GRANULOMA HEARING IMPAIRED HYPERCOAGULATION LARYNGEAL STENOSIS MIGRAINE MUSCLE TWITCHING PNEUMONIA PNEUMONIA ASPIRATION SPINAL OSTEOARTHRITIS TRANSVERSE SINUS THROMBOSIS VISION BLURRED VISUAL ACUITY REDUCED VOCAL CORD DISORDER VOCAL CORD PARALYSIS Case # 7329594 Case Type EXPEDITED (15-DAY) Product NUVARING VALTREX TRAMADOL A/APAP VENTOLIN FIORICET Health Professional Y Outcomes HO,DS,OT Role Route S C C C C VAGINAL Manufacturer Control # 2010SP006325 Dosage Text VAG Age 29 YR Duration Sex Female Country USA

Manufacturer

8341519 Date FDA Received

18-Jun-2012 Preferred Term ISCHAEMIC STROKE

Case # 8341519

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO,DS Role Route S

Manufacturer Control # 2011SP016567 Dosage Text

Age 39 YR Duration

Sex Female

Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 946 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8341519
Preferred Term HAEMORRHAGIC STROKE STRESS ANHEDONIA ANXIETY BREAST DISCHARGE BREAST FIBROSIS BREAST MASS BREAST PAIN BREAST TENDERNESS CALCULUS URETERIC CAROTID ARTERY DISSECTION CAROTID ARTERY OCCLUSION CEREBRAL ARTERY THROMBOSIS CEREBRAL INFARCTION DEPRESSION DYSFUNCTIONAL UTERINE BLEEDING EMOTIONAL DISORDER FEAR OF DISEASE HORMONE LEVEL ABNORMAL HYDRONEPHROSIS IMPAIRED WORK ABILITY MENORRHAGIA MENTAL DISORDER MUSCULOSKELETAL PAIN MYALGIA NAUSEA NECK PAIN ORAL CANDIDIASIS RENAL CYST VAGINAL HAEMORRHAGE WITHDRAWAL BLEED Product SYNTHROID MULTI-VITAMIN Role Route C C Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 947 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8657702 Date FDA Received
18-Jun-2012 Preferred Term PULMONARY EMBOLISM CARDIAC FAILURE CONGESTIVE Case # 8657702 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional N Outcomes HO Role Route S Manufacturer Control # 2012SP032595 Dosage Text Age 42 YR Duration Sex Female Country USA

Manufacturer

7806050 Date FDA Received

19-Jun-2012 Preferred Term

Case # 7806050

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO Role Route S

Manufacturer Control # 2010SP019827 Dosage Text

Age 42 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM DIZZINESS MENORRHAGIA MIGRAINE MULTIPLE INJURIES STRESS URINARY INCONTINENCE UTERINE LEIOMYOMA

8087528 Date FDA Received

19-Jun-2012 Preferred Term HEADACHE DYSPNOEA

Case # 8087528

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO,DS,OT Role Route S C

Manufacturer Control # 2011SP017557 Dosage Text

Age 31 YR Duration

Sex Female

Country USA

Manufacturer

LEVOTHYROXINE SODIUM

ACTIVITIES OF DAILY LIVING IMPAIRED ANAEMIA ANTICOAGULATION DRUG LEVEL BELOW THERAPEUTIC ANXIETY ARTHRALGIA ATELECTASIS BALANCE DISORDER CELLULITIS CHEST PAIN

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 948 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8087528
Preferred Term CONSTIPATION CONTUSION CRYING DEEP VEIN THROMBOSIS DEPRESSION DRUG SCREEN POSITIVE ENTEROCOCCUS TEST POSITIVE FALL FLANK PAIN GASTROOESOPHAGEAL REFLUX DISEASE HYPERCOAGULATION HYPERSENSITIVITY HYPOKALAEMIA HYPOTHYROIDISM ILIAC VEIN OCCLUSION IMPAIRED WORK ABILITY INJECTION INSOMNIA INTERNATIONAL NORMALISED RATIO DECREASED JOINT INJURY LYMPHADENOPATHY LYMPHOMA MULTIPLE INJURIES OVERDOSE OVERWEIGHT PAIN IN EXTREMITY PANIC ATTACK PLEURAL EFFUSION POST THROMBOTIC SYNDROME PREGNANCY Product Role Route Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 949 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8087528
Preferred Term PRURITUS PULMONARY MASS RASH SCAR SKIN ULCER SLEEP APNOEA SYNDROME SUICIDAL IDEATION TENDERNESS URINARY TRACT INFECTION VARICOSE VEIN VENA CAVA THROMBOSIS VENOUS INSUFFICIENCY WALKING AID USER Product Role Route Dosage Text Duration Manufacturer

7805664 Date FDA Received

21-Jun-2012 Preferred Term DIARRHOEA MENTAL DISORDER

Case # 7805664

Case Type EXPEDITED (15-DAY) Product NUVARING IBPROFEN KELTICAN

Health Professional N

Outcomes HO Role Route S C C

Manufacturer Control # 2010SP060308 Dosage Text

Age 29 YR Duration

Sex Female

Country DEU

Manufacturer

ABDOMINAL PAIN UPPER ECZEMA HEADACHE INTERVERTEBRAL DISC PROTRUSION MENOMETRORRHAGIA MUSCLE DISORDER PSYCHOSOMATIC DISEASE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 950 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7952991 Date FDA Received
22-Jun-2012 Preferred Term MUSCLE TWITCHING HYPOAESTHESIA ASTHENIA BREAST MASS CEREBROVASCULAR ACCIDENT HOT FLUSH HYPOKALAEMIA INSOMNIA MITRAL VALVE INCOMPETENCE MUSCULOSKELETAL DISCOMFORT NAUSEA TRANSIENT ISCHAEMIC ATTACK TRICUSPID VALVE INCOMPETENCE VENTRICULAR HYPERTROPHY Case # 7952991 Case Type EXPEDITED (15-DAY) Product NUVARING NAPROSYN Health Professional Y Outcomes HO,OT Role Route S C VAGINAL Manufacturer Control # 2007-157966-NL Dosage Text 1 DF;;VAG Age 42 YR Duration Sex Female Country USA

Manufacturer

7821311 Date FDA Received

26-Jun-2012 Preferred Term

Case # 7821311

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes OT Role Route S

Manufacturer Control # 2010SP003304 Dosage Text

Age 27 YR Duration

Sex Female

Country USA

Manufacturer

CEREBROVASCULAR ACCIDENT

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 951 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8087584 Date FDA Received
26-Jun-2012 Preferred Term ANTIPHOSPHOLIPID ANTIBODIES POSITIVE APPENDICITIS CAESAREAN SECTION HYPERCOAGULATION LEFT VENTRICULAR DYSFUNCTION LUNG NEOPLASM MITRAL VALVE INCOMPETENCE OVARIAN CYST PREGNANCY PULMONARY EMBOLISM TENDONITIS THROMBOPHLEBITIS TRICUSPID VALVE INCOMPETENCE VAGINITIS BACTERIAL Case # 8087584 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO,OT Role Route S Manufacturer Control # 2011SP016569 Dosage Text Age 21 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 952 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8460988 Date FDA Received
26-Jun-2012 Preferred Term PULMONARY EMBOLISM COAGULOPATHY ACNE AMENORRHOEA ANAEMIA BRONCHITIS CHEST DISCOMFORT CHEST X-RAY ABNORMAL FEELING ABNORMAL FIBRIN D DIMER INCREASED H1N1 INFLUENZA HAEMATEMESIS HAEMATOCHEZIA HAEMORRHOIDAL HAEMORRHAGE HEADACHE HYPERGLYCAEMIA HYPONATRAEMIA INFLUENZA PALPITATIONS PNEUMONIA BACTERIAL SINUSITIS BACTERIAL URTICARIA VITAMIN B12 DEFICIENCY Case # 8460988 Case Type EXPEDITED (15-DAY) Product NUVARING WARFARIN SODIUM Health Professional Y Outcomes HO Role Route S S Manufacturer Control # 2011SP050841 Dosage Text Age 35 YR Duration Sex Female Country USA

Manufacturer

8657471 Date FDA Received

26-Jun-2012 Preferred Term

Case # 8657471

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes DE Role Route S

Manufacturer Control # 2012SP034662 Dosage Text

Age 17 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 953 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7657747 Date FDA Received
03-Jul-2012 Preferred Term PULMONARY EMBOLISM ABDOMINAL PAIN UPPER BRONCHITIS BACTERIAL CHEST PAIN CHOLECYSTECTOMY DECREASED APPETITE DEEP VEIN THROMBOSIS DEPRESSION DRUG EFFECT DECREASED GASTROINTESTINAL DISORDER HAEMOPTYSIS HAEMORRHOIDS MUSCULOSKELETAL CHEST PAIN MYALGIA PAIN PHARYNGITIS VIRAL INFECTION WEIGHT DECREASED Case # 7657747 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes HO,DS,OT Role Route S Manufacturer Control # 2010SP010131 Dosage Text QM Age 25 YR Duration Sex Female Country USA

Manufacturer

7808330 Date FDA Received

03-Jul-2012 Preferred Term

Case # 7808330

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO,OT Role Route S

Manufacturer Control # 2010SP004877 Dosage Text

Age 24 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM ASTHMA ATELECTASIS BACK PAIN BREAST TENDERNESS CHILLS COUGH

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 954 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7808330
Preferred Term CYSTITIS DEEP VEIN THROMBOSIS ECONOMIC PROBLEM FALL GASTROINTESTINAL INFECTION GENITOURINARY TRACT INFECTION HAEMOPTYSIS HILAR LYMPHADENOPATHY INADEQUATE ANALGESIA INTERNATIONAL NORMALISED RATIO DECREASED LIMB INJURY LUNG CONSOLIDATION LUNG INFILTRATION MATERNAL EXPOSURE BEFORE PREGNANCY MENOMETRORRHAGIA MICROCYTIC ANAEMIA MIGRAINE MUSCLE SPASMS MUSCULOSKELETAL PAIN NAUSEA OBESITY OVARIAN CYST PAIN PAIN IN EXTREMITY PAPILLOEDEMA PLEURAL EFFUSION PLEURAL FIBROSIS PREGNANCY PULMONARY OEDEMA SLEEP APNOEA SYNDROME Product Role Route Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 955 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7808330
Preferred Term TINNITUS TREATMENT NONCOMPLIANCE URINARY TRACT INFECTION VAGINITIS BACTERIAL VOMITING VULVOVAGINAL MYCOTIC INFECTION Product Role Route Dosage Text Duration Manufacturer

8224975 Date FDA Received

03-Jul-2012 Preferred Term

Case # 8224975

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes DE,OT Role Route S

Manufacturer Control # 2011SP049341 Dosage Text

Age 31 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM CARDIO-RESPIRATORY ARREST DEEP VEIN THROMBOSIS FALL LOSS OF CONSCIOUSNESS PAIN PULSE ABSENT SINUS TACHYCARDIA

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 956 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8228555 Date FDA Received
03-Jul-2012 Preferred Term INJURY PULMONARY EMBOLISM ABDOMINAL PAIN UPPER ABORTION SPONTANEOUS ANTIPHOSPHOLIPID ANTIBODIES POSITIVE ANXIETY ATELECTASIS BIPOLAR DISORDER BORDERLINE PERSONALITY DISORDER CARDIOLIPIN ANTIBODY POSITIVE DRUG HYPERSENSITIVITY FATIGUE HAEMOGLOBIN DECREASED INCREASED TENDENCY TO BRUISE LUNG NEOPLASM MATERNAL EXPOSURE DURING PREGNANCY MENORRHAGIA MENSTRUATION IRREGULAR PAIN PALPITATIONS PLEURAL EFFUSION PNEUMONIA POSTPARTUM DEPRESSION PREGNANCY PULMONARY INFARCTION ROAD TRAFFIC ACCIDENT Case # 8228555 Case Type EXPEDITED (15-DAY) Product NUVARING PERPHENAZINE Health Professional Y Outcomes HO,OT Role Route S S VAGINAL Manufacturer Control # 2011SP032020 Dosage Text VAG 8 MG TID Age 24 YR Duration Sex Female Country USA

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 957 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8657624 Date FDA Received
03-Jul-2012 Preferred Term ABORTION THREATENED HAEMATOMA MATERNAL EXPOSURE DURING PREGNANCY Case # 8657624 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional Y Outcomes OT Role Route S Manufacturer Control # 2012SP033177 Dosage Text Age 35 YR Duration Sex Female Country ESP

Manufacturer

8672273 Date FDA Received

03-Jul-2012 Preferred Term

Case # 8672273

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes OT Role Route S

Manufacturer Control # 2012SP034968 Dosage Text

Age

Sex Female

Country USA

Duration

Manufacturer

INTRACARDIAC THROMBUS MULTIPLE INJURIES MYOCARDIAL INFARCTION

8672278 Date FDA Received

03-Jul-2012 Preferred Term THROMBOSIS

Case # 8672278

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes DE,HO,LT Role Route S VAGINAL

Manufacturer Control # 2012SP036302 Dosage Text VAG

Age 30 YR Duration

Sex Female

Country USA

Manufacturer

DEEP VEIN THROMBOSIS

8672413 Date FDA Received

03-Jul-2012 Preferred Term

Case # 8672413

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional N

Outcomes HO,OT Role Route S VAGINAL

Manufacturer Control # 2012SP036133 Dosage Text VAG

Age 28 YR Duration

Sex Female

Country USA

Manufacturer

GASTROINTESTINAL DISORDER CERVIX DISORDER DISEASE RECURRENCE FOOD ALLERGY HISTAMINE LEVEL INCREASED PELVIC PAIN THERMAL BURN

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 958 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8672948 Date FDA Received
03-Jul-2012 Preferred Term DEJA VU NAUSEA GRAND MAL CONVULSION HYPERHIDROSIS PANIC REACTION Case # 8672948 Case Type EXPEDITED (15-DAY) Product NUVARING EFFEXOR XR Health Professional Y Outcomes OT Role Route S S ORAL PO : 150 MG; PO Manufacturer Control # 2012SP034661 Dosage Text Age 25 YR Duration Sex Female Country USA

Manufacturer

8479655 Date FDA Received

05-Jul-2012 Preferred Term

Case # 8479655

Case Type EXPEDITED (15-DAY) Product NUVARING

Health Professional Y

Outcomes HO,DS,OT Role Route S

Manufacturer Control # 2011SP056193 Dosage Text

Age 40 YR Duration

Sex Female

Country USA

Manufacturer

PULMONARY EMBOLISM ANXIETY ATELECTASIS ATTENTION DEFICIT/HYPERACTIVITY DISORDER BASAL CELL CARCINOMA DEEP VEIN THROMBOSIS DEHYDRATION DEPRESSION FUNGAL INFECTION HEPATIC STEATOSIS HYPERTENSION HYPOTHYROIDISM MENTAL DISORDER OSTEOARTHRITIS RENAL FAILURE ACUTE VAGINAL INFECTION VULVAL DISORDER

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 959 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8680415 Date FDA Received
05-Jul-2012 Preferred Term PREGNANCY WITH CONTRACEPTIVE DEVICE ABORTION MATERNAL EXPOSURE DURING PREGNANCY Case # 8680415 Case Type EXPEDITED (15-DAY) Product NUVARING Health Professional N Outcomes OT Role Route S VAGINAL Manufacturer Control # 2012SP032387 Dosage Text VAG Age 31 YR Duration Sex Unknown Country BRA

Manufacturer

8667365 Date FDA Received

06-Jul-2012 Preferred Term

Case # 8667365

Case Type DIRECT Product NUVARING

Health Professional N

Outcomes OT Role Route S VAGINAL

Manufacturer Control #

Age 21 YR

Sex Female

Country USA

Dosage Text 1 RING MONTH VAG

Duration

Manufacturer

HEART RATE INCREASED HOT FLUSH HYPERTENSION MENOPAUSAL SYMPTOMS NERVOUSNESS PYREXIA

8657393 Date FDA Received

10-Jul-2012

Case # 8657393

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes OT

Manufacturer Control # DE-009507513-2012SP0 22011 Dosage Text

Age

Sex Unknown

Country DEU

Preferred Term THROMBOSIS

Product NUVARING Case # 8657795 Case Type NON-EXPEDITED Health Professional N

Role Route S Outcomes

Duration

Manufacturer MERCK

8657795 Date FDA Received

10-Jul-2012

Manufacturer Control # US-009507513-1207USA 000274

Age

Sex Unknown

Country USA

Preferred Term DEVICE EXPULSION MEDICAL DEVICE DISCOMFORT

Product NUVARING

Role Route S VAGINAL

Dosage Text UNK

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 960 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8660490 Date FDA Received
11-Jul-2012 Case # 8660490 Case Type NON-EXPEDITED Health Professional Y Outcomes Manufacturer Control # US-009507513-1207USA 001110 Role Route S Health Professional N Outcomes OT Dosage Text UNK Manufacturer Control # US-009507513-1207USA 000930 Dosage Text UNK Manufacturer Control # US-009507513-1207USA 000356 Role Route S C VAGINAL Dosage Text UNK Duration Age Sex Unknown Duration Age Sex Unknown Duration Age Sex Unknown Country USA

Preferred Term MEDICAL DEVICE DISCOMFORT

Product NUVARING Case Type EXPEDITED (15-DAY)

Manufacturer MERCK Country USA

8660729 Date FDA Received

11-Jul-2012

Case # 8660729

Preferred Term CEREBROVASCULAR ACCIDENT

Product NUVARING Case Type NON-EXPEDITED Health Professional N

Role Route S Outcomes

Manufacturer MERCK Country USA

8660754 Date FDA Received

11-Jul-2012

Case # 8660754

Preferred Term PROGESTERONE DECREASED BLOOD OESTROGEN DECREASED BLOOD FOLLICLE STIMULATING HORMONE DECREASED

Product NUVARING CABERGOLINE

Manufacturer MERCK

8660759 Date FDA Received

11-Jul-2012

Case # 8660759

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # US-009507513-1207USA 000933

Age

Sex Unknown

Country USA

Preferred Term DEEP VEIN THROMBOSIS

Product NUVARING

Role Route S

Dosage Text UNK

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 961 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8661393 Date FDA Received
12-Jul-2012 Case # 8661393 Case Type NON-EXPEDITED Health Professional Y Outcomes Manufacturer Control # US-009507513-1207USA 000371 Role Route S VAGINAL Dosage Text UNK Duration 26 DAY Age Sex Unknown Country USA

Preferred Term CHEST PAIN ABDOMINAL PAIN FATIGUE MIGRAINE PAIN IN EXTREMITY PRODUCT QUALITY ISSUE

Product NUVARING

Manufacturer MERCK

8661719 Date FDA Received

12-Jul-2012

Case # 8661719

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes OT

Manufacturer Control # US-009507513-1207USA 000812 Dosage Text UNK Manufacturer Control # SE-009507513-1207SW E000712 Dosage Text

Age

Sex Unknown

Country USA

Preferred Term PULMONARY EMBOLISM

Product NUVARING Case Type EXPEDITED (15-DAY) Health Professional N

Role Route S Outcomes OT

Duration 1.4 YEAR Age Sex

Manufacturer MERCK Country SWE

8663155 Date FDA Received

13-Jul-2012

Case # 8663155

Unknown

Preferred Term ABORTION MATERNAL EXPOSURE DURING PREGNANCY PREGNANCY WITH CONTRACEPTIVE DEVICE UNINTENDED PREGNANCY

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 962 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8663175 Date FDA Received
13-Jul-2012 Case # 8663175 Case Type EXPEDITED (15-DAY) Health Professional Y Outcomes OT Manufacturer Control # CH-009507513-1207CHE 001654 Dosage Text UNK UNK, qm ORAL 30 mg, qd UNK UNK, qw Manufacturer Control # US-009507513-1207USA 002740 Role Route S Health Professional N VAGINAL Dosage Text UNK UNK, Unknown Manufacturer Control # US-009507513-1207USA 002665 Role Route S VAGINAL Dosage Text UNK Duration Age Sex Unknown Duration Age Sex Unknown Country USA Duration Age Sex Unknown Country CHE

Preferred Term WEIGHT INCREASED INCREASED APPETITE DERMATITIS CONTACT

Product NUVARING ALITRETINOIN ALITRETINOIN Case # 8664536 Case Type NON-EXPEDITED Health Professional N

Role Route S S S Outcomes

Manufacturer MERCK

8664536 Date FDA Received

13-Jul-2012

Preferred Term INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION

Product NUVARING Case Type NON-EXPEDITED

Manufacturer MERCK Country USA

8664826 Date FDA Received

13-Jul-2012

Case # 8664826

Outcomes

Preferred Term INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION

Product NUVARING

Manufacturer MERCK

8664970 Date FDA Received

14-Jul-2012

Case # 8664970

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # US-009507513-1207USA 002499

Age

Sex Unknown

Country USA

Preferred Term HYPOAESTHESIA MOOD SWINGS NAUSEA WEIGHT INCREASED

Product NUVARING

Role Route S VAGINAL

Dosage Text UNK, Unknown

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 963 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8665004 Date FDA Received
15-Jul-2012 Case # 8665004 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # US-009507513-1207USA 001377 Role Route S VAGINAL Dosage Text UNK Duration Age Sex Unknown Country USA

Preferred Term INCORRECT DRUG ADMINISTRATION DURATION INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION

Product NUVARING

Manufacturer MERCK

8665051 Date FDA Received

16-Jul-2012

Case # 8665051

Case Type NON-EXPEDITED

Health Professional Y

Outcomes

Manufacturer Control # US-009507513-1207USA 002126

Age

Sex Unknown

Country USA

Preferred Term UNINTENDED PREGNANCY

Product NUVARING Case Type EXPEDITED (15-DAY) Health Professional N

Role Route S VAGINAL

Dosage Text

Duration

Manufacturer MERCK

8667466 Date FDA Received

17-Jul-2012

Case # 8667466

Outcomes OT

Manufacturer Control # US-009507513-2008-186 445-NL Dosage Text CONTINUING: NO

Age

Sex Unknown

Country USA

Preferred Term DEEP VEIN THROMBOSIS MELANOCYTIC NAEVUS POLLAKIURIA

Product NUVARING

Role Route S VAGINAL

Duration 21 DAY

Manufacturer MERCK

8667536 Date FDA Received

17-Jul-2012

Case # 8667536

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes LT

Manufacturer Control # US-009507513-1207USA 003932

Age

Sex Unknown

Country USA

Preferred Term EMBOLISM VENOUS

Product NUVARING

Role Route S VAGINAL

Dosage Text UNK

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 964 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8667548 Date FDA Received
17-Jul-2012 Case # 8667548 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # US-009507513-1207USA 002134 Role Route S C C Health Professional Y Outcomes LT VAGINAL Dosage Text UNK, qm UNK UNK Manufacturer Control # US-009507513-1207USA 003794 Role Route S Health Professional N VAGINAL Dosage Text UNK Manufacturer Control # US-009507513-1207USA 002619 Role Route S Dosage Text 1 DF, UNK Duration Age Sex Unknown Duration Age Sex Unknown Country USA Duration Age Sex Unknown Country USA

Preferred Term METRORRHAGIA

Product NUVARING FLONASE CLARITIN

Manufacturer MERCK

8667594 Date FDA Received

17-Jul-2012

Case # 8667594

Case Type EXPEDITED (15-DAY)

Preferred Term EMBOLISM VENOUS

Product NUVARING Case # 8667620 Case Type NON-EXPEDITED

Manufacturer MERCK Country USA

8667620 Date FDA Received

17-Jul-2012

Outcomes

Preferred Term BACK PAIN ANXIETY BREAST TENDERNESS DYSPNOEA MOOD SWINGS WEIGHT INCREASED

Product NUVARING

Manufacturer MERCK

8667675 Date FDA Received

17-Jul-2012

Case # 8667675

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # US-009507513-1207USA 002635

Age

Sex Unknown

Country USA

Preferred Term DEPRESSION

Product NUVARING

Role Route S VAGINAL

Dosage Text UNK

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 965 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8667958 Date FDA Received
17-Jul-2012 Case # 8667958 Case Type NON-EXPEDITED Health Professional Y Outcomes Manufacturer Control # US-009507513-1207USA 002682 Role Route S Health Professional N VAGINAL Dosage Text 1 DF, UNK Manufacturer Control # US-009507513-1207USA 001344 Role Route S Dosage Text Duration Age Sex Unknown Duration Age Sex Unknown Country USA

Preferred Term PELVIC PAIN

Product NUVARING Case # 8669091 Case Type EXPEDITED (15-DAY)

Manufacturer MERCK Country USA

8669091 Date FDA Received

17-Jul-2012

Outcomes

Preferred Term INCORRECT STORAGE OF DRUG NO ADVERSE EVENT

Product NUVARING

Manufacturer MERCK

8669409 Date FDA Received

17-Jul-2012

Case # 8669409

Case Type NON-EXPEDITED

Health Professional Y

Outcomes

Manufacturer Control # US-009507513-1207USA 002108

Age

Sex Unknown

Country USA

Preferred Term INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION

Product NUVARING Case Type NON-EXPEDITED Health Professional N

Role Route S Outcomes

Dosage Text UNK Manufacturer Control # US-009507513-1207USA 002109

Duration

Manufacturer MERCK

8669410 Date FDA Received

17-Jul-2012

Case # 8669410

Age

Sex Unknown

Country USA

Preferred Term INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION

Product NUVARING

Role Route S VAGINAL

Dosage Text UNK, qm

Duration

Manufacturer MERCK

8666638 Date FDA Received

18-Jul-2012

Case # 8666638

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes HO,OT

Manufacturer Control # US-009507513-1207USA 003290 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term PULMONARY EMBOLISM

Product NUVARING

Role Route S

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 966 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8669449 Date FDA Received
18-Jul-2012 Case # 8669449 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # US-009507513-1207USA 002178 Role Route S Health Professional Y VAGINAL Dosage Text UNK, qm Manufacturer Control # US-009507513-1207USA 002228 Role Route S Health Professional Y VAGINAL Dosage Text UNK, qm Manufacturer Control # US-009507513-1207USA 002874 Role Route S Health Professional Y VAGINAL Dosage Text 1 DF, UNK Manufacturer Control # US-009507513-1207USA 003283 Role Route S VAGINAL Dosage Text UNK Duration Age Sex Unknown Duration Age Sex Unknown Duration Age Sex Unknown Duration Age Sex Unknown Country USA

Preferred Term INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION

Product NUVARING Case Type NON-EXPEDITED

Manufacturer MERCK Country USA

8669508 Date FDA Received

18-Jul-2012

Case # 8669508

Outcomes

Preferred Term DEVICE EXPULSION

Product NUVARING Case # 8669982 Case Type NON-EXPEDITED

Manufacturer MERCK Country USA

8669982 Date FDA Received

18-Jul-2012

Outcomes

Preferred Term MENORRHAGIA

Product NUVARING Case # 8670200 Case Type NON-EXPEDITED

Manufacturer MERCK Country USA

8670200 Date FDA Received

18-Jul-2012

Outcomes

Preferred Term DYSMENORRHOEA FEELING ABNORMAL

Product NUVARING

Manufacturer MERCK

8670203 Date FDA Received

18-Jul-2012

Case # 8670203

Case Type NON-EXPEDITED

Health Professional Y

Outcomes

Manufacturer Control # US-009507513-1207USA 002807

Age

Sex Unknown

Country USA

Preferred Term MENORRHAGIA

Product NUVARING

Role Route S

Dosage Text

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 967 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8662204 Date FDA Received
19-Jul-2012 Case # 8662204 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes OT Manufacturer Control # US-009507513-1207USA 001856 Dosage Text UNK Manufacturer Control # US-009507513-1207USA 002103 Role Route S Health Professional N Outcomes Dosage Text UNK Manufacturer Control # US-009507513-1207USA 002915 Role Route S Health Professional Y VAGINAL Dosage Text UNK, qm Manufacturer Control # US-009507513-1207USA 002237 Role Route S VAGINAL Dosage Text UNK Duration Age Sex Unknown Duration Age Sex Unknown Duration Age Sex Unknown Duration Age Sex Unknown Country USA

Preferred Term PULMONARY EMBOLISM

Product NUVARING Case Type NON-EXPEDITED Health Professional Y

Role Route S Outcomes

Manufacturer MERCK Country USA

8672002 Date FDA Received

19-Jul-2012

Case # 8672002

Preferred Term DEVICE EXPULSION

Product NUVARING Case # 8672003 Case Type NON-EXPEDITED

Manufacturer MERCK Country USA

8672003 Date FDA Received

19-Jul-2012

Preferred Term DEVICE EXPULSION

Product NUVARING Case # 8672191 Case Type NON-EXPEDITED

Manufacturer MERCK Country USA

8672191 Date FDA Received

19-Jul-2012

Outcomes

Preferred Term OFF LABEL USE INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION NO ADVERSE EVENT

Product NUVARING

Manufacturer MERCK

8672434 Date FDA Received

19-Jul-2012

Case # 8672434

Case Type EXPEDITED (15-DAY)

Health Professional Y

Outcomes OT

Manufacturer Control # NL-009507513-1207NLD 001510 Dosage Text UNK

Age

Sex Unknown

Country NLD

Preferred Term FIBROADENOMA OF BREAST

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 968 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8674025 Date FDA Received
19-Jul-2012 Case # 8674025 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes HO,OT Manufacturer Control # US-009507513-1207USA 004451 Dosage Text UNK Manufacturer Control # US-009507513-1207USA 005628 Role Route S Health Professional Y VAGINAL Dosage Text UNK Manufacturer Control # US-009507513-1207USA 003314 Role Route S Health Professional Y Outcomes HO Manufacturer Control # US-009507513-1207USA 004955 Dosage Text UNK Duration Age Sex Unknown Dosage Text Duration Age Sex Unknown Duration Age Sex Unknown Duration Age Sex Unknown Country USA

Preferred Term INTRACRANIAL VENOUS SINUS THROMBOSIS

Product NUVARING Health Professional N

Role Route S Outcomes

Manufacturer MERCK Country USA

8674144 Date FDA Received

19-Jul-2012

Case # 8674144

Case Type NON-EXPEDITED

Preferred Term INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION

Product NUVARING Case Type NON-EXPEDITED

Manufacturer MERCK Country USA

8674176 Date FDA Received

19-Jul-2012

Case # 8674176

Outcomes

Preferred Term UNINTENDED PREGNANCY

Product NUVARING Case Type EXPEDITED (15-DAY)

Manufacturer MERCK Country USA

8669312 Date FDA Received

20-Jul-2012

Case # 8669312

Preferred Term FOETAL DEATH

Product NUVARING NUVARING NUVARING NUVARING GLUCOPHAGE COUMADIN CONCEPT DHA LOVENOX HEPARIN

Role Route S S S S C C C C C

Manufacturer MERCK MERCK MERCK MERCK

UNK 35-1-200 mg UNK 10000 IU, q8h

156 DAY 7 DAY

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 969 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8674576 Date FDA Received
20-Jul-2012 Case # 8674576 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes HO Manufacturer Control # US-009507513-2012SP0 26062 Dosage Text 1 DF, UNK Manufacturer Control # US-009507513-1207USA 006699 Dosage Text Duration Duration 4.6 YEAR Age Sex Unknown Age Sex Unknown Country USA

Preferred Term DEEP VEIN THROMBOSIS

Product NUVARING Case Type EXPEDITED (15-DAY) Health Professional N

Role Route S VAGINAL

Manufacturer MERCK Country USA

8675514 Date FDA Received

20-Jul-2012

Case # 8675514

Outcomes HO

Preferred Term EMBOLISM

Product NUVARING Case # 8675522 Case Type NON-EXPEDITED Health Professional N

Role Route S VAGINAL

Manufacturer MERCK

8675522 Date FDA Received

20-Jul-2012

Outcomes

Manufacturer Control # US-009507513-1207USA 004623

Age

Sex Unknown

Country USA

Preferred Term METRORRHAGIA INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION MENSTRUATION DELAYED

Product NUVARING

Role Route S VAGINAL

Dosage Text UNK, qm

Duration

Manufacturer MERCK

8675524 Date FDA Received

20-Jul-2012

Case # 8675524

Case Type EXPEDITED (15-DAY)

Health Professional Y

Outcomes HO,LT

Manufacturer Control # US-009507513-1207USA 006423 Dosage Text

Age

Sex Unknown

Country USA

Preferred Term EMBOLISM

Product NUVARING Case # 8676222 Case Type EXPEDITED (15-DAY) Health Professional Y

Role Route S VAGINAL

Duration

Manufacturer MERCK

8676222 Date FDA Received

20-Jul-2012

Outcomes OT

Manufacturer Control # DE-009507513-1207DEU 000619 Dosage Text UNK,

Age

Sex Unknown

Country DEU

Preferred Term CEREBRAL INFARCTION

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 970 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8699857 Date FDA Received
20-Jul-2012 Preferred Term DYSPAREUNIA Case # 8699857 Case Type DIRECT Product NUVARING Health Professional N Outcomes OT Role Route S VAGINAL Dosage Text ONE THREE WEEKS VAG Manufacturer Control # US-009507513-1207USA 005279 Dosage Text 1 DF, qm Duration Manufacturer Control # Age 32 YR Duration 3 WEEK Sex Female Country USA

Manufacturer

8676556 Date FDA Received

22-Jul-2012

Case # 8676556

Case Type EXPEDITED (15-DAY)

Health Professional Y

Outcomes OT

Age

Sex Unknown

Country USA

Preferred Term CARDIAC OPERATION PALPITATIONS

Product NUVARING AMOXICILLIN Case # 8676606 Case Type NON-EXPEDITED Health Professional N

Role Route S C Outcomes VAGINAL

Manufacturer MERCK

8676606 Date FDA Received

23-Jul-2012

Manufacturer Control # US-009507513-1207USA 005299

Age

Sex Unknown

Country USA

Preferred Term INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION

Product NUVARING Case Type NON-EXPEDITED Health Professional N

Role Route S VAGINAL

Dosage Text UNK, qm Manufacturer Control # US-009507513-1207USA 005242

Duration

Manufacturer MERCK

8676624 Date FDA Received

23-Jul-2012

Case # 8676624

Outcomes

Age

Sex Unknown

Country USA

Preferred Term INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION

Product NUVARING Case Type NON-EXPEDITED Health Professional N

Role Route S VAGINAL

Dosage Text UNK, qm Manufacturer Control # US-009507513-1207USA 005250

Duration

Manufacturer MERCK

8676632 Date FDA Received

23-Jul-2012

Case # 8676632

Outcomes

Age

Sex Unknown

Country USA

Preferred Term UNINTENDED PREGNANCY

Product NUVARING

Role Route S VAGINAL

Dosage Text 1 DF, qm

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 971 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8676795 Date FDA Received
23-Jul-2012 Case # 8676795 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # US-009507513-1207USA 004568 Role Route S Dosage Text UNK, qm Duration 12 DAY Age Sex Unknown Country USA

Preferred Term DEPRESSION ABDOMINAL PAIN METRORRHAGIA NAUSEA

Product NUVARING

Manufacturer MERCK

8676809 Date FDA Received

23-Jul-2012

Case # 8676809

Case Type NON-EXPEDITED

Health Professional Y

Outcomes

Manufacturer Control # US-009507513-1207USA 005277

Age

Sex Unknown

Country USA

Preferred Term MEDICAL DEVICE DISCOMFORT DEVICE EXPULSION PRODUCT QUALITY ISSUE

Product NUVARING

Role Route S VAGINAL

Dosage Text UNK

Duration

Manufacturer MERCK

8677092 Date FDA Received

23-Jul-2012

Case # 8677092

Case Type NON-EXPEDITED

Health Professional Y

Outcomes

Manufacturer Control # US-009507513-2012SP0 32755

Age

Sex Unknown

Country USA

Preferred Term CYTOLYTIC VAGINOSIS OFF LABEL USE

Product NUVARING NUVARING Case # 8678718 Case Type EXPEDITED (15-DAY) Health Professional N

Role Route S S Outcomes OT VAGINAL

Dosage Text 1 DF, UNK

Duration

Manufacturer MERCK MERCK

8678718 Date FDA Received

23-Jul-2012

Manufacturer Control # US-009507513-1207USA 006566 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term PULMONARY EMBOLISM

Product NUVARING

Role Route S

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 972 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8678735 Date FDA Received
23-Jul-2012 Case # 8678735 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes OT Manufacturer Control # US-009507513-1207USA 006563 Dosage Text UNK Manufacturer Control # US-009507513-1207USA 007574 Role Route S VAGINAL Dosage Text UNK Duration Age Sex Unknown Duration Age Sex Unknown Country USA

Preferred Term PULMONARY EMBOLISM

Product NUVARING Case Type NON-EXPEDITED Health Professional Y

Role Route S Outcomes

Manufacturer MERCK Country USA

8678952 Date FDA Received

23-Jul-2012

Case # 8678952

Preferred Term WEIGHT DECREASED ABNORMAL WITHDRAWAL BLEEDING

Product NUVARING

Manufacturer MERCK

8702486 Date FDA Received

23-Jul-2012 Preferred Term

Case # 8702486

Case Type DIRECT Product NUVARING

Health Professional N

Outcomes RI Role Route S

Manufacturer Control #

Age 36 YR

Sex Female

Country USA

Dosage Text

Duration 3 MTH

Manufacturer

VULVOVAGINAL DISCOMFORT DISCOMFORT FORMICATION FUNGAL INFECTION MEDICAL DEVICE COMPLICATION PAIN

8678996 Date FDA Received

24-Jul-2012

Case # 8678996

Case Type NON-EXPEDITED

Health Professional Y

Outcomes

Manufacturer Control # US-009507513-1207USA 007630

Age

Sex Unknown

Country USA

Preferred Term INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION NO ADVERSE EVENT

Product NUVARING

Role Route S VAGINAL

Dosage Text

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 973 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8679001 Date FDA Received
24-Jul-2012 Case # 8679001 Case Type NON-EXPEDITED Health Professional Y Outcomes Manufacturer Control # US-009507513-1207USA 008325 Role Route S Health Professional N VAGINAL Dosage Text UNK Manufacturer Control # US-009507513-1207USA 005831 Dosage Text Duration Age Sex Unknown Duration Age Sex Unknown Country USA

Preferred Term METRORRHAGIA

Product NUVARING Case # 8680038 Case Type EXPEDITED (15-DAY)

Manufacturer MERCK Country USA

8680038 Date FDA Received

24-Jul-2012

Outcomes DE

Preferred Term PULMONARY EMBOLISM

Product NUVARING Case Type EXPEDITED (15-DAY) Health Professional N

Role Route S VAGINAL

Manufacturer MERCK

8680422 Date FDA Received

24-Jul-2012

Case # 8680422

Outcomes OT

Manufacturer Control # US-009507513-1207USA 006608 Dosage Text UNK Manufacturer Control # US-009507513-1207USA 006584 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term PULMONARY EMBOLISM

Product NUVARING Case Type EXPEDITED (15-DAY) Health Professional N

Role Route S Outcomes OT

Duration

Manufacturer MERCK

8680583 Date FDA Received

24-Jul-2012

Case # 8680583

Age

Sex Unknown

Country USA

Preferred Term PERIPHERAL EMBOLISM

Product NUVARING

Role Route S

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 974 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8622013 Date FDA Received
25-Jul-2012 Case # 8622013 Case Type EXPEDITED (15-DAY) Health Professional Y Outcomes HO,DS,OT Manufacturer Control # US-009507513-2012SP0 05876 Dosage Text Duration Age Sex Unknown Country USA

Preferred Term SYSTEMIC LUPUS ERYTHEMATOSUS ANAEMIA CARDIAC DISORDER ESCHERICHIA URINARY TRACT INFECTION FOLATE DEFICIENCY INFECTION INFLUENZA LIKE ILLNESS IRON DEFICIENCY MOUTH ULCERATION PAIN PHARYNGITIS STREPTOCOCCAL PNEUMONIA PULMONARY EMBOLISM PULMONARY HYPERTENSION THROMBOSIS UNDIFFERENTIATED CONNECTIVE TISSUE DISEASE VITAMIN B12 DEFICIENCY

Product NUVARING

Role Route S

Manufacturer MERCK

8681604 Date FDA Received

25-Jul-2012

Case # 8681604

Case Type EXPEDITED (15-DAY)

Health Professional Y

Outcomes CA

Manufacturer Control # FR-009507513-1207FRA 006928 Dosage Text UNK

Age

Sex Unknown

Country FRA

Preferred Term CONGENITAL CARDIOVASCULAR ANOMALY FOETAL EXPOSURE DURING PREGNANCY

Product NUVARING

Role Route S TRANSPLACENTAL

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 975 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8682540 Date FDA Received
25-Jul-2012 Case # 8682540 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # US-009507513-1207USA 007481 Role Route S Health Professional Y Outcomes Dosage Text UNK Manufacturer Control # US-009507513-1207USA 008872 Role Route S Health Professional N VAGINAL Dosage Text 1 DF, UNK Manufacturer Control # US-009507513-1207USA 007479 Dosage Text UNK Duration Age Sex Unknown Duration Age Sex Unknown Duration Age Sex Unknown Country USA

Preferred Term DEEP VEIN THROMBOSIS

Product NUVARING Case Type NON-EXPEDITED

Manufacturer MERCK Country USA

8682689 Date FDA Received

25-Jul-2012

Case # 8682689

Preferred Term INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION

Product NUVARING Case Type EXPEDITED (15-DAY)

Manufacturer MERCK Country USA

8682824 Date FDA Received

25-Jul-2012

Case # 8682824

Outcomes OT

Preferred Term PULMONARY EMBOLISM DEEP VEIN THROMBOSIS

Product NUVARING

Role Route S

Manufacturer MERCK

8683434 Date FDA Received

26-Jul-2012

Case # 8683434

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # US-009507513-1207USA 006621

Age

Sex Unknown

Country USA

Preferred Term DEEP VEIN THROMBOSIS

Product NUVARING Case Type EXPEDITED (15-DAY) Health Professional N

Role Route S Outcomes OT

Dosage Text UNK Manufacturer Control # US-009507513-1207USA 006598 Dosage Text UNK

Duration

Manufacturer MERCK

8684246 Date FDA Received

26-Jul-2012

Case # 8684246

Age

Sex Unknown

Country USA

Preferred Term COAGULOPATHY HAEMORRHAGE

Product NUVARING

Role Route S

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 976 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8684247 Date FDA Received
26-Jul-2012 Case # 8684247 Case Type EXPEDITED (15-DAY) Health Professional Y Outcomes OT Manufacturer Control # RU-009507513-1207RUS 007085 Dosage Text Duration Age Sex Unknown Country RUS

Preferred Term STEVENS-JOHNSON SYNDROME THERAPEUTIC RESPONSE UNEXPECTED

Product NUVARING DYDROGESTERONE\ESTRADIOL Health Professional N

Role Route S S Outcomes OT VAGINAL

Manufacturer MERCK

8684435 Date FDA Received

26-Jul-2012

Case # 8684435

Case Type EXPEDITED (15-DAY)

Manufacturer Control # US-009507513-1207USA 006603 Dosage Text UNK Manufacturer Control # US-009507513-1207USA 006590 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term PULMONARY EMBOLISM

Product NUVARING Case Type EXPEDITED (15-DAY) Health Professional N

Role Route S VAGINAL

Duration

Manufacturer MERCK

8686545 Date FDA Received

26-Jul-2012

Case # 8686545

Outcomes OT

Age

Sex Unknown

Country USA

Preferred Term CEREBRAL THROMBOSIS INTRACRANIAL VENOUS SINUS THROMBOSIS

Product NUVARING

Role Route S

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 977 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7283302 Date FDA Received
27-Jul-2012 Case # 7283302 Case Type EXPEDITED (15-DAY) Health Professional Y Outcomes HO,OT Manufacturer Control # US-009507513-2009-196 762-NL Dosage Text CONTINUING: NO 2 EVERY 6 HRS PRN FOR PAIN BREATHING Duration 1.3 YEAR Age Sex Unknown Country USA

Preferred Term HAEMATOCHEZIA OVARIAN CYST ANXIETY DEEP VEIN THROMBOSIS GASTRITIS HAEMANGIOMA OF LIVER JOINT EFFUSION PULMONARY EMBOLISM WEIGHT INCREASED

Product NUVARING ADVIL

Role Route S C VAGINAL

Manufacturer MERCK

8686632 Date FDA Received

27-Jul-2012

Case # 8686632

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # US-009507513-1207USA 009568

Age

Sex Unknown

Country USA

Preferred Term AMENORRHOEA METRORRHAGIA

Product NUVARING

Role Route S VAGINAL

Dosage Text 1 DF, qm

Duration

Manufacturer MERCK

8686806 Date FDA Received

27-Jul-2012

Case # 8686806

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # US-009507513-1207USA 009641

Age

Sex Unknown

Country USA

Preferred Term INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION

Product NUVARING

Role Route S VAGINAL

Dosage Text

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 978 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8687495 Date FDA Received
27-Jul-2012 Case # 8687495 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # US-009507513-1207USA 006615 Role Route S Health Professional N Outcomes Dosage Text UNK Manufacturer Control # US-009507513-1207USA 006578 Role Route S Health Professional N Outcomes OT Dosage Text UNK Manufacturer Control # US-009507513-1207USA 006575 Dosage Text UNK Duration Age Sex Unknown Duration Age Sex Unknown Duration Age Sex Unknown Country USA

Preferred Term PERIPHERAL EMBOLISM

Product NUVARING Case Type NON-EXPEDITED

Manufacturer MERCK Country USA

8687607 Date FDA Received

27-Jul-2012

Case # 8687607

Preferred Term PERIPHERAL EMBOLISM

Product NUVARING Case Type EXPEDITED (15-DAY)

Manufacturer MERCK Country USA

8687715 Date FDA Received

27-Jul-2012

Case # 8687715

Preferred Term PULMONARY EMBOLISM DEEP VEIN THROMBOSIS

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

8688079 Date FDA Received

27-Jul-2012

Case # 8688079

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes OT

Manufacturer Control # US-009507513-1207USA 007472 Dosage Text UNK Manufacturer Control # US-009507513-1207USA 007494

Age

Sex Unknown

Country USA

Preferred Term CEREBRAL THROMBOSIS

Product NUVARING Case Type NON-EXPEDITED Health Professional N

Role Route S Outcomes

Duration

Manufacturer MERCK

8688316 Date FDA Received

27-Jul-2012

Case # 8688316

Age

Sex Unknown

Country USA

Preferred Term PERIPHERAL EMBOLISM

Product NUVARING

Role Route S VAGINAL

Dosage Text UNK

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 979 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8688321 Date FDA Received
27-Jul-2012 Case # 8688321 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes OT Manufacturer Control # US-009507513-1207USA 010004 Dosage Text UNK Manufacturer Control # US-009507513-1207USA 007484 Dosage Text UNK Manufacturer Control # US-009507513-1207USA 009725 Role Route S Health Professional Y VAGINAL Dosage Text UNK, qm Manufacturer Control # US-009507513-1207USA 008399 Role Route S Health Professional N Outcomes Dosage Text UNK Manufacturer Control # US-009507513-1207USA 007500 Role Route S Dosage Text UNK Duration Age Sex Unknown Duration Age Sex Unknown Duration Age Sex Unknown Duration Age Sex Unknown Duration Age Sex Unknown Country USA

Preferred Term PULMONARY EMBOLISM

Product NUVARING Case Type EXPEDITED (15-DAY) Health Professional N

Role Route S Outcomes OT

Manufacturer MERCK Country USA

8688775 Date FDA Received

27-Jul-2012

Case # 8688775

Preferred Term PULMONARY EMBOLISM

Product NUVARING Case Type NON-EXPEDITED Health Professional Y

Role Route S Outcomes

Manufacturer MERCK Country USA

8690907 Date FDA Received

30-Jul-2012

Case # 8690907

Preferred Term GALACTORRHOEA

Product NUVARING Case # 8690995 Case Type NON-EXPEDITED

Manufacturer MERCK Country USA

8690995 Date FDA Received

30-Jul-2012

Outcomes

Preferred Term MEDICAL DEVICE DISCOMFORT

Product NUVARING Case Type NON-EXPEDITED

Manufacturer MERCK Country USA

8691924 Date FDA Received

30-Jul-2012

Case # 8691924

Preferred Term DEEP VEIN THROMBOSIS

Product NUVARING

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 980 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8691942 Date FDA Received
30-Jul-2012 Case # 8691942 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes OT Manufacturer Control # US-009507513-1207USA 007496 Dosage Text UNK Manufacturer Control # US-009507513-2010SP0 45139 Role Route S Health Professional N VAGINAL Dosage Text UNK mg, UNK Manufacturer Control # US-009507513-1207USA 007489 Dosage Text UNK UNK Duration Age Sex Unknown Duration Age Sex Unknown Duration Age Sex Unknown Country USA

Preferred Term PULMONARY EMBOLISM

Product NUVARING Case Type NON-EXPEDITED Health Professional N

Role Route S Outcomes

Manufacturer MERCK Country USA

8692394 Date FDA Received

30-Jul-2012

Case # 8692394

Preferred Term HEADACHE

Product NUVARING Case # 8692414 Case Type EXPEDITED (15-DAY)

Manufacturer MERCK Country USA

8692414 Date FDA Received

30-Jul-2012

Outcomes OT

Preferred Term PULMONARY EMBOLISM

Product NUVARING NUVARING

Role Route S S VAGINAL

Manufacturer MERCK MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 981 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7284797 Date FDA Received
31-Jul-2012 Case # 7284797 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes HO,OT Manufacturer Control # US-009507513-2009-200 460-NL Dosage Text CONTINUING: NO Duration Age Sex Unknown Country USA

Preferred Term CERVICAL DYSPLASIA DEEP VEIN THROMBOSIS THROMBOPHLEBITIS CHEST PAIN ACUTE SINUSITIS UTERINE LEIOMYOMA VULVA CYST DEPRESSION HIDRADENITIS OEDEMA PERIPHERAL OFF LABEL USE PAIN IN EXTREMITY PHOTOREFRACTIVE KERATECTOMY

Product NUVARING NUVARING NUVARING TOPAMAX ZOLOFT PRILOSEC CLARITIN

Role Route S S S C C C C ORAL ORAL ORAL VAGINAL

Manufacturer MERCK MERCK MERCK

50 mg, QD 25 mg, QD PRN 10 mg, PRN

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 982 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7659732 Date FDA Received
31-Jul-2012 Case # 7659732 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes HO,DS,OT Manufacturer Control # US-009507513-2010SP0 08200 Dosage Text Duration Age Sex Unknown Country USA

Preferred Term OVARIAN CANCER OVARIAN CYST INTERMITTENT CLAUDICATION CATARACT SYNCOPE OSTEOARTHRITIS ANGIOPATHY ARTHRALGIA ASTHENIA BREAST CANCER BRONCHIAL HYPERREACTIVITY CYST DEEP VEIN THROMBOSIS EXOSTOSIS FOOT OPERATION HEPATIC ENZYME INCREASED MENORRHAGIA MIGRAINE NAUSEA RASH PRURITIC TINEA VERSICOLOUR WEIGHT DECREASED

Product NUVARING NUVARING PROMETRIUM SINGULAIR TOPAMAX FLUTICASONE PROPIONATE \SALMETEROL XINAFOATE ANESTHETIC (UNSPECIFIED)

Role Route S S S C C C C ORAL INHALATION EPIDURAL

Manufacturer MERCK MERCK

"CINGULAR" 50 mg, BID UNK UNK, BID 4 WEEKS PRIOR TO DVT

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 983 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7821319 Date FDA Received
31-Jul-2012 Case # 7821319 Case Type EXPEDITED (15-DAY) Health Professional Y Outcomes HO,OT Manufacturer Control # US-009507513-2010SP0 01829 Dosage Text UNK UNK, QD Duration Age Sex Unknown Country USA

Preferred Term SYNCOPE CONVULSION DEEP VEIN THROMBOSIS LUNG NEOPLASM PAIN IN EXTREMITY PULMONARY EMBOLISM SMEAR CERVIX ABNORMAL THROMBOSIS WEIGHT INCREASED

Product NUVARING VITAMINS (UNSPECIFIED)

Role Route S C VAGINAL

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 984 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8477342 Date FDA Received
31-Jul-2012 Case # 8477342 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes HO,DS Manufacturer Control # US-009507513-2011SP0 51267 Dosage Text UNK UNK, QM Duration Age Sex Unknown Country USA

Preferred Term VARICOSE VEIN DEEP VEIN THROMBOSIS ABDOMINAL PAIN UPPER ARTHRALGIA ASTHMA CONTUSION DRUG HYPERSENSITIVITY DYSMENORRHOEA FATIGUE HEADACHE HYPERCOAGULATION OVARIAN CYST PAIN PAIN IN EXTREMITY PAPILLOMA VIRAL INFECTION URTICARIA VENOUS INSUFFICIENCY

Product NUVARING BENADRYL

Role Route S S VAGINAL

Manufacturer MERCK

8694575 Date FDA Received

31-Jul-2012

Case # 8694575

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes OT

Manufacturer Control # US-009507513-1207USA 006618 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term PULMONARY EMBOLISM DEEP VEIN THROMBOSIS

Product NUVARING

Role Route S

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 985 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8694819 Date FDA Received
31-Jul-2012 Case # 8694819 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # US-009507513-2012SP0 32490 Role Route S Health Professional N VAGINAL Manufacturer Control # US-009507513-1207USA 006605 Role Route S Health Professional N Outcomes OT Dosage Text UNK Manufacturer Control # US-009507513-1207USA 007475 Dosage Text UNK Manufacturer Control # US-009507513-1207USA 007488 Dosage Text UNK Manufacturer Control # US-009507513-1207USA 009346 Dosage Text UNK Duration Age Sex Unknown Duration Age Sex Unknown Duration Age Sex Unknown Duration Age Sex Unknown Dosage Text Duration Age Sex Unknown Country USA

Preferred Term DEVICE EXPULSION

Product NUVARING Case # 8695080 Case Type NON-EXPEDITED

Manufacturer MERCK Country USA

8695080 Date FDA Received

31-Jul-2012

Outcomes

Preferred Term DEEP VEIN THROMBOSIS

Product NUVARING Case Type EXPEDITED (15-DAY)

Manufacturer MERCK Country USA

8695083 Date FDA Received

31-Jul-2012

Case # 8695083

Preferred Term PULMONARY EMBOLISM

Product NUVARING Case Type EXPEDITED (15-DAY) Health Professional N

Role Route S Outcomes OT

Manufacturer MERCK Country USA

8695085 Date FDA Received

31-Jul-2012

Case # 8695085

Preferred Term PULMONARY EMBOLISM

Product NUVARING Case Type EXPEDITED (15-DAY) Health Professional N

Role Route S Outcomes OT

Manufacturer MERCK Country USA

8695097 Date FDA Received

31-Jul-2012

Case # 8695097

Preferred Term PULMONARY EMBOLISM

Product NUVARING

Role Route S

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 986 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8695101 Date FDA Received
31-Jul-2012 Case # 8695101 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes OT Manufacturer Control # US-009507513-1207USA 006625 Dosage Text UNK Manufacturer Control # US-009507513-2012SP0 05552 Dosage Text 1 DF, qm Duration 152 DAY Age Sex Unknown Duration Age Sex Unknown Country USA

Preferred Term PULMONARY EMBOLISM

Product NUVARING Case Type EXPEDITED (15-DAY) Health Professional N

Role Route S VAGINAL

Manufacturer MERCK Country USA

8695133 Date FDA Received

31-Jul-2012

Case # 8695133

Outcomes HO

Preferred Term MENORRHAGIA INCORRECT DRUG ADMINISTRATION DURATION

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

8695169 Date FDA Received

31-Jul-2012

Case # 8695169

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes HO,DS

Manufacturer Control # US-009507513-1207USA 008709 Dosage Text UNK Manufacturer Control # US-009507513-1207USA 008780 Dosage Text UNK Manufacturer Control # US-009507513-1207USA 008719 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term DEEP VEIN THROMBOSIS

Product NUVARING Case Type EXPEDITED (15-DAY) Health Professional N

Role Route S VAGINAL

Duration

Manufacturer MERCK

8695170 Date FDA Received

31-Jul-2012

Case # 8695170

Outcomes HO,DS

Age

Sex Unknown

Country USA

Preferred Term PULMONARY EMBOLISM

Product NUVARING Case Type EXPEDITED (15-DAY) Health Professional N

Role Route S VAGINAL

Duration

Manufacturer MERCK

8695185 Date FDA Received

31-Jul-2012

Case # 8695185

Outcomes HO,DS,OT

Age

Sex Unknown

Country USA

Preferred Term PULMONARY EMBOLISM DEEP VEIN THROMBOSIS

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 987 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8695266 Date FDA Received
31-Jul-2012 Case # 8695266 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes OT Manufacturer Control # US-009507513-1207USA 007491 Dosage Text UNK Manufacturer Control # US-009507513-1207USA 008799 Dosage Text UNK Duration Age Sex Unknown Duration Age Sex Unknown Country USA

Preferred Term MYOCARDIAL INFARCTION

Product NUVARING Case Type EXPEDITED (15-DAY) Health Professional N

Role Route S VAGINAL

Manufacturer MERCK Country USA

8695601 Date FDA Received

31-Jul-2012

Case # 8695601

Outcomes DS,OT

Preferred Term PULMONARY EMBOLISM

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 988 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8695734 Date FDA Received
31-Jul-2012 Case # 8695734 Case Type EXPEDITED (15-DAY) Health Professional Y Outcomes HO,OT Manufacturer Control # US-009507513-2009SP0 30531 Dosage Text NOTED TO HAVE TAKEN ON 15DEC2005 AND 16DEC2005 Duration Age Sex Unknown Country USA

Preferred Term VISUAL FIELD DEFECT SINUS BRADYCARDIA

Product NUVARING IMITREX

Role Route S C SUBCUTANEOUS

Manufacturer MERCK

ANKLE FRACTURE BREAST DISORDER CAROTID ARTERY OCCLUSION CEREBRAL INFARCTION CONCUSSION DEPRESSION HEAD INJURY HEMIPLEGIA HUMAN PAPILLOMA VIRUS TEST POSITIVE HYPERLIPIDAEMIA ISCHAEMIA LOSS OF CONSCIOUSNESS MICTURITION URGENCY PAIN RECTOCELE SLEEP DISORDER SUICIDAL IDEATION URINARY INCONTINENCE UTERINE CERVICAL SQUAMOUS METAPLASIA WEIGHT INCREASED

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 989 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7551995 Date FDA Received
01-Aug-2012 Case # 7551995 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes HO,OT Manufacturer Control # US-009507513-2009SP0 29107 Dosage Text 225 mg, QD 25 mg, QD Duration Age Sex Unknown Country USA

Preferred Term BRONCHITIS BRONCHIAL HYPERREACTIVITY PULMONARY EMBOLISM BIPOLAR DISORDER CHLAMYDIAL INFECTION FATIGUE INCREASED TENDENCY TO BRUISE MENORRHAGIA MIGRAINE MOOD SWINGS MUSCLE SPASMS PANIC ATTACK RASH THROMBOSIS VITAMIN D DEFICIENCY

Product NUVARING EFFEXOR AMITRIPTYLINE HYDROCHLORIDE

Role Route S C C

Manufacturer MERCK

8657516 Date FDA Received

01-Aug-2012

Case # 8657516

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes

Manufacturer Control # US-009507513-2012SP0 19543

Age

Sex Unknown

Country USA

Preferred Term NAUSEA

Product NUVARING Case # 8660644 Case Type EXPEDITED (15-DAY) Health Professional

Role Route S VAGINAL

Dosage Text UNK UNK, QM Manufacturer Control # US-009507513-2012SP0 36945

Duration

Manufacturer MERCK

8660644 Date FDA Received

01-Aug-2012

Outcomes

Age

Sex Unknown

Country USA

Preferred Term DEEP VEIN THROMBOSIS

Product NUVARING

Role Route S

Dosage Text

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 990 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8663233 Date FDA Received
01-Aug-2012 Case # 8663233 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes Manufacturer Control # US-009507513-2012SP0 30310 Role Route S Health Professional Outcomes DS,OT Dosage Text 1 DF, UNK Manufacturer Control # US-009507513-2012SP0 11818 Dosage Text UNK UNK Duration Age Sex Unknown Duration Age Sex Unknown Country USA

Preferred Term DEVICE DIFFICULT TO USE

Product NUVARING Case Type EXPEDITED (15-DAY)

Manufacturer MERCK Country USA

8666205 Date FDA Received

01-Aug-2012

Case # 8666205

Preferred Term MULTIPLE SCLEROSIS CEREBROVASCULAR ACCIDENT CENTRAL NERVOUS SYSTEM INFLAMMATION DEEP VEIN THROMBOSIS DYSMENORRHOEA FATIGUE HAEMATURIA HEADACHE HYPOTHYROIDISM MENSTRUATION IRREGULAR MUSCLE SPASMS NEUROPATHY PERIPHERAL RADICULOPATHY VAGINAL HAEMORRHAGE

Product NUVARING NUVARING

Role Route S S

Manufacturer MERCK MERCK

8670268 Date FDA Received

01-Aug-2012

Case # 8670268

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes

Manufacturer Control # US-009507513-2012SP0 25434

Age

Sex Female

Country USA

Preferred Term DEVICE EXPULSION

Product NUVARING

Role Route S VAGINAL

Dosage Text

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 991 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8681638 Date FDA Received
01-Aug-2012 Case # 8681638 Case Type EXPEDITED (15-DAY) Health Professional Y Outcomes Manufacturer Control # US-009507513-2012SP0 33053 Role Route S VAGINAL Dosage Text Duration Age Sex Unknown Country USA

Preferred Term VAGINAL DISORDER INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION

Product NUVARING

Manufacturer MERCK

8695892 Date FDA Received

01-Aug-2012

Case # 8695892

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # US-009507513-1207USA 009674

Age

Sex Unknown

Country USA

Preferred Term MEDICAL DEVICE DISCOMFORT

Product NUVARING Case Type EXPEDITED (15-DAY) Health Professional

Role Route S Outcomes DS,OT

Dosage Text UNK Manufacturer Control # US-009507513-1207USA 008738 Dosage Text UNK Manufacturer Control # US-009507513-1207USA 008794 Dosage Text UNK Manufacturer Control # US-009507513-1207USA 008772 Dosage Text UNK

Duration

Manufacturer MERCK

8696385 Date FDA Received

01-Aug-2012

Case # 8696385

Age

Sex Unknown

Country USA

Preferred Term PULMONARY EMBOLISM

Product NUVARING Case Type EXPEDITED (15-DAY) Health Professional N

Role Route S VAGINAL

Duration

Manufacturer MERCK

8696710 Date FDA Received

01-Aug-2012

Case # 8696710

Outcomes HO,DS,OT

Age

Sex Unknown

Country USA

Preferred Term PULMONARY EMBOLISM

Product NUVARING Case Type EXPEDITED (15-DAY) Health Professional N

Role Route S Outcomes HO,DS

Duration

Manufacturer MERCK

8696814 Date FDA Received

01-Aug-2012

Case # 8696814

Age

Sex Unknown

Country USA

Preferred Term PULMONARY INFARCTION PULMONARY EMBOLISM

Product NUVARING

Role Route S

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 992 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8697150 Date FDA Received
01-Aug-2012 Case # 8697150 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes HO Manufacturer Control # US-009507513-1207USA 008754 Dosage Text Duration Age Sex Unknown Country USA

Preferred Term DEEP VEIN THROMBOSIS

Product NUVARING Case Type EXPEDITED (15-DAY) Health Professional N

Role Route S Outcomes HO,DS

Manufacturer MERCK

8697386 Date FDA Received

01-Aug-2012

Case # 8697386

Manufacturer Control # US-009507513-1207USA 008729 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term DEEP VEIN THROMBOSIS

Product NUVARING

Role Route S

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 993 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7825144 Date FDA Received
02-Aug-2012 Case # 7825144 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2010SP0 09187 Dosage Text 1 DF, q3w Duration Age Sex Unknown Country USA

Preferred Term CONVULSION CEREBRAL THROMBOSIS CEREBRAL HAEMORRHAGE CHLAMYDIAL INFECTION RHINITIS VIRAL UPPER RESPIRATORY TRACT INFECTION ANXIETY DEPRESSION HEADACHE MIGRAINE MUSCLE TIGHTNESS NASOPHARYNGITIS PAIN PATELLOFEMORAL PAIN SYNDROME PHARYNGITIS STREPTOCOCCAL SYSTOLIC HYPERTENSION TOOTH INFECTION URINARY TRACT INFECTION VULVOVAGINAL MYCOTIC INFECTION VULVOVAGINITIS

Product NUVARING ALUMINUM HYDROXIDE \MAGNESIUM CARBONATE KETOROLAC TROMETHAMINE AZITHROMYCIN FLUCONAZOLE FLUCONAZOLE CLOBETASOL PROPIONATE

Role Route S C C C C C C VAGINAL ORAL ORAL ORAL ORAL ORAL TOPICAL

Manufacturer MERCK

10 mg, QID 1000 mg, ONCE 150 mg, ONCE 150 mg, ONCE BID X 2 WEEKS, THEN QD X 8 WEEKS

5 DAY

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 994 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7826906 Date FDA Received
02-Aug-2012 Case # 7826906 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes HO,OT Manufacturer Control # US-009507513-2010SP0 04036 Dosage Text Duration Age Sex Unknown Country USA

Preferred Term MICROCYTIC ANAEMIA PULMONARY EMBOLISM GONORRHOEA INITIAL INSOMNIA MATERNAL EXPOSURE DURING PREGNANCY PLEURISY UNINTENDED PREGNANCY

Product NUVARING NUVARING

Role Route S S

Manufacturer MERCK MERCK

8698758 Date FDA Received

02-Aug-2012

Case # 8698758

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes OT

Manufacturer Control # US-009507513-1207USA 009450 Dosage Text UNK Manufacturer Control # US-009507513-1207USA 008744 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term PULMONARY EMBOLISM

Product NUVARING Case Type EXPEDITED (15-DAY) Health Professional

Role Route S Outcomes DS,OT

Duration 32 DAY Age Sex

Manufacturer MERCK Country USA

8698863 Date FDA Received

02-Aug-2012

Case # 8698863

Unknown

Preferred Term THROMBOSIS FOETAL MALNUTRITION FOETAL PLACENTAL THROMBOSIS MATERNAL EXPOSURE DURING PREGNANCY

Product NUVARING

Role Route S

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 995 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8698865 Date FDA Received
02-Aug-2012 Case # 8698865 Case Type EXPEDITED (15-DAY) Health Professional Outcomes DS Manufacturer Control # US-009507513-1207USA 013006 Dosage Text UNK Duration Age Sex Unknown Country USA

Preferred Term BRAIN INJURY ACTIVITIES OF DAILY LIVING IMPAIRED CONGENITAL CENTRAL NERVOUS SYSTEM ANOMALY FOETAL EXPOSURE DURING PREGNANCY FOETAL MALNUTRITION FOETAL PLACENTAL THROMBOSIS MATERNAL DRUGS AFFECTING FOETUS MATERNAL EXPOSURE DURING PREGNANCY MENTAL DISORDER MULTIPLE INJURIES PAIN PREGNANCY WITH CONTRACEPTIVE DEVICE PREMATURE BABY

Product NUVARING

Role Route S TRANSPLACENTAL

Manufacturer MERCK

8699026 Date FDA Received

02-Aug-2012

Case # 8699026

Case Type EXPEDITED (15-DAY)

Health Professional Y

Outcomes HO,OT

Manufacturer Control # US-009507513-2010SP0 25088 Dosage Text 2-3 TIMES PER MONTH (ROUTE NOT PROVIDED AND "RECOMMENDED DOSAGE ON BOX"); ALSO REPORTED AS 4X/WK

Age

Sex Unknown

Country USA

Preferred Term DEEP VEIN THROMBOSIS PULMONARY EMBOLISM

Product NUVARING IBUPROFEN

Role Route S C UNKNOWN

Duration 1.5 YEAR

Manufacturer MERCK

ANXIETY LIGAMENT SPRAIN

NAPROXEN

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 996 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8699041 Date FDA Received
02-Aug-2012 Case # 8699041 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes HO,OT Manufacturer Control # US-009507513-2012SP0 17428 Dosage Text UNK Duration Age Sex Unknown Country USA

Preferred Term MYOCARDIAL INFARCTION ALOPECIA ARRHYTHMIA ATRIAL FIBRILLATION BRADYCARDIA DEPRESSION HEART RATE IRREGULAR PALPITATIONS PULMONARY EMBOLISM PULMONARY FIBROSIS TACHYCARDIA

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 997 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8699921 Date FDA Received
02-Aug-2012 Case # 8699921 Case Type EXPEDITED (15-DAY) Health Professional Y Outcomes DE,HO,DS,OT Manufacturer Control # US-009507513-2009SP0 21058 Dosage Text Duration Age Sex Unknown Country USA

Preferred Term ATRIAL THROMBOSIS PULMONARY EMBOLISM DEEP VEIN THROMBOSIS VENA CAVA THROMBOSIS BILIARY DILATATION OCCULT BLOOD POSITIVE BACK PAIN BLOOD PRESSURE INCREASED BUNION OPERATION CONSTIPATION FATIGUE HAEMORRHOIDS HEADACHE HYPOACUSIS INCREASED TENDENCY TO BRUISE NASAL CONGESTION OFF LABEL USE PALPITATIONS PARAESTHESIA TEMPERATURE INTOLERANCE TINNITUS UPPER-AIRWAY COUGH SYNDROME

Product NUVARING NUVARING BENADRYL ALEVE IMITREX AMBIEN

Role Route S S C C C C

Manufacturer MERCK MERCK

8700292 Date FDA Received

02-Aug-2012

Case # 8700292

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1207USA 012470

Age

Sex Unknown

Country USA

Preferred Term THROMBOSIS

Product NUVARING

Role Route S

Dosage Text UNK

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 998 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8700687 Date FDA Received
02-Aug-2012 Case # 8700687 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO Manufacturer Control # US-009507513-1207USA 011560 Dosage Text UNK Duration Age Sex Unknown Country USA

Preferred Term GALLBLADDER DISORDER PALPITATIONS

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

7808450 Date FDA Received

03-Aug-2012

Case # 7808450

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes HO,OT

Manufacturer Control # US-009507513-2010SP0 38514 Dosage Text

Age

Sex Unknown

Country USA

Preferred Term PULMONARY INFARCTION PULMONARY EMBOLISM DEEP VEIN THROMBOSIS HYPERCOAGULATION ANXIETY DRUG HYPERSENSITIVITY EMPHYSEMA HYPERLIPIDAEMIA HYPERTENSION LUNG DISORDER METRORRHAGIA OFF LABEL USE PAIN IN EXTREMITY PLEURISY TRANSAMINASES INCREASED

Product NUVARING NUVARING COUMADIN COUMADIN

Role Route S S S S

Duration

Manufacturer MERCK MERCK

8108762 Date FDA Received

03-Aug-2012

Case # 8108762

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,DS,OT

Manufacturer Control # US-009507513-2011SP0 14621

Age

Sex Unknown

Country USA

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 999 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8108762
Preferred Term PNEUMONIA SINUS BRADYCARDIA HAEMATEMESIS POLYCYSTIC OVARIES PRESYNCOPE PULMONARY EMBOLISM DEEP VEIN THROMBOSIS DYSPNOEA HYPOTENSION CHEST PAIN BLOOD POTASSIUM ABNORMAL BLOOD TRIGLYCERIDES INCREASED CHEST DISCOMFORT CONFUSIONAL STATE DIZZINESS ENDOMETRIOSIS FATIGUE GENITAL INFECTION FUNGAL HEADACHE HEAD INJURY HEMIPARESIS MALAISE MENSTRUATION IRREGULAR MIGRAINE NAUSEA OFF LABEL USE PAIN IN EXTREMITY SINUS DISORDER SPEECH DISORDER SYNCOPE Product NUVARING NUVARING LOVENOX KEPPRA DIAMOX SEQUELS SKELAXIN ZANAFLEX AXERT XANAX HYDROCODONE BITARTRATE AND ACETAMINOPHEN Role Route S S S C C C C C C C 1500 mg, QD UNK UNK, QD UNK UNK, QD UNK UNK, QD UNK UNK, PRN UNK UNK, PRN UNK UNK, PRN Dosage Text Duration 274 DAY Manufacturer MERCK MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,000 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8657515 Date FDA Received
03-Aug-2012 Case # 8657515 Case Type EXPEDITED (15-DAY) Health Professional Y Outcomes HO,OT Manufacturer Control # US-009507513-2012SP0 15285 Dosage Text UNK Duration Age Sex Unknown Country USA

Preferred Term HYPERCOAGULATION CHEST DISCOMFORT DYSPNOEA EUSTACHIAN TUBE DYSFUNCTION HEADACHE MUSCULOSKELETAL PAIN NECK PAIN PULMONARY EMBOLISM WEIGHT DECREASED

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,001 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8660757 Date FDA Received
03-Aug-2012 Case # 8660757 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2011SP0 58950 Dosage Text Duration Age Sex Unknown Country USA

Preferred Term PLEURAL EFFUSION ASTHMA BRONCHIAL HYPERREACTIVITY BRONCHITIS BRONCHITIS VIRAL CERVICITIS DEPRESSION DRUG ABUSE FLANK PAIN INFECTION OBESITY OVARIAN CYST PELVIC PAIN PNEUMONIA PULMONARY EMBOLISM URINARY TRACT INFECTION

Product NUVARING

Role Route S

Manufacturer MERCK

8702317 Date FDA Received

03-Aug-2012

Case # 8702317

Case Type EXPEDITED (15-DAY)

Health Professional Y

Outcomes HO

Manufacturer Control # US-009507513-1208USA 001059 Dosage Text UNK Manufacturer Control # US-009507513-1208USA 000683 Dosage Text

Age

Sex Unknown

Country USA

Preferred Term PELVIC INFLAMMATORY DISEASE

Product NUVARING Case Type EXPEDITED (15-DAY) Health Professional N

Role Route S VAGINAL

Duration

Manufacturer MERCK

8702318 Date FDA Received

03-Aug-2012

Case # 8702318

Outcomes DS

Age

Sex Unknown

Country USA

Preferred Term ADVERSE EVENT

Product NUVARING

Role Route S

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,002 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8702328 Date FDA Received
03-Aug-2012 Case # 8702328 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes DS Manufacturer Control # US-009507513-1208USA 000687 Dosage Text Duration Age Sex Unknown Country USA

Preferred Term ADVERSE EVENT

Product NUVARING Case # 8702918 Case Type NON-EXPEDITED Health Professional Y

Role Route S Outcomes

Manufacturer MERCK

8702918 Date FDA Received

03-Aug-2012

Manufacturer Control # US-009507513-2012SP0 00176

Age

Sex Unknown

Country USA

Preferred Term THROMBOPHLEBITIS SUPERFICIAL BACK PAIN PAIN IN EXTREMITY

Product NUVARING

Role Route S

Dosage Text

Duration 6 DAY

Manufacturer MERCK

8707451 Date FDA Received

03-Aug-2012

Case # 8707451

Case Type EXPEDITED (15-DAY)

Health Professional Y

Outcomes HO,OT

Manufacturer Control # FI-009507513-1207FIN0 12418 Dosage Text UNK

Age

Sex Unknown

Country FIN

Preferred Term ABORTION INDUCED ABNORMAL WITHDRAWAL BLEEDING MATERNAL EXPOSURE DURING PREGNANCY UNINTENDED PREGNANCY

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

8726733 Date FDA Received

03-Aug-2012 Preferred Term ANKLE FRACTURE BRAIN INJURY CARDIAC ARREST COMA

Case # 8726733

Case Type DIRECT Product NUVARING

Health Professional Y

Outcomes HO,LT Role Route S

Manufacturer Control #

Age 29 YR

Sex Female

Country USA

Dosage Text MONTHS

Duration

Manufacturer

RESPIRATORY FAILURE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,003 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8707627 Date FDA Received
05-Aug-2012 Case # 8707627 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes OT Manufacturer Control # US-009507513-1207USA 011612 Dosage Text UNK Manufacturer Control # US-009507513-1207USA 012194 Dosage Text UNK Manufacturer Control # US-009507513-2010SP0 50757 Dosage Text UNK UNK, PRN UNK UNK, BID UNK UNK, QD 326 mg, QD 500 mg, QD Duration Age Sex Unknown Duration Age Sex Unknown Duration Age Sex Unknown Country USA

Preferred Term PULMONARY EMBOLISM

Product NUVARING Case Type EXPEDITED (15-DAY) Health Professional N

Role Route S VAGINAL

Manufacturer MERCK Country USA

8707631 Date FDA Received

05-Aug-2012

Case # 8707631

Outcomes OT

Preferred Term PULMONARY EMBOLISM

Product NUVARING Case Type EXPEDITED (15-DAY) Health Professional Y

Role Route S VAGINAL

Manufacturer MERCK Country USA

7633556 Date FDA Received

06-Aug-2012

Case # 7633556

Outcomes HO,DS

Preferred Term MENISCUS LESION LIGAMENT INJURY DEEP VEIN THROMBOSIS HYPOTENSION DYSPNOEA MENSTRUAL DISORDER

Product NUVARING ALBUTEROL PLASMA PROTEIN FRACTION (HUMAN) NOS MINERALS (UNSPECIFIED) (+) VITAMINS (UNSPECIFIED) IRON (UNSPECIFIED) CYANOCOBALAMIN

Role Route S C C C C C

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,004 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8343112 Date FDA Received
06-Aug-2012 Case # 8343112 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2011SP0 46655 Dosage Text Duration Age Sex Unknown Country USA

Preferred Term ENTEROCOLITIS INFECTIOUS DEEP VEIN THROMBOSIS PULMONARY EMBOLISM KERATOMILEUSIS AFFECT LABILITY ANTIPHOSPHOLIPID ANTIBODIES POSITIVE ANXIETY CERVICAL DYSPLASIA DIZZINESS DYSPNOEA EMOTIONAL DISTRESS H1N1 INFLUENZA HERPES ZOSTER HYPERCOAGULATION METRORRHAGIA MIGRAINE MONONUCLEOSIS SYNDROME PAPILLOMA VIRAL INFECTION

Product NUVARING NUVARING NUVARING CORTICOSTEROID NOS

Role Route S S S S

Manufacturer MERCK MERCK MERCK

8660459 Date FDA Received

06-Aug-2012

Case # 8660459

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes OT

Manufacturer Control # US-009507513-2012SP0 36943 Dosage Text

Age

Sex Female

Country USA

Preferred Term PULMONARY EMBOLISM

Product NUVARING

Role Route S

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,005 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8669051 Date FDA Received
06-Aug-2012 Case # 8669051 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes OT Manufacturer Control # US-009507513-2012SP0 36946 Dosage Text Duration Age Sex Female Country USA

Preferred Term PULMONARY EMBOLISM

Product NUVARING Case Type NON-EXPEDITED Health Professional N

Role Route S Outcomes

Manufacturer MERCK

8707651 Date FDA Received

06-Aug-2012

Case # 8707651

Manufacturer Control # US-009507513-1207USA 011580

Age

Sex Unknown

Country USA

Preferred Term UNINTENDED PREGNANCY

Product NUVARING Case Type NON-EXPEDITED Health Professional Y

Role Route S VAGINAL

Dosage Text UNK Manufacturer Control # US-009507513-1207USA 011564

Duration

Manufacturer MERCK

8707794 Date FDA Received

06-Aug-2012

Case # 8707794

Outcomes

Age

Sex Unknown

Country USA

Preferred Term UNINTENDED PREGNANCY

Product NUVARING ZOVIRAX VALTREX

Role Route S C C VAGINAL

Dosage Text UNK

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,006 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8707805 Date FDA Received
06-Aug-2012 Case # 8707805 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes HO Manufacturer Control # US-009507513-2009SP0 16965 Dosage Text 1 DF, QM FOR 30 DAYS Age 32 YR Sex Female Country USA

Preferred Term ENCEPHALOMALACIA EMBOLIC STROKE INFLUENZA VARICOSE VEIN CARDIAC ANEURYSM DEVICE FAILURE FIBROADENOMA OF BREAST INTERVERTEBRAL DISC DISORDER MIGRAINE PHLEBITIS WEIGHT DECREASED

Product NUVARING CEPHALEXIN TYLENOL IMITREX

Role Route S C C C VAGINAL

Duration

Manufacturer MERCK

8707819 Date FDA Received

06-Aug-2012

Case # 8707819

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes HO

Manufacturer Control # DE-009507513-1208DEU 000613 Dosage Text 1 DF, UNK 1 DF, UNK Manufacturer Control # US-009507513-1207USA 011502

Age

Sex Unknown

Country DEU

Preferred Term BLADDER PAIN

Product NUVARING NUVARING

Role Route S S Health Professional N VAGINAL VAGINAL

Duration

Manufacturer MERCK MERCK

8707994 Date FDA Received

06-Aug-2012

Case # 8707994

Case Type NON-EXPEDITED

Outcomes

Age

Sex Unknown

Country USA

Preferred Term URINARY TRACT INFECTION PRODUCT QUALITY ISSUE

Product NUVARING

Role Route S VAGINAL

Dosage Text UNK, q3w

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,007 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8708304 Date FDA Received
06-Aug-2012 Case # 8708304 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes HO Manufacturer Control # US-009507513-1208USA 000213 Dosage Text UNK Manufacturer Control # US-009507513-2009SP0 16940 Dosage Text 1 DF, QM 175 mg, qd 300 mg, qd UNK Duration Age Sex Unknown Duration Age Sex Unknown Country USA

Preferred Term DEEP VEIN THROMBOSIS

Product NUVARING Case Type EXPEDITED (15-DAY) Health Professional N

Role Route S Outcomes HO

Manufacturer MERCK Country USA

8708441 Date FDA Received

06-Aug-2012

Case # 8708441

Preferred Term TRANSVERSE SINUS THROMBOSIS SKIN PAPILLOMA VIRAL UPPER RESPIRATORY TRACT INFECTION STRESS URINARY INCONTINENCE ARTERIOVENOUS FISTULA IRRITABLE BOWEL SYNDROME LACTOSE INTOLERANCE MIGRAINE VULVOVAGINAL MYCOTIC INFECTION WEIGHT INCREASED

Product NUVARING WELLBUTRIN XL WELLBUTRIN XL WELLBUTRIN XL

Role Route S C C C VAGINAL ORAL ORAL ORAL

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,008 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8709659 Date FDA Received
06-Aug-2012 Case # 8709659 Case Type EXPEDITED (15-DAY) Health Professional Y Outcomes HO,OT Manufacturer Control # US-009507513-2009-198 050-NL Dosage Text CONTINUING: NO 137 g, UNK Duration Age Sex Unknown Country USA

Preferred Term PULMONARY EMBOLISM THROMBOSIS SARCOIDOSIS ARTHRALGIA BACK PAIN BRONCHITIS CHILLS DEEP VEIN THROMBOSIS DEPRESSION FATIGUE HEADACHE MUSCLE STRAIN OBSESSIVE-COMPULSIVE DISORDER SLEEP PARALYSIS SOMNOLENCE TEMPERATURE INTOLERANCE VULVOVAGINAL CANDIDIASIS WEIGHT FLUCTUATION

Product NUVARING SYNTHROID FLEXERIL

Role Route S C C VAGINAL

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,009 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8709954 Date FDA Received
06-Aug-2012 Case # 8709954 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2010SP0 04278 Dosage Text Duration Age Sex Unknown Country USA

Preferred Term PULMONARY EMBOLISM CHLAMYDIA TEST POSITIVE MUSCLE SPASMS DIARRHOEA

Product NUVARING NUVARING HORMONAL CONTRACEPTIVES (UNSPECIFIED) NONSTEROIDAL ANTIINFLAMMATORY DRUG (UNSPECIFIED)

Role Route S S C C

Manufacturer MERCK MERCK

UNK UNK, PRN

CERVICAL DYSPLASIA NAUSEA OFF LABEL USE VOMITING

7362123 Date FDA Received

07-Aug-2012

Case # 7362123

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO

Manufacturer Control # US-009507513-2009SP0 42237 Dosage Text UNK UNK, QM

Age 42 YR

Sex Female

Country USA

Preferred Term LYMPHADENOPATHY MEDIASTINAL DEEP VEIN THROMBOSIS BACK PAIN HAEMATURIA SARCOIDOSIS NORMOCHROMIC NORMOCYTIC ANAEMIA

Product NUVARING NUVARING NUVARING FERROUS SULFATE ASCORBIC ACID CLARITIN

Role Route S S S C C C ORAL ORAL VAGINAL

Duration

Manufacturer MERCK MERCK MERCK

SUSTAINED RELEASE 500 mg, QD EVERY OTHER DAY ON AND OFF SINCE 2005

VAGINITIS BACTERIAL OFF LABEL USE BRONCHITIS RHINITIS ALLERGIC TOOTH DISORDER

VITAMINS (UNSPECIFIED) PROTONIX LORAZEPAM

C C C

ORAL ORAL ORAL

UNK UNK, QD DELAYED RELEASE 0.5 mg, UNK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,010 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7541319 Date FDA Received
07-Aug-2012 Case # 7541319 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes HO,OT Manufacturer Control # US-009507513-2009SP0 41027 Dosage Text Age 21 YR Sex Female Country USA

Preferred Term HEPATIC CYST BRONCHITIS CHLAMYDIAL INFECTION HEADACHE PULMONARY EMBOLISM THROMBOSIS

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

8650876 Date FDA Received

07-Aug-2012

Case # 8650876

Case Type EXPEDITED (15-DAY)

Health Professional Y

Outcomes HO,OT

Manufacturer Control # US-009507513-2012SP0 11827 Dosage Text

Age

Sex Unknown

Country USA

Preferred Term LUNG DISORDER ANXIETY BRONCHITIS CARPAL TUNNEL SYNDROME CERVICAL DYSPLASIA CONTUSION COSTOCHONDRITIS DEEP VEIN THROMBOSIS HEPATIC CYST MALAISE PAIN PHARYNGITIS PULMONARY EMBOLISM RASH TENDONITIS UPPER RESPIRATORY TRACT INFECTION

Product NUVARING

Role Route S

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,011 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8664778 Date FDA Received
07-Aug-2012 Case # 8664778 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes HO,OT Manufacturer Control # US-009507513-2010SP0 25130 Dosage Text Duration Age Sex Unknown Country USA

Preferred Term PULMONARY EMBOLISM PULMONARY INFARCTION

Product NUVARING

Role Route S

Manufacturer MERCK

8672934 Date FDA Received

07-Aug-2012

Case # 8672934

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes HO

Manufacturer Control # US-009507513-2009-199 327-NL Dosage Text CONTINUING: NO

Age

Sex Unknown

Country USA

Preferred Term DEEP VEIN THROMBOSIS SINUSITIS LYMPHADENITIS BACTERIAL UPPER-AIRWAY COUGH SYNDROME HYPERSOMNIA INSOMNIA ANOVULATORY CYCLE DYSPEPSIA ENDOMETRIOSIS GASTROOESOPHAGEAL REFLUX DISEASE HAEMATEMESIS HAEMORRHOIDS LUTEAL PHASE DEFICIENCY MUSCLE SPASMS PAIN PELVIC ADHESIONS TENDONITIS VIRAL UPPER RESPIRATORY TRACT INFECTION

Product NUVARING EFFEXOR TOPAMAX PERCOCET XANAX XANAX

Role Route S C C C C C VAGINAL

Duration

Manufacturer MERCK

2 mg, BID

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,012 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8710239 Date FDA Received
07-Aug-2012 Case # 8710239 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # US-009507513-1207USA 003593 Role Route S Health Professional Y VAGINAL Dosage Text UNK Manufacturer Control # US-009507513-1207USA 003416 Role Route S Health Professional Y VAGINAL Manufacturer Control # US-009507513-1208USA 002404 Role Route S VAGINAL Dosage Text Duration Age Sex Unknown Dosage Text Duration Age Sex Unknown Duration Age Sex Unknown Country USA

Preferred Term ACNE

Product NUVARING Case # 8710251 Case Type NON-EXPEDITED

Manufacturer MERCK Country USA

8710251 Date FDA Received

07-Aug-2012

Outcomes

Preferred Term ALOPECIA

Product NUVARING Case # 8710252 Case Type NON-EXPEDITED

Manufacturer MERCK Country USA

8710252 Date FDA Received

07-Aug-2012

Outcomes

Preferred Term ALOPECIA

Product NUVARING

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,013 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8712003 Date FDA Received
07-Aug-2012 Case # 8712003 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes HO,DS Manufacturer Control # US-009507513-2011SP0 50850 Dosage Text UNK UNK, QM Duration Age Sex Unknown Country USA

Preferred Term SUICIDAL IDEATION CEREBRAL THROMBOSIS VENOUS THROMBOSIS MIGRAINE DIARRHOEA LYMPHADENOPATHY LYMPHADENOPATHY MEDIASTINAL MAJOR DEPRESSION MEDIASTINAL MASS MENTAL DISORDER NECK PAIN NEUROLOGICAL SYMPTOM OFF LABEL USE OROPHARYNGEAL PAIN PARTIAL SEIZURES VOMITING

Product NUVARING NUVARING LAMICTAL COUGH, COLD, AND FLU THERAPIES (UNSPECIFIED)

Role Route S S C C VAGINAL

Manufacturer MERCK MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,014 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8098142 Date FDA Received
09-Aug-2012 Case # 8098142 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes HO,OT Manufacturer Control # US-009507513-2011SP0 02479 Dosage Text UNK Duration Age Sex Unknown Country USA

Preferred Term HYPERCOAGULATION ORTHOSTATIC HYPOTENSION CERVICAL DYSPLASIA DEEP VEIN THROMBOSIS DENTAL CARE EMOTIONAL DISORDER HEADACHE MENTAL DISORDER OFF LABEL USE PAIN PULMONARY EMBOLISM

Product NUVARING NUVARING VALTREX

Role Route S S C VAGINAL

Manufacturer MERCK MERCK

8479571 Date FDA Received

09-Aug-2012

Case # 8479571

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,OT

Manufacturer Control # US-009507513-2012SP0 06668 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term APPENDICITIS EXCORIATION HEAD INJURY MUSCLE STRAIN PLEURAL EFFUSION PULMONARY EMBOLISM URINARY TRACT INFECTION

Product NUVARING

Role Route S

Duration 2.5 YEAR

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,015 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8614538 Date FDA Received
09-Aug-2012 Case # 8614538 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes HO,OT Manufacturer Control # US-009507513-2012SP0 00191 Dosage Text Duration Age Sex Unknown Country USA

Preferred Term SUICIDE ATTEMPT ABDOMINAL PAIN LOWER BRONCHITIS CARDIAC MURMUR CERVICAL DYSPLASIA CERVICITIS CERVICITIS HUMAN PAPILLOMA VIRUS DEPRESSION HEADACHE MAJOR DEPRESSION MENORRHAGIA MIGRAINE MUSCULAR WEAKNESS POSTPARTUM DEPRESSION POST-TRAUMATIC STRESS DISORDER PULMONARY EMBOLISM SEASONAL ALLERGY SPLENIC CYST SUICIDAL IDEATION UPPER RESPIRATORY TRACT INFECTION WRIST FRACTURE

Product NUVARING

Role Route S

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,016 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8615066 Date FDA Received
09-Aug-2012 Case # 8615066 Case Type EXPEDITED (15-DAY) Health Professional Y Outcomes HO,DS,LT,OT Manufacturer Control # US-009507513-2012SP0 22940 Dosage Text one ring for 3 weeks, followed by a ring free week one ring for 3 weeks, followed by a ring free week UNK Manufacturer Control # DE-009507513-2012SP0 31348 Dosage Text UNK Duration 97 DAY Age Sex Unknown Country DEU Duration Age Sex Unknown Country USA

Preferred Term THORACIC OUTLET SYNDROME

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

DEEP VEIN THROMBOSIS

NUVARING

VAGINAL

MERCK

PULMONARY EMBOLISM

ALBUTEROL Case Type EXPEDITED (15-DAY) Health Professional Y

C Outcomes HO

8639835 Date FDA Received

09-Aug-2012

Case # 8639835

Preferred Term FACIAL PARESIS DISORIENTATION HYPERHIDROSIS HYPOAESTHESIA HYPOTENSION PERIPHERAL COLDNESS SENSORY DISTURBANCE

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

8660561 Date FDA Received

09-Aug-2012

Case # 8660561

Case Type EXPEDITED (15-DAY)

Health Professional Y

Outcomes HO,LT,OT

Manufacturer Control # DE-009507513-2012SP0 33439 Dosage Text UNK

Age

Sex Unknown

Country DEU

Preferred Term PULMONARY EMBOLISM

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,017 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8660641 Date FDA Received
09-Aug-2012 Case # 8660641 Case Type EXPEDITED (15-DAY) Health Professional Y Outcomes HO,OT Manufacturer Control # US-009507513-2012SP0 11854 Dosage Text Age 21 YR Sex Female Country USA

Preferred Term PULMONARY EMBOLISM THROMBOSIS DEPRESSION EMOTIONAL DISORDER HYPOTHYROIDISM MIGRAINE

Product NUVARING NUVARING NUVARING

Role Route S S S

Duration

Manufacturer MERCK MERCK MERCK

8662205 Date FDA Received

09-Aug-2012

Case # 8662205

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes HO,OT

Manufacturer Control # US-009507513-2011SP0 34315 Dosage Text UNK UNK, QM 36 mg, QD

Age 22 YR

Sex Female

Country USA

Preferred Term PULMONARY EMBOLISM HYPERCOAGULATION BASAL CELL CARCINOMA LUNG NEOPLASM OVARIAN CYST

Product NUVARING CONCERTA

Role Route S C VAGINAL ORAL

Duration

Manufacturer MERCK

8662808 Date FDA Received

09-Aug-2012

Case # 8662808

Case Type EXPEDITED (15-DAY)

Health Professional Y

Outcomes HO

Manufacturer Control # US-009507513-2012SP0 11808 Dosage Text 0.12-0.015 mg/24 hrs

Age

Sex Unknown

Country USA

Preferred Term TRANSVERSE SINUS THROMBOSIS EMOTIONAL DISORDER ASTHMA CARPAL TUNNEL SYNDROME LYMPHADENOPATHY MIGRAINE

Product NUVARING NUVARING

Role Route S S VAGINAL

Duration

Manufacturer MERCK MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,018 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8664566 Date FDA Received
09-Aug-2012 Case # 8664566 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes HO,OT Manufacturer Control # US-009507513-2011SP0 53027 Dosage Text UNK Duration Age Sex Unknown Country USA

Preferred Term LIGAMENT OPERATION DEEP VEIN THROMBOSIS HYPERTENSION OFF LABEL USE PULMONARY EMBOLISM TRICUSPID VALVE INCOMPETENCE

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

8666162 Date FDA Received

09-Aug-2012

Case # 8666162

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes HO

Manufacturer Control # US-009507513-2012SP0 11830 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term VENA CAVA THROMBOSIS CHOLELITHIASIS DIVERTICULUM CEREBRAL THROMBOSIS DEEP VEIN THROMBOSIS DRUG HYPERSENSITIVITY RENAL DISORDER

Product NUVARING COUMADIN NEXIUM

Role Route S S C VAGINAL

Duration

Manufacturer MERCK

8681752 Date FDA Received

09-Aug-2012

Case # 8681752

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes OT

Manufacturer Control # FR-009507513-2012SP0 34502 Dosage Text UNK

Age 33 YR

Sex Female

Country FRA

Preferred Term UNINTENDED PREGNANCY ABORTION INDUCED

Product NUVARING

Role Route S

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,019 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7892516 Date FDA Received
10-Aug-2012 Case # 7892516 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2010SP0 62558 Dosage Text Duration Age Sex Unknown Country USA

Preferred Term HYPERCOAGULATION DEEP VEIN THROMBOSIS HEART RATE IRREGULAR LEFT VENTRICULAR DYSFUNCTION MIGRAINE PULMONARY EMBOLISM

Product NUVARING

Role Route S

Manufacturer MERCK

8087470 Date FDA Received

10-Aug-2012

Case # 8087470

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,OT

Manufacturer Control # US-009507513-2011SP0 06211 Dosage Text 1 DF, QM 81 mg, QD 120 mg, QD

Age 32 YR

Sex Female

Country USA

Preferred Term ASTHMA HYPERCOAGULATION PULMONARY EMBOLISM PAIN SLEEP APNOEA SYNDROME DYSMENORRHOEA FACIAL BONES FRACTURE HEADACHE INSOMNIA MITRAL VALVE INCOMPETENCE

Product NUVARING NUVARING ASPIRIN CARDIZEM CD CARTIA XT

Role Route S S C C C ORAL ORAL VAGINAL

Duration

Manufacturer MERCK MERCK

8162873 Date FDA Received

10-Aug-2012

Case # 8162873

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes HO,OT

Manufacturer Control # US-009507513-2011SP0 25633 Dosage Text UNK UNK

Age

Sex Unknown

Country USA

Preferred Term MYOCARDIAL INFARCTION VENTRICULAR DYSFUNCTION

Product NUVARING NUVARING

Role Route S S

Duration

Manufacturer MERCK MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,020 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8162873
Preferred Term HEART RATE IRREGULAR PULMONARY HYPERTENSION PAIN CORONARY ARTERY DISEASE MITRAL VALVE INCOMPETENCE TRICUSPID VALVE INCOMPETENCE DILATATION VENTRICULAR ALOPECIA ANXIETY CARPAL TUNNEL SYNDROME DYSFUNCTIONAL UTERINE BLEEDING DYSMENORRHOEA DYSPAREUNIA HEPATIC CONGESTION HYPERCOAGULATION INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION INCORRECT DRUG ADMINISTRATION DURATION LUNG NEOPLASM MENORRHAGIA METRORRHAGIA MIGRAINE MUSCULOSKELETAL PAIN OFF LABEL USE PLACENTAL DISORDER PULMONARY EMBOLISM PULMONARY INFARCTION TRANSAMINASES INCREASED VAGINAL DISCHARGE Product NUVARING NUVARING NUVARING COUMADIN VITAMINS (UNSPECIFIED) CORTICOSTEROIDS (UNSPECIFIED) CORTICOSTEROIDS (UNSPECIFIED) Role Route S S S S C C C 3-4 TIMES/WEEK VAGINAL Dosage Text UNK UNK UNK Duration Manufacturer MERCK MERCK MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,021 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8162873
Preferred Term VAGINITIS BACTERIAL VULVITIS Product Role Route Dosage Text Duration Manufacturer

8502193 Date FDA Received

10-Aug-2012

Case # 8502193

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes HO,OT

Manufacturer Control # US-009507513-2012SP0 00175 Dosage Text

Age

Sex Unknown

Country USA

Preferred Term CHOLELITHIASIS DEEP VEIN THROMBOSIS FALL HEPATIC STEATOSIS LIGAMENT SPRAIN MUSCLE STRAIN PULMONARY EMBOLISM

Product NUVARING

Role Route S

Duration

Manufacturer MERCK

8661946 Date FDA Received

10-Aug-2012

Case # 8661946

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes

Manufacturer Control # US-009507513-2012SP0 26946

Age

Sex Female

Country USA

Preferred Term UNINTENDED PREGNANCY INCORRECT DRUG ADMINISTRATION DURATION PREGNANCY WITH CONTRACEPTIVE DEVICE

Product NUVARING

Role Route S VAGINAL

Dosage Text 0.120MG/0.05MG PER DAY

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,022 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8669292 Date FDA Received
10-Aug-2012 Case # 8669292 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes HO,OT Manufacturer Control # US-009507513-2011SP0 42784 Dosage Text 1 DF, qm Duration 24 DAY Age Sex Unknown Country USA

Preferred Term PREMATURE RUPTURE OF MEMBRANES PULMONARY EMBOLISM DEEP VEIN THROMBOSIS ABORTION THREATENED RIGHT VENTRICULAR SYSTOLIC PRESSURE INCREASED ADJUSTMENT DISORDER BLOOD COUNT ABNORMAL CHEST PAIN DIASTOLIC DYSFUNCTION DYSPNOEA GROIN PAIN HYPERCOAGULATION MITRAL VALVE INCOMPETENCE PELVIC PAIN POLYCYSTIC OVARIES PYREXIA SINUSITIS UNINTENDED PREGNANCY

Product NUVARING NUVARING NUVARING NUVARING HORMONAL CONTRACEPTIVES (UNSPECIFIED)

Role Route S S S S C VAGINAL

Manufacturer MERCK MERCK MERCK MERCK

UNK

8678661 Date FDA Received

10-Aug-2012

Case # 8678661

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes OT

Manufacturer Control # US-009507513-2012SP0 17432 Dosage Text UNK

Age 34 YR

Sex Female

Country USA

Preferred Term PULMONARY EMBOLISM DEEP VEIN THROMBOSIS

Product NUVARING

Role Route S

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,023 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8680300 Date FDA Received
10-Aug-2012 Case # 8680300 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes HO Manufacturer Control # US-009507513-2011SP0 40939 Dosage Text UNK UNK Duration Age Sex Unknown Country USA

Preferred Term DEEP VEIN THROMBOSIS DRUG HYPERSENSITIVITY CYSTITIS VULVOVAGINAL MYCOTIC INFECTION

Product NUVARING NUVARING

Role Route S S VAGINAL

Manufacturer MERCK MERCK

8683265 Date FDA Received

10-Aug-2012

Case # 8683265

Case Type NON-EXPEDITED

Health Professional Y

Outcomes

Manufacturer Control # US-009507513-1207USA 008978

Age

Sex Unknown

Country USA

Preferred Term MENSTRUAL DISORDER INCORRECT STORAGE OF DRUG DRUG INEFFECTIVE

Product NUVARING VYVANSE

Role Route S C VAGINAL

Dosage Text

Duration

Manufacturer MERCK

8716309 Date FDA Received

10-Aug-2012

Case # 8716309

Case Type NON-EXPEDITED

Health Professional Y

Outcomes

Manufacturer Control # US-009507513-2012SP0 29421

Age

Sex Unknown

Country USA

Preferred Term MYDRIASIS

Product NUVARING TRANSDERM SCOP

Role Route S S Outcomes VAGINAL

Dosage Text

Duration

Manufacturer MERCK

8716320 Date FDA Received

10-Aug-2012

Case # 8716320

Case Type NON-EXPEDITED

Health Professional Y

Manufacturer Control # US-009507513-1207USA 005240

Age

Sex Unknown

Country USA

Preferred Term UNINTENDED PREGNANCY NO ADVERSE EVENT

Product NUVARING

Role Route S VAGINAL

Dosage Text UNK, qm

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,024 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8716328 Date FDA Received
10-Aug-2012 Case # 8716328 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes HO,OT Manufacturer Control # US-009507513-2011SP0 46642 Dosage Text Duration Age Sex Unknown Country USA

Preferred Term PULMONARY EMBOLISM ABORTION SPONTANEOUS ANXIETY DEEP VEIN THROMBOSIS DEPRESSION GONORRHOEA INSOMNIA MENTAL DISORDER PHYSICAL ASSAULT

Product NUVARING

Role Route S

Manufacturer MERCK

8716334 Date FDA Received

10-Aug-2012

Case # 8716334

Case Type NON-EXPEDITED

Health Professional Y

Outcomes

Manufacturer Control # US-009507513-1207USA 000696

Age

Sex Unknown

Country USA

Preferred Term DEVICE EXPULSION WRONG TECHNIQUE IN DRUG USAGE PROCESS

Product NUVARING

Role Route S VAGINAL

Dosage Text UNK

Duration

Manufacturer MERCK

8716339 Date FDA Received

10-Aug-2012

Case # 8716339

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # US-009507513-1207USA 007682

Age

Sex Unknown

Country USA

Preferred Term ACCIDENTAL OVERDOSE

Product NUVARING

Role Route S VAGINAL

Dosage Text 3 weeks in, 1 week out

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,025 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8716385 Date FDA Received
10-Aug-2012 Case # 8716385 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # US-009507513-1207USA 011488 Role Route S VAGINAL Dosage Text 1 DF, qm Duration Age Sex Unknown Country USA

Preferred Term INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION NO ADVERSE EVENT

Product NUVARING

Manufacturer MERCK

8716410 Date FDA Received

10-Aug-2012

Case # 8716410

Case Type NON-EXPEDITED

Health Professional Y

Outcomes

Manufacturer Control # US-009507513-1207USA 011523

Age

Sex Unknown

Country USA

Preferred Term METRORRHAGIA INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION MENSTRUATION DELAYED

Product NUVARING

Role Route S VAGINAL

Dosage Text

Duration

Manufacturer MERCK

8716411 Date FDA Received

10-Aug-2012

Case # 8716411

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # US-009507513-1207USA 013103

Age

Sex Unknown

Country USA

Preferred Term ALOPECIA

Product NUVARING Case # 8716421 Case Type NON-EXPEDITED Health Professional Y

Role Route S VAGINAL

Dosage Text UNK Manufacturer Control # US-009507513-1207USA 011583

Duration

Manufacturer MERCK

8716421 Date FDA Received

10-Aug-2012

Outcomes

Age

Sex Unknown

Country USA

Preferred Term THROMBOPHLEBITIS SUPERFICIAL

Product NUVARING

Role Route S VAGINAL

Dosage Text 0.12mg/0.015mg, UNK

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,026 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8716422 Date FDA Received
10-Aug-2012 Case # 8716422 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # US-009507513-1207USA 011591 Role Route S VAGINAL Dosage Text 1 DF, qm Duration Age Sex Unknown Country USA

Preferred Term DYSMENORRHOEA METRORRHAGIA

Product NUVARING

Manufacturer MERCK

8716430 Date FDA Received

10-Aug-2012

Case # 8716430

Case Type NON-EXPEDITED

Health Professional Y

Outcomes

Manufacturer Control # US-009507513-1207USA 013093

Age

Sex Unknown

Country USA

Preferred Term METRORRHAGIA

Product NUVARING Case # 8716472 Case Type NON-EXPEDITED Health Professional Y

Role Route S VAGINAL

Dosage Text 3 weeks in, 1 week out Manufacturer Control # US-009507513-1208USA 003350

Duration

Manufacturer MERCK

8716472 Date FDA Received

10-Aug-2012

Outcomes

Age

Sex Unknown

Country USA

Preferred Term DYSPNOEA

Product NUVARING

Role Route S VAGINAL

Dosage Text 1 DF, UNK

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,027 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8716477 Date FDA Received
10-Aug-2012 Case # 8716477 Case Type EXPEDITED (15-DAY) Health Professional Y Outcomes HO Manufacturer Control # US-009507513-2009SP0 17678 Dosage Text 1 DF, QM 150 mg, QD UNK UNK, PRN Duration Age Sex Unknown Country USA

Preferred Term DEEP VEIN THROMBOSIS SKIN ULCER TENDONITIS UTERINE LEIOMYOMA HYPERCHOLESTEROLAEMIA BREAST MASS CHEST PAIN HEADACHE HYPERCOAGULATION OEDEMA PERIPHERAL OFF LABEL USE PAIN PAIN IN EXTREMITY SEASONAL ALLERGY

Product NUVARING NUVARING SYNTHROID OMEGA-3-ACID ETHYL ESTERS PREVACID

Role Route S S C C C

Manufacturer MERCK MERCK

8716480 Date FDA Received

10-Aug-2012

Case # 8716480

Case Type NON-EXPEDITED

Health Professional Y

Outcomes

Manufacturer Control # US-009507513-1208USA 002860

Age

Sex Unknown

Country USA

Preferred Term METRORRHAGIA

Product NUVARING NUVARING TOPAMAX

Role Route S S C VAGINAL

Dosage Text UNK

Duration

Manufacturer MERCK MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,028 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8716481 Date FDA Received
10-Aug-2012 Case # 8716481 Case Type NON-EXPEDITED Health Professional Y Outcomes Manufacturer Control # US-009507513-1208USA 003020 Role Route S VAGINAL Dosage Text UNK Duration Age Sex Unknown Country USA

Preferred Term HYPOMENORRHOEA INCORRECT DRUG ADMINISTRATION DURATION

Product NUVARING

Manufacturer MERCK

8716492 Date FDA Received

10-Aug-2012

Case # 8716492

Case Type NON-EXPEDITED

Health Professional Y

Outcomes

Manufacturer Control # US-009507513-1208USA 003305

Age

Sex Unknown

Country USA

Preferred Term METRORRHAGIA

Product NUVARING VITAMINS (UNSPECIFIED) CELEXA

Role Route S C C Health Professional N Outcomes HO,OT VAGINAL

Dosage Text UNK, 1 ring for 3 weeks

Duration

Manufacturer MERCK

8716498 Date FDA Received

10-Aug-2012

Case # 8716498

Case Type EXPEDITED (15-DAY)

Manufacturer Control # US-009507513-2010SP0 29016 Dosage Text 1 DF, QM

Age

Sex Unknown

Country USA

Preferred Term CEREBRAL ARTERY THROMBOSIS EMOTIONAL DISORDER

Product NUVARING DEPAKOTE SEROQUEL WELLBUTRIN

Role Route S C C C Outcomes OT VAGINAL

Duration

Manufacturer MERCK

8716501 Date FDA Received

10-Aug-2012

Case # 8716501

Case Type EXPEDITED (15-DAY)

Health Professional N

Manufacturer Control # US-009507513-1208USA 002538 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term PULMONARY EMBOLISM

Product NUVARING

Role Route S

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,029 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8716503 Date FDA Received
10-Aug-2012 Case # 8716503 Case Type NON-EXPEDITED Health Professional Y Outcomes Manufacturer Control # US-009507513-1208USA 003311 Role Route S Health Professional Y VAGINAL Dosage Text UNK, qm Manufacturer Control # CZ-009507513-1207CZE 012357 Dosage Text UNK Duration Age Sex Unknown Duration Age Sex Unknown Country USA

Preferred Term INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION

Product NUVARING Case Type EXPEDITED (15-DAY)

Manufacturer MERCK Country CZE

8716682 Date FDA Received

10-Aug-2012

Case # 8716682

Outcomes HO

Preferred Term ABORTION INDUCED PREGNANCY WITH CONTRACEPTIVE DEVICE UNINTENDED PREGNANCY

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

8718790 Date FDA Received

10-Aug-2012

Case # 8718790

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # US-009507513-1208USA 002997

Age

Sex Unknown

Country USA

Preferred Term DECIDUAL CAST

Product NUVARING Case # 8741998 Case Type DIRECT Product NUVARING LOVENOX COUMADIN Health Professional N

Role Route S VAGINAL

Dosage Text UNK Manufacturer Control #

Duration

Manufacturer MERCK

8741998 Date FDA Received

10-Aug-2012 Preferred Term

Outcomes HO,DS,LT,OT,RI Role Route S C C VAGINAL

Age 26 YR

Sex Female

Country USA

Dosage Text 0.15MG DAILY VAG

Duration

Manufacturer SCHERING PLOUGH

INFLUENZA LIKE ILLNESS PAIN PNEUMONIA DEEP VEIN THROMBOSIS OEDEMA PERIPHERAL PULMONARY EMBOLISM

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,030 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8742321 Date FDA Received
10-Aug-2012 Preferred Term DEEP VEIN THROMBOSIS NON-HODGKIN'S LYMPHOMA SUPERIOR VENA CAVA SYNDROME Case # 8742321 Case Type DIRECT Product NUVARING Health Professional N Outcomes OT Role Route S Dosage Text Manufacturer Control # Age 30 YR Duration Sex Female Country USA

Manufacturer

8718890 Date FDA Received

11-Aug-2012

Case # 8718890

Case Type NON-EXPEDITED

Health Professional Y

Outcomes

Manufacturer Control # US-009507513-1208USA 000421

Age

Sex Unknown

Country USA

Preferred Term INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION NO ADVERSE EVENT

Product NUVARING

Role Route S VAGINAL

Dosage Text

Duration

Manufacturer MERCK

8718958 Date FDA Received

11-Aug-2012

Case # 8718958

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # US-009507513-1208USA 000431

Age

Sex Unknown

Country USA

Preferred Term METRORRHAGIA OFF LABEL USE

Product NUVARING

Role Route S VAGINAL

Dosage Text 1 DF, qm

Duration

Manufacturer MERCK

8718967 Date FDA Received

11-Aug-2012

Case # 8718967

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # US-009507513-1208USA 003184

Age

Sex Unknown

Country USA

Preferred Term BURNING SENSATION DEVICE BREAKAGE

Product NUVARING BACILLUS COAGULANS\LYSINE

Role Route S C VAGINAL

Dosage Text 3 week in, 1 week out

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,031 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8718969 Date FDA Received
11-Aug-2012 Case # 8718969 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # US-009507513-1208USA 003145 Role Route S VAGINAL Dosage Text UNK Duration Age Sex Unknown Country USA

Preferred Term MENORRHAGIA DYSMENORRHOEA

Product NUVARING

Manufacturer MERCK

8718973 Date FDA Received

11-Aug-2012

Case # 8718973

Case Type NON-EXPEDITED

Health Professional Y

Outcomes

Manufacturer Control # US-009507513-1208USA 003140

Age

Sex Unknown

Country USA

Preferred Term DEVICE BREAKAGE

Product NUVARING Case # 8718988 Case Type NON-EXPEDITED Health Professional N

Role Route S Outcomes

Dosage Text UNK Manufacturer Control # US-009507513-1208USA 003344

Duration

Manufacturer MERCK

8718988 Date FDA Received

12-Aug-2012

Age

Sex Unknown

Country USA

Preferred Term INCORRECT DRUG ADMINISTRATION DURATION INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION

Product NUVARING

Role Route S VAGINAL

Dosage Text UNK UNK, qm

Duration

Manufacturer MERCK

8718989 Date FDA Received

12-Aug-2012

Case # 8718989

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # US-009507513-1208USA 000423

Age

Sex Unknown

Country USA

Preferred Term BREAST TENDERNESS HEADACHE INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION NAUSEA

Product NUVARING

Role Route S VAGINAL

Dosage Text 3 weeks in, 1 week out

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,032 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8718991 Date FDA Received
12-Aug-2012 Case # 8718991 Case Type NON-EXPEDITED Health Professional Y Outcomes Manufacturer Control # US-009507513-1208USA 001671 Role Route S VAGINAL Dosage Text Duration Age Sex Unknown Country USA

Preferred Term DEVICE EXPULSION NO ADVERSE EVENT

Product NUVARING

Manufacturer MERCK

7006071 Date FDA Received

13-Aug-2012

Case # 7006071

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes HO,OT

Manufacturer Control # US-009507513-2008-174 108-NL Dosage Text DOSE TEXT: 3 WEEKS IN, 1 WEEK OUT, CONTINUING: NO 25 g, UNK 20 mg, QD

Age

Sex Unknown

Country USA

Preferred Term CONVULSION

Product NUVARING

Role Route S VAGINAL

Duration 128 DAY

Manufacturer MERCK

THROMBOTIC STROKE VENOUS THROMBOSIS ASTHENIA DYSPNOEA LIVEDO RETICULARIS MUSCULOSKELETAL PAIN VENOUS INSUFFICIENCY

LEVOTHYROXINE SODIUM FUROSEMIDE

C C

ORAL

MERCK

8719021 Date FDA Received

13-Aug-2012

Case # 8719021

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # US-009507513-1208USA 003325

Age

Sex Unknown

Country USA

Preferred Term INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION MENSTRUATION DELAYED UNINTENDED PREGNANCY

Product NUVARING IBUPROFEN

Role Route S C VAGINAL

Dosage Text 1 DF, qm UNK, prn

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,033 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8719043 Date FDA Received
13-Aug-2012 Case # 8719043 Case Type NON-EXPEDITED Health Professional Y Outcomes Manufacturer Control # US-009507513-1207USA 013102 Role Route S Health Professional N VAGINAL Dosage Text 1 DF, qm Manufacturer Control # US-009507513-1207USA 008400 Role Route S VAGINAL Dosage Text UNK Duration Age Sex Unknown Duration Age Sex Unknown Country USA

Preferred Term INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION

Product NUVARING Case Type NON-EXPEDITED

Manufacturer MERCK Country USA

8719254 Date FDA Received

13-Aug-2012

Case # 8719254

Outcomes

Preferred Term METRORRHAGIA ABNORMAL WITHDRAWAL BLEEDING

Product NUVARING

Manufacturer MERCK

8719257 Date FDA Received

13-Aug-2012

Case # 8719257

Case Type NON-EXPEDITED

Health Professional Y

Outcomes

Manufacturer Control # US-009507513-1208USA 002868

Age

Sex Unknown

Country USA

Preferred Term ANXIETY DEVICE EXPULSION METRORRHAGIA NERVOUSNESS

Product NUVARING NUVARING

Role Route S S VAGINAL

Dosage Text UNK

Duration

Manufacturer MERCK MERCK

8719278 Date FDA Received

13-Aug-2012

Case # 8719278

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # US-009507513-1208USA 004266

Age

Sex Unknown

Country USA

Preferred Term UNINTENDED PREGNANCY

Product NUVARING

Role Route S VAGINAL

Dosage Text

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,034 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8719417 Date FDA Received
13-Aug-2012 Case # 8719417 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes DS Manufacturer Control # US-009507513-1208USA 001182 Dosage Text 0.120 mg/day of etonogestrel and 0. 015 mg/day of ethinyl estradiol/21 days Manufacturer Control # US-009507513-2011SP0 26445 Dosage Text Duration Age Sex Unknown Duration Age Sex Unknown Country USA

Preferred Term BLADDER OBSTRUCTION

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

8276077 Date FDA Received

14-Aug-2012

Case # 8276077

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes HO,OT

Country USA

Preferred Term HYPERCOAGULATION LOBAR PNEUMONIA PULMONARY EMBOLISM PULMONARY INFARCTION

Product NUVARING MODAFINIL FLUOCINONIDE VITAMINS (UNSPECIFIED) OMEGA-3-ACID ETHYL ESTERS

Role Route S C C C C VAGINAL

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,035 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8558854 Date FDA Received
14-Aug-2012 Case # 8558854 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes HO,DS,OT Manufacturer Control # US-009507513-2011SP0 56191 Dosage Text Duration Age Sex Unknown Country USA

Preferred Term CELLULITIS STAPHYLOCOCCAL INFECTION ABSCESS PULMONARY EMBOLISM ANXIETY ARTHROPOD BITE BIPOLAR DISORDER MOOD SWINGS RHINITIS ALLERGIC SOMNOLENCE SUICIDAL IDEATION UPPER RESPIRATORY TRACT INFECTION

Product NUVARING TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE CELEXA

Role Route S S S C

Manufacturer MERCK

8650612 Date FDA Received

14-Aug-2012

Case # 8650612

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes HO,DS,OT

Manufacturer Control # US-009507513-2011SP0 51912 Dosage Text 100 g, QD UNK UNK, QD UNK UNK, QD UNK UNK, QD

Age

Sex Unknown

Country USA

Preferred Term COMA CEREBRAL VENOUS THROMBOSIS INSOMNIA DRUG ABUSE PARANOIA ANTICOAGULATION DRUG LEVEL BELOW THERAPEUTIC CARDIAC MURMUR DEPRESSION MUSCLE TIGHTNESS

Product NUVARING CYTOMEL CALCIUM (UNSPECIFIED) VITAMINS (UNSPECIFIED) FOLIC ACID

Role Route S C C C C

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,036 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8665016 Date FDA Received
14-Aug-2012 Case # 8665016 Case Type NON-EXPEDITED Health Professional Y Outcomes Manufacturer Control # US-009507513-1207USA 001248 Role Route S Health Professional Y Outcomes Dosage Text UNK, qm Manufacturer Control # US-009507513-2012SP0 32086 Role Route S Health Professional Y VAGINAL Dosage Text 0.015/0.12MG Manufacturer Control # US-009507513-1208USA 004499 Role Route S Health Professional N VAGINAL Dosage Text UNK Manufacturer Control # US-009507513-2010SP0 46916 Dosage Text UNK Duration 1.7 YEAR Age Sex Unknown Duration Age Sex Unknown Duration Age Sex Unknown Duration Age Sex Unknown Country USA

Preferred Term MENORRHAGIA

Product NUVARING Case # 8722390 Case Type NON-EXPEDITED

Manufacturer MERCK Country USA

8722390 Date FDA Received

14-Aug-2012

Preferred Term UNINTENDED PREGNANCY

Product NUVARING Case Type NON-EXPEDITED

Manufacturer MERCK Country USA

8722395 Date FDA Received

14-Aug-2012

Case # 8722395

Outcomes

Preferred Term ARTHROPATHY

Product NUVARING Case # 8722405 Case Type EXPEDITED (15-DAY)

Manufacturer MERCK Country USA

8722405 Date FDA Received

14-Aug-2012

Outcomes HO,OT

Preferred Term DEEP VEIN THROMBOSIS BREAST MASS FALL JOINT INJURY PULMONARY EMBOLISM

Product NUVARING

Role Route S

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,037 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8722409 Date FDA Received
14-Aug-2012 Case # 8722409 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # US-009507513-1208USA 003057 Role Route S Health Professional Y VAGINAL Dosage Text 3 weeks in, 1 week out Manufacturer Control # US-009507513-1208USA 004187 Role Route S VAGINAL Dosage Text UNK Duration Age Sex Unknown Duration Age Sex Unknown Country USA

Preferred Term MENSTRUATION IRREGULAR

Product NUVARING Case Type NON-EXPEDITED

Manufacturer MERCK Country USA

8722410 Date FDA Received

14-Aug-2012

Case # 8722410

Outcomes

Preferred Term UNINTENDED PREGNANCY NO ADVERSE EVENT

Product NUVARING

Manufacturer MERCK

8723603 Date FDA Received

14-Aug-2012

Case # 8723603

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # US-009507513-1208USA 003342

Age

Sex Unknown

Country USA

Preferred Term DEVICE EXPULSION INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION

Product NUVARING

Role Route S VAGINAL

Dosage Text UNK, qm

Duration

Manufacturer MERCK

8723791 Date FDA Received

15-Aug-2012

Case # 8723791

Case Type NON-EXPEDITED

Health Professional Y

Outcomes

Manufacturer Control # US-009507513-1208USA 004560

Age

Sex Unknown

Country USA

Preferred Term INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION

Product NUVARING

Role Route S VAGINAL

Dosage Text UNK, qm

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,038 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8724351 Date FDA Received
15-Aug-2012 Case # 8724351 Case Type EXPEDITED (15-DAY) Health Professional Y Outcomes HO,OT Manufacturer Control # US-009507513-2010SP0 51451 Dosage Text UNK UNK, QM Duration Age Sex Unknown Country USA

Preferred Term PULMONARY EMBOLISM PULMONARY INFARCTION BACK PAIN CERVICAL DYSPLASIA DYSURIA

Product NUVARING NUVARING

Role Route S S

Manufacturer MERCK MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,039 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8693263 Date FDA Received
21-Aug-2012 Case # 8693263 Case Type EXPEDITED (15-DAY) Health Professional Outcomes DE,HO,DS,LT Manufacturer Control # US-VIROPHARMA INCORPORATED-20120 718CINRY3158 Dosage Text Age 37 YR Sex Female Country USA

Preferred Term PULMONARY EMBOLISM CARDIAC ARREST CONVULSION CEREBRAL INFARCTION SYNCOPE OFF LABEL USE HEREDITARY ANGIOEDEMA DEPRESSION ACUTE SINUSITIS

Product CINRYZE CINRYZE CINRYZE CINRYZE CINRYZE CINRYZE CINRYZE CINRYZE ORTHO TRI CYCLEN NUVARING EPIPEN CLONAZEPAM FEXOFENADINE METOPROLOL TARTRATE NORTRIPTYLINE PRILOSEC CITALOPRAM HYDROBROMIDE MELATONIN REMERON

Role Route S S S S S S S S S S C C C C C C C C C INTRAMUSCULAR ORAL ORAL UNKNOWN UNKNOWN UNKNOWN ORAL ORAL ORAL UNKNOWN

Duration

Manufacturer VIRONPHARMA VIRONPHARMA VIRONPHARMA VIRONPHARMA VIRONPHARMA VIRONPHARMA VIRONPHARMA VIRONPHARMA

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,040 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8314019 Date FDA Received
22-Aug-2012 Case # 8314019 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2011SP0 30606 Dosage Text Duration Age Sex Unknown Country USA

Preferred Term ANAEMIA CAVERNOUS SINUS THROMBOSIS DEEP VEIN THROMBOSIS EMOTIONAL DISORDER CHLAMYDIAL INFECTION DYSMENORRHOEA DYSPAREUNIA INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION MIGRAINE VAGINAL DISCHARGE VAGINITIS BACTERIAL

Product NUVARING NUVARING ALBUTEROL HEMP

Role Route S S C C

Manufacturer MERCK MERCK

UNK UNK, TIW

8341354 Date FDA Received

22-Aug-2012

Case # 8341354

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,OT

Manufacturer Control # US-009507513-2011SP0 46463 Dosage Text UNK UNK INCREASED TO 20 MG DAILY PRIOR TO 03DEC2009; LATER INCREASED TO 30 MG DAILY

Age

Sex Unknown

Country USA

Preferred Term PAIN IN EXTREMITY PULMONARY EMBOLISM HEADACHE

Product NUVARING NUVARING ADDERALL XR

Role Route S S C VAGINAL VAGINAL ORAL

Duration 124 DAY

Manufacturer MERCK MERCK

SEXUAL ABUSE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,041 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8341654 Date FDA Received
22-Aug-2012 Case # 8341654 Case Type EXPEDITED (15-DAY) Health Professional Y Outcomes HO,OT Manufacturer Control # US-009507513-2011SP0 31788 Dosage Text Duration Age Sex Unknown Country USA

Preferred Term DRUG RESISTANCE PULMONARY EMBOLISM HYPERCOAGULATION BRONCHITIS ANGINA PECTORIS METABOLIC SYNDROME CARDIOMEGALY ACUTE SINUSITIS COUGH DEPRESSION INTERNATIONAL NORMALISED RATIO INCREASED OTITIS MEDIA ACUTE PHARYNGITIS

Product NUVARING NUVARING COUMADIN VITAMINS (UNSPECIFIED) VITAMIN B COMPLEX HOODIA GORDONII HYDROCHLOROTHIAZIDE

Role Route S S S C C C C

Manufacturer MERCK MERCK

8662755 Date FDA Received

22-Aug-2012

Case # 8662755

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,OT

Manufacturer Control # US-009507513-2011SP0 51275 Dosage Text TAKEN ON A REGULAR BASIS SINCE AGE 13 1 DF, QD 1 PACKET (1000 MG) DAILY

Age

Sex Unknown

Country USA

Preferred Term PULMONARY EMBOLISM PELVIC VENOUS THROMBOSIS

Product NUVARING FLONASE

Role Route S C

Duration

Manufacturer MERCK

OFF LABEL USE BACK PAIN MUSCLE SPASMS

VITAMINS (UNSPECIFIED) ASCORBIC ACID [COMPOSITION UNSPECIFIED]

C C C

8668146
Date - Time: 02-04-2013 9:43:10 AM EST Note: If the field is blank, there is no data Page: 1,042 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8668146
FDA Received Date 22-Aug-2012 Case # 8668146 Case Type EXPEDITED (15-DAY) Health Professional Y Outcomes HO,OT Manufacturer Control # US-009507513-2011SP0 43793 Age Sex Unknown Country USA

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,043 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8668146
Preferred Term PULMONARY EMBOLISM DEEP VEIN THROMBOSIS OFF LABEL USE Product NUVARING NUVARING ASIAN GINSENG\BEE POLLEN \ELEUTHERO\EPHEDRA\GINGER \GOLDENSEAL\GOTU KOLA \ROYAL JELLY\SPIRULINA \VITAMIN E Role Route S S C VAGINAL VAGINAL Dosage Text 0.120 mg/0.015 mg per day 0.120 mg/0.015 mg per day UNK Duration Manufacturer MERCK MERCK

APPENDICITIS BACK PAIN BARTHOLIN'S CYST BREAST PAIN BRONCHITIS BRONCHOSPASM CERVICAL DYSPLASIA CHEST PAIN CONSTIPATION DEPRESSION DYSFUNCTIONAL UTERINE BLEEDING HAEMORRHAGIC OVARIAN CYST INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION INCORRECT DRUG ADMINISTRATION DURATION MUSCLE STRAIN NECK PAIN OVARIAN CYST OVERWEIGHT PLEURISY ROAD TRAFFIC ACCIDENT TONSILLAR DISORDER VAGINAL DISCHARGE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,044 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8680890 Date FDA Received
22-Aug-2012 Case # 8680890 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes OT Manufacturer Control # US-009507513-2011SP0 35862 Dosage Text UNK UNK Duration Age Sex Unknown Country USA

Preferred Term CHOLELITHIASIS THROMBOSIS BRONCHITIS ANXIETY BACK PAIN CYST DEEP VEIN THROMBOSIS DERMAL CYST DYSPEPSIA GASTROOESOPHAGEAL REFLUX DISEASE HEADACHE HERPES ZOSTER LACERATION MENSTRUATION IRREGULAR OEDEMA PERIPHERAL OTITIS EXTERNA POLYCYSTIC OVARIES ROAD TRAFFIC ACCIDENT THROMBOPHLEBITIS SUPERFICIAL VIITH NERVE PARALYSIS

Product NUVARING NUVARING IMITREX

Role Route S S C

Manufacturer MERCK MERCK

8737385 Date FDA Received

22-Aug-2012

Case # 8737385

Case Type NON-EXPEDITED

Health Professional Y

Outcomes

Manufacturer Control # US-009507513-1207USA 004749

Age

Sex Unknown

Country USA

Preferred Term DEVICE EXPULSION

Product NUVARING

Role Route S

Dosage Text UNK, q3w

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,045 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8737394 Date FDA Received
22-Aug-2012 Case # 8737394 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # US-009507513-1207USA 002871 Role Route S Health Professional Y VAGINAL Dosage Text UNK Manufacturer Control # US-009507513-1207USA 003478 Role Route S Health Professional N VAGINAL Manufacturer Control # US-009507513-1207USA 006406 Role Route S VAGINAL Dosage Text UNK Duration Age Sex Unknown Dosage Text Duration Age Sex Unknown Duration Age Sex Unknown Country USA

Preferred Term METRORRHAGIA

Product NUVARING Case # 8737454 Case Type NON-EXPEDITED

Manufacturer MERCK Country USA

8737454 Date FDA Received

22-Aug-2012

Outcomes

Preferred Term DEEP VEIN THROMBOSIS

Product NUVARING Case Type NON-EXPEDITED

Manufacturer MERCK Country USA

8737515 Date FDA Received

22-Aug-2012

Case # 8737515

Outcomes

Preferred Term UNINTENDED PREGNANCY INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION MENSTRUATION DELAYED

Product NUVARING

Manufacturer MERCK

8737581 Date FDA Received

22-Aug-2012

Case # 8737581

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # US-009507513-1207USA 007656

Age

Sex Unknown

Country USA

Preferred Term METRORRHAGIA

Product NUVARING CORTICOSTEROIDS (UNSPECIFIED)

Role Route S C VAGINAL

Dosage Text 3 weeks in, 2 week out UNK

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,046 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8737691 Date FDA Received
22-Aug-2012 Case # 8737691 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # US-009507513-1207USA 009059 Role Route S Health Professional Y Product NUVARING ETHINYL ESTRADIOL/ ETONOGESTREL Case Type DIRECT Product NUVARING NORVASC LISINOPRIL Health Professional Y VAGINAL Dosage Text UNK,3 weekss in 1 week out Manufacturer Control # Age 48 YR Dosage Text INTRAVAGINAL Duration Sex Female Duration Age Sex Unknown Country USA

Preferred Term INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION

Product NUVARING Case Type DIRECT

Manufacturer MERCK Country USA

8749478 Date FDA Received

22-Aug-2012 Preferred Term

Case # 8749478

Outcomes HO,DS,LT Role Route S C Outcomes DE,HO,DS,LT,OT Role Route S C C VAGINAL

Manufacturer MERCK

JUGULAR VEIN THROMBOSIS CEREBRAL HAEMORRHAGE

8749971 Date FDA Received

22-Aug-2012 Preferred Term

Case # 8749971

Manufacturer Control #

Age 43 YR

Sex Female

Country USA

Dosage Text

Duration

Manufacturer

ACUTE MYOCARDIAL INFARCTION CARDIAC ARREST

7281761 Date FDA Received

23-Aug-2012

Case # 7281761

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes HO,DS,OT

Manufacturer Control # US-009507513-2009-189 370-NL

Age

Sex Unknown

Country USA

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,047 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7281761
Preferred Term OVARIAN CYST RUPTURED Product NUVARING Role Route S VAGINAL Dosage Text DOSE TEXT: 3 WEEKS EVERY MONTH, CONTINUING: NO 50 g, UNK 10 mg, QD UNK UNK, PRN MERCK Duration Manufacturer MERCK

GASTRIC ULCER OSTEOARTHRITIS DEEP VEIN THROMBOSIS BLOOD ALKALINE PHOSPHATASE INCREASED ACROCHORDON ANAEMIA ARTHRITIS ASTHMA BACK PAIN BIRTH MARK CARPAL TUNNEL SYNDROME CONJUNCTIVITIS ALLERGIC EPICONDYLITIS GASTROOESOPHAGEAL REFLUX DISEASE INSOMNIA MENISCUS LESION MUSCLE STRAIN NIGHTMARE PHLEBITIS PLANTAR FASCIITIS RESTLESS LEGS SYNDROME RHINITIS ALLERGIC SCIATICA THROMBOPHLEBITIS TINEA PEDIS VENA CAVA FILTER INSERTION

LEVOXYL SYNTHROID SINGULAIR PROVENTIL

C C C C ORAL ORAL

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,048 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7523173 Date FDA Received
23-Aug-2012 Case # 7523173 Case Type EXPEDITED (15-DAY) Health Professional Y Outcomes HO,DS,OT Manufacturer Control # US-009507513-2010SP0 26653 Dosage Text Duration Age Sex Unknown Country USA

Preferred Term CERVICAL DYSPLASIA HYPONATRAEMIA PNEUMONIA ADJUSTMENT DISORDER ANAEMIA ANXIETY BRONCHITIS CELLULITIS DEPRESSED MOOD DRUG HYPERSENSITIVITY HAEMORRHOIDS HERPES SIMPLEX MUSCLE SPASMS PAPILLOMA VIRAL INFECTION PHARYNGITIS PULMONARY EMBOLISM RASH URINARY TRACT INFECTION UTERINE STENOSIS VULVAL DISORDER

Product NUVARING UNSPECIFIED INGREDIENT DARVOCET-N 50

Role Route S S C

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,049 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7545170 Date FDA Received
23-Aug-2012 Case # 7545170 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes HO,OT Manufacturer Control # US-009507513-2010SP0 14788 Dosage Text Duration Age Sex Unknown Country USA

Preferred Term OVARIAN CYST ARTHRALGIA CARDIAC MURMUR DEPRESSION DYSPNOEA EPISTAXIS HEART RATE INCREASED HYPERCOAGULATION MOOD SWINGS MYALGIA PULMONARY EMBOLISM PULMONARY INFARCTION SLEEP APNOEA SYNDROME SUPRAVENTRICULAR TACHYCARDIA SYNCOPE THROMBOSIS TRANSIENT ISCHAEMIC ATTACK VISION BLURRED WEIGHT INCREASED

Product NUVARING

Role Route S

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,050 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7805912 Date FDA Received
23-Aug-2012 Case # 7805912 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2010SP0 26376 Dosage Text Duration 91 DAY Age Sex Unknown Country USA

Preferred Term ABORTION MISSED PULMONARY EMBOLISM ABDOMINAL DISCOMFORT ANXIETY DEEP VEIN THROMBOSIS DEPRESSION HAEMANGIOMA OF LIVER NIGHT SWEATS PYREXIA TENSION HEADACHE THROMBOPHLEBITIS SUPERFICIAL UNINTENDED PREGNANCY

Product NUVARING PROVENTIL

Role Route S C

Manufacturer MERCK MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,051 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8336708 Date FDA Received
23-Aug-2012 Case # 8336708 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes HO,OT Manufacturer Control # US-009507513-2011SP0 12082 Dosage Text 10-325-4-6 X/DAY UNK UNK, PRN UNK UNK, PRN Duration Age Sex Unknown Country USA

Preferred Term ROAD TRAFFIC ACCIDENT FACIAL BONES FRACTURE CEREBRAL HAEMORRHAGE DEEP VEIN THROMBOSIS

Product NUVARING PERCOCET ALBUTEROL ACETAMINOPHEN \DICHLORALPHENAZONE \ISOMETHEPTENE MUCATE LYRICA TRIAZOLAM

Role Route S C C C

Manufacturer MERCK

LACERATION DRUG ABUSE AFFECTIVE DISORDER ALOPECIA DYSPAREUNIA HEADACHE LARYNGITIS PELVIC PAIN POST-TRAUMATIC STRESS DISORDER SUBSTANCE USE UPPER RESPIRATORY TRACT INFECTION

C C

225 mg, BID

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,052 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8447278 Date FDA Received
23-Aug-2012 Case # 8447278 Case Type EXPEDITED (15-DAY) Health Professional Y Outcomes HO,DS,OT Manufacturer Control # US-009507513-2011SP0 48235 Dosage Text UNK ORAL ORAL ORAL INHALATION 25 mg, QD 10 meq, QD 800 mg, BID 1 PUFF EACH NOSTRIL Duration 204 DAY Age Sex Unknown Country USA

Preferred Term LOBAR PNEUMONIA PULMONARY EMBOLISM HYPOKALAEMIA ANAEMIA MUSCLE SPASMS BACK PAIN DEVICE EXPULSION HYPERCOAGULATION PREGNANCY THROMBOSIS

Product NUVARING HYDROCHLOROTHIAZIDE K-TAB MOTRIN NASACORT AQ

Role Route S C C C C

Manufacturer MERCK

8482027 Date FDA Received

23-Aug-2012

Case # 8482027

Case Type EXPEDITED (15-DAY)

Health Professional Y

Outcomes HO,OT

Manufacturer Control # US-009507513-2011SP0 56194 Dosage Text

Age

Sex Unknown

Country USA

Preferred Term LUNG DISORDER PULMONARY EMBOLISM HYPERCOAGULATION HAEMORRHAGIC DISORDER Atypical pneumonia DEEP VEIN THROMBOSIS LUNG NEOPLASM MENORRHAGIA MIGRAINE MUSCLE SPASMS OFF LABEL USE STREPTOCOCCAL INFECTION

Product NUVARING NUVARING UNSPECIFIED INGREDIENT COUMADIN

Role Route S S S S

Duration

Manufacturer MERCK MERCK

365 DAY

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,053 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8666163 Date FDA Received
23-Aug-2012 Case # 8666163 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes OT Manufacturer Control # US-009507513-1207USA 001851 Dosage Text Duration Age Sex Unknown Country USA

Preferred Term NO ADVERSE EVENT

Product NUVARING Case # 8676201 Case Type EXPEDITED (15-DAY) Health Professional N

Role Route S Outcomes HO,OT

Manufacturer MERCK

8676201 Date FDA Received

23-Aug-2012

Manufacturer Control # US-009507513-2011SP0 43796 Dosage Text

Age

Sex Unknown

Country USA

Preferred Term PULMONARY EMBOLISM MIGRAINE AMENORRHOEA ARTHROPATHY CONJUNCTIVITIS CYST DEPRESSION HEADACHE KERATOMILEUSIS LIGAMENT SPRAIN LIMB DISCOMFORT MICTURITION URGENCY MUSCLE SPASMS OVARIAN CYST VAGINAL INFECTION VISION BLURRED WEIGHT INCREASED

Product NUVARING NUVARING

Role Route S S

Duration

Manufacturer MERCK MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,054 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8678521 Date FDA Received
23-Aug-2012 Case # 8678521 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes HO,OT Manufacturer Control # US-009507513-2012SP0 11826 Dosage Text UNK UNK UNK 1.2 YEAR Duration Age Sex Unknown Country USA

Preferred Term PNEUMONIA PULMONARY EMBOLISM DIABETES MELLITUS DIARRHOEA GLUCOSE TOLERANCE IMPAIRED MITRAL VALVE INCOMPETENCE OBESITY TRICUSPID VALVE INCOMPETENCE

Product NUVARING NUVARING NUVARING

Role Route S S S VAGINAL VAGINAL VAGINAL

Manufacturer MERCK MERCK MERCK

8697722 Date FDA Received

23-Aug-2012

Case # 8697722

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes HO,OT

Manufacturer Control # US-009507513-2012SP0 10635 Dosage Text

Age

Sex Unknown

Country USA

Preferred Term MENINGITIS VIRAL PULMONARY INFARCTION ANTIPHOSPHOLIPID ANTIBODIES POSITIVE EAR PAIN HYPERCOAGULATION METABOLIC ACIDOSIS MUSCLE SPASMS NAUSEA PHARYNGITIS STREPTOCOCCAL PULMONARY EMBOLISM VOMITING

Product NUVARING DILAUDID

Role Route S S

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,055 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8705452 Date FDA Received
23-Aug-2012 Case # 8705452 Case Type EXPEDITED (15-DAY) Health Professional Y Outcomes HO,OT Manufacturer Control # US-009507513-2012SP0 22371 Dosage Text UNK Duration Age Sex Unknown Country USA

Preferred Term PULMONARY EMBOLISM ABDOMINAL PAIN UPPER ANTICOAGULATION DRUG LEVEL BELOW THERAPEUTIC ANXIETY BREAST MASS COSTOCHONDRITIS PULMONARY FIBROSIS

Product NUVARING

Role Route S

Manufacturer MERCK

8716274 Date FDA Received

23-Aug-2012

Case # 8716274

Case Type EXPEDITED (15-DAY)

Health Professional Y

Outcomes HO,DS,OT

Manufacturer Control # US-009507513-2012SP0 22374 Dosage Text UNK UNK UNK 12 mg, qd

Age

Sex Unknown

Country USA

Preferred Term CHOLELITHIASIS ANTIPHOSPHOLIPID ANTIBODIES POSITIVE PULMONARY EMBOLISM ALOPECIA ANTICOAGULATION DRUG LEVEL BELOW THERAPEUTIC ANTIPHOSPHOLIPID SYNDROME ARTHRALGIA CHOLECYSTECTOMY DRUG HYPERSENSITIVITY DRUG RESISTANCE JOINT INJURY PARESIS PULMONARY THROMBOSIS VENA CAVA FILTER INSERTION

Product NUVARING COUMADIN COUMADIN COUMADIN

Role Route S S S S

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,056 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8737970 Date FDA Received
23-Aug-2012 Case # 8737970 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # US-009507513-1208USA 002456 Role Route S VAGINAL Dosage Text Duration Age Sex Unknown Country USA

Preferred Term COITAL BLEEDING CERVICITIS METRORRHAGIA WEIGHT INCREASED

Product NUVARING

Manufacturer MERCK

8738193 Date FDA Received

23-Aug-2012

Case # 8738193

Case Type NON-EXPEDITED

Health Professional Y

Outcomes

Manufacturer Control # US-009507513-1207USA 011587

Age

Sex Unknown

Country USA

Preferred Term THROMBOSIS

Product NUVARING Case # 8739081 Case Type NON-EXPEDITED Health Professional N

Role Route S VAGINAL

Dosage Text UNK Manufacturer Control # US-009507513-1208USA 000160

Duration

Manufacturer MERCK

8739081 Date FDA Received

23-Aug-2012

Outcomes

Age

Sex Unknown

Country USA

Preferred Term UNINTENDED PREGNANCY

Product NUVARING

Role Route S VAGINAL

Dosage Text 0.120 mg/day of etonogestrel and 0. 015 mg/day of ethinyl estradiol/21 days Manufacturer Control # US-009507513-1207USA 013114

Duration

Manufacturer MERCK

8739423 Date FDA Received

23-Aug-2012

Case # 8739423

Case Type NON-EXPEDITED

Health Professional Y

Outcomes

Age

Sex Unknown

Country USA

Preferred Term PAIN WITHDRAWAL BLEED

Product NUVARING

Role Route S VAGINAL

Dosage Text UNK

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,057 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8739872 Date FDA Received
23-Aug-2012 Case # 8739872 Case Type EXPEDITED (15-DAY) Health Professional Y Outcomes HO,DS,OT Manufacturer Control # US-009507513-2011SP0 58562 Dosage Text UNK UNK Duration Age Sex Unknown Country USA

Preferred Term PULMONARY EMBOLISM DEEP VEIN THROMBOSIS ABDOMINAL PAIN CHEST PAIN COAGULOPATHY COUGH HYPERTENSION MIGRAINE MUSCLE STRAIN NAUSEA PAIN IN EXTREMITY TREATMENT NONCOMPLIANCE

Product NUVARING COUMADIN

Role Route S S

Manufacturer MERCK

8740005 Date FDA Received

23-Aug-2012

Case # 8740005

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # US-009507513-1208USA 001240

Age

Sex Unknown

Country USA

Preferred Term OEDEMA GENITAL

Product NUVARING Case # 8740236 Case Type NON-EXPEDITED Health Professional Y

Role Route S VAGINAL

Dosage Text 0.15/0.012 mg/day Manufacturer Control # US-009507513-1208USA 002353

Duration

Manufacturer MERCK

8740236 Date FDA Received

23-Aug-2012

Outcomes

Age

Sex Unknown

Country USA

Preferred Term PRODUCT COLOUR ISSUE

Product NUVARING

Role Route S VAGINAL

Dosage Text UNK

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,058 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8740240 Date FDA Received
23-Aug-2012 Case # 8740240 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # US-009507513-1208USA 002349 Role Route S Health Professional Y VAGINAL Dosage Text 1 ring for 3 weeks Manufacturer Control # US-009507513-1208USA 002585 Role Route S VAGINAL Dosage Text 1 DF, 3 week in 1 week out Duration Age Sex Unknown Duration Age Sex Unknown Country USA

Preferred Term DEVICE EXPULSION

Product NUVARING Case # 8740267 Case Type NON-EXPEDITED

Manufacturer MERCK Country USA

8740267 Date FDA Received

23-Aug-2012

Outcomes

Preferred Term METRORRHAGIA MUSCLE SPASMS

Product NUVARING

Manufacturer MERCK

8740335 Date FDA Received

23-Aug-2012

Case # 8740335

Case Type NON-EXPEDITED

Health Professional Y

Outcomes

Manufacturer Control # US-009507513-1208USA 004032

Age

Sex Unknown

Country USA

Preferred Term NAUSEA DEVICE EXPULSION

Product NUVARING

Role Route S VAGINAL

Dosage Text 3 weeks in, 1 week out

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,059 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8740340 Date FDA Received
23-Aug-2012 Case # 8740340 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2009-194 846-NL Dosage Text DOSE TEXT: 3 WEEKS IN; 1 WEEK OUT, CONTINUING: NO UNK UNK, PRN Duration Age Sex Unknown Country USA

Preferred Term PULMONARY EMBOLISM

Product NUVARING

Role Route S

Manufacturer MERCK

DEEP VEIN THROMBOSIS ABDOMINAL PAIN ABNORMAL BEHAVIOUR ANKLE FRACTURE DEPRESSED MOOD DEVICE EXPULSION FRUSTRATION HEADACHE MEDICATION ERROR MENTAL DISORDER MIGRAINE NAUSEA PAIN IN EXTREMITY PSYCHIATRIC SYMPTOM SLEEP DISORDER TREATMENT NONCOMPLIANCE UTERINE SPASM VAGINITIS BACTERIAL

IBUPROFEN

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,060 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8740343 Date FDA Received
23-Aug-2012 Case # 8740343 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2010SP0 31305 Dosage Text Duration Age Sex Unknown Country USA

Preferred Term PULMONARY EMBOLISM BLOOD DISORDER DEEP VEIN THROMBOSIS LUNG INFILTRATION VAGINITIS BACTERIAL

Product NUVARING

Role Route S

Manufacturer MERCK

8740374 Date FDA Received

23-Aug-2012

Case # 8740374

Case Type NON-EXPEDITED

Health Professional Y

Outcomes

Manufacturer Control # US-009507513-1208USA 004654

Age

Sex Unknown

Country USA

Preferred Term ALOPECIA

Product NUVARING Case # 8740391 Case Type NON-EXPEDITED Health Professional Y

Role Route S Outcomes

Dosage Text

Duration

Manufacturer MERCK

8740391 Date FDA Received

23-Aug-2012

Manufacturer Control # US-009507513-1208USA 004730

Age

Sex Unknown

Country USA

Preferred Term DEVICE EXPULSION DEVICE BREAKAGE

Product NUVARING

Role Route S VAGINAL

Dosage Text 0.12/0.015mg, per 24 hours

Duration

Manufacturer MERCK

8740407 Date FDA Received

23-Aug-2012

Case # 8740407

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # US-009507513-1208USA 004682

Age

Sex Unknown

Country USA

Preferred Term INCORRECT STORAGE OF DRUG NO ADVERSE EVENT

Product NUVARING

Role Route S

Dosage Text UNK

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,061 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8740428 Date FDA Received
23-Aug-2012 Case # 8740428 Case Type EXPEDITED (15-DAY) Health Professional Y Outcomes OT Manufacturer Control # US-009507513-1208USA 006224 Dosage Text 0.120/0.015 mg per day/ 21 days Manufacturer Control # US-009507513-1208USA 005414 Role Route S VAGINAL Dosage Text Duration Age Sex Unknown Duration Age Sex Unknown Country USA

Preferred Term PULMONARY EMBOLISM

Product NUVARING Case Type NON-EXPEDITED Health Professional N

Role Route S VAGINAL

Manufacturer MERCK Country USA

8740441 Date FDA Received

23-Aug-2012

Case # 8740441

Outcomes

Preferred Term METRORRHAGIA DEVICE EXPULSION INCORRECT DRUG ADMINISTRATION DURATION

Product NUVARING

Manufacturer MERCK

8740449 Date FDA Received

23-Aug-2012

Case # 8740449

Case Type NON-EXPEDITED

Health Professional Y

Outcomes

Manufacturer Control # US-009507513-1208USA 005410

Age

Sex Unknown

Country USA

Preferred Term METRORRHAGIA DYSMENORRHOEA

Product NUVARING VITAMINS (UNSPECIFIED) OMEGA-3-ACID ETHYL ESTERS VITAMIN D

Role Route S C C C VAGINAL

Dosage Text UNK

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,062 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8740460 Date FDA Received
23-Aug-2012 Case # 8740460 Case Type EXPEDITED (15-DAY) Health Professional Y Outcomes HO,DS,OT Manufacturer Control # US-009507513-2010SP0 15492 Dosage Text UNK UNK Duration Age Sex Unknown Country USA

Preferred Term PULMONARY EMBOLISM DEEP VEIN THROMBOSIS PHLEBITIS CERVICAL DYSPLASIA DIABETES MELLITUS GALLBLADDER DISORDER HYPERTENSION INFECTION LYMPHADENOPATHY MIGRAINE MUSCLE RUPTURE PAPILLOMA VIRAL INFECTION POST-TRAUMATIC STRESS DISORDER PULMONARY HYPERTENSION SURGERY VARICOSE VEIN

Product NUVARING NUVARING NUVARING

Role Route S S S VAGINAL

Manufacturer MERCK MERCK MERCK

8740465 Date FDA Received

23-Aug-2012

Case # 8740465

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # US-009507513-1208USA 006048

Age

Sex Unknown

Country USA

Preferred Term MUSCLE SPASMS

Product NUVARING Case # 8740466 Case Type NON-EXPEDITED Health Professional N

Role Route S VAGINAL

Dosage Text 3weeks in 1 week out Manufacturer Control # US-009507513-1208USA 006090

Duration

Manufacturer MERCK

8740466 Date FDA Received

23-Aug-2012

Outcomes

Age

Sex Unknown

Country USA

Preferred Term ADVERSE EVENT

Product NUVARING

Role Route S VAGINAL

Dosage Text UNK

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,063 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8740467 Date FDA Received
23-Aug-2012 Case # 8740467 Case Type NON-EXPEDITED Health Professional Y Outcomes Manufacturer Control # US-009507513-1208USA 006070 Role Route S Health Professional N VAGINAL Dosage Text UNK Manufacturer Control # US-009507513-1208USA 006554 Role Route S VAGINAL Dosage Text UNK, qm Duration Duration 4.6 YEAR Age Sex Unknown Age Sex Unknown Country USA

Preferred Term OVULATION DISORDER

Product NUVARING Case Type NON-EXPEDITED

Manufacturer MERCK Country USA

8740476 Date FDA Received

23-Aug-2012

Case # 8740476

Outcomes

Preferred Term INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION INCORRECT DRUG ADMINISTRATION DURATION

Product NUVARING

Manufacturer MERCK

8740481 Date FDA Received

23-Aug-2012

Case # 8740481

Case Type NON-EXPEDITED

Health Professional Y

Outcomes

Manufacturer Control # US-009507513-1208USA 006107

Age

Sex Unknown

Country USA

Preferred Term NAUSEA INCORRECT DRUG ADMINISTRATION DURATION

Product NUVARING

Role Route S VAGINAL

Dosage Text UNK, qm

Duration

Manufacturer MERCK

8740490 Date FDA Received

23-Aug-2012

Case # 8740490

Case Type EXPEDITED (15-DAY)

Health Professional Y

Outcomes HO,OT

Manufacturer Control # US-009507513-2011SP0 50836 Dosage Text

Age

Sex Unknown

Country USA

Preferred Term PULMONARY EMBOLISM CERVICAL DYSPLASIA INFLUENZA

Product NUVARING

Role Route S

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,064 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8740494 Date FDA Received
23-Aug-2012 Case # 8740494 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # US-009507513-1208USA 007019 Role Route S Health Professional Y VAGINAL Dosage Text 3 week in 1 week out Manufacturer Control # US-009507513-1208USA 007103 Role Route S C C C C C Outcomes Manufacturer Control # US-009507513-1208USA 006929 Role Route S Health Professional N VAGINAL Dosage Text UNK Manufacturer Control # US-009507513-1208USA 006945 Role Route S VAGINAL Dosage Text UNK Duration Age Sex Unknown Duration Age Sex Unknown Country USA VAGINAL Dosage Text 1 DF, qm Duration Age Sex Unknown Duration Age Sex Unknown Country USA

Preferred Term INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION

Product NUVARING Case Type NON-EXPEDITED

Manufacturer MERCK Country USA

8740496 Date FDA Received

23-Aug-2012

Case # 8740496

Outcomes

Preferred Term WITHDRAWAL BLEED DEVICE EXPULSION

Product NUVARING KLONOPIN VICODIN PERCOCET IBUPROFEN LACTOBACILLUS REUTERI

Manufacturer MERCK

8740507 Date FDA Received

23-Aug-2012

Case # 8740507

Case Type NON-EXPEDITED

Health Professional N

Preferred Term MENORRHAGIA

Product NUVARING Case # 8740524 Case Type NON-EXPEDITED

Manufacturer MERCK Country USA

8740524 Date FDA Received

23-Aug-2012

Outcomes

Preferred Term UNINTENDED PREGNANCY NO ADVERSE EVENT

Product NUVARING

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,065 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8740534 Date FDA Received
23-Aug-2012 Case # 8740534 Case Type NON-EXPEDITED Health Professional Y Outcomes Manufacturer Control # US-009507513-1208USA 006636 Role Route S Health Professional N Outcomes OT Manufacturer Control # US-009507513-1208USA 008009 Dosage Text UNK Duration Age Sex Unknown Dosage Text Duration Age Sex Unknown Country USA

Preferred Term INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION

Product NUVARING Case Type EXPEDITED (15-DAY)

Manufacturer MERCK Country USA

8740561 Date FDA Received

23-Aug-2012

Case # 8740561

Preferred Term PULMONARY EMBOLISM DEEP VEIN THROMBOSIS

Product NUVARING

Role Route S ENDOCERVICAL

Manufacturer MERCK

8740565 Date FDA Received

23-Aug-2012

Case # 8740565

Case Type EXPEDITED (15-DAY)

Health Professional N

Outcomes OT

Manufacturer Control # US-009507513-1208USA 008011 Dosage Text UNK Manufacturer Control # US-009507513-1208USA 007470 Dosage Text

Age

Sex Unknown

Country USA

Preferred Term PULMONARY EMBOLISM

Product NUVARING Case Type EXPEDITED (15-DAY) Health Professional N

Role Route S VAGINAL

Duration

Manufacturer MERCK

8740568 Date FDA Received

23-Aug-2012

Case # 8740568

Outcomes DS,OT

Age

Sex Unknown

Country USA

Preferred Term PULMONARY EMBOLISM

Product NUVARING Case Type EXPEDITED (15-DAY) Health Professional N

Role Route S Outcomes OT

Duration

Manufacturer MERCK

8740576 Date FDA Received

23-Aug-2012

Case # 8740576

Manufacturer Control # US-009507513-1208USA 008480 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term PULMONARY EMBOLISM

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,066 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8740579 Date FDA Received
23-Aug-2012 Case # 8740579 Case Type NON-EXPEDITED Health Professional Y Outcomes Manufacturer Control # US-009507513-1208USA 008778 Role Route S Health Professional N VAGINAL Dosage Text UNK Manufacturer Control # US-009507513-2012SP0 25394 Dosage Text UNK Duration Age Sex Unknown Duration Age Sex Unknown Country USA

Preferred Term DEVICE EXPULSION

Product NUVARING Case # 8590103 Case Type EXPEDITED (15-DAY)

Manufacturer MERCK Country USA

8590103 Date FDA Received

24-Aug-2012

Outcomes HO

Preferred Term VASCULAR PSEUDOANEURYSM CARPAL TUNNEL SYNDROME CONSTIPATION HYPOAESTHESIA ISCHAEMIA PAIN IN EXTREMITY PERIPHERAL EMBOLISM POST PROCEDURAL COMPLICATION

Product NUVARING

Role Route S

Manufacturer MERCK

8671647 Date FDA Received

24-Aug-2012

Case # 8671647

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,OT

Manufacturer Control # US-009507513-2012SP0 34987 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Lung infiltration Pulmonary embolism Pulmonary infarction Incorrect drug administration duration Metrorrhagia Bronchitis Headache Hypertension Loss of libido

Product NUVARING NUVARING NUVARING venlafaxine hydrochloride venlafaxine hydrochloride venlafaxine hydrochloride

Role Route S S S C C C VAGINAL

Duration

Manufacturer MERCK MERCK MERCK

112.5 mg, qd

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,067 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8681123 Date FDA Received
24-Aug-2012 Case # 8681123 Case Type EXPEDITED (15-DAY) Health Professional Y Outcomes HO Manufacturer Control # NL-009507513-1207NLD 007720 Dosage Text UNK Duration 4.4 YEAR Age Sex Unknown Country NLD

Preferred Term ANGINA PECTORIS CORONARY ARTERY EMBOLISM INFARCTION MYOCARDIAL INFARCTION

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,068 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8688335 Date FDA Received
24-Aug-2012 Case # 8688335 Case Type EXPEDITED (15-DAY) Health Professional Y Outcomes HO,OT Manufacturer Control # US-009507513-2011SP0 42221 Dosage Text 2400 mg, bid 600 mg, bid Duration Age Sex Unknown Country USA

Preferred Term URINARY TRACT INFECTION PULMONARY EMBOLISM CHEST PAIN ANAEMIA AORTIC ARTERIOSCLEROSIS ASTHMA ATELECTASIS BACK PAIN COLITIS ULCERATIVE DILATATION VENTRICULAR DIZZINESS DYSPNOEA FEELING COLD FLUSHING GASTROENTERITIS HAEMATOCHEZIA HEADACHE HERPES SIMPLEX HYPERCOAGULATION MITRAL VALVE INCOMPETENCE NIGHT SWEATS PLEURAL EFFUSION PNEUMONIA BACTERIAL STRESS

Product NUVARING ASACOL ACTIGALL

Role Route S C C ORAL ORAL

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,069 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8740910 Date FDA Received
24-Aug-2012 Case # 8740910 Case Type EXPEDITED (15-DAY) Health Professional Y Outcomes HO,OT Manufacturer Control # US-009507513-2011SP0 50148 Dosage Text 1 DF, QM Duration Age Sex Unknown Country USA

Preferred Term PULMONARY EMBOLISM ANXIETY COITAL BLEEDING DYSPAREUNIA FATIGUE RENAL CYST

Product NUVARING NUVARING

Role Route S S VAGINAL

Manufacturer MERCK MERCK

8742429 Date FDA Received

24-Aug-2012

Case # 8742429

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Manufacturer Control # US-009507513-1208USA 000136

Age

Sex Unknown

Country USA

Preferred Term INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION

Product NUVARING Case Type NON-EXPEDITED Health Professional N

Role Route S VAGINAL

Dosage Text 1 DF, UNK Manufacturer Control # US-009507513-1208USA 000837

Duration

Manufacturer MERCK

8742488 Date FDA Received

24-Aug-2012

Case # 8742488

Outcomes

Age

Sex Unknown

Country USA

Preferred Term INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION

Product NUVARING Case Type NON-EXPEDITED Health Professional N

Role Route S VAGINAL

Dosage Text UNK Manufacturer Control # US-009507513-1208USA 000081

Duration

Manufacturer MERCK

8742731 Date FDA Received

24-Aug-2012

Case # 8742731

Outcomes

Age

Sex Unknown

Country USA

Preferred Term INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION

Product NUVARING

Role Route S VAGINAL

Dosage Text

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,070 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8743090 Date FDA Received
24-Aug-2012 Case # 8743090 Case Type EXPEDITED (15-DAY) Health Professional N Outcomes OT Manufacturer Control # US-009507513-1208USA 008485 Dosage Text UNK Manufacturer Control # US-009507513-1208USA 008476 Dosage Text UNK Manufacturer Control # US-009507513-1208USA 008010 Role Route S Health Professional Y Outcomes OT Dosage Text UNK Manufacturer Control # IL-009507513-1207ISR0 08613 Dosage Text UNK Duration Age Sex Unknown Duration Age Sex Unknown Duration Age Sex Unknown Duration Age Sex Unknown Country USA

Preferred Term PULMONARY EMBOLISM

Product NUVARING Case Type EXPEDITED (15-DAY) Health Professional N

Role Route S Outcomes OT

Manufacturer MERCK Country USA

8743182 Date FDA Received

24-Aug-2012

Case # 8743182

Preferred Term PULMONARY EMBOLISM

Product NUVARING Case Type NON-EXPEDITED Health Professional N

Role Route S VAGINAL

Manufacturer MERCK Country USA

8743183 Date FDA Received

24-Aug-2012

Case # 8743183

Outcomes

Preferred Term DEEP VEIN THROMBOSIS

Product NUVARING Case Type EXPEDITED (15-DAY)

Manufacturer MERCK Country ISR

8743287 Date FDA Received

24-Aug-2012

Case # 8743287

Preferred Term ABORTION INDUCED INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION UNINTENDED PREGNANCY

Product NUVARING

Role Route S

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,071 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8743478 Date FDA Received
24-Aug-2012 Case # 8743478 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # US-009507513-1208USA 009371 Role Route S VAGINAL Dosage Text 3 weeks in, one week out Duration Age Sex Unknown Country USA

Preferred Term INCORRECT DRUG ADMINISTRATION DURATION DEVICE EXPULSION

Product NUVARING

Manufacturer MERCK

8750454 Date FDA Received

24-Aug-2012 Preferred Term

Case # 8750454

Case Type DIRECT Product NUVARING

Health Professional Y

Outcomes HO Role Route S VAGINAL

Manufacturer Control #

Age 38 YR

Sex Female

Country USA

Dosage Text 1 RING, ONCE MONTHLY, VAG Manufacturer Control # US-009507513-1207USA 007147

Duration

Manufacturer MERCK

PULMONARY EMBOLISM

8745654 Date FDA Received

26-Aug-2012

Case # 8745654

Case Type NON-EXPEDITED

Health Professional N

Outcomes

Age

Sex Unknown

Country USA

Preferred Term DEVICE EXPULSION

Product NUVARING Case # 8745875 Case Type NON-EXPEDITED Health Professional N

Role Route S Outcomes

Dosage Text 1 DF, qm Manufacturer Control # US-009507513-1208USA 008647

Duration

Manufacturer MERCK

8745875 Date FDA Received

27-Aug-2012

Age

Sex Unknown

Country USA

Preferred Term PAIN IN EXTREMITY DIZZINESS OFF LABEL USE VOMITING

Product NUVARING

Role Route S VAGINAL

Dosage Text 3 weeks in 1 week out

Duration 3 DAY

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,072 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8747648 Date FDA Received
27-Aug-2012 Case # 8747648 Case Type NON-EXPEDITED Health Professional N Outcomes Manufacturer Control # US-009507513-1208USA 008460 Role Route S Health Professional N Outcomes OT Dosage Text UNK Manufacturer Control # US-009507513-1208USA 008465 Dosage Text UNK Manufacturer Control # US-009507513-1208USA 008239 Role Route S C Health Professional Outcomes OT VAGINAL Dosage Text UNK UNK Manufacturer Control # US-009507513-1208USA 008068 Dosage Text Duration Age Sex Unknown Country USA Duration Age Sex Unknown Duration Age Sex Unknown Duration Age Sex Unknown Country USA

Preferred Term CEREBRAL VENOUS THROMBOSIS

Product NUVARING Case Type EXPEDITED (15-DAY)

Manufacturer MERCK Country USA

8747650 Date FDA Received

27-Aug-2012

Case # 8747650

Preferred Term CEREBROVASCULAR ACCIDENT

Product NUVARING Case Type NON-EXPEDITED Health Professional

Role Route S VAGINAL

Manufacturer MERCK Country USA

8755798 Date FDA Received

27-Aug-2012

Case # 8755798

Outcomes

Preferred Term Acne Metrorrhagia

Product NUVARING lisinopril Case # 8755860 Case Type EXPEDITED (15-DAY)

Manufacturer MERCK

8755860 Date FDA Received

27-Aug-2012

Preferred Term Cerebrovascular accident

Product NUVARING Case Type EXPEDITED (15-DAY) Health Professional

Role Route S Outcomes HO,DS,OT

Manufacturer MERCK

8755863 Date FDA Received

27-Aug-2012

Case # 8755863

Manufacturer Control # US-009507513-2012SP0 00252

Age

Sex Unknown

Country USA

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,073 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8755863
Preferred Term Pyelonephritis Cholecystitis Pulmonary embolism Amenorrhoea Antinuclear antibody Asthma Atypical pneumonia Cholecystectomy Clostridial infection Clostridium difficile colitis Colitis Crohn's disease Dysphagia Fall Gastric disorder Gastritis erosive Gastrointestinal disorder Gastrooesophageal reflux disease Granulomatous liver disease Haemorrhoids Hiatus hernia Infectious mononucleosis Intestinal polyp Lymphadenopathy Oedema peripheral Oesophageal ulcer Peptic ulcer Presyncope Sciatica Smear cervix abnormal Product NUVARING NUVARING NUVARING Role Route S S S Dosage Text Duration Manufacturer MERCK MERCK MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,074 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8756403 Date FDA Received
27-Aug-2012 Preferred Term Cardiac arrest Deep vein thrombosis Ovarian cyst Pulmonary embolism Case # 8756403 Case Type DIRECT Product NUVARING Health Professional Outcomes DE Role Route S VAGINAL Manufacturer Control # CTU 485873 Dosage Text Age 25 YR Duration Sex Female Country USA

Manufacturer ORGANON

7149471 Date FDA Received

28-Aug-2012

Case # 7149471

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO

Manufacturer Control # US-009507513-2009SP0 17305 Dosage Text 1 DF, UNK 30 mg, PRN 25 mg, QD

Age

Sex Unknown

Country USA

Preferred Term Subarachnoid haemorrhage Cerebral venous thrombosis Chest pain Cerebral thrombosis Dysfunctional uterine bleeding Hypercoagulation Hypertension Pelvic pain

Product NUVARING RESTORIL TOPROL XL

Role Route S C C

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,075 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8341391 Date FDA Received
28-Aug-2012 Case # 8341391 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,DS,OT Manufacturer Control # US-009507513-2011SP0 46645 Dosage Text Duration Age Sex Unknown Country USA

Preferred Term Hydrocephalus Haemorrhage intracranial Cerebrovascular accident Bronchospasm Cervical dysplasia Cervicitis Constipation Excoriation Gastric disorder Gastritis Headache Hypersensitivity Ligament sprain Migraine Musculoskeletal pain Nasopharyngitis Neck pain Palpitations Papilloma viral infection Urticaria

Product NUVARING NUVARING MINERALS (UNSPECIFIED) (+) VITAMINS (UNSPECIFIED)

Role Route S S C

Manufacturer MERCK MERCK

1 DF, QD

8694555 Date FDA Received

29-Aug-2012

Case # 8694555

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,DS,OT

Manufacturer Control # US-009507513-2011SP0 46646 Dosage Text UNK 0.120-0.015 mg

Age

Sex Unknown

Country USA

Preferred Term Respiratory failure Intracranial venous sinus thrombosis

Product NUVARING NUVARING

Role Route S S VAGINAL VAGINAL

Duration

Manufacturer MERCK MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,076 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8694555
Preferred Term Cerebral infarction Brain oedema Hypercoagulation Adverse drug reaction Agitation Alopecia Anaemia Anxiety Back pain Balance disorder Claustrophobia Cognitive disorder Convulsion Cystocele Depression Dizziness Dyspepsia Dyspnoea exertional Ear pain Endometrial hypertrophy Headache Hyperlipidaemia Hypersomnia Hypertension Inadequate diet Influenza Joint dislocation Meniscus lesion Pain in extremity Pelvic pain Polymenorrhoea Product CYMBALTA GLUCOPHAGE vitamins (unspecified) Role Route C C C Dosage Text 60 mg, bid 500 mg, tid Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,077 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8694555
Preferred Term Seasonal allergy Sleep disorder Snoring Stress urinary incontinence Transient ischaemic attack Treatment noncompliance Urinary tract infection Vulvovaginal candidiasis Product Role Route Dosage Text Duration Manufacturer

8740354 Date FDA Received

29-Aug-2012

Case # 8740354

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-2012SP0 32085

Age

Sex Unknown

Country USA

Preferred Term Unintended pregnancy

Product NUVARING Case # 8758979 Case Type EXPEDITED (15-DAY) Health Professional

Role Route S VAGINAL

Dosage Text 0.015/0.12 mg Manufacturer Control # DK-009507513-2012SP0 24606 Dosage Text UNK UNK, Unknown UNK UNK, Unknown UNK

Duration

Manufacturer MERCK

8758979 Date FDA Received

29-Aug-2012

Outcomes HO,DS,OT

Age

Sex Unknown

Country DNK

Preferred Term Thrombosis Pulmonary embolism Pulmonary embolism Dyspnoea Limb discomfort Oedema peripheral Pain in extremity

Product NUVARING NUVARING NUVARING

Role Route S S S

Duration

Manufacturer MERCK MERCK MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,078 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8759251 Date FDA Received
29-Aug-2012 Case # 8759251 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1207USA 006926 Role Route S Dosage Text Duration Age Sex Unknown Country USA

Preferred Term Device expulsion No adverse event

Product NUVARING

Manufacturer MERCK

8759265 Date FDA Received

29-Aug-2012

Case # 8759265

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1208USA 005827

Age

Sex Unknown

Country USA

Preferred Term Unintended pregnancy

Product NUVARING

Role Route S VAGINAL

Dosage Text 0.120 mg/day of etonogestrel and 0.015 mg/day of ethinyl estradiol/21 days

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,079 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8760005 Date FDA Received
29-Aug-2012 Case # 8760005 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,DS,OT Manufacturer Control # US-009507513-2011SP0 12499 Dosage Text TAKES 2 TABLETS ON SATURDAYS Duration Age Sex Unknown Country USA

Preferred Term Hypercoagulation Pleurisy Dyspnoea

Product NUVARING SYNTHROID CHROMIUM PICOLINATE (+) EPHEDRA (+) GARCINIA (+) GUARANA (+) LEVOCARNI

Role Route S C C

Manufacturer MERCK

Chest pain Deep vein thrombosis Emotional disorder Herpes simplex Mental disorder Myofascial pain syndrome Oedema peripheral Pain in extremity Sinus arrhythmia Urinary tract infection

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,080 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8760045 Date FDA Received
29-Aug-2012 Case # 8760045 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2009SP0 29611 Dosage Text Duration Age Sex Unknown Country USA

Preferred Term Pulmonary embolism Pulmonary infarction Bronchitis bacterial Candidiasis Pharyngitis Epistaxis

Product NUVARING NUVARING NUVARING PROVENTIL ZOLOFT CAFFEINE

Role Route S S S C C C

Manufacturer MERCK MERCK MERCK MERCK

150 mg, BID TAKEN ONCE IN AWHILE, NO MORE THAN ONCE A MONTH

Spinal disorder Back pain Bronchitis Depression Dermatitis contact Folliculitis Off label use Tinea infection

IRON (UNSPECIFIED) (+) VITAMINS (UNSPECIFIED)

8760648 Date FDA Received

30-Aug-2012

Case # 8760648

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1207USA 011433

Age

Sex Unknown

Country USA

Preferred Term Device expulsion

Product NUVARING

Role Route S VAGINAL

Dosage Text 3 weeks in 1 week out

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,081 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8760696 Date FDA Received
30-Aug-2012 Case # 8760696 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1207USA 010295 Role Route S Health Professional VAGINAL Manufacturer Control # US-009507513-1207USA 011457 Role Route S Health Professional VAGINAL Dosage Text "0.120 mg/ 0.015 mg per day Manufacturer Control # US-009507513-1208USA 010391 Role Route S Health Professional VAGINAL Manufacturer Control # US-009507513-1207USA 008476 Role Route S Health Professional Outcomes Dosage Text UNK, qm Manufacturer Control # US-009507513-1208USA 010975 Role Route S Dosage Text UNK Duration Age Sex Unknown Duration Age Sex Unknown Dosage Text Duration Age Sex Unknown Duration Age Sex Unknown Dosage Text Duration Age Sex Unknown Country USA

Preferred Term Device expulsion

Product NUVARING Case # 8760698 Case Type NON-EXPEDITED

Manufacturer MERCK Country USA

8760698 Date FDA Received

30-Aug-2012

Outcomes

Preferred Term Fatigue

Product NUVARING Case # 8760750 Case Type NON-EXPEDITED

Manufacturer MERCK Country USA

8760750 Date FDA Received

30-Aug-2012

Outcomes

Preferred Term Inappropriate schedule of drug administration

Product NUVARING

Manufacturer MERCK Country USA

8760756 Date FDA Received

30-Aug-2012

Case # 8760756

Case Type NON-EXPEDITED

Outcomes

Preferred Term Medical device discomfort

Product NUVARING Case Type NON-EXPEDITED

Manufacturer MERCK Country USA

8760963 Date FDA Received

30-Aug-2012

Case # 8760963

Preferred Term Deep vein thrombosis

Product NUVARING

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,082 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8761990 Date FDA Received
30-Aug-2012 Case # 8761990 Case Type EXPEDITED (15-DAY) Health Professional Outcomes DS,OT Manufacturer Control # US-009507513-1208USA 011546 Dosage Text Duration Age Sex Unknown Country USA

Preferred Term Pulmonary embolism Anhedonia Anxiety Pain

Product NUVARING

Role Route S

Manufacturer MERCK

8738148 Date FDA Received

31-Aug-2012

Case # 8738148

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,OT

Manufacturer Control # US-009507513-2011SP0 30599 Dosage Text UNK UNK UNK

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism Back pain Pneumonia Abscess Anaemia Dermatitis allergic Haemoptysis Pain Rectal haemorrhage Sinus disorder Skin lesion

Product NUVARING NUVARING NUVARING

Role Route S S S VAGINAL VAGINAL

Duration

Manufacturer MERCK MERCK MERCK

8763370 Date FDA Received

31-Aug-2012

Case # 8763370

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes OT

Manufacturer Control # US-009507513-1208USA 008457 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism

Product NUVARING

Role Route S

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,083 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8763382 Date FDA Received
31-Aug-2012 Case # 8763382 Case Type EXPEDITED (15-DAY) Health Professional Outcomes OT Manufacturer Control # US-009507513-1207USA 006602 Dosage Text UNK Manufacturer Control # US-009507513-1208USA 011540 Role Route S Health Professional Outcomes Dosage Text UNK Manufacturer Control # US-009507513-1207USA 000326 Role Route S Health Professional VAGINAL Dosage Text UNK UNK, qd Manufacturer Control # US-009507513-1207USA 001337 Role Route S VAGINAL Dosage Text Duration Age Sex Unknown Duration Age Sex Unknown Duration Age Sex Unknown Duration Age Sex Unknown Country USA

Preferred Term Pulmonary embolism

Product NUVARING Case # 8764125 Case Type NON-EXPEDITED Health Professional

Role Route S Outcomes

Manufacturer MERCK Country USA

8764125 Date FDA Received

31-Aug-2012

Preferred Term Cerebral venous thrombosis

Product NUVARING Case Type NON-EXPEDITED

Manufacturer MERCK Country USA

8657755 Date FDA Received

01-Sep-2012

Case # 8657755

Preferred Term Device breakage

Product NUVARING Case # 8667593 Case Type NON-EXPEDITED

Manufacturer MERCK Country USA

8667593 Date FDA Received

01-Sep-2012

Outcomes

Preferred Term Pyrexia Asthenia Drug dose omission Inappropriate schedule of drug administration

Product NUVARING

Manufacturer MERCK

8764862 Date FDA Received

01-Sep-2012

Case # 8764862

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1208USA 007829

Age

Sex Unknown

Country USA

Preferred Term Menorrhagia

Product NUVARING

Role Route S VAGINAL

Dosage Text

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,084 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8764872 Date FDA Received
01-Sep-2012 Case # 8764872 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1208USA 012385 Role Route S VAGINAL Dosage Text UNK Duration Age Sex Unknown Country USA

Preferred Term Therapeutic response unexpected Hormone therapy

Product NUVARING

Manufacturer MERCK

8764873 Date FDA Received

01-Sep-2012

Case # 8764873

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1208USA 012381

Age

Sex Unknown

Country USA

Preferred Term Metrorrhagia

Product NUVARING Case # 8764890 Case Type NON-EXPEDITED Health Professional

Role Route S VAGINAL

Dosage Text 3 weeks in 1 week out Manufacturer Control # US-009507513-1207USA 009226

Duration

Manufacturer MERCK

8764890 Date FDA Received

01-Sep-2012

Outcomes

Age

Sex Unknown

Country USA

Preferred Term Burning sensation

Product NUVARING Case # 8764891 Case Type NON-EXPEDITED Health Professional

Role Route S VAGINAL

Dosage Text

Duration

Manufacturer MERCK

8764891 Date FDA Received

01-Sep-2012

Outcomes

Manufacturer Control # US-009507513-1208USA 004707

Age

Sex Unknown

Country USA

Preferred Term Depression

Product NUVARING LAMICTAL

Role Route S C Health Professional Outcomes

Dosage Text

Duration

Manufacturer MERCK

8683151 Date FDA Received

03-Sep-2012

Case # 8683151

Case Type NON-EXPEDITED

Manufacturer Control # US-009507513-1207USA 008469

Age

Sex Unknown

Country USA

Preferred Term Incorrect drug administration duration Inappropriate schedule of drug administration

Product NUVARING

Role Route S VAGINAL

Dosage Text UNK, qm

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,085 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8764965 Date FDA Received
03-Sep-2012 Case # 8764965 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1208USA 001104 Role Route S Health Professional VAGINAL Manufacturer Control # US-009507513-1208USA 007825 Role Route S Health Professional Outcomes HO,LT,OT Dosage Text 3 weeks in 1 week out Manufacturer Control # US-009507513-2011SP0 48229 Dosage Text Duration Age Sex Unknown Duration Age Sex Unknown Dosage Text Duration Age Sex Unknown Country USA

Preferred Term Device expulsion

Product NUVARING Case # 8765166 Case Type NON-EXPEDITED

Manufacturer MERCK Country USA

8765166 Date FDA Received

03-Sep-2012

Outcomes

Preferred Term Inappropriate schedule of drug administration

Product NUVARING

Manufacturer MERCK Country USA

8421248 Date FDA Received

04-Sep-2012

Case # 8421248

Case Type EXPEDITED (15-DAY)

Preferred Term Chest pain Coagulopathy Depression Dysmenorrhoea Headache Pulmonary embolism Vaginal infection Weight increased

Product NUVARING

Role Route S

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,086 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8765976 Date FDA Received
04-Sep-2012 Case # 8765976 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,DS,OT Manufacturer Control # US-009507513-2011SP0 00372 Dosage Text 1 DF, UNK 1 mg, BID Duration Age Sex Unknown Country USA

Preferred Term Cerebrovascular accident Ischaemic stroke VIIth nerve paralysis Affective disorder Anxiety Depression Gastrooesophageal reflux disease Migraine

Product NUVARING IBUPROFEN KLONOPIN

Role Route S C C ORAL VAGINAL

Manufacturer MERCK

8765984 Date FDA Received

04-Sep-2012

Case # 8765984

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes OT

Manufacturer Control # NL-009507513-2012SP0 25269 Dosage Text UNK

Age

Sex Unknown

Country NLD

Preferred Term Abortion spontaneous Inappropriate schedule of drug administration Unintended pregnancy

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

8766104 Date FDA Received

04-Sep-2012

Case # 8766104

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1208USA 011909

Age

Sex Unknown

Country USA

Preferred Term Metrorrhagia

Product NUVARING

Role Route S VAGINAL

Dosage Text UNK

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,087 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8766137 Date FDA Received
04-Sep-2012 Case # 8766137 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-2012SP0 13772 Role Route S C C C Health Professional VAGINAL ORAL ORAL ORAL Dosage Text UNK UNK, QM UNK, qd 25 mg, UNK 5 mg, tid Manufacturer Control # US-009507513-1208USA 012638 Dosage Text UNK Manufacturer Control # US-009507513-2010SP0 53353 Dosage Text 1 DF, QM UNK UNK, QD Duration Age Sex Unknown Duration Age Sex Unknown Country USA Duration Age Sex Unknown Country USA

Preferred Term Unintended pregnancy

Product NUVARING vitamins (unspecified) promethazine REGLAN

Manufacturer MERCK

8766329 Date FDA Received

04-Sep-2012

Case # 8766329

Case Type EXPEDITED (15-DAY)

Outcomes DS

Preferred Term Thrombosis

Product NUVARING Case # 8766350 Case Type EXPEDITED (15-DAY) Health Professional

Role Route S Outcomes HO,OT

Manufacturer MERCK Country USA

8766350 Date FDA Received

04-Sep-2012

Preferred Term Thyroid neoplasm Pulmonary embolism Antiphospholipid antibodies positive Dysmenorrhoea Urticaria

Product NUVARING NUVARING METICORTEN

Role Route S S C VAGINAL

Manufacturer MERCK MERCK MERCK

8766365 Date FDA Received

04-Sep-2012

Case # 8766365

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1208USA 009083

Age

Sex Unknown

Country USA

Preferred Term Device expulsion Inappropriate schedule of drug administration

Product NUVARING

Role Route S VAGINAL

Dosage Text

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,088 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8767882 Date FDA Received
04-Sep-2012 Case # 8767882 Case Type EXPEDITED (15-DAY) Health Professional Outcomes OT Manufacturer Control # US-009507513-1208USA 011534 Dosage Text UNK Manufacturer Control # US-009507513-1208USA 009942 Role Route S VAGINAL Dosage Text UNK Duration Age Sex Unknown Duration Age Sex Unknown Country USA

Preferred Term Pulmonary embolism

Product NUVARING Case # 8768936 Case Type NON-EXPEDITED Health Professional

Role Route S Outcomes

Manufacturer MERCK Country USA

8768936 Date FDA Received

04-Sep-2012

Preferred Term Unintended pregnancy Inappropriate schedule of drug administration

Product NUVARING

Manufacturer MERCK

8769008 Date FDA Received

04-Sep-2012

Case # 8769008

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1208USA 012137

Age

Sex Unknown

Country USA

Preferred Term Vaginal cyst

Product NUVARING Case # 8653613 Case Type EXPEDITED (15-DAY) Health Professional

Role Route S VAGINAL

Dosage Text 0.015/0.012 Manufacturer Control # US-009507513-2012SP0 11823 Dosage Text UNK

Duration

Manufacturer MERCK

8653613 Date FDA Received

05-Sep-2012

Outcomes HO,DS,OT

Age

Sex Unknown

Country USA

Preferred Term Myocardial infarction Aneurysm Brain neoplasm Cerebral venous thrombosis Chronic tonsillitis Endometriosis Fall Gastrooesophageal reflux disease Hyperaesthesia

Product NUVARING

Role Route S

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,089 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8653613
Preferred Term Hypercoagulation Hysterectomy Incision site haemorrhage Intervertebral disc degeneration Iron deficiency anaemia Joint dislocation Macular degeneration Mastoiditis Migraine Nervousness Off label use Osteoarthritis Ovarian cyst Portal vein thrombosis Radius fracture Rheumatic disorder Rotator cuff syndrome Salpingo-oophorectomy unilateral Seasonal allergy Sinusitis Sleep apnoea syndrome Spinal column stenosis Spinal osteoarthritis Synovial cyst Tendon disorder Tendonitis Transient ischaemic attack Urinary tract infection Uterine leiomyoma Product Role Route Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,090 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8768710 Date FDA Received
05-Sep-2012 Case # 8768710 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-2012SP0 33540 Role Route S Health Professional VAGINAL Dosage Text UNK Manufacturer Control # US-009507513-1208USA 011537 Dosage Text UNK Manufacturer Control # US-009507513-1209USA 000720 Role Route S VAGINAL Dosage Text 3 weeks in, 1 week out Duration Age Sex Unknown Duration Age Sex Unknown Duration Age Sex Unknown Country USA

Preferred Term Unintended pregnancy

Product NUVARING Case # 8769347 Case Type EXPEDITED (15-DAY)

Manufacturer MERCK Country USA

8769347 Date FDA Received

05-Sep-2012

Outcomes OT

Preferred Term Pulmonary embolism

Product NUVARING Case # 8769556 Case Type NON-EXPEDITED Health Professional

Role Route S Outcomes

Manufacturer MERCK Country USA

8769556 Date FDA Received

05-Sep-2012

Preferred Term Incorrect storage of drug Wrong technique in drug usage process

Product NUVARING

Manufacturer MERCK

8769686 Date FDA Received

05-Sep-2012

Case # 8769686

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1209USA 001293

Age

Sex Unknown

Country USA

Preferred Term Inappropriate schedule of drug administration Device expulsion No adverse event

Product NUVARING

Role Route S VAGINAL

Dosage Text

Duration

Manufacturer MERCK

8769704 Date FDA Received

05-Sep-2012

Case # 8769704

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes DS,OT

Manufacturer Control # US-009507513-1208USA 012646 Dosage Text

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism

Product NUVARING

Role Route S

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,091 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8769818 Date FDA Received
05-Sep-2012 Case # 8769818 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1208USA 010762 Role Route S VAGINAL Dosage Text UNK Duration Age Sex Unknown Country USA

Preferred Term Inappropriate schedule of drug administration Inappropriate schedule of drug administration Vaginal haemorrhage

Product NUVARING

Manufacturer MERCK

8771707 Date FDA Received

05-Sep-2012

Case # 8771707

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes OT

Manufacturer Control # US-009507513-1209USA 000937 Dosage Text

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism

Product NUVARING Case # 8772151 Case Type EXPEDITED (15-DAY) Health Professional

Role Route S Outcomes DS,OT

Duration

Manufacturer MERCK

8772151 Date FDA Received

05-Sep-2012

Manufacturer Control # US-009507513-1208USA 012648 Dosage Text UNK Manufacturer Control # US-009507513-2011SP0 37140 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism

Product NUVARING Case # 8772443 Case Type EXPEDITED (15-DAY) Health Professional

Role Route S VAGINAL

Duration

Manufacturer MERCK

8772443 Date FDA Received

05-Sep-2012

Outcomes DE,HO,OT

Age

Sex Unknown

Country USA

Preferred Term Ventricular fibrillation Pulmonary embolism Deep vein thrombosis Migraine

Product NUVARING NUVARING

Role Route S S

Duration

Manufacturer MERCK MERCK

8665373 Date FDA Received

06-Sep-2012

Case # 8665373

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,OT

Manufacturer Control # US-009507513-2011SP0 46637

Age

Sex Unknown

Country USA

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,092 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8665373
Preferred Term Pulmonary embolism Deep vein thrombosis Abdominal pain Alcohol use Anxiety Breast abscess Breast cellulitis Breast inflammation Breast mass Cerebrovascular accident Cervical dysplasia Chest discomfort Chills Cough Depression Dermatitis Dizziness Dyspareunia Dyspepsia Emotional disorder Extrasystoles Fear Headache Heart rate irregular Hepatic steatosis Hernia repair Hyperhidrosis Mastitis Memory impairment Menorrhagia Mitral valve incompetence Product NUVARING VITAMINS (UNSPECIFIED) Role Route S C Dosage Text UNK UNK UNK, QD Duration Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,093 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8665373
Preferred Term Nausea Oedema peripheral Pain in extremity Pallor Palpitations Panic attack Pulmonary fibrosis Pulmonary valve incompetence Supraventricular extrasystoles Tricuspid valve incompetence Vaginal haemorrhage Ventricular extrasystoles Ventricular tachycardia Vomiting Weight increased Product Role Route Dosage Text Duration Manufacturer

8770204 Date FDA Received

06-Sep-2012

Case # 8770204

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,OT

Manufacturer Control # US-009507513-1209USA 001493 Dosage Text UNK Manufacturer Control # US-009507513-1208USA 000039

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism

Product NUVARING Case # 8770574 Case Type NON-EXPEDITED Health Professional

Role Route S VAGINAL

Duration

Manufacturer MERCK

8770574 Date FDA Received

06-Sep-2012

Outcomes

Age

Sex Unknown

Country USA

Preferred Term Vaginal discharge

Product NUVARING

Role Route S VAGINAL

Dosage Text 1 ring for 3 weeks

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,094 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8770576 Date FDA Received
06-Sep-2012 Case # 8770576 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1209USA 000711 Role Route S Health Professional VAGINAL Dosage Text UNK Manufacturer Control # US-009507513-1208USA 008418 Role Route S VAGINAL Dosage Text UNK Duration Age Sex Unknown Duration Age Sex Unknown Country USA

Preferred Term Metrorrhagia

Product NUVARING Case # 8770673 Case Type NON-EXPEDITED

Manufacturer MERCK Country USA

8770673 Date FDA Received

06-Sep-2012

Outcomes

Preferred Term Device expulsion Inappropriate schedule of drug administration

Product NUVARING

Manufacturer MERCK

8770871 Date FDA Received

06-Sep-2012

Case # 8770871

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes DS,OT

Manufacturer Control # US-009507513-1208USA 012639 Dosage Text UNK Manufacturer Control # US-009507513-1208USA 009754

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism

Product NUVARING Case # 8770994 Case Type NON-EXPEDITED Health Professional

Role Route S Outcomes

Duration

Manufacturer MERCK

8770994 Date FDA Received

06-Sep-2012

Age

Sex Unknown

Country USA

Preferred Term Metrorrhagia

Product NUVARING Case # 8771010 Case Type NON-EXPEDITED Health Professional

Role Route S VAGINAL

Dosage Text UNK UNK, qm Manufacturer Control # US-009507513-1209USA 000705

Duration

Manufacturer MERCK

8771010 Date FDA Received

06-Sep-2012

Outcomes

Age

Sex Unknown

Country USA

Preferred Term Weight increased Abdominal pain lower

Product NUVARING

Role Route S VAGINAL

Dosage Text UNK

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,095 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8771518 Date FDA Received
06-Sep-2012 Case # 8771518 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-1209USA 001491 Dosage Text UNK Duration Age Sex Unknown Country USA

Preferred Term Intracranial venous sinus thrombosis Cerebrovascular accident

Product NUVARING

Role Route S

Manufacturer MERCK

8771678 Date FDA Received

06-Sep-2012

Case # 8771678

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO

Manufacturer Control # US-009507513-1209USA 001500 Dosage Text UNK Manufacturer Control # US-009507513-2010SP0 10757 Dosage Text

Age

Sex Unknown

Country USA

Preferred Term Deep vein thrombosis

Product NUVARING Case # 8771684 Case Type EXPEDITED (15-DAY) Health Professional

Role Route S Outcomes HO,OT

Duration

Manufacturer MERCK

8771684 Date FDA Received

06-Sep-2012

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism Deep vein thrombosis Fallopian tube operation Haematuria

Product NUVARING ADVIL

Role Route S C

Duration

Manufacturer MERCK

8772056 Date FDA Received

06-Sep-2012

Case # 8772056

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1208USA 005949

Age

Sex Unknown

Country USA

Preferred Term Muscle spasms Device expulsion Muscle spasms Urinary incontinence

Product NUVARING

Role Route S VAGINAL

Dosage Text 3 weeks in, 1 week out

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,096 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8772079 Date FDA Received
06-Sep-2012 Case # 8772079 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1207USA 007707 Role Route S VAGINAL Dosage Text UNK Duration Age Sex Unknown Country USA

Preferred Term Dysmenorrhoea Incorrect drug administration duration

Product NUVARING

Manufacturer MERCK

8772342 Date FDA Received

06-Sep-2012

Case # 8772342

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1208USA 008175

Age

Sex Unknown

Country USA

Preferred Term Inappropriate schedule of drug administration Device expulsion

Product NUVARING

Role Route S VAGINAL

Dosage Text 0.015/.012

Duration

Manufacturer MERCK

8772347 Date FDA Received

06-Sep-2012

Case # 8772347

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1209USA 001298

Age

Sex Unknown

Country USA

Preferred Term Contusion Nodule Thrombosis

Product NUVARING

Role Route S VAGINAL

Dosage Text 1 DF, qm

Duration

Manufacturer MERCK

8772361 Date FDA Received

06-Sep-2012

Case # 8772361

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1208USA 009639

Age

Sex Unknown

Country USA

Preferred Term Drug hypersensitivity

Product NUVARING

Role Route S VAGINAL

Dosage Text 1 DF, qm

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,097 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8772738 Date FDA Received
06-Sep-2012 Case # 8772738 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1209USA 001278 Role Route S Health Professional VAGINAL Dosage Text UNK UNK, qm Manufacturer Control # US-009507513-2012SP0 05878 Dosage Text UNK Duration Age Sex Unknown Duration Age Sex Unknown Country USA

Preferred Term Incorrect storage of drug

Product NUVARING Case # 8672947 Case Type EXPEDITED (15-DAY)

Manufacturer MERCK Country USA

8672947 Date FDA Received

07-Sep-2012

Outcomes HO,OT

Preferred Term Pneumonia necrotising Abnormal loss of weight Anger Asthma Back pain Chronic obstructive pulmonary disease Cough Exostosis Haemoptysis Hypertension Lung infiltration Muscle spasms Papilloma viral infection Plantar fasciitis Pneumonia Pulmonary embolism Treatment noncompliance Urticaria

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,098 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8702367 Date FDA Received
07-Sep-2012 Case # 8702367 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2012SP0 10634 Dosage Text Duration Age Sex Unknown Country USA

Preferred Term Blood potassium decreased Pulmonary embolism Anxiety Abortion spontaneous Chest pain Constipation Dizziness Fibroadenoma of breast Nasopharyngitis Urinary tract infection

Product NUVARING NUVARING NUVARING

Role Route S S S

Manufacturer MERCK MERCK MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,099 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8702880 Date FDA Received
07-Sep-2012 Case # 8702880 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2012SP0 11815 Dosage Text UNK Duration Age Sex Unknown Country USA

Preferred Term Leukopenia Pulmonary embolism Gastrooesophageal reflux disease Syncope Diabetes mellitus Asthma Abdominal pain Arthritis Chest pain Cough Dizziness Goitre Headache Hepatic steatosis Myocardial ischaemia Nephrolithiasis Ovarian cyst Visual impairment

Product NUVARING metformin ranitidine albuterol tramadol hydrochloride CYMBALTA

Role Route S C C C S C

Manufacturer MERCK

8716487 Date FDA Received

07-Sep-2012

Case # 8716487

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,LT,OT

Manufacturer Control # US-009507513-1208USA 001887 Dosage Text 0.120mg/day of etonogestrel and 0. 015 mg/day of ethinyl estradiol/21 days

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,100 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8755880 Date FDA Received
07-Sep-2012 Case # 8755880 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,DS,OT Manufacturer Control # US-009507513-2011SP0 37383 Dosage Text 5 mg, QD Duration Age Sex Unknown Country USA

Preferred Term Pulmonary embolism Deep vein thrombosis Coagulopathy Chest pain Abdominal pain upper Alopecia Back pain Diplopia Dry throat Dysarthria Dysphagia Dyspnoea Facial pain Headache Insomnia Pain in extremity Vaginal infection Visual acuity reduced

Product NUVARING COUMADIN RELPAX TREXIMET

Role Route S S S S

Manufacturer MERCK

8773385 Date FDA Received

07-Sep-2012

Case # 8773385

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1209USA 000436

Age

Sex Unknown

Country USA

Preferred Term Therapeutic response decreased

Product NUVARING

Role Route S VAGINAL

Dosage Text 0.120 mg/day of etonogestrel and 0.015 mg/day of ethinyl estradiol/21 days

Duration

Manufacturer MERCK

Product quality issue

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,101 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8773798 Date FDA Received
07-Sep-2012 Case # 8773798 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO Manufacturer Control # US-009507513-2012SP0 01709 Dosage Text UNK Duration Age Sex Unknown Country USA

Preferred Term Deep vein thrombosis Vena cava filter insertion Anaemia Diarrhoea Dizziness Gastrointestinal haemorrhage Human chorionic gonadotropin positive Stress

Product NUVARING COUMADIN

Role Route S S

Manufacturer MERCK

8774404 Date FDA Received

07-Sep-2012

Case # 8774404

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1209USA 001678

Age

Sex Unknown

Country USA

Preferred Term Incorrect storage of drug No adverse event

Product NUVARING

Role Route S VAGINAL

Dosage Text UNK

Duration

Manufacturer MERCK

8774407 Date FDA Received

07-Sep-2012

Case # 8774407

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1208USA 007169

Age

Sex Unknown

Country USA

Preferred Term Inappropriate schedule of drug administration Device expulsion

Product NUVARING DORIBAX

Role Route S C VAGINAL

Dosage Text UNK

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,102 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8774583 Date FDA Received
07-Sep-2012 Case # 8774583 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1208USA 008423 Role Route S VAGINAL Dosage Text 3 weeks then new ring Duration Age Sex Unknown Country USA

Preferred Term Urinary tract disorder Inappropriate schedule of drug administration

Product NUVARING

Manufacturer MERCK

8774624 Date FDA Received

07-Sep-2012

Case # 8774624

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,LT,OT

Manufacturer Control # US-009507513-2012SP0 26606 Dosage Text

Age

Sex Unknown

Country USA

Preferred Term Deep vein thrombosis Pulmonary embolism

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

8774642 Date FDA Received

07-Sep-2012

Case # 8774642

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1207USA 011713

Age

Sex Unknown

Country USA

Preferred Term Inappropriate schedule of drug administration

Product NUVARING Health Professional

Role Route S VAGINAL

Dosage Text 3 weeks in 1 week out, qm Manufacturer Control # US-009507513-1207USA 007635

Duration

Manufacturer MERCK

8774655 Date FDA Received

07-Sep-2012

Case # 8774655

Case Type NON-EXPEDITED

Outcomes

Age

Sex Unknown

Country USA

Preferred Term Hypertension

Product NUVARING Case # 8774013 Case Type NON-EXPEDITED Health Professional

Role Route S VAGINAL

Dosage Text UNK Manufacturer Control # US-009507513-1209USA 001205

Duration

Manufacturer MERCK

8774013 Date FDA Received

08-Sep-2012

Outcomes

Age

Sex Unknown

Country USA

Preferred Term Device expulsion

Product NUVARING

Role Route S VAGINAL

Dosage Text 3 weeks in, 1 week out

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,103 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8775600 Date FDA Received
09-Sep-2012 Case # 8775600 Case Type EXPEDITED (15-DAY) Health Professional Outcomes OT Manufacturer Control # US-009507513-1209USA 001175 Dosage Text 0.120 mg/day of etonogestrel and 0.015 mg/day of ethinyl estradiol, 21 days Duration Age Sex Unknown Country USA

Preferred Term Pulmonary embolism

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

Deep vein thrombosis Drug administration error

8775665 Date FDA Received

09-Sep-2012

Case # 8775665

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1207USA 011441

Age

Sex Unknown

Country USA

Preferred Term Inappropriate schedule of drug administration Device expulsion No adverse event

Product NUVARING

Role Route S VAGINAL

Dosage Text

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,104 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7797716 Date FDA Received
10-Sep-2012 Case # 7797716 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2010SP0 28437 Dosage Text Duration Age Sex Unknown Country USA

Preferred Term Cervical dysplasia Pulmonary embolism Acne Arthralgia Back pain Chest pain Chlamydial infection Contusion Cystitis Deep vein thrombosis Gonorrhoea Headache Hypoaesthesia Insomnia Mouth ulceration Paraesthesia Rhinitis allergic Road traffic accident Sinusitis Urinary tract infection

Product NUVARING NUVARING

Role Route S S

Manufacturer MERCK MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,105 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8756869 Date FDA Received
10-Sep-2012 Case # 8756869 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO Manufacturer Control # US-009507513-2011SP0 31789 Dosage Text Duration Age Sex Unknown Country USA

Preferred Term Deep vein thrombosis Thrombophlebitis superficial Headache Hypercoagulation Hypothyroidism Nausea Off label use Vomiting

Product NUVARING NUVARING

Role Route S S

Manufacturer MERCK MERCK

8759609 Date FDA Received

10-Sep-2012

Case # 8759609

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,OT

Manufacturer Control # US-009507513-2011SP0 30646 Dosage Text

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism Anxiety Skin disorder Atrial flutter Groin pain Joint effusion Muscle strain Ovarian cyst Patellofemoral pain syndrome Pleural effusion Pneumonia Rash

Product NUVARING NUVARING COUMADIN

Role Route S S S

Duration

Manufacturer MERCK MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,106 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8775080 Date FDA Received
10-Sep-2012 Case # 8775080 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1208USA 008444 Role Route S VAGINAL Dosage Text 1 ring for 3 weeks, followed by 1 ringfree week Manufacturer Control # US-009507513-1208USA 010731 Role Route S Health Professional VAGINAL Dosage Text 3 weeks in 1 week out Manufacturer Control # US-009507513-2011SP0 26441 Age Sex Unknown Duration Age Sex Unknown Duration Age Sex Unknown Country USA

Preferred Term Menorrhagia

Product NUVARING

Manufacturer MERCK

8775175 Date FDA Received

10-Sep-2012

Case # 8775175

Case Type NON-EXPEDITED

Health Professional

Outcomes

Country USA

Preferred Term Uterine spasm

Product NUVARING Case # 8775237 Case Type EXPEDITED (15-DAY)

Manufacturer MERCK Country USA

8775237 Date FDA Received

10-Sep-2012

Outcomes HO,OT

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,107 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8775237
Preferred Term Hypercoagulation Intervertebral disc degeneration Spinal osteoarthritis Abdominal pain Abnormal weight gain Blood cholesterol increased Constipation C-reactive protein increased Deep vein thrombosis Diarrhoea Dissociation Early satiety Fibroadenoma of breast Fibromyalgia Gastritis erosive Gastrooesophageal reflux disease Headache Incorrect drug administration duration Intervertebral disc disorder Intervertebral disc protrusion Irritable bowel syndrome Lipoma of breast Metrorrhagia Narcolepsy Nausea Pelvic pain Pulmonary embolism Sinusitis Snoring Vomiting Weight decreased Product NUVARING NUVARING NUVARING Role Route S S S Dosage Text Duration Manufacturer MERCK MERCK MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,108 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8775334 Date FDA Received
10-Sep-2012 Case # 8775334 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2011SP0 31790 Dosage Text Duration Age Sex Unknown Country USA

Preferred Term Urinary retention postoperative Chest pain Cholecystectomy Deep vein thrombosis Emotional disorder Gallbladder disorder Hand fracture Hypercoagulation Hypertension Mental disorder Pulmonary embolism

Product NUVARING

Role Route S

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,109 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8775970 Date FDA Received
10-Sep-2012 Case # 8775970 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,DS,LT,OT Manufacturer Control # US-009507513-2010SP0 36928 Dosage Text Duration Age Sex Unknown Country USA

Preferred Term Pneumonia Acute respiratory failure Intracranial pressure increased Cardiac disorder Cerebral infarction Complex regional pain syndrome Convulsion Depression Dysmenorrhoea Foot fracture Hepatic enzyme increased Hepatic steatosis Hyperglycaemia Hypertension Intracranial venous sinus thrombosis Ischaemic hepatitis Ischaemic stroke Muscle contracture Nasal septum deviation Partial seizures Sinusitis Subarachnoid haemorrhage Subdural haemorrhage

Product NUVARING NUVARING METFORMIN

Role Route S S C

Manufacturer MERCK MERCK

TAKEN SINCE AGE 16

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,110 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8776255 Date FDA Received
10-Sep-2012 Case # 8776255 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1208USA 008701 Role Route S VAGINAL Dosage Text 1 ring for 3 weeks, followed by a week (of ring) free interval. Duration Age Sex Unknown Country USA

Preferred Term Unintended pregnancy

Product NUVARING

Manufacturer MERCK

Abnormal withdrawal bleeding Inappropriate schedule of drug administration

8776670 Date FDA Received

10-Sep-2012

Case # 8776670

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1208USA 009198

Age

Sex Unknown

Country USA

Preferred Term Metrorrhagia Inappropriate schedule of drug administration

Product NUVARING

Role Route S VAGINAL

Dosage Text UNK

Duration

Manufacturer MERCK

8777523 Date FDA Received

10-Sep-2012

Case # 8777523

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes OT

Manufacturer Control # ES-009507513-1208ESP 011136 Dosage Text UNK

Age

Sex Unknown

Country ESP

Preferred Term Abortion induced Unintended pregnancy

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

8675512 Date FDA Received

11-Sep-2012

Case # 8675512

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-2012SP0 33081

Age

Sex Unknown

Country USA

Preferred Term Device expulsion

Product NUVARING

Role Route S

Dosage Text

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,111 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8702872 Date FDA Received
11-Sep-2012 Case # 8702872 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2009SP0 40437 Dosage Text UNK 10 mg, QD 10 mg, QD 10 mg, QD 1 DF, QD UNK UNK, PRN 15 mg, QW 50 mg, QD MERCK Duration Age Sex Unknown Country USA

Preferred Term Pulmonary infarction Vena cava thrombosis Pulmonary embolism Visual impairment Menstrual disorder Arthralgia Dyspnoea Lung disorder Asthenia Bronchitis Dyspareunia Influenza Pelvic inflammatory disease Pneumonia Trichomoniasis

Product NUVARING NORVASC METICORTEN NORVASC FOLIC ACID DARVOCET-N METHOTREXATE ZOLOFT

Role Route S C C C C C C C VAGINAL

Manufacturer MERCK

8740329 Date FDA Received

11-Sep-2012

Case # 8740329

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO

Manufacturer Control # US-009507513-1208USA 003715 Dosage Text

Age

Sex Unknown

Country USA

Preferred Term Thrombophlebitis Thrombosis

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

8740588 Date FDA Received

11-Sep-2012

Case # 8740588

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,OT

Manufacturer Control # US-009507513-1208USA 008450 Dosage Text UNK UNK, q3w

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,112 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8759344 Date FDA Received
11-Sep-2012 Case # 8759344 Case Type EXPEDITED (15-DAY) Health Professional Outcomes OT Manufacturer Control # BR-009507513-2011SP0 55306 Dosage Text UNK UNK, Unknown UNK UNK, Unknown Duration Age Sex Unknown Country BRA

Preferred Term Abortion Inappropriate schedule of drug administration Caesarean section Complication of pregnancy Drug administration error Surgery Thrombosis

Product NUVARING NUVARING

Role Route S S VAGINAL VAGINAL

Manufacturer MERCK MERCK

8776705 Date FDA Received

11-Sep-2012

Case # 8776705

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO

Manufacturer Control # US-009507513-2011SP0 30613 Dosage Text

Age

Sex Unknown

Country USA

Preferred Term Deep vein thrombosis Hypercoagulation Mental disorder Family stress Anxiety Cellulitis Chest pain Dysmenorrhoea Insomnia

Product NUVARING NUVARING IMITREX (SUMATRIPTAN) LORTAB

Role Route S S C S

Duration

Manufacturer MERCK MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,113 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8777129 Date FDA Received
11-Sep-2012 Case # 8777129 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1209USA 002357 Role Route S VAGINAL Dosage Text 1 DF, q3w Duration Age Sex Unknown Country USA

Preferred Term Thrombosis Headache Metrorrhagia

Product NUVARING

Manufacturer MERCK

8777160 Date FDA Received

11-Sep-2012

Case # 8777160

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,LT

Manufacturer Control # US-009507513-1209USA 002395 Dosage Text

Age

Sex Unknown

Country USA

Preferred Term Thrombosis

Product NUVARING Case # 8777172 Case Type NON-EXPEDITED Health Professional

Role Route S VAGINAL

Duration

Manufacturer MERCK

8777172 Date FDA Received

11-Sep-2012

Outcomes

Manufacturer Control # US-009507513-1209USA 002388

Age

Sex Unknown

Country USA

Preferred Term Inappropriate schedule of drug administration

Product NUVARING Health Professional

Role Route S VAGINAL

Dosage Text

Duration

Manufacturer MERCK

8778328 Date FDA Received

11-Sep-2012

Case # 8778328

Case Type NON-EXPEDITED

Outcomes

Manufacturer Control # US-009507513-1209USA 003119

Age

Sex Unknown

Country USA

Preferred Term Menstruation irregular

Product NUVARING Case # 8718996 Case Type NON-EXPEDITED Health Professional

Role Route S VAGINAL

Dosage Text UNK Manufacturer Control # US-009507513-1208USA 003327

Duration

Manufacturer MERCK

8718996 Date FDA Received

12-Sep-2012

Outcomes

Age

Sex Unknown

Country USA

Preferred Term Device breakage No adverse event

Product NUVARING

Role Route S VAGINAL

Dosage Text 0.120/0.015 mg per day

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,114 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8760010 Date FDA Received
12-Sep-2012 Case # 8760010 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-2012SP0 32089 Role Route S VAGINAL Dosage Text 0.015/0.12MG/ UNSPECIFIED BY REPORTER. Manufacturer Control # US-009507513-2011SP0 14622 Dosage Text Duration Age Sex Unknown Duration Age Sex Unknown Country USA

Preferred Term Unintended pregnancy

Product NUVARING

Manufacturer MERCK

8760206 Date FDA Received

12-Sep-2012

Case # 8760206

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,OT

Country USA

Preferred Term Pulmonary embolism Arthralgia Cellulitis Conduction disorder Deep vein thrombosis Mental disorder Mitral valve incompetence Muscle strain Musculoskeletal pain Nausea Neck pain Post-traumatic stress disorder Pulmonary hypertension Right ventricular failure Road traffic accident Skin lesion Upper respiratory tract infection

Product NUVARING

Role Route S

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,115 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8761134 Date FDA Received
12-Sep-2012 Case # 8761134 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO Manufacturer Control # US-009507513-2012SP0 24811 Dosage Text UNK Duration Age Sex Unknown Country USA

Preferred Term Pre-eclampsia Deep vein thrombosis Maternal exposure before pregnancy Thrombosis

Product NUVARING

Role Route S

Manufacturer MERCK

8779236 Date FDA Received

12-Sep-2012

Case # 8779236

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes OT

Manufacturer Control # DE-009507513-1208DEU 008134 Dosage Text UNK

Age

Sex Unknown

Country DEU

Preferred Term Abortion spontaneous Unintended pregnancy

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

8790506 Date FDA Received

12-Sep-2012 Preferred Term Dysgeusia Fluid retention Painful respiration Pollakiuria

Case # 8790506

Case Type DIRECT Product NUVARING

Health Professional

Outcomes

Manufacturer Control # CTU 487519

Age 31 YR Duration 5 DAY

Sex Female

Country USA

Role Route S VAGINAL

Dosage Text

Manufacturer

Vulvovaginal burning sensation Vulvovaginal discomfort Vulvovaginal pain Weight increased

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,116 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8740852 Date FDA Received
13-Sep-2012 Case # 8740852 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2011SP0 56413 Dosage Text Duration Age Sex Unknown Country USA

Preferred Term Pulmonary embolism Deep vein thrombosis Metaplasia Limb discomfort Breast enlargement Breast fibrosis

Product NUVARING NUVARING NUVARING NUVARING

Role Route S S S S

Manufacturer MERCK MERCK MERCK MERCK

8761359 Date FDA Received

13-Sep-2012

Case # 8761359

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,DS,OT

Manufacturer Control # US-009507513-2010SP0 10131 Dosage Text UNK UNK, QM

Age

Sex Unknown

Country USA

Preferred Term Bronchitis Cholecystectomy Deep vein thrombosis Depression Gastrointestinal disorder Haemorrhoids Headache Nausea Pharyngitis Pulmonary embolism

Product NUVARING

Role Route S

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,117 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8762456 Date FDA Received
13-Sep-2012 Case # 8762456 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2012SP0 24809 Dosage Text UNK Duration Age Sex Unknown Country USA

Preferred Term Vaginitis bacterial Abdominal pain Back pain Cervical cyst Muscle spasms Non-cardiac chest pain Pulmonary embolism Road traffic accident Urinary tract infection Uterine haemorrhage

Product NUVARING

Role Route S

Manufacturer MERCK

8762604 Date FDA Received

13-Sep-2012

Case # 8762604

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,OT

Manufacturer Control # US-009507513-2011SP0 51270 Dosage Text

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism Burns second degree Headache Nervous system disorder

Product NUVARING

Role Route S

Duration

Manufacturer MERCK

8780937 Date FDA Received

13-Sep-2012

Case # 8780937

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes OT

Manufacturer Control # BR-009507513-1209BRA 004728 Dosage Text UNK

Age

Sex Unknown

Country BRA

Preferred Term Abortion spontaneous Unintended pregnancy

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,118 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8780950 Date FDA Received
13-Sep-2012 Case # 8780950 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1209USA 003816 Role Route S S Health Professional VAGINAL VAGINAL Dosage Text 1 DF, qm 1 DF, qm Manufacturer Control # US-009507513-1209USA 002932 Role Route S Health Professional Outcomes Dosage Text UNK Manufacturer Control # US-009507513-1209USA 001117 Role Route S Health Professional VAGINAL Dosage Text 1 DF, UNK Manufacturer Control # US-009507513-1209USA 000821 Role Route S S C C VAGINAL Dosage Text UNK Duration Age Sex Unknown Duration Age Sex Unknown Duration Age Sex Unknown Duration Age Sex Unknown Country USA

Preferred Term Device expulsion

Product NUVARING NUVARING

Manufacturer MERCK MERCK Country USA

8780959 Date FDA Received

13-Sep-2012

Case # 8780959

Case Type NON-EXPEDITED

Outcomes

Preferred Term Device expulsion

Product NUVARING Case # 8781029 Case Type NON-EXPEDITED

Manufacturer MERCK Country USA

8781029 Date FDA Received

13-Sep-2012

Preferred Term Unintended pregnancy

Product NUVARING Case # 8781062 Case Type NON-EXPEDITED

Manufacturer MERCK Country USA

8781062 Date FDA Received

13-Sep-2012

Outcomes

Preferred Term Menstruation delayed Inappropriate schedule of drug administration

Product NUVARING NUVARING LEXAPRO ZYRTEC

Manufacturer MERCK MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,119 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8781083 Date FDA Received
13-Sep-2012 Case # 8781083 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1209USA 003901 Role Route S Health Professional VAGINAL Dosage Text UNK Manufacturer Control # CL-009507513-1209CHL 003197 Dosage Text delivers 0.120mg/ 0.015mg, qd Manufacturer Control # DE-009507513-1209DEU 000533 Dosage Text Duration Age Sex Unknown Duration Age Sex Unknown Duration Age Sex Unknown Country USA

Preferred Term Deep vein thrombosis

Product NUVARING Case # 8781145 Case Type EXPEDITED (15-DAY)

Manufacturer MERCK Country CHL

8781145 Date FDA Received

13-Sep-2012

Outcomes OT

Preferred Term Systemic lupus erythematosus

Product NUVARING Case Type EXPEDITED (15-DAY) Health Professional

Role Route S VAGINAL

Manufacturer MERCK Country DEU

8781197 Date FDA Received

13-Sep-2012

Case # 8781197

Outcomes OT

Preferred Term Pancreatitis Bone marrow disorder Factor V Leiden mutation Histamine intolerance Lactose intolerance Mastocytosis

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

8781201 Date FDA Received

13-Sep-2012

Case # 8781201

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1208USA 009078

Age

Sex Unknown

Country USA

Preferred Term Thrombosis

Product NUVARING

Role Route S VAGINAL

Dosage Text UNK

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,120 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8781203 Date FDA Received
13-Sep-2012 Case # 8781203 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1208USA 009230 Role Route S VAGINAL Dosage Text 0.12/0.015/24 mg Duration Age Sex Unknown Country USA

Preferred Term Device expulsion Device physical property issue

Product NUVARING

Manufacturer MERCK

8781597 Date FDA Received

13-Sep-2012

Case # 8781597

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1209USA 002369

Age

Sex Unknown

Country USA

Preferred Term Back pain

Product NUVARING Case # 8781599 Case Type NON-EXPEDITED Health Professional

Role Route S VAGINAL

Dosage Text UNK Manufacturer Control # US-009507513-1209USA 003604

Duration

Manufacturer MERCK

8781599 Date FDA Received

13-Sep-2012

Outcomes

Age

Sex Unknown

Country USA

Preferred Term Deep vein thrombosis

Product NUVARING Case # 8781842 Case Type NON-EXPEDITED Health Professional

Role Route S VAGINAL

Dosage Text UNK Manufacturer Control # US-009507513-1209USA 002343

Duration

Manufacturer MERCK

8781842 Date FDA Received

13-Sep-2012

Outcomes

Age

Sex Unknown

Country USA

Preferred Term Transient ischaemic attack

Product NUVARING Case Type NON-EXPEDITED Health Professional

Role Route S Outcomes

Dosage Text UNK Manufacturer Control # US-009507513-1209USA 000886

Duration

Manufacturer MERCK

8782360 Date FDA Received

13-Sep-2012

Case # 8782360

Age

Sex Unknown

Country USA

Preferred Term Inappropriate schedule of drug administration

Product NUVARING

Role Route S VAGINAL

Dosage Text 1 ring for 3 weeks

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,121 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8782470 Date FDA Received
13-Sep-2012 Case # 8782470 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2011SP0 35870 Dosage Text Duration Age Sex Unknown Country USA

Preferred Term Nephropathy Pulmonary embolism Anxiety Arthralgia Cardiac disorder Deep vein thrombosis Depression Haemangioma of liver Headache Migraine Nasal disorder Nasal septum deviation Neck pain Obstructive airways disorder Sinus disorder Sleep apnoea syndrome Vertigo positional

Product NUVARING NUVARING

Role Route S S VAGINAL

Manufacturer MERCK MERCK

8782481 Date FDA Received

13-Sep-2012

Case # 8782481

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1209USA 001171

Age

Sex Unknown

Country USA

Preferred Term Metrorrhagia

Product NUVARING

Role Route S VAGINAL

Dosage Text 0.120 mg/day of etonogestrel and 0.015 mg/day/21 days

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,122 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8782571 Date FDA Received
13-Sep-2012 Case # 8782571 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1208USA 009561 Role Route S Health Professional VAGINAL Dosage Text UNK Manufacturer Control # US-009507513-2010SP0 05950 Dosage Text UNK UNK, PRN INHALATION Duration Age Sex Unknown Duration Age Sex Unknown Country USA

Preferred Term Thrombosis

Product NUVARING Case # 8784354 Case Type EXPEDITED (15-DAY)

Manufacturer MERCK Country USA

8784354 Date FDA Received

13-Sep-2012

Outcomes HO,OT

Preferred Term Dyspnoea Deep vein thrombosis Pulmonary embolism Chest discomfort Anxiety Costochondritis Dysmenorrhoea Dysphagia Gastrooesophageal reflux disease Microcytic anaemia Oesophageal spasm Panic attack Vitamin D deficiency

Product NUVARING PROVENTIL FLOVENT METOPROLOL

Role Route S C C C VAGINAL

Manufacturer MERCK MERCK

8791116 Date FDA Received

13-Sep-2012 Preferred Term Infertility female Cystitis

Case # 8791116

Case Type DIRECT Product NUVARING

Health Professional

Outcomes OT Role Route S VAGINAL

Manufacturer Control # CTU 487674 Dosage Text 1 ring insert once a mont vag

Age

Sex Female

Country USA

Duration

Manufacturer

Pelvic inflammatory disease Vaginitis bacterial

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,123 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8662988 Date FDA Received
14-Sep-2012 Case # 8662988 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1207USA 000869 Role Route S Health Professional VAGINAL Manufacturer Control # US-009507513-2012SP0 05879 Dosage Text Duration Age Sex Unknown Dosage Text Duration Age Sex Unknown Country USA

Preferred Term Varicose veins pelvic

Product NUVARING Case # 8666748 Case Type EXPEDITED (15-DAY)

Manufacturer MERCK Country USA

8666748 Date FDA Received

14-Sep-2012

Outcomes HO,DS,OT

Preferred Term Convulsion Cerebrovascular accident Anaemia Carotid artery stenosis Carotid artery thrombosis Cognitive disorder Emotional disorder Encephalomalacia Hypokalaemia Mental disorder Paraesthesia Sleep disorder Thrombocytosis

Product NUVARING UNSPECIFIED INGREDIENT

Role Route S S

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,124 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8769253 Date FDA Received
14-Sep-2012 Case # 8769253 Case Type EXPEDITED (15-DAY) Health Professional Outcomes DE,HO,DS,LT,OT Manufacturer Control # US-009507513-1208USA 010021 Dosage Text 1 DF, UNK INTRAVENOUS INTRAVENOUS INTRAVENOUS INTRAVENOUS INTRAVENOUS INTRAVENOUS INTRAVENOUS INTRAVENOUS INTRAMUSCULAR ORAL ORAL 1000 IU, prn 1000 IU, prn 1000 IU, prn 1000 IU, prn 1000 IU, prn 1000 IU, prn 1000 IU, prn 1000 IU, prn 0.025 mg, qd 0.3 mg, prn 0.5 mg, bid 180 mg, qd 25 mg, bid 25 mg, bid ORAL ORAL ORAL ORAL 20 mg, qd 20 mg, qd 3 mg, prn 15 mg, qd Manufacturer Control # US-009507513-1209USA 002345 Role Route S VAGINAL Dosage Text 1 DF/ every Duration Age Sex Unknown MERCK Country USA MERCK Duration Age Sex Unknown Country USA

Preferred Term Cardiac arrest Pulmonary embolism Cerebral infarction Brain oedema Craniectomy Loss of consciousness Syncope Convulsion Blood pressure systolic decreased Hypotension Electrocardiogram ST-T segment abnormal Dizziness Nausea Abdominal pain Asthenia Abdominal distension

Product NUVARING CINRYZE CINRYZE CINRYZE CINRYZE CINRYZE CINRYZE CINRYZE CINRYZE ORTHO TRI-CYCLEN EPIPEN clonazepam fexofenadine hydrochloride metoprolol nortriptyline PRILOSEC citalopram melatonin REMERON

Role Route S S S S S S S S S S C C C C C C C C C Health Professional

Manufacturer MERCK

8785141 Date FDA Received

14-Sep-2012

Case # 8785141

Case Type NON-EXPEDITED

Outcomes

Preferred Term Unintended pregnancy

Product NUVARING

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,125 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8785320 Date FDA Received
14-Sep-2012 Case # 8785320 Case Type EXPEDITED (15-DAY) Health Professional Outcomes OT Manufacturer Control # US-009507513-1209USA 004276 Dosage Text UNK Manufacturer Control # US-009507513-1209USA 004273 Dosage Text UNK Manufacturer Control # US-009507513-1209USA 004303 Role Route S Dosage Text 1 DF, 3 weeks in, one week out Duration Age Sex Unknown Duration Age Sex Unknown Duration Age Sex Unknown Country USA

Preferred Term Pulmonary embolism

Product NUVARING Case # 8785684 Case Type EXPEDITED (15-DAY) Health Professional

Role Route S Outcomes OT

Manufacturer MERCK Country USA

8785684 Date FDA Received

14-Sep-2012

Preferred Term Pulmonary embolism

Product NUVARING Case # 8785721 Case Type NON-EXPEDITED Health Professional

Role Route S Outcomes

Manufacturer MERCK Country USA

8785721 Date FDA Received

14-Sep-2012

Preferred Term Breast haemorrhage Breast discharge Breast tenderness

Product NUVARING

Manufacturer MERCK

8786186 Date FDA Received

14-Sep-2012

Case # 8786186

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,OT

Manufacturer Control # US-009507513-2010SP0 42947 Dosage Text

Age

Sex Unknown

Country USA

Preferred Term Atelectasis Anaemia Anxiety Fibrin D dimer increased Hypoxia Pneumonitis Pulmonary embolism

Product NUVARING

Role Route S

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,126 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8786549 Date FDA Received
14-Sep-2012 Case # 8786549 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1208USA 010191 Role Route S Health Professional VAGINAL Dosage Text UNK, qm Manufacturer Control # US-009507513-1207USA 011727 Role Route S VAGINAL Dosage Text UNK Duration Age Sex Unknown Duration Age Sex Unknown Country USA

Preferred Term Metrorrhagia

Product NUVARING Case # 8788617 Case Type NON-EXPEDITED

Manufacturer MERCK Country USA

8788617 Date FDA Received

15-Sep-2012

Outcomes

Preferred Term Weight decreased Hair growth abnormal

Product NUVARING

Manufacturer MERCK

8788650 Date FDA Received

15-Sep-2012

Case # 8788650

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes OT

Manufacturer Control # DE-009507513-1209DEU 001992 Dosage Text UNK Manufacturer Control # US-009507513-1208USA 008173

Age

Sex Unknown

Country DEU

Preferred Term Cervix carcinoma

Product NUVARING Case # 8788671 Case Type NON-EXPEDITED Health Professional

Role Route S VAGINAL

Duration

Manufacturer MERCK

8788671 Date FDA Received

15-Sep-2012

Outcomes

Age

Sex Unknown

Country USA

Preferred Term Musculoskeletal pain Drug administration error

Product NUVARING

Role Route S VAGINAL

Dosage Text UNK

Duration

Manufacturer MERCK

8788682 Date FDA Received

16-Sep-2012

Case # 8788682

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1208USA 005818

Age

Sex Unknown

Country USA

Preferred Term Inappropriate schedule of drug administration

Product NUVARING

Role Route S VAGINAL

Dosage Text UNK

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,127 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8788734 Date FDA Received
16-Sep-2012 Case # 8788734 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1207USA 008377 Role Route S Health Professional VAGINAL Dosage Text UNK Manufacturer Control # US-009507513-1209USA 005168 Role Route S Dosage Text UNK Duration Age Sex Unknown Duration Age Sex Unknown Country USA

Preferred Term Hypoaesthesia

Product NUVARING Case # 8788740 Case Type NON-EXPEDITED

Manufacturer MERCK Country USA

8788740 Date FDA Received

16-Sep-2012

Outcomes

Preferred Term Inappropriate schedule of drug administration No adverse event

Product NUVARING

Manufacturer MERCK

8788801 Date FDA Received

16-Sep-2012

Case # 8788801

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1207USA 010663

Age

Sex Unknown

Country USA

Preferred Term Vaginal discharge Incorrect drug administration duration

Product NUVARING lisinopril Case Type EXPEDITED (15-DAY) Health Professional

Role Route S C Outcomes HO,OT VAGINAL

Dosage Text UNK

Duration

Manufacturer MERCK

7257935 Date FDA Received

17-Sep-2012

Case # 7257935

Manufacturer Control # US-009507513-2009SP0 21070 Dosage Text 800 mg, TID 25 mg, hs

Age

Sex Unknown

Country USA

Preferred Term Peripheral artery thrombosis Cholecystitis Multiple sclerosis Abortion induced Abortion spontaneous Acne Acute myocardial infarction

Product NUVARING NEURONTIN AMITRIPTYLINE HYDROCHLORIDE

Role Route S C C ORAL ORAL

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,128 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7257935
Preferred Term Alcohol use Anaemia Antiphospholipid syndrome Anxiety Carotid artery stent insertion Cerebral cyst Chest pain Coagulation factor IX level increased Coronary artery disease Deafness Deep vein thrombosis Dyspnoea Ectopic pregnancy Eustachian tube dysfunction Gallbladder necrosis Hepatitis C antibody positive Herpes virus infection Hidradenitis Hypnopompic hallucination Hypoaesthesia Impaired work ability International normalised ratio abnormal Maternal exposure before pregnancy Oropharyngeal pain Pain Palpitations Peripheral arterial occlusive disease Peripheral vascular disorder Pregnancy Product quality issue Protein S deficiency Product Role Route Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,129 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7257935
Preferred Term Retained placenta or membranes Sinus tachycardia Sleep apnoea syndrome Supraventricular extrasystoles Surgical failure Vulval disorder Product Role Route Dosage Text Duration Manufacturer

8758626 Date FDA Received

17-Sep-2012

Case # 8758626

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,OT

Manufacturer Control # US-009507513-2010SP0 62524 Dosage Text UNK UNK, QM

Age

Sex Unknown

Country USA

Preferred Term Hypercoagulation Coagulopathy Deep vein thrombosis Pulmonary embolism Pulmonary infarction Synovial cyst Tendon sheath lesion excision Wrist surgery

Product NUVARING

Role Route S

Duration

Manufacturer MERCK

8788614 Date FDA Received

17-Sep-2012

Case # 8788614

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1208USA 008320

Age

Sex Unknown

Country USA

Preferred Term Breast enlargement

Product NUVARING

Role Route S VAGINAL

Dosage Text one Nuvaring inserted vaginally continuously for three weeks and then removed for a one week break

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,130 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8788665 Date FDA Received
17-Sep-2012 Case # 8788665 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1209USA 002386 Role Route S Health Professional VAGINAL Dosage Text 1 DF, 3 weeks in 1 weeks out Manufacturer Control # US-009507513-1209USA 002379 Role Route S Health Professional VAGINAL Dosage Text UNK UNK, qm Manufacturer Control # US-009507513-1209USA 005199 Role Route S Health Professional VAGINAL Dosage Text UNK Manufacturer Control # US-009507513-1209USA 005053 Role Route S Health Professional VAGINAL Dosage Text 0.15/0.12mg/1 every 3 weeks Manufacturer Control # US-009507513-1209USA 001176 Role Route S VAGINAL Dosage Text 3 weeks in, 1 week out Duration Age Sex Unknown Duration Age Sex Unknown Duration Age Sex Unknown Duration Age Sex Unknown Duration Age Sex Unknown Country USA

Preferred Term Device expulsion

Product NUVARING Case # 8788666 Case Type NON-EXPEDITED

Manufacturer MERCK Country USA

8788666 Date FDA Received

17-Sep-2012

Outcomes

Preferred Term Inappropriate schedule of drug administration

Product NUVARING

Manufacturer MERCK Country USA

8788976 Date FDA Received

17-Sep-2012

Case # 8788976

Case Type NON-EXPEDITED

Outcomes

Preferred Term Device expulsion

Product NUVARING Case # 8789051 Case Type NON-EXPEDITED

Manufacturer MERCK Country USA

8789051 Date FDA Received

17-Sep-2012

Outcomes

Preferred Term Unintended pregnancy

Product NUVARING Case # 8789091 Case Type NON-EXPEDITED

Manufacturer MERCK Country USA

8789091 Date FDA Received

17-Sep-2012

Outcomes

Preferred Term Incorrect drug administration duration Inappropriate schedule of drug administration

Product NUVARING

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,131 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8789821 Date FDA Received
17-Sep-2012 Case # 8789821 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2012SP0 28994 Dosage Text UNK Duration Age Sex Unknown Country USA

Preferred Term Hydronephrosis Abdominal pain Anaemia Chest pain Constipation Diarrhoea Haematuria Headache Hypokalaemia Increased tendency to bruise Maxillofacial operation Migraine Night sweats Pulmonary embolism Pulmonary infarction Temperature intolerance Vision blurred White blood cell count increased

Product NUVARING

Role Route S

Manufacturer MERCK

8789950 Date FDA Received

17-Sep-2012

Case # 8789950

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1208USA 007972

Age

Sex Unknown

Country USA

Preferred Term Device expulsion No adverse event Product quality issue

Product NUVARING

Role Route S VAGINAL

Dosage Text UNK

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,132 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8790095 Date FDA Received
17-Sep-2012 Case # 8790095 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1208USA 008336 Role Route S VAGINAL Dosage Text Duration Age Sex Unknown Country USA

Preferred Term Device expulsion Incorrect drug administration duration

Product NUVARING

Manufacturer MERCK

8790396 Date FDA Received

17-Sep-2012

Case # 8790396

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1208USA 003429

Age

Sex Unknown

Country USA

Preferred Term Muscle spasms Skin warm

Product NUVARING MONISTAT PENTASA

Role Route S C C Health Professional Outcomes VAGINAL

Dosage Text 1 ring for 3 wks, 1 wk off 500 mg, bid Manufacturer Control # US-009507513-1209USA 005492

Duration

Manufacturer MERCK

8792279 Date FDA Received

17-Sep-2012

Case # 8792279

Case Type NON-EXPEDITED

Age

Sex Unknown

Country USA

Preferred Term Skin mass Device difficult to use Device expulsion

Product NUVARING

Role Route S VAGINAL

Dosage Text UNK

Duration

Manufacturer MERCK

8794447 Date FDA Received

17-Sep-2012

Case # 8794447

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1209USA 003821

Age

Sex Unknown

Country USA

Preferred Term Menstruation irregular

Product NUVARING

Role Route S VAGINAL

Dosage Text 1 DF, qm

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,133 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8794880 Date FDA Received
17-Sep-2012 Case # 8794880 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1208USA 010783 Role Route S VAGINAL Dosage Text 1 ring for 3 weeks followed by a week free break Manufacturer Control # US-009507513-1209USA 004991 Role Route S S VAGINAL VAGINAL Dosage Text UNK UNK Duration Age Sex Unknown Duration Age Sex Unknown Country USA

Preferred Term Medical device complication

Product NUVARING

Manufacturer MERCK

8795358 Date FDA Received

17-Sep-2012

Case # 8795358

Case Type NON-EXPEDITED

Health Professional

Outcomes

Country USA

Preferred Term Overdose

Product NUVARING NUVARING

Manufacturer MERCK MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,134 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8655555 Date FDA Received
18-Sep-2012 Case # 8655555 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,DS,OT Manufacturer Control # US-009507513-2010SP0 02783 Dosage Text 1 DF, QM 1 DF, QM Duration Age Sex Unknown Country USA

Preferred Term Dyspnoea Antiphospholipid syndrome Abdominal pain Adjustment disorder Anxiety Cerebrovascular accident Depression Dermatitis atopic Encephalomalacia Head injury Hyperlipidaemia Hypotension Hypothyroidism Nervous system disorder Papilloma viral infection Postpartum depression Pyrexia Sensory loss Urine abnormality Urticaria Victim of crime Vomiting

Product NUVARING NUVARING

Role Route S S VAGINAL VAGINAL

Manufacturer MERCK MERCK

8678690 Date FDA Received

18-Sep-2012

Case # 8678690

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,OT

Manufacturer Control # US-009507513-2012SP0 14009 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,135 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8678690
Preferred Term Abdominal distension Abdominal pain Angina pectoris Anxiety Arrhythmia Asthma Basedow's disease Benign intracranial hypertension Carbuncle Cerebellar haemangioma Cerebral thrombosis Chest pain Cholelithiasis Colitis Deep vein thrombosis Depression Dermatitis contact Drug hypersensitivity Drug ineffective Dyskinesia Dyspnoea Epidural blood patch Gastrooesophageal reflux disease Genital herpes Haemorrhagic disorder Haemorrhoids Headache Hormone level abnormal Hypersensitivity Hypoaesthesia International normalised ratio increased Product Role Route Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,136 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8678690
Preferred Term Knee arthroplasty Migraine Migraine with aura Nasal congestion Neck pain Nervousness Nervous system disorder Oropharyngeal pain Pain Palpitations Papilloedema Paraesthesia Phlebitis Post lumbar puncture syndrome Pyelonephritis Rectal haemorrhage Restless legs syndrome Retinal haemorrhage Rhinorrhoea Seasonal allergy Sinusitis Tension headache Thyroiditis Tonsillar disorder Transverse sinus thrombosis Tremor Ulcer Upper-airway cough syndrome Ventricular extrasystoles Vomiting Vomiting projectile Product Role Route Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,137 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8678690
Preferred Term Wisdom teeth removal Product Role Route Dosage Text Duration Manufacturer

8791622 Date FDA Received

18-Sep-2012

Case # 8791622

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,OT

Manufacturer Control # CA-009507513-1209CAN 007273 Dosage Text

Age

Sex Unknown

Country CAN

Preferred Term Pulmonary embolism Deep vein thrombosis Dyspnoea

Product NUVARING

Role Route S

Duration

Manufacturer MERCK

8791750 Date FDA Received

18-Sep-2012

Case # 8791750

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1208USA 008695

Age

Sex Unknown

Country USA

Preferred Term Deep vein thrombosis

Product NUVARING Case # 8791802 Case Type EXPEDITED (15-DAY) Health Professional

Role Route S VAGINAL

Dosage Text 1 ring every 28 days Manufacturer Control # US-009507513-2010SP0 29106 Dosage Text continuously

Duration

Manufacturer MERCK

8791802 Date FDA Received

18-Sep-2012

Outcomes HO,OT

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism Cholecystectomy Incorrect drug administration duration Migraine Off label use Vitamin D deficiency

Product NUVARING NUVARING

Role Route S S VAGINAL

Duration

Manufacturer MERCK MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,138 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8791859 Date FDA Received
18-Sep-2012 Case # 8791859 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1209USA 002854 Role Route S C Health Professional Outcomes VAGINAL Dosage Text 3 weeks in, 1 week out UNK Manufacturer Control # US-009507513-1209USA 001110 Role Route S VAGINAL Dosage Text UNK Duration Age Sex Unknown Country USA Duration Age Sex Unknown Country USA

Preferred Term Menstruation delayed

Product NUVARING SEDATIVUM

Manufacturer MERCK

8792122 Date FDA Received

18-Sep-2012

Case # 8792122

Case Type NON-EXPEDITED

Preferred Term Inappropriate schedule of drug administration No adverse event

Product NUVARING

Manufacturer MERCK

8792703 Date FDA Received

18-Sep-2012

Case # 8792703

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1209USA 001044

Age

Sex Unknown

Country USA

Preferred Term Inappropriate schedule of drug administration Device expulsion

Product NUVARING

Role Route S VAGINAL

Dosage Text 3 weeks in, 1 week out

Duration

Manufacturer MERCK

8793149 Date FDA Received

18-Sep-2012

Case # 8793149

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO

Manufacturer Control # BR-009507513-1208BRA 003905 Dosage Text UNK

Age

Sex Unknown

Country BRA

Preferred Term Cystocele Drug administration error Dysmenorrhoea Inappropriate schedule of drug administration

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,139 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8793234 Date FDA Received
18-Sep-2012 Case # 8793234 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1209USA 006758 Role Route S Health Professional VAGINAL Dosage Text 3 weeks in, 1 week out Manufacturer Control # US-009507513-2010SP0 56198 Dosage Text UNK UNK, QD UNK Duration Age Sex Unknown Duration Age Sex Unknown Country USA

Preferred Term Device expulsion

Product NUVARING Case # 7927570 Case Type EXPEDITED (15-DAY)

Manufacturer MERCK Country USA

7927570 Date FDA Received

19-Sep-2012

Outcomes HO,OT

Preferred Term Hypercoagulation Deep vein thrombosis Ligament sprain Contusion Extrasystoles Palpitations Tricuspid valve incompetence

Product NUVARING VITAMINS COUMADIN

Role Route S C S

Manufacturer MERCK

8760847 Date FDA Received

19-Sep-2012

Case # 8760847

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes OT

Manufacturer Control # BE-009507513-1208BEL 008125 Dosage Text 1 DF, UNK

Age 27 YR

Sex Female

Country BEL

Preferred Term Abortion induced complete Unintended pregnancy

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,140 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8781394 Date FDA Received
19-Sep-2012 Case # 8781394 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2011SP0 56190 Dosage Text UNK Duration Age Sex Unknown Country USA

Preferred Term Nephrotic syndrome Renal vein thrombosis Anaemia Enterococcal infection Generalised oedema Herpes simplex Hypoaesthesia Hypocoagulable state Hypoxia Lupus nephritis Muscle spasms Paraesthesia Pleural effusion Pneumonia Pulmonary embolism Systemic lupus erythematosus

Product NUVARING NUVARING

Role Route S S

Manufacturer MERCK MERCK

8796245 Date FDA Received

19-Sep-2012

Case # 8796245

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1209USA 004552

Age

Sex Unknown

Country USA

Preferred Term Oligomenorrhoea

Product NUVARING NUVARING

Role Route S S VAGINAL

Dosage Text UNK

Duration

Manufacturer MERCK MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,141 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8796714 Date FDA Received
19-Sep-2012 Case # 8796714 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1209USA 006698 Role Route S Health Professional VAGINAL Dosage Text 3 weeks in, 1 week out Manufacturer Control # US-009507513-1209USA 004267 Dosage Text UNK Manufacturer Control # US-009507513-2010SP0 63657 Dosage Text UNK UNK Duration Age Sex Unknown Duration Age Sex Unknown Duration Age Sex Unknown Country USA

Preferred Term Metrorrhagia

Product NUVARING Case # 8796754 Case Type EXPEDITED (15-DAY)

Manufacturer MERCK Country USA

8796754 Date FDA Received

19-Sep-2012

Outcomes HO,OT

Preferred Term Pulmonary embolism

Product NUVARING Case # 8797004 Case Type EXPEDITED (15-DAY) Health Professional

Role Route S Outcomes HO,DS,OT

Manufacturer MERCK Country USA

8797004 Date FDA Received

19-Sep-2012

Preferred Term Asthma Hypercoagulation Chest pain Dermatomyositis Eyelid infection Infection Mental disorder Off label use Pain in extremity Pulmonary embolism Thyroid disorder Vulvovaginal candidiasis

Product NUVARING PHENTERMINE

Role Route S C

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,142 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8797230 Date FDA Received
19-Sep-2012 Case # 8797230 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1209USA 006335 Role Route S Health Professional VAGINAL Dosage Text UNK Manufacturer Control # US-009507513-1209USA 005136 Role Route S Health Professional VAGINAL Dosage Text UNK UNK, qm Manufacturer Control # US-009507513-1209USA 006694 Role Route S Health Professional Outcomes Dosage Text 0.12/0.015/24 mg Manufacturer Control # US-009507513-1209USA 001502 Role Route S VAGINAL Dosage Text 0.12/0.015 Duration Age Sex Unknown Duration Age Sex Unknown Duration Age Sex Female Age 20 YR Sex Female Country USA

Preferred Term Device expulsion

Product NUVARING Case # 8797720 Case Type NON-EXPEDITED

Duration

Manufacturer MERCK Country USA

8797720 Date FDA Received

19-Sep-2012

Outcomes

Preferred Term Unintended pregnancy

Product NUVARING Case # 8799360 Case Type NON-EXPEDITED

Manufacturer MERCK Country USA

8799360 Date FDA Received

19-Sep-2012

Outcomes

Preferred Term Retroperitoneal haemorrhage

Product NUVARING Case Type NON-EXPEDITED

Manufacturer MERCK Country USA

8799588 Date FDA Received

19-Sep-2012

Case # 8799588

Preferred Term Device expulsion No adverse event Product quality issue

Product NUVARING

Manufacturer MERCK

8799709 Date FDA Received

19-Sep-2012

Case # 8799709

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1209USA 007084

Age

Sex Unknown

Country USA

Preferred Term Pseudopolyp

Product NUVARING

Role Route S VAGINAL

Dosage Text UNK

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,143 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8614333 Date FDA Received
20-Sep-2012 Case # 8614333 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2011SP0 46467 Dosage Text Duration Age Sex Unknown Country USA

Preferred Term Abortion spontaneous Superior sagittal sinus thrombosis Pulmonary embolism Adverse drug reaction Antiphospholipid antibodies Anxiety Cavernous sinus thrombosis Central nervous system lesion Cholelithiasis Cognitive disorder Deep vein thrombosis Depression Hypercoagulation Lung neoplasm Mental disorder Status migrainosus Thrombophlebitis superficial Unintended pregnancy

Product NUVARING NUVARING LIPITOR

Role Route S S C

Manufacturer MERCK MERCK

8664682 Date FDA Received

20-Sep-2012

Case # 8664682

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,OT

Manufacturer Control # US-009507513-2012SP0 11840 Dosage Text UNK UNK UNK UNK

Age

Sex Unknown

Country USA

Preferred Term Viral infection Viral infection Intracranial venous sinus thrombosis Subarachnoid haemorrhage Abortion induced

Product NUVARING NUVARING NUVARING NUVARING PLAVIX

Role Route S S S S S

Duration

Manufacturer MERCK MERCK MERCK MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,144 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8664682
Preferred Term Abdominal pain upper Acrochordon Adenoidectomy Alopecia Anaemia Anxiety Axillary vein thrombosis Blood iron decreased Bronchial hyperreactivity Candidiasis Chest discomfort Chlamydial infection Conjunctivitis Constipation Cyst Deep vein thrombosis Depression Device expulsion Diphtheria Drug hypersensitivity Dysfunctional uterine bleeding Dysmenorrhoea Eczema Gonorrhoea Haemangioma of liver Haematuria Hallucination Hand fracture Headache Head injury Ingrowing nail Product Role Route Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,145 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8664682
Preferred Term Irritability Lymphadenopathy Menorrhagia Migraine Multiple injuries Muscle spasms Oedema peripheral Oropharyngeal pain Pharyngitis Pharyngitis streptococcal Premenstrual syndrome Rash Sleep disorder Snoring Swelling Thrombophlebitis superficial Thrombosis Tonsillectomy Tonsillitis Treatment noncompliance Upper respiratory tract infection Urinary tract infection Vaginal disorder Vaginal infection Vaginitis bacterial Varicose vein Vascular procedure complication Venous thrombosis Vulvovaginal candidiasis Vulvovaginal discomfort Vulvovaginal pain Product Role Route Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,146 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8681333 Date FDA Received
20-Sep-2012 Case # 8681333 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2012SP0 17149 Dosage Text 0.12-0.015 mg, every month for 3 weeks Duration Age Sex Unknown Country USA

Preferred Term Pulmonary embolism Deep vein thrombosis Muscle spasms Rash papular Road traffic accident Thrombophlebitis

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

8683006 Date FDA Received

20-Sep-2012

Case # 8683006

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,OT

Manufacturer Control # US-009507513-2011SP0 50842 Dosage Text

Age

Sex Unknown

Country USA

Preferred Term Oligohydramnios Pulmonary embolism Drug screen positive Cervical dysplasia

Product NUVARING NUVARING PROZAC

Role Route S S S

Duration

Manufacturer MERCK MERCK

8683437 Date FDA Received

20-Sep-2012

Case # 8683437

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO

Manufacturer Control # US-009507513-2012SP0 17433 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Rectocele repair Deep vein thrombosis Anoplasty Asthma Back pain Colitis Dyspnoea

Product NUVARING NUVARING

Role Route S S

Duration

Manufacturer MERCK MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,147 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8759169 Date FDA Received
20-Sep-2012 Case # 8759169 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,DS,LT,OT Manufacturer Control # US-009507513-1208USA 010698 Dosage Text 0.120 mg/day of etonogestrel and 0.015 mg/day of ethinyl estradiol/21 days Duration Age Sex Female Country USA

Preferred Term Pulmonary embolism

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

Dyspnoea Gait disturbance Pain in extremity

8795735 Date FDA Received

20-Sep-2012

Case # 8795735

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO

Manufacturer Control # US-009507513-2010SP0 06068 Dosage Text 5 mg, UNK

Age

Sex Female

Country USA

Preferred Term Hypercoagulation Deep vein thrombosis Acute sinusitis Antiphospholipid syndrome Constipation Menorrhagia Post thrombotic syndrome Spinal osteoarthritis Therapeutic response increased Urinary tract infection staphylococcal

Product NUVARING COUMADIN

Role Route S S

Duration

Manufacturer MERCK

8797764 Date FDA Received

20-Sep-2012

Case # 8797764

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1209USA 007251

Age

Sex Female

Country USA

Preferred Term Incorrect drug administration duration Inappropriate schedule of drug administration

Product NUVARING

Role Route S VAGINAL

Dosage Text

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,148 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8797807 Date FDA Received
20-Sep-2012 Case # 8797807 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1209USA 005040 Role Route S Health Professional VAGINAL Dosage Text UNK Manufacturer Control # US-009507513-2011SP0 40941 Dosage Text Duration Age Sex Unknown Age 23 YR Sex Female Country USA

Preferred Term Inappropriate schedule of drug administration

Product NUVARING

Duration

Manufacturer MERCK Country USA

8798223 Date FDA Received

20-Sep-2012

Case # 8798223

Case Type EXPEDITED (15-DAY)

Outcomes HO,DS,OT

Preferred Term Hypercoagulation Deep vein thrombosis Haematoma Haemorrhagic anaemia Pulmonary embolism Pulmonary granuloma Smear cervix abnormal

Product NUVARING

Role Route S

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,149 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8798356 Date FDA Received
20-Sep-2012 Case # 8798356 Case Type EXPEDITED (15-DAY) Health Professional Outcomes DE,OT Manufacturer Control # US-009507513-2011SP0 13905 Dosage Text Duration Age Sex Unknown Country USA

Preferred Term Pulmonary embolism Hypercoagulation Cardio-respiratory arrest Abdominal pain Abdominal pain upper Bronchitis Deep vein thrombosis Dermatitis Hypertension Muscle spasms Ovulation pain Pelvic mass Pharyngitis Respiratory tract infection Road traffic accident Trichomoniasis Urine analysis abnormal

Product NUVARING NUVARING CINNAMON

Role Route S S C

Manufacturer MERCK MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,150 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8799058 Date FDA Received
20-Sep-2012 Case # 8799058 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2010SP0 48873 Dosage Text Duration Age Sex Unknown Country USA

Preferred Term Pulmonary embolism Hypercoagulation Drug hypersensitivity Headache Depression Abdominal pain Nausea Vomiting

Product NUVARING PROPOXYPHENE EFFEXOR XR FLEXERIL ALBUTEROL TYLENOL EXCEDRIN (ACETAMINOPHEN (+) ASPIRIN (+) CAFFEINE)

Role Route S C C C C C C

Manufacturer MERCK

150 mg, QD UNK UNK, PRN UNK UNK, PRN UNK UNK, PRN UNK UNK, PRN

8808482 Date FDA Received

20-Sep-2012 Preferred Term

Case # 8808482

Case Type DIRECT Product NUVARING

Health Professional

Outcomes OT Role Route S

Manufacturer Control #

Age 28 YR

Sex Female

Country USA

Dosage Text

Duration

Manufacturer

Pregnancy with contraceptive device Product quality issue

8808993 Date FDA Received

20-Sep-2012 Preferred Term Headache

Case # 8808993

Case Type DIRECT Product NUVARING

Health Professional

Outcomes HO,DS,LT,RI Role Route S VAGINAL

Manufacturer Control #

Age 17 YR

Sex Female

Country USA

Dosage Text 1 ring for 3 weks vag

Duration

Manufacturer ORGANON

Intracranial venous sinus thrombosis Paraesthesia Vomiting

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,151 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8688274 Date FDA Received
21-Sep-2012 Case # 8688274 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO Manufacturer Control # US-009507513-2012SP0 17146 Dosage Text UNK UNK UNK Duration Age Sex Female Country USA

Preferred Term Deep vein thrombosis Myalgia Contusion Anxiety disorder Contusion Diarrhoea Fall Fatigue Ovarian cyst Panic disorder Vomiting White blood cell count increased

Product NUVARING NUVARING NUVARING

Role Route S S S

Manufacturer MERCK MERCK MERCK

8717582 Date FDA Received

21-Sep-2012

Case # 8717582

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes DS,OT

Manufacturer Control # US-009507513-2012SP0 19311 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism Cerebrovascular accident Deep vein thrombosis Headache Urticaria

Product NUVARING

Role Route S

Duration

Manufacturer MERCK

8800421 Date FDA Received

21-Sep-2012

Case # 8800421

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1209USA 002349

Age

Sex Female

Country USA

Preferred Term Menstruation irregular

Product NUVARING

Role Route S VAGINAL

Dosage Text 3 weeks in, 1 week out

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,152 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8802390 Date FDA Received
21-Sep-2012 Case # 8802390 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1209USA 008716 Role Route S Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2009SP0 16952 Dosage Text 1 DF, QM WEEKLY X 1 MONTH, THEN 1 PER MONTH AS SUPPRESSIVE TREATMENT - UPDATE (09APR2010) UPDATE (09APR2010) (STARTED IN OR AROUND AUG2004) UPDATE (09APR2010) UPDATE (09APR2010) Duration Age Sex Unknown Dosage Text Duration Age Sex Male Country USA

Preferred Term Penis disorder

Product NUVARING Case # 8802515 Case Type EXPEDITED (15-DAY)

Manufacturer MERCK Country USA

8802515 Date FDA Received

21-Sep-2012

Preferred Term Rectal haemorrhage Pulmonary embolism

Product NUVARING DIFLUCAN

Role Route S C VAGINAL

Manufacturer MERCK

Deep vein thrombosis

BENEFIBER

Pharyngitis Upper respiratory tract infection Chest pain Chiropractic Constipation Cyst Cyst removal Dyspnoea Hiatus hernia Papule Throat tightness Urinary tract infection Vaginal haemorrhage

clotrimazole PREMARIN

C C

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,153 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8802546 Date FDA Received
21-Sep-2012 Case # 8802546 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2011SP0 05797 Dosage Text Duration Age Sex Unknown Country USA

Preferred Term Pleural effusion Blood glucose increased Deep vein thrombosis Headache Pulmonary embolism Pulmonary infarction Sleep apnoea syndrome Surgery

Product NUVARING

Role Route S

Manufacturer MERCK

8802838 Date FDA Received

21-Sep-2012

Case # 8802838

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1209USA 004377

Age 43 YR

Sex Male

Country USA

Preferred Term Penis injury

Product NUVARING Case # 8804502 Case Type NON-EXPEDITED Health Professional

Role Route S Outcomes

Dosage Text 1 UNK, UNK Manufacturer Control # US-009507513-1209USA 006372

Duration

Manufacturer MERCK

8804502 Date FDA Received

23-Sep-2012

Age 25 YR

Sex Female

Country USA

Preferred Term Unintended pregnancy

Product NUVARING CIPRO BACTRIM DS

Role Route S C C VAGINAL

Dosage Text

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,154 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8804531 Date FDA Received
23-Sep-2012 Case # 8804531 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1208USA 008298 Role Route S C C VAGINAL Dosage Text 0.120mg/0.015mg UNK, prn UNK, prn Duration Age Sex Female Country USA

Preferred Term Device difficult to use Medical device discomfort Fungal infection Device breakage Device expulsion

Product NUVARING ibuprofen MONISTAT

Manufacturer MERCK

8804578 Date FDA Received

23-Sep-2012

Case # 8804578

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO

Manufacturer Control # US-009507513-1209USA 006489 Dosage Text Nuvaring,vaginal 0.015/0.012

Age

Sex Female

Country USA

Preferred Term Urinary tract infection Abdominal pain upper Decreased appetite Diarrhoea Vomiting

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

8681334 Date FDA Received

24-Sep-2012

Case # 8681334

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,DS,LT,OT

Manufacturer Control # US-009507513-2012SP0 11838

Age

Sex Unknown

Country USA

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,155 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8681334
Preferred Term Deep vein thrombosis Abdominal pain Anxiety Asthenia Asthma Back pain Bronchitis Chest pain Depression Dyspnoea Fall Headache Heart rate irregular Hepatic steatosis Injury Insomnia Laceration Ligament sprain Limb injury Migraine Ovarian cyst Ovarian cyst ruptured Panic attack Phlebitis Pruritus Pulmonary embolism Scoliosis Smear cervix abnormal Spinal osteoarthritis Syncope Product NUVARING Role Route S Dosage Text UNK Duration Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,156 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8803471 Date FDA Received
24-Sep-2012 Case # 8803471 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1209USA 007046 Role Route S C Health Professional Outcomes Manufacturer Control # US-009507513-1209USA 004770 Role Route S Health Professional VAGINAL Dosage Text UNK Manufacturer Control # US-009507513-1209USA 000085 Role Route S Health Professional VAGINAL Dosage Text UNK Manufacturer Control # US-009507513-1209USA 007836 Role Route S Health Professional VAGINAL Dosage Text UNK Manufacturer Control # US-009507513-1209USA 008648 Role Route S VAGINAL Dosage Text Duration Age Sex Female Age 24 YR Sex Female Duration Age Sex Female Duration Age Sex Female Country USA VAGINAL Dosage Text 3 weeks in, 1 week out Duration Age Sex Female Country USA

Preferred Term Metrorrhagia

Product NUVARING RITALIN

Manufacturer MERCK

8803557 Date FDA Received

24-Sep-2012

Case # 8803557

Case Type NON-EXPEDITED

Preferred Term Inappropriate schedule of drug administration

Product NUVARING

Manufacturer MERCK Country USA

8803659 Date FDA Received

24-Sep-2012

Case # 8803659

Case Type NON-EXPEDITED

Outcomes

Preferred Term Metrorrhagia

Product NUVARING Case # 8803690 Case Type NON-EXPEDITED

Manufacturer MERCK Country USA

8803690 Date FDA Received

24-Sep-2012

Outcomes

Preferred Term Alopecia

Product NUVARING Case # 8803737 Case Type NON-EXPEDITED

Duration

Manufacturer MERCK Country USA

8803737 Date FDA Received

24-Sep-2012

Outcomes

Preferred Term Metrorrhagia

Product NUVARING

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,157 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8804127 Date FDA Received
24-Sep-2012 Case # 8804127 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1209USA 009305 Role Route S Health Professional Outcomes HO,OT Dosage Text UNK Manufacturer Control # US-009507513-2010SP0 62564 Dosage Text Duration Age Sex Unknown Duration Age Sex Male Country USA

Preferred Term Medical device discomfort

Product NUVARING Case Type EXPEDITED (15-DAY)

Manufacturer MERCK Country USA

8804452 Date FDA Received

24-Sep-2012

Case # 8804452

Preferred Term Suicidal ideation Anxiety Arthropathy Blood cholesterol increased Bronchitis Cervical dysplasia Deep vein thrombosis Depression Device expulsion Eczema Endocrine toxicity Gastroenteritis Hyperlipidaemia Hypertension Hypoaesthesia oral Incisional hernia Incorrect drug administration duration Irritable bowel syndrome Ligament sprain Loss of consciousness Migraine Muscle twitching

Product NUVARING

Role Route S

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,158 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8804452
Preferred Term Oedema peripheral Osteoarthritis Otitis media Ovarian cyst Pulmonary embolism Sinusitis Tension headache Tooth abscess Uterine enlargement Uterine leiomyoma Weight increased Product Role Route Dosage Text Duration Manufacturer

8806081 Date FDA Received

25-Sep-2012

Case # 8806081

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,LT

Manufacturer Control # US-009507513-1209USA 008144 Dosage Text 1 ring for 3 week followed by ring free period Manufacturer Control # US-009507513-1209USA 000262

Age

Sex Female

Country USA

Preferred Term Pulmonary embolism

Product NUVARING

Role Route S

Duration

Manufacturer MERCK

8806102 Date FDA Received

25-Sep-2012

Case # 8806102

Case Type NON-EXPEDITED

Health Professional

Outcomes

Age

Sex Female

Country USA

Preferred Term Back pain Inappropriate schedule of drug administration Incorrect drug administration duration Metrorrhagia

Product NUVARING

Role Route S VAGINAL

Dosage Text UNK

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,159 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8806119 Date FDA Received
25-Sep-2012 Case # 8806119 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO Manufacturer Control # US-009507513-1209USA 008125 Dosage Text UNK Manufacturer Control # US-009507513-2009SP0 31151 Dosage Text Duration Age Sex Unknown Duration Age Sex Female Country USA

Preferred Term Pulmonary embolism

Product NUVARING Case # 8680236 Case Type EXPEDITED (15-DAY) Health Professional

Role Route S VAGINAL

Manufacturer MERCK Country USA

8680236 Date FDA Received

26-Sep-2012

Outcomes HO,DS,OT

Preferred Term Hypokalaemia Pulmonary embolism Pulmonary hypertension Aortic valve sclerosis Breast calcifications Arrhythmia Arrhythmia supraventricular Arthralgia Menstruation irregular Pain in extremity Palpitations Polycystic ovaries Subcutaneous nodule Tachycardia

Product NUVARING NUVARING EFFEXOR ZYRTEC IRON

Role Route S S C C C

Manufacturer MERCK MERCK

8810244 Date FDA Received

26-Sep-2012

Case # 8810244

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1209USA 009400

Age

Sex Female

Country USA

Preferred Term Device expulsion Inappropriate schedule of drug administration

Product NUVARING

Role Route S VAGINAL

Dosage Text 3 weeks in then insert new ring

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,160 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8810281 Date FDA Received
26-Sep-2012 Case # 8810281 Case Type EXPEDITED (15-DAY) Health Professional Outcomes DE,OT Manufacturer Control # US-009507513-1209USA 009617 Dosage Text UNK Manufacturer Control # US-009507513-1209USA 006116 Role Route S VAGINAL Dosage Text 4 weeks in Age 50 YR Sex Female Duration Age Sex Unknown Country USA

Preferred Term Pulmonary embolism

Product NUVARING Case # 8810284 Case Type NON-EXPEDITED Health Professional

Role Route S VAGINAL

Manufacturer MERCK Country USA

8810284 Date FDA Received

26-Sep-2012

Outcomes

Preferred Term Overdose Incorrect drug administration duration Medication error

Product NUVARING

Duration

Manufacturer MERCK

8810295 Date FDA Received

26-Sep-2012

Case # 8810295

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,LT,OT

Manufacturer Control # US-009507513-2012SP0 29447 Dosage Text 1 DF, 3 weeks on, 1 week off 1500 mg, qd 145 mg, qd 100 mg, qd Manufacturer Control # US-009507513-1209USA 008902 Dosage Text

Age

Sex Female

Country USA

Preferred Term Pulmonary embolism

Product NUVARING NUVARING metformin TRIGLIDE ZOLOFT

Role Route S S C C C Health Professional Outcomes OT VAGINAL

Duration

Manufacturer MERCK MERCK

8810347 Date FDA Received

26-Sep-2012

Case # 8810347

Case Type EXPEDITED (15-DAY)

Age 27 YR

Sex Female

Country USA

Preferred Term Cerebral infarction

Product NUVARING

Role Route S

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,161 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8810380 Date FDA Received
26-Sep-2012 Case # 8810380 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1209USA 009893 Role Route S Health Professional VAGINAL Dosage Text UNK Manufacturer Control # US-009507513-1209USA 009318 Role Route S VAGINAL Dosage Text 3 weeks in, 1 weeks out Age 43 YR Sex Female Duration Age Sex Female Country USA

Preferred Term Coital bleeding

Product NUVARING Case # 8810389 Case Type NON-EXPEDITED

Manufacturer MERCK Country USA

8810389 Date FDA Received

26-Sep-2012

Outcomes

Preferred Term Weight increased Abdominal distension Menorrhagia Menstruation irregular Metrorrhagia

Product NUVARING

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,162 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8794417 Date FDA Received
27-Sep-2012 Case # 8794417 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2012SP0 28985 Dosage Text UNK Duration Age Sex Unknown Country USA

Preferred Term Loss of consciousness Bronchitis Deep vein thrombosis Fall Infection Laceration Pleural effusion Portal vein thrombosis Pulmonary embolism Pulmonary infarction Pulmonary venous thrombosis Sinus arrhythmia Sinusitis Syncope Thrombosis

Product NUVARING

Role Route S

Manufacturer MERCK

8810445 Date FDA Received

27-Sep-2012

Case # 8810445

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1209USA 004407

Age

Sex Female

Country USA

Preferred Term Abnormal withdrawal bleeding

Product NUVARING Case Type NON-EXPEDITED Health Professional

Role Route S VAGINAL

Dosage Text 1 DF, qm Manufacturer Control # US-009507513-1209USA 009320

Duration

Manufacturer MERCK

8810449 Date FDA Received

27-Sep-2012

Case # 8810449

Outcomes

Age 24 YR

Sex Female

Country USA

Preferred Term Abnormal withdrawal bleeding Device expulsion

Product NUVARING

Role Route S VAGINAL

Dosage Text 3 week in, 1 week out

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,163 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8810621 Date FDA Received
27-Sep-2012 Case # 8810621 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1209USA 009102 Role Route S Health Professional Outcomes Dosage Text 1 DF, UNK Manufacturer Control # US-009507513-1209USA 009161 Role Route S Health Professional Outcomes Dosage Text UNK Manufacturer Control # US-009507513-1209USA 007426 Role Route S Health Professional VAGINAL Dosage Text UNK Manufacturer Control # US-009507513-2011SP0 56415 Dosage Text UNK UNK Duration Age Sex Unknown Duration Age Sex Unknown Duration Age Sex Unknown Duration Age Sex Female Country USA

Preferred Term Menstruation irregular

Product NUVARING Case # 8810626 Case Type NON-EXPEDITED

Manufacturer MERCK Country USA

8810626 Date FDA Received

27-Sep-2012

Preferred Term Abnormal withdrawal bleeding

Product NUVARING Case Type NON-EXPEDITED

Manufacturer MERCK Country USA

8811765 Date FDA Received

27-Sep-2012

Case # 8811765

Preferred Term Chlamydial infection

Product NUVARING Case # 8304081 Case Type EXPEDITED (15-DAY)

Manufacturer MERCK Country USA

8304081 Date FDA Received

28-Sep-2012

Outcomes HO,DS,OT

Preferred Term Cardiac failure Ankle fracture Deep vein thrombosis Hyperinsulinaemia Pain Polycystic ovaries Pulmonary embolism

Product NUVARING NUVARING

Role Route S S

Manufacturer MERCK MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,164 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8707544 Date FDA Received
28-Sep-2012 Case # 8707544 Case Type EXPEDITED (15-DAY) Health Professional Outcomes OT Manufacturer Control # US-009507513-1207USA 011562 Dosage Text UNK Duration Age Sex Female Country USA

Preferred Term Abortion induced Maternal exposure during pregnancy Pregnancy with contraceptive device Unintended pregnancy

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

8740590 Date FDA Received

28-Sep-2012

Case # 8740590

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,OT

Manufacturer Control # US-009507513-2011SP0 47492 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Deep vein thrombosis Depression Anxiety Ear disorder Hypothyroidism Nasal disorder Pain in extremity Pharyngeal disorder

Product NUVARING NUVARING

Role Route S S

Duration

Manufacturer MERCK MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,165 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8743899 Date FDA Received
28-Sep-2012 Case # 8743899 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2011SP0 53028 Dosage Text UNK UNK ORAL 10 mg, qd Duration Age Sex Unknown Country USA

Preferred Term Systemic lupus erythematosus Pulmonary embolism Drug hypersensitivity Anaemia Anxiety Asthma exercise induced Bipolar disorder Depression Genital lesion Headache Infectious mononucleosis Oral herpes Otitis media acute Pharyngitis Sexual abuse Sinus congestion Upper limb fracture Urinary tract infection Varicella Vomiting

Product NUVARING AMBIEN LEXAPRO

Role Route S S C VAGINAL

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,166 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8757006 Date FDA Received
28-Sep-2012 Case # 8757006 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2008-188 067-NL Dosage Text DOSE TEXT: 3 WEEKS IN/ 1 WEEK OUT, CONTINUING: NO Duration Age Sex Unknown Country USA

Preferred Term Pulmonary embolism

Product NUVARING

Role Route S

Manufacturer MERCK

Bronchitis Dermatitis contact Hypocoagulable state Ovarian cyst Pleurisy Pulmonary embolism

8814656 Date FDA Received

28-Sep-2012

Case # 8814656

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes OT

Manufacturer Control # DK-009507513-1209DNK 009282 Dosage Text

Age

Sex Female

Country DNK

Preferred Term Abortion Device expulsion Unintended pregnancy

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

8814659 Date FDA Received

28-Sep-2012

Case # 8814659

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1209USA 008500

Age 25 YR

Sex Female

Country USA

Preferred Term Menorrhagia Hypomenorrhoea

Product NUVARING XANAX

Role Route S C VAGINAL

Dosage Text 3 weeks in 1 week out UNK, qd

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,167 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8815361 Date FDA Received
28-Sep-2012 Case # 8815361 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1209USA 011027 Role Route S VAGINAL Dosage Text 1 DF, UNK Age 38 YR Sex Female Country USA

Preferred Term Pain Device physical property issue Menstruation irregular

Product NUVARING

Duration

Manufacturer MERCK

8815441 Date FDA Received

28-Sep-2012

Case # 8815441

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1209USA 011299

Age

Sex Female

Country USA

Preferred Term Metrorrhagia Hypomenorrhoea

Product NUVARING

Role Route S VAGINAL

Dosage Text 1 ring for 3 weeks

Duration

Manufacturer MERCK

8815615 Date FDA Received

28-Sep-2012

Case # 8815615

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes DS,OT

Manufacturer Control # US-009507513-1209USA 010198 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Myocardial infarction Pulmonary embolism

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

8815772 Date FDA Received

28-Sep-2012

Case # 8815772

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,OT

Manufacturer Control # US-009507513-2010SP0 56526 Dosage Text 1 DF, QM 81 mg, QD

Age

Sex Unknown

Country USA

Preferred Term Pneumonia Hypercoagulation Pulmonary embolism Deep vein thrombosis Urinary tract infection

Product NUVARING NUVARING ASPIRIN

Role Route S S C VAGINAL

Duration

Manufacturer MERCK MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,168 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8815835 Date FDA Received
28-Sep-2012 Case # 8815835 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2011SP0 12083 Dosage Text Duration Age Sex Unknown Country USA

Preferred Term Hypercoagulation Cervical dysplasia Colonoscopy Deep vein thrombosis Genital discharge Haemorrhoids Headache Incorrect drug administration duration Ligament sprain Night sweats Ovarian cyst Pelvic pain Pulmonary embolism Pulmonary infarction Syncope

Product NUVARING

Role Route S ORAL

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,169 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8815884 Date FDA Received
28-Sep-2012 Case # 8815884 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2008-180 467-NL Dosage Text DOSE TEXT: Q 25 DAYS, CONTINUING: NO Duration Age Sex Unknown Country USA

Preferred Term Subdural haematoma

Product NUVARING

Role Route S

Manufacturer MERCK

Adenomyosis Cerebral venous thrombosis Cervicitis Dysfunctional uterine bleeding Explorative laparotomy Gastrooesophageal reflux disease Hysterectomy Leiomyoma Lymphoproliferative disorder Menorrhagia Neck mass Off label use Pneumonia Urinary tract infection Uterine dilation and curettage

8815974 Date FDA Received

28-Sep-2012

Case # 8815974

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1209USA 009620

Age

Sex Unknown

Country USA

Preferred Term Deep vein thrombosis

Product NUVARING

Role Route S

Dosage Text UNK

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,170 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8816131 Date FDA Received
29-Sep-2012 Case # 8816131 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1209USA 010678 Role Route S C C C Health Professional Outcomes Manufacturer Control # US-009507513-1209USA 012058 Role Route S VAGINAL Dosage Text UNK Age 30 YR Sex Female Country USA VAGINAL Dosage Text 1 ring for 3 weeks then a week free break UNK Duration Age Sex Female Country USA

Preferred Term Metrorrhagia

Product NUVARING PLAN B vitamins (unspecified) biotin

Manufacturer MERCK

8819536 Date FDA Received

30-Sep-2012

Case # 8819536

Case Type NON-EXPEDITED

Preferred Term Incorrect drug administration duration Inappropriate schedule of drug administration

Product NUVARING

Duration

Manufacturer MERCK

8819537 Date FDA Received

30-Sep-2012

Case # 8819537

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1209USA 011067

Age

Sex Female

Country USA

Preferred Term Product quality issue Device expulsion

Product NUVARING

Role Route S VAGINAL

Dosage Text 1 ring in for 3 weeks/out for 1 week

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,171 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8316034 Date FDA Received
01-Oct-2012 Case # 8316034 Case Type EXPEDITED (15-DAY) Health Professional Outcomes DE,HO,DS,LT,OT Manufacturer Control # US-009507513-2011SP0 58154 Dosage Text 50 MIC ESTROGEN 120 ETONOGESTREL/ ONCE A MONTH Duration Age Sex Unknown Country USA

Preferred Term Pulmonary embolism

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

Myocardial infarction Blood testosterone abnormal Cardiac arrest Deep vein thrombosis Hormone level abnormal Lower respiratory tract infection Pneumonia Thrombosis Trichomoniasis Urinary tract infection

NUVARING

MERCK

8341849 Date FDA Received

01-Oct-2012

Case # 8341849

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,DS,OT

Manufacturer Control # US-009507513-2011SP0 30647 Dosage Text

Age

Sex Unknown

Country USA

Preferred Term Chest pain Tachycardia Carotid artery dissection Back injury Arthralgia Arthritis Arthropod bite Blood triglycerides increased Carotid artery occlusion Carpal tunnel syndrome

Product NUVARING NUVARING MIRENA PHENDIMETRAZINE HYDROCHLORIDE

Role Route S S S C

Duration

Manufacturer MERCK MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,172 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8341849
Preferred Term Cellulitis Chest discomfort Chest X-ray abnormal Colonic polyp Cyst Diarrhoea Diplopia Gastrooesophageal reflux disease Head injury Herpes virus infection Hypercoagulation Joint injury Laryngitis Lung neoplasm Migraine Musculoskeletal chest pain Musculoskeletal pain Oedema peripheral Oral surgery Palpitations Pharyngitis Pulmonary embolism Pulmonary hypertension Sinus polyp Tonsillitis Weight increased Product Role Route Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,173 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8668571 Date FDA Received
01-Oct-2012 Case # 8668571 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2012SP0 27418 Dosage Text UNK Duration Age Sex Unknown Country USA

Preferred Term Cholelithiasis Abdominal pain Chest pain Cholecystectomy Cholecystitis acute Cholelithiasis Deep vein thrombosis Dental caries Dyspnoea Eye pain Gastrointestinal disorder Headache Helicobacter infection Hepatic steatosis Hypertension Liver function test abnormal Maternal exposure during pregnancy Migraine Nephrotic syndrome Obesity Oesophagitis Proteinuria Toothache Unintended pregnancy

Product NUVARING

Role Route S

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,174 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8723201 Date FDA Received
01-Oct-2012 Case # 8723201 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,DS,OT Manufacturer Control # US-009507513-2012SP0 20668 Dosage Text UNK 1 mg, qd UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK UNK Manufacturer Control # US-009507513-1207USA 011708 Role Route S Dosage Text 0.015/0.12MG, 3 STANDARD DOSES OF 1 Duration Age Sex Female Country USA Duration Age Sex Unknown Country USA

Preferred Term Pulmonary embolism Carpal tunnel syndrome Chest pain Oedema peripheral Sickle cell anaemia with crisis Pain in extremity Ovarian cyst Infection Dyspnoea Depression Vaginal discharge

Product NUVARING folic acid prednisone metronidazole fluconazole cephalexin sulfamerazine (+) trimethoprim morphine ibuprofen famotidine azithromycin diphenhydramine hydrochloride hydrocodone acetaminophen prochlorperazine nitrofurantoin

Role Route S C C C C C C C C C C C C C C C Health Professional Outcomes

Manufacturer MERCK

8738255 Date FDA Received

01-Oct-2012

Case # 8738255

Case Type NON-EXPEDITED

Preferred Term Device expulsion

Product NUVARING

Manufacturer MERCK

No adverse event

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,175 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8804536 Date FDA Received
01-Oct-2012 Case # 8804536 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2009-189 324-NL Dosage Text DOSE TEXT: 3 WEEKS PER MONTH, CONTINUING: NO Duration Age Sex Unknown Country USA

Preferred Term Hypertension

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

Headache Off label use Menometrorrhagia Coital bleeding Deep vein thrombosis Diverticulitis Dyspareunia Dyspepsia Ear disorder Endometrial ablation Hepatic steatosis Hepatomegaly Hypertriglyceridaemia Hysteroscopy Ligament sprain Metrorrhagia Muscle contractions involuntary Pain in extremity Polycystic ovaries Seborrhoea Smear cervix abnormal Uterine dilation and curettage Uterine leiomyoma

NUVARING VITAMINS (UNSPECIFIED) HYDROCHLOROTHIAZIDE

S C C ORAL 25 mg, QD

MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,176 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8817224 Date FDA Received
01-Oct-2012 Case # 8817224 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1209USA 004496 Role Route S Health Professional VAGINAL Dosage Text UNK Manufacturer Control # US-009507513-2012SP0 34991 Dosage Text Duration Age Sex Unknown Age 27 YR Sex Female Country USA

Preferred Term Inappropriate schedule of drug administration

Product NUVARING

Duration

Manufacturer MERCK Country USA

8818044 Date FDA Received

01-Oct-2012

Case # 8818044

Case Type EXPEDITED (15-DAY)

Outcomes OT

Preferred Term Pulmonary embolism

Product NUVARING Case # 8818093 Case Type EXPEDITED (15-DAY) Health Professional

Role Route S VAGINAL

Manufacturer MERCK

8818093 Date FDA Received

01-Oct-2012

Outcomes HO,OT

Manufacturer Control # US-009507513-1209USA 011017 Dosage Text 0.120/0.015 mg 3 weeks on, 1 week out

Age

Sex Female

Country USA

Preferred Term Pulmonary embolism Deep vein thrombosis

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

8818350 Date FDA Received

01-Oct-2012

Case # 8818350

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes OT

Manufacturer Control # US-009507513-1209USA 009612 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism Deep vein thrombosis

Product NUVARING

Role Route S

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,177 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8818387 Date FDA Received
01-Oct-2012 Case # 8818387 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,DS,OT Manufacturer Control # US-009507513-2010SP0 65476 Dosage Text Duration Age Sex Unknown Country USA

Preferred Term Convulsion Abdominal pain Acne Blood glucose increased Colonic polyp Deep vein thrombosis Encephalitis herpes Frequent bowel movements Genital herpes Gonorrhoea Haematochezia Human papilloma virus test positive Hypercoagulation Infection Migraine Paranasal cyst Pelvic inflammatory disease Rectal polyp Smear cervix abnormal Superior sagittal sinus thrombosis Syncope Urinary tract infection

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

8819440 Date FDA Received

01-Oct-2012

Case # 8819440

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1209USA 000415

Age

Sex Female

Country USA

Preferred Term Inappropriate schedule of drug administration

Product NUVARING

Role Route S VAGINAL

Dosage Text UNK

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,178 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8820105 Date FDA Received
01-Oct-2012 Case # 8820105 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1209USA 011979 Role Route S VAGINAL Dosage Text 1 ring for 3 weeks followed by a week free break Manufacturer Control # US-009507513-2009-190 526-NL Dosage Text DOSE TEXT: 3 WEEKS IN, 1 WEEK OUT, CONTINUING: NO Duration Age Sex Female Age 27 YR Sex Female Country USA

Preferred Term Device expulsion

Product NUVARING

Duration

Manufacturer MERCK

8676158 Date FDA Received

02-Oct-2012

Case # 8676158

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,DS,OT

Country USA

Preferred Term Cerebrovascular accident

Product NUVARING

Role Route S

Manufacturer MERCK

Off label use Enchondroma Periarthritis Pyrexia

NUVARING

MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,179 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8716298 Date FDA Received
02-Oct-2012 Case # 8716298 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2012SP0 23039 Dosage Text UNK 5 mg, qd Duration Age Sex Unknown Country USA

Preferred Term Abortion spontaneous Emotional disorder Antiphospholipid syndrome Convulsion Headache Nausea Pre-eclampsia Subarachnoid haemorrhage Superior sagittal sinus thrombosis Thrombosis Unintended pregnancy Vomiting

Product NUVARING prednisone

Role Route S C VAGINAL ORAL

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,180 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8802805 Date FDA Received
02-Oct-2012 Case # 8802805 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2009-200 464-NL Dosage Text CONTINUING: NO EVERY 8 HOURS PRN UNK UNK, PRN PRN PRN ORAL 10 MG BID QD Q 6-8 H Duration Age Sex Unknown Country USA

Preferred Term Hypokalaemia Pulmonary embolism Acute sinusitis Irritable bowel syndrome Off label use Dislocation of vertebra Neck pain Spinal pain Dislocation of vertebra Facet joint syndrome Intervertebral disc disorder Lumbarisation Myalgia

Product NUVARING NUVARING XANAX ADVIL SKELAXIN AMOXICILLIN BACLOFEN LEXAPRO NORCO

Role Route S S C C C C C C C ORAL VAGINAL

Manufacturer MERCK MERCK

8820180 Date FDA Received

02-Oct-2012

Case # 8820180

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes OT

Manufacturer Control # US-009507513-1209USA 011210 Dosage Text UNK

Age 34 YR

Sex Female

Country USA

Preferred Term Breast cancer

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,181 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8820320 Date FDA Received
02-Oct-2012 Case # 8820320 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1209USA 010716 Role Route S VAGINAL Dosage Text UNK Duration Age Sex Female Country USA

Preferred Term Feelings of worthlessness Depressed mood Depression Feeling of despair Social avoidant behaviour

Product NUVARING

Manufacturer MERCK

8820349 Date FDA Received

02-Oct-2012

Case # 8820349

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1209USA 003818

Age

Sex Unknown

Country USA

Preferred Term Inappropriate schedule of drug administration Drug prescribing error Incorrect drug administration duration

Product NUVARING

Role Route S VAGINAL

Dosage Text 1 DF, 4 weeks

Duration

Manufacturer MERCK

8821022 Date FDA Received

02-Oct-2012

Case # 8821022

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1209USA 010369

Age

Sex Unknown

Country USA

Preferred Term Hyperplasia

Product NUVARING

Role Route S VAGINAL

Dosage Text

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,182 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8821393 Date FDA Received
02-Oct-2012 Case # 8821393 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,DS,OT Manufacturer Control # US-009507513-2010SP0 42534 Dosage Text 10 mg, hs NASAL PUFFS PER NOSTRIL UNK UNK, PRN MERCK MERCK Duration Age Sex Unknown Country USA

Preferred Term Hemiparesis Hypovolaemia Hypothyroidism Cerebrovascular accident Intracranial venous sinus thrombosis Anxiety Asthmatic crisis Blood cholesterol abnormal Breast discharge Breast pain Breast swelling Cellulitis Cerebral haemorrhage Cognitive disorder Deep vein thrombosis Depression Headache Hypersensitivity Hypertension Keloid scar Lyme disease Nausea Nodule Oedema peripheral Seasonal allergy Viral infection Vomiting

Product NUVARING SINGULAIR NASONEX VITAMINS (UNSPECIFIED) PROVENTIL

Role Route S C C C C

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,183 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8821463 Date FDA Received
02-Oct-2012 Case # 8821463 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO Manufacturer Control # CL-009507513-1207CHL 001710 Dosage Text delivers 0.120 mg/ 0.015mg per day UNK Age 39 YR Sex Female Country CHL

Preferred Term Nasal septal operation Metrorrhagia

Product NUVARING PLEXUS (ambroxol hydrochloride (+) dextromethorphan hydrobromide) Case # 8821742 Case Type EXPEDITED (15-DAY) Health Professional

Role Route S C VAGINAL

Duration

Manufacturer MERCK

8821742 Date FDA Received

02-Oct-2012

Outcomes HO,DS,OT

Manufacturer Control # US-009507513-2011SP0 40391 Dosage Text

Age

Sex Female

Country USA

Preferred Term Pulmonary embolism Infection Adenomyosis Atelectasis Cervicitis General physical condition abnormal Hysterectomy Menometrorrhagia Migraine Pleural effusion Pulmonary infarction Restless legs syndrome Salpingectomy Uterine leiomyoma

Product NUVARING NUVARING

Role Route S S

Duration

Manufacturer MERCK MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,184 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8821764 Date FDA Received
02-Oct-2012 Case # 8821764 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1210USA 000760 Role Route S Health Professional VAGINAL Manufacturer Control # US-009507513-2009-190 399-NL Dosage Text CONTINUING: NO Duration Age Sex Unknown Dosage Text Duration Age Sex Unknown Country USA

Preferred Term Hyperplasia

Product NUVARING Case # 7284945 Case Type EXPEDITED (15-DAY)

Manufacturer MERCK Country USA

7284945 Date FDA Received

03-Oct-2012

Outcomes HO,OT

Preferred Term Ovarian cyst ruptured Transverse sinus thrombosis Venous thrombosis Sinusitis Burns first degree Burns third degree Contusion Haematuria Joint injury Laceration Ligament sprain Muscle strain Nasopharyngitis Off label use Rib fracture Road traffic accident Spinal fracture

Product NUVARING NUVARING NUVARING GLUCOPHAGE

Role Route S S S C

Manufacturer MERCK MERCK MERCK

ALSO USED FOR WEIGHT LOSS

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,185 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8695071 Date FDA Received
03-Oct-2012 Case # 8695071 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2011SP0 50839 Dosage Text UNK Duration Age Sex Unknown Country USA

Preferred Term Chest pain Antiphospholipid antibodies positive Cardiac disorder Deep vein thrombosis Fall Gastrooesophageal reflux disease Hypertension Pulmonary embolism Pulmonary hypertension Sleep apnoea syndrome Sterilisation Transfusion

Product NUVARING

Role Route S

Manufacturer MERCK

8698426 Date FDA Received

03-Oct-2012

Case # 8698426

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,OT

Manufacturer Control # US-009507513-2012SP0 11811

Age

Sex Unknown

Country USA

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,186 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8698426
Preferred Term Coagulopathy Pulmonary embolism Anxiety Breast discharge Breast pain Deep vein thrombosis Depression Diarrhoea Enzyme abnormality Gene mutation Headache High risk sexual behaviour Impaired fasting glucose Insomnia Intervertebral disc protrusion Leukocytosis Neck pain Ovarian cyst Overweight Pelvic pain Pharyngitis Post-traumatic stress disorder Pruritus Rhinitis allergic Road traffic accident Suicidal ideation Thrombectomy Thrombolysis Vaginal infection Vena cava filter insertion Vulvovaginitis Product NUVARING FLAGYL Role Route S C Dosage Text UNK 500 mg, bid Duration Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,187 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8710997 Date FDA Received
03-Oct-2012 Case # 8710997 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2012SP0 17349 Dosage Text UNK Duration Age Sex Unknown Country USA

Preferred Term Convulsion Alcoholism Anaemia Animal bite Anticoagulation drug level below therapeutic Anxiety Attention deficit/hyperactivity disorder Bronchitis Deep vein thrombosis Dental caries Depression Drug dependence Foot fracture Gestational diabetes Infection Insomnia Night sweats Pain management Pneumonia Pulmonary embolism Streptococcus test positive Synovial cyst

Product NUVARING

Role Route S

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,188 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8776211 Date FDA Received
03-Oct-2012 Case # 8776211 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2010SP0 25231 Dosage Text Duration Age Sex Unknown Country USA

Preferred Term Subarachnoid haemorrhage Hypercoagulation Intracranial venous sinus thrombosis Adverse drug reaction Anxiety Autoimmune thrombocytopenia Benign intracranial hypertension Bronchitis Deep vein thrombosis Depression Dizziness Fatigue Gastrooesophageal reflux disease Hypersomnia Hypoaesthesia Migraine with aura Nephrolithiasis Oropharyngeal pain Pain in extremity Protein C deficiency Protein S deficiency Sinus headache Speech disorder

Product NUVARING NUVARING NUVARING

Role Route S S S

Manufacturer MERCK MERCK MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,189 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8815551 Date FDA Received
03-Oct-2012 Case # 8815551 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2012SP0 34976 Dosage Text UNK Duration Age Sex Unknown Country USA

Preferred Term Pleural effusion Blood pressure decreased Cholelithiasis Facial bones fracture Pulmonary embolism Pulmonary infarction Soft tissue injury Victim of spousal abuse

Product NUVARING

Role Route S

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,190 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8822996 Date FDA Received
03-Oct-2012 Case # 8822996 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2010SP0 26331 Dosage Text Duration Age Sex Unknown Country USA

Preferred Term Bipolar disorder Pulmonary embolism Pulmonary infarction Calculus ureteric Deep vein thrombosis Dyspepsia Glucose tolerance impaired Hydronephrosis Ligament sprain Malaise Pleural effusion Pollakiuria Seasonal allergy Sinus disorder Snoring Weight increased

Product NUVARING SEROQUEL SEROQUEL

Role Route S S S

Manufacturer MERCK

8823021 Date FDA Received

03-Oct-2012

Case # 8823021

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1209USA 011278

Age

Sex Female

Country USA

Preferred Term Unintended pregnancy Incorrect storage of drug

Product NUVARING

Role Route S VAGINAL

Dosage Text

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,191 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8823505 Date FDA Received
03-Oct-2012 Case # 8823505 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1209USA 010577 Role Route S Dosage Text 1 time insertion every 3 weeks with one week ring free break Duration Age Sex Female Country USA

Preferred Term Metrorrhagia

Product NUVARING

Manufacturer MERCK

Incorrect drug administration duration

8823753 Date FDA Received

03-Oct-2012

Case # 8823753

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1209USA 010909

Age

Sex Female

Country USA

Preferred Term Inappropriate schedule of drug administration

Product NUVARING Health Professional

Role Route S VAGINAL

Dosage Text 1 DF, qm Manufacturer Control # US-009507513-1209USA 010887

Duration

Manufacturer MERCK

8823849 Date FDA Received

03-Oct-2012

Case # 8823849

Case Type NON-EXPEDITED

Outcomes

Age 25 YR

Sex Female

Country USA

Preferred Term Palpitations Anxiety Migraine Mood swings Pain in extremity Vomiting

Product NUVARING

Role Route S VAGINAL

Dosage Text 1 DF, qm

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,192 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8823864 Date FDA Received
03-Oct-2012 Case # 8823864 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,DS,OT Manufacturer Control # US-009507513-2007-153 550-NL Dosage Text DOSE TEXT: 3 WEEKS IN, 1 WEEK OUT, CONTINUING: NO FREQUENCY: OM Duration Age Sex Unknown Country USA

Preferred Term Dyslipidaemia

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

Cerebral infarction Deep vein thrombosis Uterovaginal prolapse Adjustment disorder Depression Dysmenorrhoea Extraocular muscle paresis Fall Hypertension Joint dislocation Menorrhagia Metrorrhagia Pain in extremity Pelvic pain Rash Rotator cuff syndrome Transient ischaemic attack Urinary incontinence Vaginal discharge Vulvovaginal pruritus

EXCEDRIN (ACETAMINOPHEN (+) ASPIRIN (+) CAFFEINE) ESTROGENS (UNSPECIFIED) TRIAZOLAM

C C C

FREQUENCY: PRN

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,193 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8823976 Date FDA Received
03-Oct-2012 Case # 8823976 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1210USA 000820 Role Route S VAGINAL Dosage Text UNK Age 28 YR Sex Female Country USA

Preferred Term Vulvovaginal mycotic infection Abdominal pain Nausea Vaginitis bacterial

Product NUVARING

Duration

Manufacturer MERCK

8824069 Date FDA Received

03-Oct-2012

Case # 8824069

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1209USA 011110

Age 26 YR

Sex Female

Country USA

Preferred Term Menstruation delayed Incorrect drug administration duration

Product NUVARING

Role Route S VAGINAL

Dosage Text 1 DF, qm

Duration

Manufacturer MERCK

8343193 Date FDA Received

04-Oct-2012

Case # 8343193

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,OT

Manufacturer Control # US-009507513-2011SP0 44702 Dosage Text

Age

Sex Unknown

Country USA

Preferred Term Iron deficiency anaemia Mesenteric vein thrombosis Ovarian cyst Hypercoagulation Emotional disorder Herpes simplex serology positive Mental disorder

Product NUVARING NUVARING LEVOTHYROXINE SODIUM MAXALT

Role Route S S C C

Duration

Manufacturer MERCK MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,194 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8673732 Date FDA Received
04-Oct-2012 Case # 8673732 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2012SP0 11833 Dosage Text UNK UNK Duration Age Sex Unknown Country USA

Preferred Term Infection Intracranial venous sinus thrombosis Pulmonary embolism Adverse drug reaction Asthenia Back pain Bursitis Deep vein thrombosis Depression Hypercalcaemia Hypertension Intervertebral disc operation Intervertebral disc protrusion Lumbar radiculopathy Migraine Mobility decreased Muscle spasms Muscular weakness Pyrexia Rash Sciatica Stress

Product NUVARING NUVARING vancomycin

Role Route S S S

Manufacturer MERCK MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,195 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8690853 Date FDA Received
04-Oct-2012 Case # 8690853 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1207USA 008401 Role Route S VAGINAL Dosage Text UNK Duration Age Sex Female Country USA

Preferred Term Thrombosis Embolism venous

Product NUVARING

Manufacturer MERCK

8798786 Date FDA Received

04-Oct-2012

Case # 8798786

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,OT

Manufacturer Control # US-009507513-2011SP0 45027 Dosage Text 100 mg, QD

Age

Sex Unknown

Country USA

Preferred Term Hypercoagulation Pulmonary embolism Back pain Asthenia Ataxia Breast pain Drug ineffective Dysphonia Factor V deficiency Fatigue Headache Insomnia Low density lipoprotein increased Major depression Nervous system disorder Oropharyngeal pain Paraesthesia Rhinitis Sensation of heaviness

Product NUVARING SERTRALINE HYDROCHLORIDE ZANTAC

Role Route S C C ORAL

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,196 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8821067 Date FDA Received
04-Oct-2012 Case # 8821067 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2011SP0 48222 Dosage Text UNK LAXATIVE 1 DF, QD Duration Age Sex Unknown Country USA

Preferred Term Cerebrovascular accident Hyperlipidaemia Presyncope Abdominal pain Candidiasis Hypertension Palpitations

Product NUVARING HERBS (UNSPECIFIED) VITAMINS (UNSPECIFIED)

Role Route S C C

Manufacturer MERCK

8823434 Date FDA Received

04-Oct-2012

Case # 8823434

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes OT

Manufacturer Control # US-009507513-1209USA 009100 Dosage Text UNK Manufacturer Control # US-009507513-1209USA 011650 Dosage Text

Age 22 YR

Sex Female

Country USA

Preferred Term Abortion spontaneous

Product NUVARING Case # 8824295 Case Type EXPEDITED (15-DAY) Health Professional

Role Route S VAGINAL

Duration

Manufacturer MERCK

8824295 Date FDA Received

04-Oct-2012

Outcomes OT

Age

Sex Female

Country USA

Preferred Term Abortion induced Unintended pregnancy

Product NUVARING

Role Route S

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,197 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8824388 Date FDA Received
04-Oct-2012 Case # 8824388 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1208USA 002848 Role Route S C Dosage Text Duration Age Sex Female Country USA

Preferred Term Coital bleeding Cervicitis Metrorrhagia Weight increased

Product NUVARING hormonal contraceptives (unspecified)

Manufacturer MERCK

8824588 Date FDA Received

04-Oct-2012

Case # 8824588

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1210USA 000328

Age 38 YR

Sex Female

Country USA

Preferred Term Inappropriate schedule of drug administration

Product NUVARING Health Professional

Role Route S VAGINAL

Dosage Text 1 ring for 3 weeks then a week free break,UNK Manufacturer Control # US-009507513-1210USA 001600

Duration

Manufacturer MERCK

8824857 Date FDA Received

04-Oct-2012

Case # 8824857

Case Type NON-EXPEDITED

Outcomes

Age

Sex Female

Country USA

Preferred Term Unintended pregnancy

Product NUVARING

Role Route S VAGINAL

Dosage Text

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,198 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8825324 Date FDA Received
04-Oct-2012 Case # 8825324 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,DS,OT Manufacturer Control # US-009507513-2010SP0 04876 Dosage Text Duration Age Sex Unknown Country USA

Preferred Term Stent placement Pulmonary embolism Migraine Arthralgia Deep vein thrombosis Diarrhoea Flank pain Herpes simplex Hydronephrosis Hypercoagulation Hypertension Oedema peripheral Pleurisy Psoriasis Tendonitis

Product NUVARING NUVARING NUVARING

Role Route S S S

Manufacturer MERCK MERCK MERCK

8825326 Date FDA Received

04-Oct-2012

Case # 8825326

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1209USA 010985

Age

Sex Unknown

Country USA

Preferred Term Paraesthesia Hypoaesthesia

Product NUVARING

Role Route S

Dosage Text

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,199 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8825526 Date FDA Received
04-Oct-2012 Case # 8825526 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2012SP0 34968 Dosage Text UNK UNK, prn UNK UNK UNK UNK Duration Age Sex Female Country USA

Preferred Term Acute myocardial infarction Thrombosis Female sterilisation Abortion induced Ovarian cyst Anogenital warts Asthma Chest pain Coronary artery disease Deep vein thrombosis Depression Ectopic pregnancy Embolism Fungal infection Heart rate irregular Hypercholesterolaemia Hypertension Loop electrosurgical excision procedure Ovarian enlargement Peripheral vascular disorder Pulmonary embolism Urinary tract infection Vaginitis bacterial Ventricular hypokinesia Weight decreased

Product NUVARING ALEVE ORTHO EVRA DEPO-PROVERA UNSPECIFIED INGREDIENTS NORPLANT

Role Route S C S S S S VAGINAL ORAL TRANSDERMAL INTRAMUSCULAR ORAL SUBDERMAL

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,200 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8825567 Date FDA Received
04-Oct-2012 Case # 8825567 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2011SP0 59163 Dosage Text Duration Age Sex Female Country USA

Preferred Term Deep vein thrombosis Pulmonary embolism Adverse drug reaction Alopecia Atrial fibrillation Bunion Bunion operation Dry skin Electrocardiogram abnormal Hyperlipidaemia Migraine Mitral valve prolapse Orthostatic hypotension Pleural effusion Sinusitis Weight increased

Product NUVARING NUVARING

Role Route S S

Manufacturer MERCK MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,201 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8825667 Date FDA Received
04-Oct-2012 Case # 8825667 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2010SP0 14804 Dosage Text Duration Age Sex Unknown Country USA

Preferred Term Hydronephrosis Anxiety Cervical dysplasia Chest pain Depression Dizziness Human papilloma virus test positive Musculoskeletal chest pain Palpitations Pulmonary embolism

Product NUVARING

Role Route S

Manufacturer MERCK

8825721 Date FDA Received

04-Oct-2012

Case # 8825721

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1210USA 000827

Age 23 YR

Sex Female

Country USA

Preferred Term Metrorrhagia

Product NUVARING Case # 8825764 Case Type EXPEDITED (15-DAY) Health Professional

Role Route S Outcomes DE,OT

Dosage Text UNK Manufacturer Control # US-009507513-1210USA 002338 Dosage Text UNK Manufacturer Control # US-009507513-1210USA 002362 Dosage Text UNK

Duration

Manufacturer MERCK

8825764 Date FDA Received

04-Oct-2012

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism

Product NUVARING Case # 8825857 Case Type EXPEDITED (15-DAY) Health Professional

Role Route S VAGINAL

Duration

Manufacturer MERCK

8825857 Date FDA Received

04-Oct-2012

Outcomes DS

Age

Sex Unknown

Country USA

Preferred Term Deep vein thrombosis

Product NUVARING

Role Route S

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,202 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8829728 Date FDA Received
05-Oct-2012 Preferred Term Vulvovaginal pain Alopecia Anxiety Dyspareunia Case # 8829728 Case Type DIRECT Product NUVARING Health Professional Outcomes OT Role Route S Dosage Text Manufacturer Control # Age 27 YR Duration Sex Female Country USA

Manufacturer

8791767 Date FDA Received

08-Oct-2012

Case # 8791767

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,OT

Manufacturer Control # US-009507513-2008-183 726-NL

Age

Sex Unknown

Country USA

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,203 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8791767
Preferred Term Cholecystectomy Deep vein thrombosis Urinary tract infection Constipation Pain in extremity Adenoidectomy Back pain Bronchitis Chlamydia test positive Cholelithiasis Depression Drug ineffective Dysmenorrhoea Hepatic steatosis Hot flush Hypercoagulation Hypersensitivity Menstruation irregular Night sweats Oedema peripheral Ovarian cyst ruptured Ovulation pain Pain in extremity Pollakiuria Polycystic ovaries Sleep disorder Tonsillectomy Upper respiratory tract infection Venous insufficiency Product NUVARING PROZAC GLUCOPHAGE albuterol PRILOSEC Role Route S C C C C VAGINAL Dosage Text CONTINUING: NO UNK DF, UNK UNK DF, UNK UNK, prn MERCK Duration Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,204 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8826122 Date FDA Received
08-Oct-2012 Case # 8826122 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2009SP0 35328 Dosage Text UNK UNK, QM 1 DF, QD 1 DF, QD 1 DF, QD 1 DF, QD 1 DF, QD 1 DF, QD UNK UNK, PRN Manufacturer Control # PT-009507513-1210PRT 001676 Dosage Text UNK Age 21 YR Sex Female Country PRT Duration Age Sex Unknown Country USA

Preferred Term Atelectasis Pulmonary embolism Deep vein thrombosis

Product NUVARING VITAMINS (UNSPECIFIED) ASCORBIC ACID VITAMIN E OMEGA-3 MARINE TRIGLYCERIDES FLAXSEED SELENIUM (UNSPECIFIED) ADVIL MIGRAINE

Role Route S C C C C C C C Outcomes OT VAGINAL

Manufacturer MERCK

8827272 Date FDA Received

08-Oct-2012

Case # 8827272

Case Type EXPEDITED (15-DAY)

Health Professional

Preferred Term Flatulence Abdominal pain Diarrhoea

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

8828760 Date FDA Received

08-Oct-2012

Case # 8828760

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes DS

Manufacturer Control # US-009507513-1210USA 002366 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Thrombosis

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,205 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8828964 Date FDA Received
08-Oct-2012 Case # 8828964 Case Type EXPEDITED (15-DAY) Health Professional Outcomes OT Manufacturer Control # US-009507513-1210USA 002361 Dosage Text UNK Manufacturer Control # US-009507513-1210USA 002350 Dosage Text UNK Manufacturer Control # US-009507513-2010SP0 19044 Dosage Text Duration Age Sex Unknown Duration Age Sex Unknown Duration Age Sex Unknown Country USA

Preferred Term Cerebrovascular accident

Product NUVARING Case Type EXPEDITED (15-DAY) Health Professional

Role Route S Outcomes OT

Manufacturer MERCK Country USA

8830038 Date FDA Received

08-Oct-2012

Case # 8830038

Preferred Term Pulmonary embolism

Product NUVARING Case # 8830602 Case Type EXPEDITED (15-DAY) Health Professional

Role Route S VAGINAL

Manufacturer MERCK Country USA

8830602 Date FDA Received

08-Oct-2012

Outcomes HO,OT

Preferred Term Ectopic pregnancy Adnexa uteri mass Fungal infection Migraine Osteoarthritis Pulmonary embolism Unintended pregnancy

Product NUVARING

Role Route S

Manufacturer MERCK

8830619 Date FDA Received

08-Oct-2012

Case # 8830619

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,DS,OT

Manufacturer Control # US-009507513-1210USA 002347 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism Deep vein thrombosis

Product NUVARING

Role Route S

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,206 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8667561 Date FDA Received
09-Oct-2012 Case # 8667561 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO Manufacturer Control # US-009507513-1207USA 002950 Dosage Text UNK Duration Age Sex Female Country USA

Preferred Term Deep vein thrombosis

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,207 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8738166 Date FDA Received
09-Oct-2012 Case # 8738166 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2012SP0 22373 Dosage Text Nuvaring Duration Age Sex Unknown Country USA

Preferred Term Tongue ulceration Anaemia Antinuclear antibody positive Chest pain Deep vein thrombosis Electrocauterisation Ethmoid sinus surgery Mitral valve incompetence Nasal septal operation Nasal septum deviation Nasal turbinate hypertrophy Pain in extremity Pulmonary artery dilatation Pulmonary embolism Pulmonary valve incompetence Sinus antrostomy Sinus bradycardia Sinusitis Sphenoid sinus operation Surgery Thrombosis Thyroglossal cyst Tricuspid valve incompetence Ventricular hypertrophy

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,208 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8806063 Date FDA Received
09-Oct-2012 Case # 8806063 Case Type EXPEDITED (15-DAY) Health Professional Outcomes OT Manufacturer Control # DE-009507513-1209DEU 008733 Dosage Text UNK Manufacturer Control # US-009507513-2009SP0 36859 Dosage Text UNK UNK, QM 40 mg, QD UNK UNK, PRN Duration Age Sex Unknown Age 34 YR Sex Unknown Country DEU

Preferred Term Glioblastoma multiforme

Product NUVARING Case # 8810191 Case Type EXPEDITED (15-DAY) Health Professional

Role Route S VAGINAL

Duration

Manufacturer MERCK Country USA

8810191 Date FDA Received

09-Oct-2012

Outcomes HO,OT

Preferred Term Pulmonary embolism Thrombosis Deep vein thrombosis Blood pressure increased Cellulitis Chest pain Dizziness Dysuria Hypersensitivity Hypertension Otitis externa Otitis media Pain in extremity Palpitations Paraesthesia

Product NUVARING FAMOTIDINE IBUPROFEN

Role Route S C C VAGINAL

Manufacturer MERCK

8825325 Date FDA Received

09-Oct-2012

Case # 8825325

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes DS,OT

Manufacturer Control # US-009507513-1210USA 001068 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Cerebrovascular accident

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,209 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8828856 Date FDA Received
09-Oct-2012 Case # 8828856 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1209USA 012057 Role Route S Health Professional VAGINAL Dosage Text UNK Manufacturer Control # PT-009507513-1210PRT 001679 Dosage Text UNK Age 31 YR Sex Female Duration Age Sex Female Country USA

Preferred Term Hypersensitivity

Product NUVARING Case # 8828928 Case Type EXPEDITED (15-DAY)

Manufacturer MERCK Country PRT

8828928 Date FDA Received

09-Oct-2012

Outcomes OT

Preferred Term Flatulence Abdominal pain Diarrhoea

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

8830318 Date FDA Received

09-Oct-2012

Case # 8830318

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes DS,OT

Manufacturer Control # US-009507513-1210USA 002331 Dosage Text UNK Manufacturer Control # CH-009507513-1210CHE 001640 Dosage Text 11.7/2.7 mg, UNK 11.7/2.7 mg, UNK UNK UNK

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism

Product NUVARING Case # 8830357 Case Type EXPEDITED (15-DAY) Health Professional

Role Route S Outcomes OT

Duration

Manufacturer MERCK

8830357 Date FDA Received

09-Oct-2012

Age 32 YR

Sex Female

Country CHE

Preferred Term Eczema

Product NUVARING NUVARING NUVARING QLAIRA

Role Route S S S S ORAL VAGINAL VAGINAL

Duration

Manufacturer MERCK MERCK MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,210 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8830836 Date FDA Received
09-Oct-2012 Case # 8830836 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2012SP0 28991 Dosage Text UNK Duration Age Sex Unknown Country USA

Preferred Term Costochondritis Pulmonary embolism Depression Off label use Thrombosis

Product NUVARING NUVARING

Role Route S S

Manufacturer MERCK MERCK

8831568 Date FDA Received

09-Oct-2012

Case # 8831568

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes DS,OT

Manufacturer Control # US-009507513-1210USA 002329 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism Deep vein thrombosis

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,211 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8831712 Date FDA Received
09-Oct-2012 Case # 8831712 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO Manufacturer Control # US-009507513-2009SP0 40687 Dosage Text Duration Age Sex Unknown Country USA

Preferred Term Superior sagittal sinus thrombosis Abdominal pain Appendicitis Calculus ureteric Cellulitis Haematuria Headache Nausea Pelvic inflammatory disease Pelvic pain Pruritus Staphylococcal infection Vomiting

Product NUVARING

Role Route S

Manufacturer MERCK

8831747 Date FDA Received

09-Oct-2012

Case # 8831747

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1210USA 003279

Age 20 YR

Sex Female

Country USA

Preferred Term Menstruation delayed

Product NUVARING Case # 8832006 Case Type NON-EXPEDITED Health Professional

Role Route S VAGINAL

Dosage Text 3 weeks in, 1 week out Manufacturer Control # US-009507513-1210USA 002481

Duration

Manufacturer MERCK

8832006 Date FDA Received

09-Oct-2012

Outcomes

Age

Sex Female

Country USA

Preferred Term Unintended pregnancy

Product NUVARING

Role Route S VAGINAL

Dosage Text UNK

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,212 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8832183 Date FDA Received
09-Oct-2012 Case # 8832183 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2010SP0 55778 Dosage Text 75 mg, UNK 10 mg, UNK Duration Age Sex Unknown Country USA

Preferred Term Anticoagulation drug level Pulmonary embolism Asthma Adverse drug reaction Alopecia Anxiety disorder due to a general medical condition Pain in extremity Stress

Product NUVARING LEVOTHYROXINE SODIUM ABILIFY

Role Route S C C

Manufacturer MERCK

8832184 Date FDA Received

09-Oct-2012

Case # 8832184

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1209USA 010677

Age

Sex Unknown

Country USA

Preferred Term Irritability Anxiety Burning sensation Crying Inappropriate schedule of drug administration Mental disorder Mood swings Panic attack Treatment noncompliance

Product NUVARING

Role Route S VAGINAL

Dosage Text

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,213 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8832272 Date FDA Received
09-Oct-2012 Case # 8832272 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1210USA 002486 Role Route S C Outcomes Manufacturer Control # US-009507513-1210USA 002476 Role Route S Health Professional VAGINAL Dosage Text UNK Manufacturer Control # US-009507513-1210USA 002364 Dosage Text Duration Age Sex Unknown Age 37 YR Sex Female Country USA VAGINAL Dosage Text 0.015/0.12mg, unk Duration Age Sex Female Country USA

Preferred Term Unintended pregnancy

Product NUVARING antimicrobial (unspecified)

Manufacturer MERCK

8832295 Date FDA Received

09-Oct-2012

Case # 8832295

Case Type NON-EXPEDITED

Health Professional

Preferred Term Unintended pregnancy

Product NUVARING Case # 8832303 Case Type EXPEDITED (15-DAY)

Duration

Manufacturer MERCK Country USA

8832303 Date FDA Received

09-Oct-2012

Outcomes DS,OT

Preferred Term Pulmonary embolism

Product NUVARING Case # 8832382 Case Type NON-EXPEDITED Health Professional

Role Route S VAGINAL

Manufacturer MERCK

8832382 Date FDA Received

09-Oct-2012

Outcomes

Manufacturer Control # US-009507513-1209USA 008282

Age

Sex Unknown

Country USA

Preferred Term Metrorrhagia Device expulsion Off label use

Product NUVARING NUVARING

Role Route S S

Dosage Text UNK

Duration

Manufacturer MERCK MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,214 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8762102 Date FDA Received
10-Oct-2012 Case # 8762102 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2012SP0 24808 Dosage Text UNK UNK, prn Duration Age Sex Unknown Country USA

Preferred Term Pulmonary embolism Papilloma viral infection Anticoagulation drug level below therapeutic Arthralgia Blood cholesterol increased Chest pain Diabetes mellitus Dysmenorrhoea Hypertension International normalised ratio decreased Pain Pleurisy Pneumonia Rubber sensitivity Treatment noncompliance Upper respiratory tract infection

Product NUVARING hydrochlorothiazide

Role Route S C VAGINAL

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,215 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8815606 Date FDA Received
10-Oct-2012 Case # 8815606 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2008-177 920-NL Dosage Text CONTINUING: NO FREQUENCY: TW Duration Age Sex Unknown Country USA

Preferred Term Deep vein thrombosis Pulmonary embolism Sinusitis Seasonal allergy Urinary tract infection Constipation Abdominal pain Migraine Off label use Hepatic cyst Somatisation disorder Anxiety Melanosis coli Rectal polyp

Product NUVARING NUVARING EXCEDRIN (ACETAMINOPHEN (+) ASPIRIN (+) CAFFEINE) ZELNORM CONCERTA testosterone TOPAMAX FIORICET VERAPAMIL SINGULAIR NASONEX ADVAIR CLARITIN ZYRTEC ALLEGRA CLARINEX LORATADINE GUAIFENESIN (+) PHENYLEPHRINE HYDROCHLORIDE MAXAIR

Role Route S S C C C S C C C C C C C C C C C C ORAL ORAL ORAL ORAL VAGINAL

Manufacturer MERCK MERCK

ACTION TAKEN: WITHDRAWN UNK UNK, bid ACTION TAKEN: WITHDRAWN

MERCK

MERCK MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,216 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8832620 Date FDA Received
10-Oct-2012 Case # 8832620 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1210USA 002791 Role Route S VAGINAL Dosage Text Duration Age Sex Female Country USA

Preferred Term Device breakage Medical device complication

Product NUVARING

Manufacturer MERCK

8832704 Date FDA Received

10-Oct-2012

Case # 8832704

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1210USA 003927

Age

Sex Unknown

Country USA

Preferred Term Weight increased

Product NUVARING Case # 8833366 Case Type EXPEDITED (15-DAY) Health Professional

Role Route S Outcomes HO,OT

Dosage Text

Duration

Manufacturer MERCK

8833366 Date FDA Received

10-Oct-2012

Manufacturer Control # US-009507513-1210USA 002407 Dosage Text UNK Manufacturer Control # US-009507513-2010SP0 53045 Dosage Text

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism

Product NUVARING Case # 8833564 Case Type EXPEDITED (15-DAY) Health Professional

Role Route S VAGINAL

Duration

Manufacturer MERCK

8833564 Date FDA Received

10-Oct-2012

Outcomes HO,OT

Age

Sex Unknown

Country USA

Preferred Term Lymphoma Hypercoagulation Pneumonia Adenoidectomy Anxiety Atelectasis Bronchitis Calcinosis Chronic obstructive pulmonary disease

Product NUVARING DARVOCET-N CODEINE

Role Route S S S

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,217 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8833564
Preferred Term Contusion Cyst Deep vein thrombosis Drug hypersensitivity Eye disorder Gastrooesophageal reflux disease Headache Hypersensitivity Injection Keratitis Ligament sprain Migraine Muscle spasms Muscle strain Nausea Pain in extremity Phlebitis Plantar fasciitis Pulmonary embolism Pulmonary infarction Syncope Tonsillectomy Varicose vein Vocal cord polyp Vomiting Product Role Route Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,218 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8834021 Date FDA Received
10-Oct-2012 Case # 8834021 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1210USA 003430 Role Route S VAGINAL Dosage Text 1 DF, UNK Duration Age Sex Female Country USA

Preferred Term Abdominal pain Abdominal distension

Product NUVARING

Manufacturer MERCK

8834065 Date FDA Received

10-Oct-2012

Case # 8834065

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1210USA 004006

Age 25 YR

Sex Female

Country USA

Preferred Term Nausea Dizziness Menorrhagia

Product NUVARING

Role Route S VAGINAL

Dosage Text 3 weeks

Duration

Manufacturer MERCK

8834231 Date FDA Received

10-Oct-2012

Case # 8834231

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1210USA 003428

Age

Sex Female

Country USA

Preferred Term Inappropriate schedule of drug administration No adverse event

Product NUVARING

Role Route S VAGINAL

Dosage Text UNK

Duration

Manufacturer MERCK

8834232 Date FDA Received

10-Oct-2012

Case # 8834232

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1210USA 003445

Age

Sex Female

Country USA

Preferred Term Inappropriate schedule of drug administration Device expulsion

Product NUVARING

Role Route S VAGINAL

Dosage Text

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,219 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8834250 Date FDA Received
10-Oct-2012 Case # 8834250 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1210USA 002055 Role Route S Health Professional VAGINAL Dosage Text UNK Manufacturer Control # US-009507513-1209USA 011219 Role Route S VAGINAL Dosage Text Duration Age Sex Female Duration Age Sex Female Country USA

Preferred Term Vaginal infection

Product NUVARING Case # 8834580 Case Type NON-EXPEDITED

Manufacturer MERCK Country USA

8834580 Date FDA Received

10-Oct-2012

Outcomes

Preferred Term Device expulsion No adverse event

Product NUVARING

Manufacturer MERCK

8834602 Date FDA Received

10-Oct-2012

Case # 8834602

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,LT,OT

Manufacturer Control # US-009507513-2010SP0 42279 Dosage Text UNK UNK, QD

Age

Sex Unknown

Country USA

Preferred Term Breast cancer in situ Pulmonary embolism Coagulopathy Costochondritis Depression Drug hypersensitivity Facet joint syndrome Hot flush Lordosis Myofascial pain syndrome Sleep disorder Stress fracture Vitamin D deficiency

Product NUVARING VITAMINS (UNSPECIFIED)

Role Route S C

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,220 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8834688 Date FDA Received
10-Oct-2012 Case # 8834688 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2009-200 154-NL Dosage Text CONTINUING: NO Duration Age Sex Unknown Country USA

Preferred Term Cholecystitis chronic Blood cholesterol increased Cholecystectomy Cholelithiasis Deep vein thrombosis Pregnancy Pulmonary embolism Thrombophlebitis superficial

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

8834737 Date FDA Received

10-Oct-2012

Case # 8834737

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,DS,OT

Manufacturer Control # US-009507513-2011SP0 27540 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Ovarian cyst Hepatic steatosis Muscle strain Nephrolithiasis Ovarian cyst ruptured Portal vein thrombosis Road traffic accident Splenic vein thrombosis Uterine leiomyoma

Product NUVARING

Role Route S

Duration

Manufacturer MERCK

7826821 Date FDA Received

11-Oct-2012

Case # 7826821

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,OT

Manufacturer Control # US-009507513-2010SP0 06063 Dosage Text

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism

Product NUVARING

Role Route S

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,221 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7826821
Preferred Term Hypokalaemia Neuropathy peripheral Sinus tachycardia Product COUMADIN HYDROCHLOROTHIAZIDE KEPPRA Role Route S C C ORAL Dosage Text 5 mg, QD 12.5 mg, UNK UNCLEAR WHETHER 16JAN RENEWAL OR START DATE 50 ?g, QD 10 mg, QD 550 mg, BID ORAL ORAL ORAL ORAL ORAL 160/800 MG 150 mg, ONCE 500 mg, BID Q 8 HRS PRN 2 mg, ONCE 20/12.5 MG Duration Manufacturer

Off label use Vulvovaginal mycotic infection Cystitis Abdominal pain lower Multiple sclerosis Encephalopathy Convulsion Blood testosterone decreased Coagulopathy Constipation Pollakiuria

FLONASE SINGULAIR ANAPROX DS BACTRIM DS DIFLUCAN FLAGYL IBUPROFEN VALIUM BENAZEPRIL HYDROCHLORIDE (+) HYDROCHLOROTHIAZIDE CYMBALTA HYDROCODONE POLISTIREX (+) PHENYLTOLOXAMINE POLISTIREX

C C C C C C C C C C C

NASAL ORAL

1 TSP

Accident at work Adverse drug reaction Anxiety Back injury Bruxism Carpal tunnel syndrome Depression Dizziness Dyspnoea Dysuria Hangover Head injury Influenza like illness

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,222 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7826821
Preferred Term Insomnia Joint injury Mammogram abnormal Occipital neuralgia Paraesthesia Road traffic accident Sleep apnoea syndrome Somnolence Urinary tract infection Vaginal haemorrhage Weight increased Product Role Route Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,223 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8343164 Date FDA Received
11-Oct-2012 Case # 8343164 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,DS,OT Manufacturer Control # US-009507513-2011SP0 45605 Dosage Text 0.05 mg, QD Duration Age Sex Unknown Country USA

Preferred Term Biliary dyskinesia Deep vein thrombosis Chest pain Cholecystectomy Diarrhoea Drug hypersensitivity Dyspnoea Endometrial ablation Female sterilisation Gastroenteritis viral Hepatic steatosis Neck pain Ovarian cyst Post thrombotic syndrome Pulmonary embolism Thrombosis Thyroxine increased Venous injury

Product NUVARING SYNTHROID

Role Route S C VAGINAL ORAL

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,224 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8716478 Date FDA Received
11-Oct-2012 Case # 8716478 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2011SP0 46641 Dosage Text UNK Duration Age Sex Unknown Country USA

Preferred Term Cerebral infarction Cerebral artery occlusion Attention deficit/hyperactivity disorder Depression Diverticulitis Dysthymic disorder Hyperlipidaemia Iron deficiency anaemia Limb injury Lipids increased Melanocytic naevus Mole excision Myeloproliferative disorder Thrombocytosis Transient ischaemic attack

Product NUVARING LEXAPRO

Role Route S C

Manufacturer MERCK

8818228 Date FDA Received

11-Oct-2012

Case # 8818228

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1209USA 011523

Age

Sex Female

Country USA

Preferred Term Thrombosis

Product NUVARING

Role Route S VAGINAL

Dosage Text 1 ring in for 3 weeks/out for 1 week

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,225 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8833806 Date FDA Received
11-Oct-2012 Case # 8833806 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1210USA 003878 Role Route S C C Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2010SP0 12136 Dosage Text Duration Age Sex Unknown Country USA VAGINAL Dosage Text 1 ring/Every 28 days Duration Age Sex Female Country USA

Preferred Term Medical device discomfort Device expulsion

Product NUVARING vitamins (unspecified) ZYRTEC

Manufacturer MERCK

8835504 Date FDA Received

11-Oct-2012

Case # 8835504

Case Type EXPEDITED (15-DAY)

Preferred Term Organ failure Pancreatitis Anaemia Deep vein thrombosis Gallbladder disorder Gastritis Hepatic function abnormal Inflammation Mesenteric lymphadenopathy Mesenteric vein thrombosis Ovarian cyst

Product NUVARING HORMONAL CONTRACEPTIVES (UNSPECIFIED)

Role Route S S

Manufacturer MERCK

8835764 Date FDA Received

11-Oct-2012

Case # 8835764

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1210USA 003709

Age

Sex Female

Country USA

Preferred Term Urinary tract infection

Product NUVARING

Role Route S VAGINAL

Dosage Text UNK

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,226 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8836171 Date FDA Received
11-Oct-2012 Case # 8836171 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2010SP0 09218 Dosage Text Duration Age Sex Unknown Country USA

Preferred Term Pneumonia Acute chest syndrome Bone lesion Cardiomegaly Cholelithiasis Decreased appetite Drug ineffective Lung infiltration Nausea Pleural fibrosis Pregnancy Pruritus generalised Pulmonary embolism Pulmonary hypertension Pulmonary infarction Pyelonephritis Respiratory arrest Sickle cell anaemia with crisis Stress Thromboembolectomy Vena cava filter insertion Vomiting Vulvovaginal mycotic infection

Product NUVARING

Role Route S

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,227 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8836407 Date FDA Received
11-Oct-2012 Case # 8836407 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1210USA 004017 Role Route S VAGINAL Dosage Text 3 weeks in, 1 week out Duration Age Sex Female Country USA

Preferred Term Discomfort Product quality issue Vaginal discharge

Product NUVARING

Manufacturer MERCK

8838833 Date FDA Received

11-Oct-2012 Preferred Term Pulmonary embolism

Case # 8838833

Case Type DIRECT Product NUVARING

Health Professional

Outcomes OT Role Route S VAGINAL

Manufacturer Control #

Age 25 YR

Sex Female

Country USA

Dosage Text One ring Once a month vag Manufacturer Control # US-009507513-2012SP0 34971 Dosage Text UNK

Duration

Manufacturer MERCK

8825406 Date FDA Received

12-Oct-2012

Case # 8825406

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,OT

Age

Sex Unknown

Country USA

Preferred Term Deep vein thrombosis Knee operation Anxiety Abdominal pain Adverse drug reaction Anxiety Back pain Breast pain Chest pain Cholecystectomy Cholelithiasis Constipation Depression Dysmenorrhoea

Product NUVARING NUVARING BENICAR

Role Route S S C ORAL

Duration

Manufacturer MERCK MERCK

40 mg, UNK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,228 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8825406
Preferred Term Fatigue Gastrooesophageal reflux disease Hyperglycaemia Hypertension Iron deficiency anaemia Joint injury Joint instability Lower extremity mass Migraine Muscle spasms Myomectomy Nausea Neck mass Neck surgery Pain in extremity Palpitations Pelvic pain Peripheral vascular disorder Rash Retinal detachment Tonsillectomy Tremor Uterine leiomyoma Weight increased Product Role Route Dosage Text Duration Manufacturer

8836730 Date FDA Received

12-Oct-2012

Case # 8836730

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1209USA 011680

Age 20 YR

Sex Female

Country USA

Preferred Term Metrorrhagia

Product NUVARING

Role Route S VAGINAL

Dosage Text 1 DF, 3 weeks in, 1 week out

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,229 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8837211 Date FDA Received
12-Oct-2012 Case # 8837211 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2011SP0 14799 Dosage Text 1 PUFF BID PRN 0.8 ml, QW INJECTION Duration Age Sex Unknown Country USA

Preferred Term Lung infiltration Deep vein thrombosis Pulmonary embolism Pulmonary infarction Hepatic cyst Transient ischaemic attack Asthenia Chest pain Dizziness Headache Oedema peripheral Peripheral embolism Pneumonia Syncope

Product NUVARING ADVAIR XOPENEX ALBUTEROL METHOTREXATE GONADOTROPIN, CHORIONIC

Role Route S C C C C C SUBCUTANEOUS VAGINAL INHALATION INHALATION

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,230 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8837600 Date FDA Received
12-Oct-2012 Case # 8837600 Case Type EXPEDITED (15-DAY) Health Professional Outcomes OT Manufacturer Control # US-009507513-2010SP0 03304 Dosage Text Duration Age Sex Unknown Country USA

Preferred Term Smear cervix abnormal Polycystic ovaries Transient ischaemic attack Bronchitis Chest pain Endodontic procedure Fatigue Hidradenitis Hirsutism Hypertension Malaise Migraine Nausea Papilloma viral infection Pharyngitis Rhinorrhoea

Product NUVARING NUVARING NUVARING

Role Route S S S

Manufacturer MERCK MERCK MERCK

8837640 Date FDA Received

12-Oct-2012

Case # 8837640

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1210USA 003478

Age

Sex Female

Country USA

Preferred Term Medical device discomfort Product quality issue

Product NUVARING

Role Route S VAGINAL

Dosage Text 1 ring

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,231 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8837767 Date FDA Received
12-Oct-2012 Case # 8837767 Case Type EXPEDITED (15-DAY) Health Professional Outcomes OT Manufacturer Control # US-009507513-2011SP0 01283 Dosage Text Duration Age Sex Unknown Country USA

Preferred Term Deep vein thrombosis Cervical dysplasia Papilloma viral infection Vaginal discharge Vaginal disorder

Product NUVARING

Role Route S

Manufacturer MERCK

8838634 Date FDA Received

12-Oct-2012

Case # 8838634

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,LT

Manufacturer Control # CA-009507513-1210CAN 005774 Dosage Text 1 DF, UNK

Age 25 YR

Sex Female

Country CAN

Preferred Term Pleural effusion Pulmonary embolism Pulmonary infarction

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

8838690 Date FDA Received

12-Oct-2012

Case # 8838690

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes DS

Manufacturer Control # US-009507513-1210USA 002082 Dosage Text

Age

Sex Unknown

Country USA

Preferred Term Deep vein thrombosis

Product NUVARING

Role Route S

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,232 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8838728 Date FDA Received
12-Oct-2012 Case # 8838728 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,LT,OT Manufacturer Control # US-009507513-2010SP0 26025 Dosage Text Duration Age Sex Unknown Country USA

Preferred Term Abortion spontaneous Ovarian cyst Anaemia Cardiomegaly Necrosis Abdominoplasty Anxiety Atelectasis Cystitis Depression Hiatus hernia Leukocytosis Postpartum depression Pulmonary embolism Pyrexia Unintended pregnancy Uterine leiomyoma Weight decreased

Product NUVARING NUVARING UNSPECIFIED INGREDIENT DARVOCET-N VALIUM

Role Route S S S C C VAGINAL

Manufacturer MERCK MERCK

8838731 Date FDA Received

12-Oct-2012

Case # 8838731

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,DS,OT

Manufacturer Control # US-009507513-2010SP0 31888 Dosage Text 1 DF, QM

Age

Sex Unknown

Country USA

Preferred Term Atypical pneumonia Asthma Convulsion Pulmonary granuloma Subcutaneous emphysema

Product NUVARING NUVARING FENTANYL TRILEPTAL ZOLOFT

Role Route S S S C C INTRAVENOUS VAGINAL

Duration

Manufacturer MERCK MERCK

50 mg, QD

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,233 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8838731
Preferred Term Abdominal pain lower Acute sinusitis Anaemia Antiphospholipid antibodies positive Atelectasis Bronchitis Cardiomegaly Dizziness Dyspnoea Excoriation Haemoptysis Herpes simplex Hypersensitivity Hypotension Infection Ligament sprain Malaise Mental disorder Migraine with aura Musculoskeletal chest pain Nasopharyngitis Occipital neuralgia Pain Pericardial effusion Pulmonary embolism Pulmonary infarction Respiratory disorder Sinus tachycardia Streptococcal infection Syncope Thermal burn Product Role Route Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,234 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8838731
Preferred Term Upper respiratory tract infection Vomiting Product Role Route Dosage Text Duration Manufacturer

8838746 Date FDA Received

12-Oct-2012

Case # 8838746

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1209USA 004209

Age

Sex Unknown

Country USA

Preferred Term Abdominal distension Amenorrhoea Inappropriate schedule of drug administration

Product NUVARING

Role Route S VAGINAL

Dosage Text UNK

Duration

Manufacturer MERCK

8838761 Date FDA Received

12-Oct-2012

Case # 8838761

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO

Manufacturer Control # US-009507513-2011SP0 26444 Dosage Text

Age

Sex Unknown

Country USA

Preferred Term Transverse sinus thrombosis Influenza like illness Asthenia Menorrhagia Oral herpes

Product NUVARING NUVARING

Role Route S S

Duration

Manufacturer MERCK MERCK

8839998 Date FDA Received

12-Oct-2012 Preferred Term Pulmonary embolism Heart rate increased Pulmonary thrombosis

Case # 8839998

Case Type DIRECT Product NUVARING

Health Professional

Outcomes HO,LT Role Route S VAGINAL

Manufacturer Control #

Age 27 YR

Sex Female

Country USA

Dosage Text

Duration 3 WEEK

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,235 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8818385 Date FDA Received
15-Oct-2012 Case # 8818385 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,DS,OT Manufacturer Control # US-009507513-2012SP0 34984 Dosage Text UNK Duration Age Sex Unknown Country USA

Preferred Term Streptococcus test positive Anxiety Deep vein thrombosis Dizziness Fatigue Gastrooesophageal reflux disease Iron deficiency anaemia Menstruation irregular Migraine Pulmonary embolism Thrombosis

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

8839162 Date FDA Received

15-Oct-2012

Case # 8839162

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1210USA 005536

Age

Sex Female

Country USA

Preferred Term Dysmenorrhoea Depressed mood Metrorrhagia Nausea

Product NUVARING

Role Route S

Dosage Text UNK

Duration

Manufacturer MERCK

8840349 Date FDA Received

15-Oct-2012

Case # 8840349

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes OT

Manufacturer Control # US-009507513-1210USA 005842 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,236 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8840350 Date FDA Received
15-Oct-2012 Case # 8840350 Case Type EXPEDITED (15-DAY) Health Professional Outcomes OT Manufacturer Control # US-009507513-1210USA 005840 Dosage Text UNK Manufacturer Control # US-009507513-1210USA 006446 Dosage Text Duration Age Sex Unknown Duration Age Sex Unknown Country USA

Preferred Term Pulmonary embolism

Product NUVARING Case # 8840415 Case Type EXPEDITED (15-DAY) Health Professional

Role Route S Outcomes DS,OT

Manufacturer MERCK Country USA

8840415 Date FDA Received

15-Oct-2012

Preferred Term Abortion induced

Product NUVARING Case # 8840420 Case Type EXPEDITED (15-DAY) Health Professional

Role Route S Outcomes OT

Manufacturer MERCK

8840420 Date FDA Received

15-Oct-2012

Manufacturer Control # US-009507513-2010SP0 07300 Dosage Text 1 DF, Unknown

Age

Sex Unknown

Country USA

Preferred Term Smear cervix abnormal Adjustment disorder with depressed mood Arthralgia Deep vein thrombosis Exostosis Haemorrhoids Onychomycosis Plantar fasciitis Tendonitis Upper respiratory tract infection Weight decreased

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,237 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8840421 Date FDA Received
15-Oct-2012 Case # 8840421 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1210USA 006444 Role Route S Health Professional Outcomes HO,DS,OT Manufacturer Control # US-009507513-2011SP0 51913 Dosage Text UNK UNK Duration Age Sex Unknown Dosage Text Duration Age Sex Unknown Country USA

Preferred Term Pregnancy

Product NUVARING Case # 8840617 Case Type EXPEDITED (15-DAY)

Manufacturer MERCK Country USA

8840617 Date FDA Received

15-Oct-2012

Preferred Term Cerebrovascular accident Cerebral haemorrhage Anxiety Blood disorder Cervical dysplasia Depression Dermatitis contact Dizziness Ear infection Hypercoagulation Insomnia Night sweats Otitis media acute Papilloma viral infection Respiratory disorder Sinus headache Sinusitis Superior sagittal sinus thrombosis Upper respiratory tract infection Vaginal discharge Venous thrombosis Vulvovaginitis

Product NUVARING NUVARING

Role Route S S VAGINAL VAGINAL

Manufacturer MERCK MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,238 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8840939 Date FDA Received
15-Oct-2012 Case # 8840939 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1210USA 006399 Role Route S Health Professional Outcomes Manufacturer Control # US-009507513-1210USA 005003 Role Route S S VAGINAL VAGINAL Dosage Text 3 weeks in, 1 week ring free break UNK Duration Age Sex Female Dosage Text Duration Age Sex Unknown Country USA

Preferred Term Pregnancy

Product NUVARING Case # 8841260 Case Type NON-EXPEDITED

Manufacturer MERCK Country USA

8841260 Date FDA Received

15-Oct-2012

Preferred Term Metrorrhagia Headache Migraine

Product NUVARING NUVARING

Manufacturer MERCK MERCK

8707471 Date FDA Received

16-Oct-2012

Case # 8707471

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-2012SP0 31262

Age

Sex Unknown

Country USA

Preferred Term Discomfort Inappropriate schedule of drug administration

Product NUVARING

Role Route S VAGINAL

Dosage Text 1 DF, Every 4 weeks

Duration

Manufacturer MERCK

8766127 Date FDA Received

16-Oct-2012

Case # 8766127

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes OT

Manufacturer Control # DK-009507513-1208DNK 011732 Dosage Text UNK

Age 23 YR

Sex Female

Country DNK

Preferred Term Paralysis Cerebral thrombosis

Product NUVARING

Role Route S

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,239 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8786392 Date FDA Received
16-Oct-2012 Case # 8786392 Case Type EXPEDITED (15-DAY) Health Professional Outcomes OT Manufacturer Control # IE-009507513-1209IRL0 02673 Dosage Text UNK Manufacturer Control # US-009507513-1209USA 005194 Role Route S VAGINAL Dosage Text Duration Age Sex Female Age 25 YR Sex Female Country IRL

Preferred Term Ventricular fibrillation

Product NUVARING Case # 8789042 Case Type NON-EXPEDITED Health Professional

Role Route S Outcomes

Duration

Manufacturer MERCK Country USA

8789042 Date FDA Received

16-Oct-2012

Preferred Term Unintended pregnancy

Product NUVARING

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,240 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8796803 Date FDA Received
16-Oct-2012 Case # 8796803 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2009SP0 17659 Dosage Text 1 DF, QM Duration Age Sex Unknown Country USA

Preferred Term Caesarean section Abdominal distension Anxiety Chest pain Cholelithiasis Dysuria Fall Female sterilisation Insomnia Ligament sprain Menorrhagia Migraine Nausea Ovarian cyst Pain in extremity Polyp Pregnancy Splenomegaly Stress Thrombosis Weight decreased

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

8839169 Date FDA Received

16-Oct-2012

Case # 8839169

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1210USA 004245

Age

Sex Female

Country USA

Preferred Term Metrorrhagia

Product NUVARING

Role Route S VAGINAL

Dosage Text

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,241 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8841307 Date FDA Received
16-Oct-2012 Case # 8841307 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1209USA 005172 Role Route S VAGINAL Dosage Text 15 Microgram, daily intravaginally Age 18 YR Sex Female Country USA

Preferred Term Headache Exertional headache Movement disorder Phonophobia Photophobia

Product NUVARING

Duration

Manufacturer MERCK

8841808 Date FDA Received

16-Oct-2012

Case # 8841808

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1210USA 005742

Age

Sex Female

Country USA

Preferred Term Inappropriate schedule of drug administration

Product NUVARING Health Professional

Role Route S VAGINAL

Dosage Text UNK Manufacturer Control # US-009507513-1210USA 005838 Dosage Text UNK

Duration

Manufacturer MERCK

8842092 Date FDA Received

16-Oct-2012

Case # 8842092

Case Type EXPEDITED (15-DAY)

Outcomes OT

Age

Sex Unknown

Country USA

Preferred Term Cerebrovascular accident Deep vein thrombosis

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

8842272 Date FDA Received

16-Oct-2012

Case # 8842272

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1210USA 005502

Age 19 YR

Sex Female

Country USA

Preferred Term Menstruation delayed Incorrect drug administration duration

Product NUVARING

Role Route S VAGINAL

Dosage Text 3 weeks in, 1 week out

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,242 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8842331 Date FDA Received
16-Oct-2012 Case # 8842331 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1209USA 010338 Role Route S VAGINAL Dosage Text UNK Duration Age Sex Female Country USA

Preferred Term Device expulsion Device material issue No adverse event

Product NUVARING

Manufacturer MERCK

8843272 Date FDA Received

16-Oct-2012

Case # 8843272

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO

Manufacturer Control # US-009507513-1210USA 006539 Dosage Text UNK Manufacturer Control # US-009507513-1209USA 007050

Age

Sex Unknown

Country USA

Preferred Term Pregnancy

Product NUVARING Case # 8843815 Case Type NON-EXPEDITED Health Professional

Role Route S VAGINAL

Duration

Manufacturer MERCK

8843815 Date FDA Received

16-Oct-2012

Outcomes

Age

Sex Unknown

Country USA

Preferred Term Inappropriate schedule of drug administration

Product NUVARING Health Professional

Role Route S VAGINAL

Dosage Text UNK Manufacturer Control # US-009507513-1209USA 007793

Duration

Manufacturer MERCK

8843816 Date FDA Received

16-Oct-2012

Case # 8843816

Case Type NON-EXPEDITED

Outcomes

Age

Sex Unknown

Country USA

Preferred Term Genital pain Inappropriate schedule of drug administration Vaginal inflammation

Product NUVARING

Role Route S VAGINAL

Dosage Text UNK

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,243 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8843834 Date FDA Received
16-Oct-2012 Case # 8843834 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1210USA 005514 Role Route S VAGINAL Dosage Text 1 ring for 3 weeks followed by a week free break UNK, qd UNK, qd Manufacturer Control # US-009507513-1209USA 010373 Role Route S VAGINAL Dosage Text Duration Age Sex Unknown Country USA Duration Age Sex Female Country USA

Preferred Term Pain in extremity

Product NUVARING

Manufacturer MERCK

Paraesthesia

CLARITIN VALTREX

C C Health Professional Outcomes

MERCK

8843835 Date FDA Received

16-Oct-2012

Case # 8843835

Case Type NON-EXPEDITED

Preferred Term Deep vein thrombosis

Product NUVARING

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,244 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8843865 Date FDA Received
16-Oct-2012 Case # 8843865 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2009SP0 33713 Dosage Text Duration Age Sex Female Country USA

Preferred Term Pulmonary embolism Pneumonia Nephrolithiasis Hydronephrosis Deep vein thrombosis Pelvic pain Menorrhagia Chest pain Anxiety Back pain Borderline personality disorder Chest pain Congestive cardiomyopathy Family stress Insomnia Major depression Pelvic inflammatory disease Unintended pregnancy Vaginal haemorrhage

Product NUVARING NUVARING NUVARING ORTHO TRI-CYCLEN LO/OVRAL IBUPROFEN LOPRESSOR LORTAB

Role Route S S S S S C C C

Manufacturer MERCK MERCK MERCK

UNK UNK, PRN

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,245 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8843880 Date FDA Received
16-Oct-2012 Case # 8843880 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,DS,OT Manufacturer Control # US-009507513-2011SP0 56193 Dosage Text UNK UNK Duration Age Sex Unknown Country USA

Preferred Term Squamous cell carcinoma Renal failure acute Anxiety Arthroscopy Cervical dysplasia Chloasma Cyst Deep vein thrombosis Dehydration Fungal infection Hypertension Ligament operation Ligament rupture Mental disorder Premenstrual syndrome Pulmonary embolism Staphylococcal infection Vulvar dysplasia Vulvovaginal candidiasis

Product NUVARING NUVARING

Role Route S S

Manufacturer MERCK MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,246 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8830923 Date FDA Received
17-Oct-2012 Case # 8830923 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2011SP0 59164 Dosage Text Duration Age Sex Unknown Country USA

Preferred Term Pulmonary embolism Abdominal pain Back pain Bronchitis Cervical dysplasia Chest pain Headache Incorrect drug administration duration Musculoskeletal chest pain Oropharyngeal pain Ovarian cyst Road traffic accident Thyroid therapy

Product NUVARING

Role Route S

Manufacturer MERCK

8837018 Date FDA Received

17-Oct-2012

Case # 8837018

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1210USA 004795

Age

Sex Female

Country USA

Preferred Term Medical device discomfort Device expulsion Product quality issue

Product NUVARING

Role Route S VAGINAL

Dosage Text .015mg/.012mg

Duration

Manufacturer MERCK

8844065 Date FDA Received

17-Oct-2012

Case # 8844065

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1210USA 005524

Age 39 YR

Sex Female

Country USA

Preferred Term Device expulsion

Product NUVARING

Role Route S VAGINAL

Dosage Text 3 weeks in, 1week out

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,247 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8844322 Date FDA Received
17-Oct-2012 Case # 8844322 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1209USA 004205 Role Route S S Health Professional Outcomes Manufacturer Control # US-009507513-1207USA 008534 Role Route S Dosage Text Duration Age Sex Female VAGINAL Dosage Text UNK Duration Age Sex Female Country USA

Preferred Term Nausea Off label use

Product NUVARING NUVARING Case # 8844832 Case Type NON-EXPEDITED

Manufacturer MERCK MERCK Country USA

8844832 Date FDA Received

17-Oct-2012

Preferred Term Headache Muscle spasms Nausea Pain

Product NUVARING

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,248 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8844960 Date FDA Received
17-Oct-2012 Case # 8844960 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,DS,OT Manufacturer Control # US-009507513-2011SP0 25677 Dosage Text UNK UNK UNK UNK UNK UNK UNK 1 DF, ONCE ORAL UNK Duration Age Sex Unknown Country USA

Preferred Term Hypercoagulation Ovarian cyst Hyponatraemia Pneumonia Pleural effusion Pulmonary embolism Pulmonary infarction Pleurisy Anaemia Emotional disorder Mental disorder Bronchitis Drug intolerance Metrorrhagia Pelvic mass Upper respiratory tract infection Urinary tract infection Vaginal discharge Vaginal haemorrhage

Product NUVARING NUVARING NUVARING NUVARING NUVARING NUVARING NUVARING NUVARING LORTAB VITAMINS (UNSPECIFIED) Z-pac

Role Route S S S S S S S S S C C VAGINAL VAGINAL VAGINAL VAGINAL VAGINAL VAGINAL VAGINAL

Manufacturer MERCK MERCK MERCK MERCK MERCK MERCK MERCK MERCK

8845119 Date FDA Received

17-Oct-2012

Case # 8845119

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1210USA 005714

Age 28 YR

Sex Female

Country USA

Preferred Term Stress Incorrect drug administration duration Memory impairment

Product NUVARING

Role Route S VAGINAL

Dosage Text UNK

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,249 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8845710 Date FDA Received
17-Oct-2012 Case # 8845710 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1210USA 003281 Role Route S VAGINAL Dosage Text 3 weeks in, 1 week out Age 21 YR Sex Female Country USA

Preferred Term Unintended pregnancy Breast tenderness Increased appetite Nausea Off label use

Product NUVARING

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,250 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8845991 Date FDA Received
17-Oct-2012 Case # 8845991 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2009-199 669-NL Dosage Text CONTINUING: NO ORAL ORAL 10 mg, QD 10 mg, BID Duration Age Sex Unknown Country USA

Preferred Term Syncope Ventricular extrasystoles Biliary dyskinesia Pulmonary embolism Arthritis Cervicobrachial syndrome Complex regional pain syndrome Contusion Cystocele Deep vein thrombosis Drug ineffective Dyspnoea Inflammation Mental status changes Oedema Off label use Pain Palpitations Polycystic ovaries Pyrexia Tendon sheath incision Thrombophlebitis superficial

Product NUVARING NUVARING LEXAPRO PROPRANOLOL HYDROCHLORIDE

Role Route S S C C

Manufacturer MERCK MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,251 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8846082 Date FDA Received
17-Oct-2012 Case # 8846082 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-2012SP0 29906 Role Route S VAGINAL Dosage Text UNK Duration Age Sex Unknown Country USA

Preferred Term Deep vein thrombosis Infection

Product NUVARING

Manufacturer MERCK

8849335 Date FDA Received

17-Oct-2012

Case # 8849335

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,OT

Manufacturer Control # US-009507513-2009SP0 26924 Dosage Text

Age

Sex Female

Country USA

Preferred Term Deep vein thrombosis Pulmonary embolism Fibroadenoma of breast Hernia obstructive Hernia repair Hyperglycaemia Omentectomy Varicose vein Venous insufficiency

Product NUVARING PHENTERMINE

Role Route S C

Duration

Manufacturer MERCK

8846855 Date FDA Received

18-Oct-2012

Case # 8846855

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes OT

Manufacturer Control # US-009507513-1210USA 003476 Dosage Text

Age

Sex Female

Country USA

Preferred Term Dyspnoea Blister Urticaria Vulvovaginal burning sensation Vulvovaginal pruritus

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,252 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8846993 Date FDA Received
18-Oct-2012 Case # 8846993 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2009-198 567-NL Dosage Text Duration Age Sex Unknown Country USA

Preferred Term Myocardial infarction Pneumonia Fluid overload Cardiac failure congestive Bronchitis Chest pain Cough Depressed mood Dysmenorrhoea Dyspareunia Gastroenteritis Menorrhagia Menstruation delayed Metrorrhagia Migraine Musculoskeletal pain Nausea Nodule Pain in extremity Pelvic pain Pulmonary embolism Pyrexia Unintended pregnancy Urinary tract infection Vaginal cyst Vaginitis bacterial Viral upper respiratory tract infection

Product NUVARING MIRENA CEPHALEXIN AMITRIPTYLINE HYDROCHLORIDE

Role Route S S C C

Manufacturer MERCK

500 mg, UNK 10 mg, UNK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,253 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8847036 Date FDA Received
18-Oct-2012 Case # 8847036 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1209USA 010672 Role Route S VAGINAL Dosage Text Duration Age Sex Female Country USA

Preferred Term Inappropriate schedule of drug administration Device expulsion

Product NUVARING

Manufacturer MERCK

8847265 Date FDA Received

18-Oct-2012

Case # 8847265

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,DS,OT

Manufacturer Control # US-009507513-2012SP0 35543 Dosage Text UNK 0.25 mg, prn

Age

Sex Unknown

Country USA

Preferred Term Abortion spontaneous Pulmonary embolism Adjustment disorder Anxiety Arrhythmia Back pain Depression Homicide Lung neoplasm Maternal exposure before pregnancy Nightmare Poor quality sleep Sinus bradycardia Syncope Vaginal haemorrhage

Product NUVARING XANAX

Role Route S C

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,254 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8847297 Date FDA Received
18-Oct-2012 Case # 8847297 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1210USA 007291 Role Route S VAGINAL Dosage Text 1 ring for 3 weeks follow by a week free break Duration Age Sex Female Country USA

Preferred Term Vaginal discharge Vulvovaginal burning sensation Vulvovaginal pruritus

Product NUVARING

Manufacturer MERCK

8847751 Date FDA Received

18-Oct-2012

Case # 8847751

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,DS,OT

Manufacturer Control # US-009507513-2010SP0 38523 Dosage Text

Age

Sex Female

Country USA

Preferred Term Cerebrovascular accident Chest discomfort Hypertension Low density lipoprotein abnormal Mitral valve incompetence Palpitations Thrombosis Transient ischaemic attack Tricuspid valve incompetence

Product NUVARING

Role Route S

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,255 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8847867 Date FDA Received
18-Oct-2012 Case # 8847867 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,DS,OT Manufacturer Control # US-009507513-2010SP0 04869 Dosage Text UNK Duration Age Sex Unknown Country USA

Preferred Term Upper limb fracture Arthropod bite Attention deficit/hyperactivity disorder Blood cholesterol increased Cerebrovascular accident Cervical dysplasia Fall Gastrooesophageal reflux disease Haematuria Headache Hypertension Hypotension Liver function test abnormal Menopause Pelvic fracture Pulmonary embolism Sinusitis Temporomandibular joint syndrome Upper limb fracture Vitamin D deficiency

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,256 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8847911 Date FDA Received
18-Oct-2012 Case # 8847911 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO Manufacturer Control # US-009507513-2009SP0 17640 Dosage Text 1 DF, QM Duration Age Sex Unknown Country USA

Preferred Term Scar Acne Antiphospholipid antibodies positive Chest pain Contusion Deep vein thrombosis Dyspnoea Dysthymic disorder Fibrocystic breast disease Gastroenteritis viral Haematocrit decreased Haematoma Headache Loop electrosurgical excision procedure Oral herpes Pain Smear cervix abnormal

Product NUVARING

Role Route S

Manufacturer MERCK

8848171 Date FDA Received

18-Oct-2012

Case # 8848171

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1210USA 000085

Age 21 YR

Sex Female

Country USA

Preferred Term Vulvovaginal discomfort

Product NUVARING

Role Route S VAGINAL

Dosage Text 1 ring for 3 week on an 1 week off,vaginal . 015/0.12

Duration

Manufacturer MERCK

Device breakage Device expulsion Wrong technique in drug usage process

penicillin (unspecified)

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,257 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8848753 Date FDA Received
18-Oct-2012 Case # 8848753 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO Manufacturer Control # US-009507513-1210USA 008363 Dosage Text UNK Duration Age Sex Unknown Country USA

Preferred Term Premature labour Maternal exposure before pregnancy

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

8746092 Date FDA Received

19-Oct-2012

Case # 8746092

Case Type NON-EXPEDITED

Health Professional

Outcomes DE,HO,DS,LT

Manufacturer Control # USJNJFOC-20120811046 Dosage Text

Age

Sex Female

Country USA

Preferred Term Cerebrovascular accident Angioedema Pulmonary embolism Hemiplegia Cardiac arrest Abdominal distension Bundle branch block right Convulsion Syncope Abdominal pain Nausea Hypotension Oxygen saturation decreased

Product CILEST CINRYZE CINRYZE CINRYZE CINRYZE CINRYZE CINRYZE CINRYZE CINRYZE CINRYZE CINRYZE CINRYZE CINRYZE CINRYZE CINRYZE CINRYZE CINRYZE CINRYZE CINRYZE CINRYZE CINRYZE

Role Route S S S S S S S S S S S S S S S S S S S S S ORAL INTRAVENOUS INTRAVENOUS INTRAVENOUS INTRAVENOUS INTRAVENOUS INTRAVENOUS INTRAVENOUS INTRAVENOUS INTRAVENOUS INTRAVENOUS INTRAVENOUS INTRAVENOUS INTRAVENOUS INTRAVENOUS INTRAVENOUS INTRAVENOUS INTRAVENOUS INTRAVENOUS INTRAVENOUS INTRAVENOUS

Duration

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,258 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8746092
Preferred Term Product CINRYZE CINRYZE CINRYZE CINRYZE CINRYZE CINRYZE CINRYZE CINRYZE CINRYZE CINRYZE CINRYZE CINRYZE NUVARING EPIPEN KLONOPIN FEXOFENADINE FEXOFENADINE METOPROLOL NORTRIPTYLINE PRILOSEC CELEXA MELATONIN REMERON OMEPRAZOLE Role Route S S S S S S S S S S S S S C C C C C C C C C C C INTRAVENOUS INTRAVENOUS INTRAVENOUS INTRAVENOUS INTRAVENOUS INTRAVENOUS INTRAVENOUS INTRAVENOUS INTRAVENOUS INTRAVENOUS INTRAVENOUS INTRAVENOUS UNKNOWN INTRAMUSCULAR ORAL ORAL ORAL UNKNOWN UNKNOWN UNKNOWN ORAL ORAL ORAL UNKNOWN Manufacturer Control # US-009507513-1209USA 009660 Role Route S VAGINAL Dosage Text UNK Duration Age Sex Female Country USA Dosage Text Duration Manufacturer

8849029 Date FDA Received

19-Oct-2012

Case # 8849029

Case Type NON-EXPEDITED

Health Professional

Outcomes

Preferred Term Peripheral embolism

Product NUVARING

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,259 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8850654 Date FDA Received
19-Oct-2012 Case # 8850654 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO Manufacturer Control # US-009507513-1210USA 003484 Dosage Text UNK Manufacturer Control # US-009507513-1210USA 002693 Role Route S Health Professional VAGINAL Dosage Text UNK Manufacturer Control # US-009507513-2009SP0 27035 Dosage Text Duration Age Sex Unknown Duration Age Sex Female Age 32 YR Sex Female Country USA

Preferred Term Cerebrovascular accident

Product NUVARING Case Type NON-EXPEDITED Health Professional

Role Route S VAGINAL

Duration

Manufacturer MERCK Country USA

8851296 Date FDA Received

20-Oct-2012

Case # 8851296

Outcomes

Preferred Term Hepatic adenoma

Product NUVARING Case # 8765903 Case Type EXPEDITED (15-DAY)

Manufacturer MERCK Country USA

8765903 Date FDA Received

22-Oct-2012

Outcomes HO,OT

Preferred Term Anaemia Deep vein thrombosis Pulmonary embolism Urinary tract infection Anxiety Constipation Depression Iron deficiency anaemia Muscle spasms Weight increased

Product NUVARING NUVARING HYDROCODONE TYLENOL

Role Route S S C C

Manufacturer MERCK MERCK

UNK UNK, PRN 400 mg, PRN

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,260 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8773282 Date FDA Received
22-Oct-2012 Case # 8773282 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2012SP0 22605 Dosage Text Duration Age Sex Unknown Country USA

Preferred Term Hyperlipidaemia Acute sinusitis Asthenia Cerebrovascular accident Cervicitis human papilloma virus Dehydration Dizziness Epidural blood patch Generalised anxiety disorder Herpes simplex Lumbar puncture Metrorrhagia Post lumbar puncture syndrome Psychiatric symptom Rubber sensitivity Sinusitis Smear cervix abnormal Synovial cyst Tension headache Uterine polyp Varicose vein Vertigo

Product NUVARING

Role Route S

Manufacturer MERCK

8789054 Date FDA Received

22-Oct-2012

Case # 8789054

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes DS,LT

Manufacturer Control # US-009507513-1209USA 003788 Dosage Text UNK, qm

Age

Sex Female

Country USA

Preferred Term Deep vein thrombosis

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,261 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8803772 Date FDA Received
22-Oct-2012 Case # 8803772 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,LT,OT Manufacturer Control # US-009507513-1209USA 006384 Dosage Text UNK Duration Age Sex Female Country USA

Preferred Term Pulmonary embolism Off label use

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

8851999 Date FDA Received

22-Oct-2012

Case # 8851999

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,OT

Manufacturer Control # US-009507513-2011SP0 03700 Dosage Text

Age

Sex Unknown

Country USA

Preferred Term Pneumonia Frustration Hypercoagulation Mental disorder Ovarian cyst Pleural effusion Pulmonary embolism Pulmonary infarction

Product NUVARING

Role Route S

Duration

Manufacturer MERCK

8852916 Date FDA Received

22-Oct-2012

Case # 8852916

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1210USA 008601

Age

Sex Female

Country USA

Preferred Term Inappropriate schedule of drug administration

Product NUVARING Health Professional

Role Route S VAGINAL

Dosage Text

Duration

Manufacturer MERCK

8853153 Date FDA Received

22-Oct-2012

Case # 8853153

Case Type NON-EXPEDITED

Outcomes

Manufacturer Control # US-009507513-1210USA 007400

Age

Sex Female

Country USA

Preferred Term Abnormal behaviour Mental disorder

Product NUVARING

Role Route S VAGINAL

Dosage Text

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,262 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8853171 Date FDA Received
22-Oct-2012 Case # 8853171 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1210USA 004179 Role Route S S Health Professional VAGINAL VAGINAL Dosage Text 3 weeks in one week ring free break 3 weeks in one week ring free break Manufacturer Control # US-009507513-1210USA 008192 Role Route S VAGINAL Dosage Text Duration Age Sex Unknown Age 21 YR Sex Female Country USA

Preferred Term Device expulsion Inappropriate schedule of drug administration

Product NUVARING NUVARING

Duration

Manufacturer MERCK MERCK Country USA

8853316 Date FDA Received

22-Oct-2012

Case # 8853316

Case Type NON-EXPEDITED

Outcomes

Preferred Term Inappropriate schedule of drug administration No adverse event

Product NUVARING

Manufacturer MERCK

8853398 Date FDA Received

22-Oct-2012

Case # 8853398

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1210USA 008609

Age

Sex Female

Country USA

Preferred Term Vulvovaginal pain Device breakage Product quality issue

Product NUVARING

Role Route S VAGINAL

Dosage Text 0.015/0.012 mg

Duration

Manufacturer MERCK

8853459 Date FDA Received

22-Oct-2012

Case # 8853459

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes OT

Manufacturer Control # US-009507513-1210USA 005843 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,263 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8853463 Date FDA Received
22-Oct-2012 Case # 8853463 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1210USA 008606 Role Route S Health Professional VAGINAL Manufacturer Control # US-009507513-1210USA 006245 Role Route S Health Professional VAGINAL Dosage Text UNK Manufacturer Control # US-009507513-2012SP0 22369 Dosage Text Duration Age Sex Unknown Age 20 YR Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term Thrombosis

Product NUVARING Case # 8853722 Case Type NON-EXPEDITED

Manufacturer MERCK Country USA

8853722 Date FDA Received

22-Oct-2012

Outcomes

Preferred Term Vaginitis chlamydial

Product NUVARING Case # 8740591 Case Type EXPEDITED (15-DAY)

Duration

Manufacturer MERCK Country USA

8740591 Date FDA Received

23-Oct-2012

Outcomes HO,OT

Preferred Term Lobar pneumonia Abnormal weight gain Acute sinusitis Alcohol use Anxiety Arthralgia Aspiration pleural cavity Bronchitis Cervix carcinoma Craniocerebral injury Cystitis Depression Fatigue Gastrooesophageal reflux disease Goitre Headache

Product NUVARING

Role Route S

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,264 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8740591
Preferred Term Hepatomegaly Hepatosplenomegaly Insomnia Laceration Ligament sprain Migraine Nonspecific reaction Otitis media acute Ovarian cyst Pleuritic pain Pulmonary embolism Pyelonephritis Rhinitis allergic Spinal osteoarthritis Stress Tympanic membrane perforation Upper respiratory tract infection Urinary tract infection Vaginitis bacterial Victim of crime Vulvovaginal candidiasis Product Role Route Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,265 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8774081 Date FDA Received
23-Oct-2012 Case # 8774081 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,LT,OT Manufacturer Control # US-009507513-1209USA 002289 Dosage Text 0.120 mg/day of etonogestrel and 0.015 mg/day of ethinyl estradiol / 21 days Duration Age Sex Female Country USA

Preferred Term Pulmonary embolism

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

Abdominal pain Fatigue Menometrorrhagia Muscle spasms Pain Stress Transient ischaemic attack

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,266 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8838744 Date FDA Received
23-Oct-2012 Case # 8838744 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,LT,OT Manufacturer Control # US-009507513-2011SP0 48230 Dosage Text 1 DF, UNK 300 mg, qpm 400 mg, qpm 300 mg, qpm 400 mg, qpm 1 PUFF EVERY BEDTIME HANDIHALER; 1 PUFF DAILY EVERY 72 HOURS 1000 mg, hs 522 mg, qam 0.25 mg, hs 1-2 TABLETS QID PRN 2 mg, hs 100 mg, QD 1%/5MG/10,000 U; 4 DROPS IN AFFECTED EARS QID MERCK Duration Age Sex Unknown Country USA

Preferred Term Suicide attempt Overdose Pneumonia Musculoskeletal pain Flank pain Oedema peripheral Pain in extremity Pulmonary embolism Bipolar disorder Hypersomnia Drug intolerance Chills Diarrhoea Vulvovaginitis Constipation Off label use Gastrooesophageal reflux disease

Product NUVARING NUVARING SEROQUEL SEROQUEL SEROQUEL SEROQUEL MORPHINE ASMANEX SPIRIVA FENTANYL NIASPAN WELLBUTRIN MIRAPEX MK-9384 LUNESTA DESVENLAFAXINE SUCCINATE CORTISPORIN OTIC

Role Route S S S S S S S C C C C C C C C C C INHALATION INHALATION TRANSDERMAL ORAL ORAL ORAL ORAL ORAL ORAL INTRA-AURAL ORAL ORAL ORAL ORAL VAGINAL

Manufacturer MERCK MERCK

Presyncope

MAGNESIUM (UNSPECIFIED) POTASSIUM (UNSPECIFIED) TYLENOL WITH CODEINE #3

C C C ORAL 300MG/30 MG; TAKE 1-2 QID PRN

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,267 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8853673 Date FDA Received
23-Oct-2012 Case # 8853673 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1210USA 002346 Role Route S Health Professional VAGINAL Dosage Text 1 DF, q3w 1 ring for 3 weeks Manufacturer Control # US-009507513-1210USA 009772 Role Route S VAGINAL Dosage Text 3 weeks in, oen week out Age 46 YR Sex Female Duration Age Sex Female Country USA

Preferred Term Inappropriate schedule of drug administration

Product NUVARING

Manufacturer MERCK Country USA

8854288 Date FDA Received

23-Oct-2012

Case # 8854288

Case Type NON-EXPEDITED

Outcomes

Preferred Term Inappropriate schedule of drug administration

Product NUVARING

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,268 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8854488 Date FDA Received
23-Oct-2012 Case # 8854488 Case Type EXPEDITED (15-DAY) Health Professional Outcomes DE,HO,OT Manufacturer Control # US-009507513-2011SP0 14807 Dosage Text Duration Age Sex Unknown Country USA

Preferred Term Hypertensive heart disease Pulmonary embolism Pulmonary infarction Deep vein thrombosis Bipolar disorder Musculoskeletal pain Breast tenderness Abdominal pain lower Pain Drug dependence Substance abuse Intentional overdose Paranoia Suicide attempt

Product NUVARING SINGULAIR PRILOSEC SOMA CLARITIN NASACORT URECHOLINE XOPENEX baclofen ATIVAN COGENTIN ZYPREXA DARVOCET-N RESTORIL (temazepam) EFFEXOR BACTRIM LYRICA

Role Route S C C C C C C C C C C C C C C C C

Manufacturer MERCK MERCK MERCK MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,269 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8688118 Date FDA Received
24-Oct-2012 Case # 8688118 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2012SP0 00189 Dosage Text UNK Duration Age Sex Unknown Country USA

Preferred Term Deep vein thrombosis Bronchitis Cardiac murmur functional Cystitis Food poisoning Haematuria Intra-uterine contraceptive device insertion Muscle strain Nephrolithiasis Pulmonary embolism

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

8740573 Date FDA Received

24-Oct-2012

Case # 8740573

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,DS,OT

Manufacturer Control # US-009507513-2011SP0 46042 Dosage Text UNK UNK UNK

Age

Sex Unknown

Country USA

Preferred Term Pulmonary hypertension Pulmonary embolism Deep vein thrombosis Chest pain Diabetes mellitus Hypertension Left ventricular dysfunction Nodule Respiratory distress Sinus bradycardia Sleep apnoea syndrome

Product NUVARING albuterol fluticasone propionate (+) salmeterol xinafoate

Role Route S C C

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,270 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8858715 Date FDA Received
24-Oct-2012 Case # 8858715 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1210USA 009994 Role Route S Health Professional VAGINAL Manufacturer Control # US-009507513-2012SP0 00427 Dosage Text UNK UNK Duration Age Sex Unknown Dosage Text Duration Age Sex Female Country USA

Preferred Term Vulvovaginal mycotic infection

Product NUVARING Case Type EXPEDITED (15-DAY)

Manufacturer MERCK Country USA

8859382 Date FDA Received

24-Oct-2012

Case # 8859382

Outcomes HO,DS,OT

Preferred Term Post-traumatic stress disorder Pulmonary embolism Deep vein thrombosis Anxiety Back pain Chest pain Contusion Depression Dysuria Fatigue Hypoaesthesia Pain in extremity Palpitations Sinus tachycardia

Product NUVARING TOPAMAX ADDERALL XR

Role Route S C C VAGINAL

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,271 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8716499 Date FDA Received
25-Oct-2012 Case # 8716499 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,DS,OT Manufacturer Control # US-009507513-2012SP0 23053 Dosage Text UNK Duration Age Sex Unknown Country USA

Preferred Term Asthma Pulmonary embolism Breast cellulitis Bronchitis Colonic polyp Deep vein thrombosis Depression Drug level fluctuating Dysmenorrhoea Haemangioma of liver Hypercoagulation Irritable bowel syndrome Lactose intolerance Menorrhagia Migraine Staphylococcal infection Subcutaneous abscess Ulcer haemorrhage

Product NUVARING NUVARING

Role Route S S VAGINAL

Manufacturer MERCK MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,272 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8773437 Date FDA Received
25-Oct-2012 Case # 8773437 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2012SP0 03704 Dosage Text UNK UNK Duration Age Sex Unknown Country USA

Preferred Term Pulmonary embolism Mitral valve prolapse Supraventricular tachycardia Anxiety Coagulopathy Constipation Drug hypersensitivity Headache Hypertension Lung neoplasm Menorrhagia Migraine Overweight Supraventricular tachycardia Tooth extraction Viral rhinitis

Product NUVARING NUVARING verapamil

Role Route S S C VAGINAL

Manufacturer MERCK MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,273 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8785215 Date FDA Received
25-Oct-2012 Case # 8785215 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,DS,OT Manufacturer Control # US-009507513-2012SP0 28982 Dosage Text UNK Duration Age Sex Unknown Country USA

Preferred Term Pulmonary hypertension Atrial septal defect repair Catheterisation cardiac Deep vein thrombosis Heart rate irregular Lung infiltration Mental disorder Mitral valve incompetence Pleural effusion Pulmonary embolism Pulmonary infarction Right ventricular failure Thrombectomy Tricuspid valve incompetence Urinary tract infection Vena cava filter insertion

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,274 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8821739 Date FDA Received
25-Oct-2012 Case # 8821739 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,DS,OT Manufacturer Control # US-009507513-2012SP0 34981 Dosage Text 0.12/0.015 mg UNK Duration Age Sex Unknown Country USA

Preferred Term Renal failure Pulmonary embolism Pleuritic pain Pleural effusion Abdominal pain upper Drug level below therapeutic Dyspnoea Functional gastrointestinal disorder Muscle spasms Musculoskeletal chest pain Pneumonitis Post thrombotic syndrome Pulmonary hypertension Rhinitis allergic Upper-airway cough syndrome

Product NUVARING NUVARING TUMS vitamins (unspecified)

Role Route S S C C

Manufacturer MERCK MERCK

8859604 Date FDA Received

25-Oct-2012

Case # 8859604

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1210USA 008432

Age

Sex Female

Country USA

Preferred Term Metrorrhagia

Product NUVARING Case # 8859607 Case Type NON-EXPEDITED Health Professional

Role Route S VAGINAL

Dosage Text UNK Manufacturer Control # US-009507513-1210USA 009589

Duration

Manufacturer MERCK

8859607 Date FDA Received

25-Oct-2012

Outcomes

Age

Sex Female

Country USA

Preferred Term Device expulsion

Product NUVARING

Role Route S VAGINAL

Dosage Text 1 DF, q3w

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,275 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8860606 Date FDA Received
25-Oct-2012 Case # 8860606 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1210USA 010683 Role Route S Health Professional VAGINAL Dosage Text 1 ring for 3 weeks then a week free break Manufacturer Control # US-009507513-1210USA 010531 Role Route S VAGINAL Dosage Text 1 DF, for 3 weeks Duration Age Sex Female Age 33 YR Sex Female Country USA

Preferred Term Inappropriate schedule of drug administration

Product NUVARING

Duration

Manufacturer MERCK Country USA

8860989 Date FDA Received

25-Oct-2012

Case # 8860989

Case Type NON-EXPEDITED

Outcomes

Preferred Term Incorrect drug administration duration Inappropriate schedule of drug administration

Product NUVARING

Manufacturer MERCK

8866245 Date FDA Received

25-Oct-2012

Case # 8866245

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes OT

Manufacturer Control # US-009507513-1210USA 009018 Dosage Text UNK Manufacturer Control # US-009507513-1210USA 008245

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism

Product NUVARING Case # 8866278 Case Type NON-EXPEDITED Health Professional

Role Route S VAGINAL

Duration

Manufacturer MERCK

8866278 Date FDA Received

25-Oct-2012

Outcomes

Age

Sex Female

Country USA

Preferred Term Muscle spasms

Product NUVARING Case # 8877806 Case Type NON-EXPEDITED Health Professional

Role Route S VAGINAL

Dosage Text

Duration

Manufacturer MERCK

8877806 Date FDA Received

25-Oct-2012

Outcomes

Manufacturer Control # US-009507513-1210USA 009684

Age 38 YR

Sex Female

Country USA

Preferred Term Amniotic cavity disorder Unintended pregnancy

Product NUVARING

Role Route S VAGINAL

Dosage Text UNK

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,276 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8878703 Date FDA Received
25-Oct-2012 Case # 8878703 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1210USA 011258 Role Route S Health Professional VAGINAL Manufacturer Control # US-009507513-1210USA 002135 Dosage Text 0.12/0.015/24 mg Duration Age Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term Transient ischaemic attack

Product NUVARING Case Type EXPEDITED (15-DAY)

Manufacturer MERCK Country USA

8831714 Date FDA Received

26-Oct-2012

Case # 8831714

Outcomes HO,LT

Preferred Term Pulmonary embolism Deep vein thrombosis

Product NUVARING hydrochlorothiazide atenolol

Role Route S C C Health Professional Outcomes VAGINAL

Manufacturer MERCK

8861216 Date FDA Received

26-Oct-2012

Case # 8861216

Case Type NON-EXPEDITED

Manufacturer Control # US-009507513-1210USA 008769

Age

Sex Female

Country USA

Preferred Term Unintended pregnancy Back pain Breast tenderness Fatigue Nausea

Product NUVARING

Role Route S VAGINAL

Dosage Text 0.15/0.012

Duration

Manufacturer MERCK

8861217 Date FDA Received

26-Oct-2012

Case # 8861217

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1210USA 004261

Age

Sex Female

Country USA

Preferred Term Vulvovaginal dryness Product quality issue

Product NUVARING

Role Route S VAGINAL

Dosage Text 1 DF, qm

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,277 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8862171 Date FDA Received
26-Oct-2012 Case # 8862171 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO Manufacturer Control # US-009507513-1210USA 010750 Dosage Text UNK Age 19 YR Sex Female Country USA

Preferred Term Cerebral venous thrombosis

Product NUVARING Z-PAK

Role Route S C Health Professional Outcomes OT

Duration

Manufacturer MERCK

8863048 Date FDA Received

26-Oct-2012

Case # 8863048

Case Type EXPEDITED (15-DAY)

Manufacturer Control # IE-009507513-2012SP02 9759 Dosage Text UNK UNK UNK

Age 41 YR

Sex Female

Country IRL

Preferred Term Abortion spontaneous Unintended pregnancy Incorrect drug administration duration

Product NUVARING CERAZETTE CERAZETTE

Role Route S C C VAGINAL

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,278 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8878925 Date FDA Received
26-Oct-2012 Case # 8878925 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2009SP0 43048 Dosage Text UNK UNK, QD Duration Age Sex Unknown Country USA

Preferred Term Deep vein thrombosis Pulmonary embolism Blood cholesterol increased Blood triglycerides increased Deep vein thrombosis Endometrial ablation Headache Intervertebral disc degeneration Menorrhagia Sinusitis Upper respiratory tract infection Uterine dilation and curettage Venous insufficiency Weight decreased

Product NUVARING VITAMINS (UNSPECIFIED)

Role Route S C

Manufacturer MERCK

8878945 Date FDA Received

26-Oct-2012

Case # 8878945

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes DS,OT

Manufacturer Control # US-009507513-1210USA 010360 Dosage Text UNK Manufacturer Control # US-009507513-1210USA 011926

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism

Product NUVARING Case # 8874091 Case Type NON-EXPEDITED Health Professional

Role Route S Outcomes

Duration

Manufacturer MERCK

8874091 Date FDA Received

29-Oct-2012

Age

Sex Unknown

Country USA

Preferred Term Adverse event

Product NUVARING

Role Route S VAGINAL

Dosage Text

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,279 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8686548 Date FDA Received
30-Oct-2012 Case # 8686548 Case Type EXPEDITED (15-DAY) Health Professional Outcomes OT Manufacturer Control # US-009507513-2011SP0 00809 Dosage Text UNK UNK Duration Age Sex Unknown Country USA

Preferred Term Abortion spontaneous Pulmonary embolism Abdominal pain Back pain Chest pain Foot fracture Maternal drugs affecting foetus Oropharyngeal pain Sinusitis Uterine spasm Viral infection

Product NUVARING NUVARING

Role Route S S

Manufacturer MERCK MERCK

8871749 Date FDA Received

30-Oct-2012

Case # 8871749

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1210USA 008762

Age

Sex Female

Country USA

Preferred Term Unintended pregnancy

Product NUVARING

Role Route S VAGINAL

Dosage Text 0.120 mg/day of etonogestrel and 0.015 mg/day of ethyl estradiol for 3 weeks

Duration

Manufacturer MERCK

Inappropriate schedule of drug administration

8874116 Date FDA Received

30-Oct-2012

Case # 8874116

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1210USA 011203

Age

Sex Female

Country USA

Preferred Term Alopecia

Product NUVARING

Role Route S VAGINAL

Dosage Text

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,280 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8874128 Date FDA Received
30-Oct-2012 Case # 8874128 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1210USA 011185 Role Route S Health Professional VAGINAL Dosage Text UNK Manufacturer Control # US-009507513-2011SP0 47265 Dosage Text Duration Age Sex Unknown Duration Age Sex Female Country USA

Preferred Term Metrorrhagia

Product NUVARING Case # 8874604 Case Type EXPEDITED (15-DAY)

Manufacturer MERCK Country USA

8874604 Date FDA Received

30-Oct-2012

Outcomes HO,DS,OT

Preferred Term Pulmonary embolism Chest pain Constipation Deep vein thrombosis Lung infiltration Musculoskeletal chest pain Nocturia Tension headache Visual acuity reduced Wisdom teeth removal

Product NUVARING

Role Route S

Manufacturer MERCK

8716484 Date FDA Received

31-Oct-2012

Case # 8716484

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes OT

Manufacturer Control # US-009507513-1208USA 001890 Dosage Text 0.120 mg/day of etonogestrel and 0.015 mg/day of ethinylestradiol/21 days

Age 36 YR

Sex Female

Country USA

Preferred Term Cerebrovascular accident

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,281 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8786420 Date FDA Received
31-Oct-2012 Case # 8786420 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2011SP0 40937 Dosage Text Duration Age Sex Unknown Country USA

Preferred Term Loss of consciousness Pulmonary embolism Arthralgia Asthma Chest pain Cystitis haemorrhagic Deep vein thrombosis Depression Dyspnoea Headache Joint swelling Laceration Ligament sprain Lung disorder Meningitis viral Papilloma viral infection Pneumonia Pyrexia Sexually transmitted disease Thrombosis Viral infection

Product NUVARING NUVARING

Role Route S S

Manufacturer MERCK MERCK

8874184 Date FDA Received

31-Oct-2012

Case # 8874184

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1210USA 012888

Age

Sex Female

Country USA

Preferred Term Influenza like illness

Product NUVARING

Role Route S

Dosage Text 1 DF, qm

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,282 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8876431 Date FDA Received
31-Oct-2012 Case # 8876431 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1210USA 013893 Role Route S VAGINAL Dosage Text UNK Age 46 YR Sex Female Country USA

Preferred Term Menstruation delayed Incorrect drug administration duration

Product NUVARING

Duration

Manufacturer MERCK

8879721 Date FDA Received

31-Oct-2012

Case # 8879721

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes OT

Manufacturer Control # US-009507513-1210USA 012634 Dosage Text UNK Manufacturer Control # US-009507513-1210USA 014546

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism

Product NUVARING Case # 8879931 Case Type NON-EXPEDITED Health Professional

Role Route S Outcomes

Duration

Manufacturer MERCK

8879931 Date FDA Received

31-Oct-2012

Age 28 YR

Sex Unknown

Country USA

Preferred Term Overdose

Product NUVARING Case # 8880026 Case Type NON-EXPEDITED Health Professional

Role Route S VAGINAL

Dosage Text 3 weeks in, 1week out Manufacturer Control # US-009507513-1210USA 008977

Duration

Manufacturer MERCK

8880026 Date FDA Received

31-Oct-2012

Outcomes

Age

Sex Female

Country USA

Preferred Term Menorrhagia

Product NUVARING Case # 8880229 Case Type EXPEDITED (15-DAY) Health Professional

Role Route S Outcomes OT

Dosage Text UNK Manufacturer Control # US-009507513-1210USA 012632 Dosage Text UNK

Duration

Manufacturer MERCK

8880229 Date FDA Received

31-Oct-2012

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,283 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8817297 Date FDA Received
01-Nov-2012 Case # 8817297 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2012SP0 35096 Dosage Text UNK in for 3 weeks, out for 1 Duration Age Sex Unknown Country USA

Preferred Term Pulmonary embolism Mitral valve incompetence Ectropion of cervix Abdominal pain lower Cystitis Gastrointestinal disorder Gastrooesophageal reflux disease Genital herpes Haemorrhoids Menorrhagia Pregnancy Rosacea Vaginal haemorrhage

Product NUVARING NUVARING MAXALT

Role Route S S C VAGINAL VAGINAL

Manufacturer MERCK MERCK

8879244 Date FDA Received

01-Nov-2012

Case # 8879244

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1210USA 008011

Age

Sex Female

Country USA

Preferred Term Metrorrhagia Inappropriate schedule of drug administration

Product NUVARING

Role Route S VAGINAL

Dosage Text UNK

Duration

Manufacturer MERCK

8879274 Date FDA Received

01-Nov-2012

Case # 8879274

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1210USA 006673

Age

Sex Female

Country USA

Preferred Term Vulvovaginal swelling

Product NUVARING

Role Route S

Dosage Text

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,284 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8879465 Date FDA Received
01-Nov-2012 Case # 8879465 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1210USA 014332 Role Route S C Outcomes HO Manufacturer Control # GR-009507513-1210GR C012145 Dosage Text UNK Age 40 YR Sex Female Country GRC VAGINAL Dosage Text UNK, 3 week in one week ring free break Duration Age Sex Female Country USA

Preferred Term Metrorrhagia Off label use

Product NUVARING vitamins (unspecified) Case # 8880694 Case Type EXPEDITED (15-DAY) Health Professional

Manufacturer MERCK

8880694 Date FDA Received

01-Nov-2012

Preferred Term Amnesia Nervousness

Product NUVARING

Role Route S

Duration

Manufacturer MERCK

8881104 Date FDA Received

01-Nov-2012

Case # 8881104

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,OT

Manufacturer Control # US-009507513-2010SP0 12807 Dosage Text UPDATE (29SEP2010) REPORTED 20MG/ DAILY

Age

Sex Female

Country USA

Preferred Term Suicide attempt Suicidal ideation

Product NUVARING LEXAPRO

Role Route S C

Duration

Manufacturer MERCK

Abdominal pain lower Anxiety Dysmenorrhoea Major depression Medical device discomfort Pulmonary embolism

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,285 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8885559 Date FDA Received
01-Nov-2012 Case # 8885559 Case Type EXPEDITED (15-DAY) Health Professional Outcomes OT Manufacturer Control # CA-009507513-1210CAN 014659 Dosage Text Age 20 YR Sex Female Country CAN

Preferred Term Abortion induced Pregnancy on contraceptive

Product NUVARING

Role Route S UNKNOWN

Duration

Manufacturer MERCK

8845180 Date FDA Received

02-Nov-2012

Case # 8845180

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO

Manufacturer Control # US-009507513-1210USA 003442 Dosage Text 0.120mg/0.015mg

Age 43 YR

Sex Female

Country USA

Preferred Term Pain in extremity Pulmonary embolism

Product NUVARING

Role Route S

Duration

Manufacturer MERCK

8882463 Date FDA Received

02-Nov-2012

Case # 8882463

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1211USA 000257

Age

Sex Female

Country USA

Preferred Term Oligomenorrhoea

Product NUVARING Case # 8885760 Case Type NON-EXPEDITED Health Professional

Role Route S VAGINAL

Dosage Text

Duration

Manufacturer MERCK

8885760 Date FDA Received

02-Nov-2012

Outcomes

Manufacturer Control # US-009507513-1210USA 014736

Age

Sex Female

Country USA

Preferred Term Inappropriate schedule of drug administration

Product NUVARING

Role Route S VAGINAL

Dosage Text 3 week, 1 week ring free break

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,286 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8875399 Date FDA Received
05-Nov-2012 Case # 8875399 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-1210USA 004995 Dosage Text UNK Duration Age Sex Female Country USA

Preferred Term Dyspnoea Dyspnoea exertional Pulmonary embolism

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

8884894 Date FDA Received

05-Nov-2012

Case # 8884894

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1211USA 000487

Age

Sex Female

Country USA

Preferred Term Unintended pregnancy

Product NUVARING Case # 8886213 Case Type NON-EXPEDITED Health Professional

Role Route S VAGINAL

Dosage Text 1 DF, qm Manufacturer Control # US-009507513-1211USA 001030

Duration

Manufacturer MERCK

8886213 Date FDA Received

05-Nov-2012

Outcomes

Age

Sex Unknown

Country USA

Preferred Term Inappropriate schedule of drug administration

Product NUVARING Health Professional

Role Route S Outcomes OT

Dosage Text

Duration

Manufacturer MERCK

8886277 Date FDA Received

05-Nov-2012

Case # 8886277

Case Type EXPEDITED (15-DAY)

Manufacturer Control # FR-009507513-1210FRA 012373 Dosage Text

Age

Sex Female

Country FRA

Preferred Term Abortion induced Unintended pregnancy

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,287 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8887024 Date FDA Received
05-Nov-2012 Case # 8887024 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1211USA 000925 Role Route S Health Professional Y Product NUVARING Outcomes HO,LT Role Route S Dosage Text Dosage Text 3 weeks inserted 1 week ring free break Manufacturer Control # Age 54 YR Duration Sex Female Duration Age Sex Female Country USA

Preferred Term Amenorrhoea

Product NUVARING Case # 8892203 Case Type DIRECT

Manufacturer MERCK Country USA

8892203 Date FDA Received

05-Nov-2012 Preferred Term Deep vein thrombosis Pulmonary embolism

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,288 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7043432 Date FDA Received
06-Nov-2012 Case # 7043432 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2008-184 819-NL Dosage Text DOSE TEXT: 3 WEEKS IN, 1 WEEK OUT, CONTINUING: NO FREQUENCY: QD; WITH CALCIUM FREQUENCY: BID TOPICAL Duration Age Sex Unknown Country USA

Preferred Term Partial seizures

Product NUVARING

Role Route S

Manufacturer MERCK

Haemorrhagic stroke Migraine Diarrhoea Aphasia Cervical dysplasia Convulsion Drug hypersensitivity Dysmenorrhoea Ear disorder Human papilloma virus test positive Hypercoagulation Hyperreflexia Hypoaesthesia Intracranial venous sinus thrombosis Muscle tightness Muscular weakness Pain in extremity Presyncope Tonsillar disorder Treatment noncompliance Weight increased

VITAMINS (UNSPECIFIED) MINOCYCLINE HYDROCHLORIDE clindamycin

C C C

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,289 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8675676 Date FDA Received
06-Nov-2012 Case # 8675676 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2012SP0 05860 Dosage Text UNK UNK UNK Duration Age Sex Unknown Country USA

Preferred Term Convulsion Cerebral ischaemia Cerebral haemorrhage Abdominal pain Appendix disorder Deformity Emotional disorder Gastric disorder Headache Ligament sprain Road traffic accident Thrombosis

Product NUVARING NUVARING NUVARING

Role Route S S S

Manufacturer MERCK MERCK MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,290 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8708394 Date FDA Received
06-Nov-2012 Case # 8708394 Case Type EXPEDITED (15-DAY) Health Professional Outcomes OT Manufacturer Control # US-009507513-2012SP0 22610 Dosage Text UNK UNK UNK Duration Age Sex Unknown Country USA

Preferred Term Pulmonary embolism Deep vein thrombosis Chronic sinusitis Asthma Nasal septum deviation Nasal turbinate hypertrophy Sinus antrostomy Allergic sinusitis Cough Dyspnoea Ethmoid sinus surgery Foetal death Fracture Gastrooesophageal reflux disease Headache Hypothyroidism Lung neoplasm Maternal exposure during pregnancy Nasal septal operation Pulmonary hypertension Seasonal allergy Vitamin D deficiency Vocal cord disorder

Product NUVARING NUVARING NUVARING FIORINAL (acetaminophen (+) aspirin (+) caffeine) SYNTHROID doxycycline SINGULAIR

Role Route S S S C C C C VAGINAL VAGINAL

Manufacturer MERCK MERCK MERCK

MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,291 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8887811 Date FDA Received
06-Nov-2012 Case # 8887811 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1211USA 001366 Role Route S VAGINAL Dosage Text 3 weeks in, 1 week out Duration Age Sex Female Country USA

Preferred Term Inappropriate schedule of drug administration Inappropriate schedule of drug administration

Product NUVARING

Manufacturer MERCK

8888799 Date FDA Received

06-Nov-2012

Case # 8888799

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,OT

Manufacturer Control # US-009507513-2010SP0 19264 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Cholecystitis acute Deep vein thrombosis Fibula fracture Pulmonary embolism

Product NUVARING

Role Route S

Duration

Manufacturer MERCK

8889001 Date FDA Received

06-Nov-2012

Case # 8889001

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes DS,OT

Manufacturer Control # US-009507513-1211USA 000375 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism

Product NUVARING

Role Route S

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,292 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8889211 Date FDA Received
06-Nov-2012 Case # 8889211 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2006-150 706-NL Dosage Text 1 DF, UNK Duration Age Sex Unknown Country USA

Preferred Term Loss of consciousness Pulmonary embolism Deep vein thrombosis Pain Abdominal pain Discomfort Hepatic enzyme increased Menstruation irregular Musculoskeletal pain Thrombosis Urinary tract infection

Product NUVARING HORMONAL CONTRACEPTIVES (UNSPECIFIED) DEPO-PROVERA IBUPROFEN

Role Route S S S C VAGINAL

Manufacturer MERCK

800 mg, PRN

8890687 Date FDA Received

06-Nov-2012

Case # 8890687

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1211USA 000219

Age 43 YR

Sex Female

Country USA

Preferred Term Muscle spasms Product shape issue

Product NUVARING

Role Route S VAGINAL

Dosage Text 1 ring every 28 days

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,293 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8342965 Date FDA Received
07-Nov-2012 Case # 8342965 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2011SP0 40934 Dosage Text UNK Duration Age Sex Unknown Country USA

Preferred Term Hypokalaemia Back pain Bronchiectasis Deep vein thrombosis Diarrhoea Dyspepsia Eructation Increased bronchial secretion Lung cyst Nausea Neck pain Polyp Pulmonary embolism Pulmonary pneumatocele Road traffic accident Soft tissue mass Vomiting

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,294 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8711317 Date FDA Received
07-Nov-2012 Case # 8711317 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2012SP0 23044 Dosage Text UNK Duration Age Sex Unknown Country USA

Preferred Term Pulmonary embolism Amenorrhoea Antiphospholipid syndrome Arthralgia Autoimmune disorder Back pain Cyst Deep vein thrombosis Depression Emotional disorder Hiatus hernia Hypomenorrhoea Inappropriate schedule of drug administration Irritable bowel syndrome Ligament sprain Menometrorrhagia Metrorrhagia Migraine Obesity Ovarian cyst Thrombosis Uterine leiomyoma Uterine spasm Vaginal discharge Vaginal odour Vaginitis gardnerella Vulvovaginal discomfort

Product NUVARING

Role Route S

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,295 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8818351 Date FDA Received
07-Nov-2012 Case # 8818351 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1209USA 009519 Role Route S VAGINAL Dosage Text 1 ring every 28 days Duration Age Sex Female Country USA

Preferred Term Drug dose omission Device expulsion

Product NUVARING

Manufacturer MERCK

8890506 Date FDA Received

07-Nov-2012

Case # 8890506

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1211USA 001772

Age

Sex Female

Country USA

Preferred Term Drug dose omission Product quality issue

Product NUVARING

Role Route S VAGINAL

Dosage Text UNK

Duration

Manufacturer MERCK

8891254 Date FDA Received

07-Nov-2012

Case # 8891254

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1211USA 002287

Age 20 YR

Sex Female

Country USA

Preferred Term Mood swings

Product NUVARING Case # 8895356 Case Type NON-EXPEDITED Health Professional

Role Route S VAGINAL

Dosage Text UNK Manufacturer Control # US-009507513-1211USA 002920

Duration

Manufacturer MERCK

8895356 Date FDA Received

07-Nov-2012

Outcomes

Age

Sex Female

Country USA

Preferred Term Hot flush Device expulsion

Product NUVARING LYRICA SAVELLA XANAX

Role Route S S S S

Dosage Text UNK

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,296 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8896473 Date FDA Received
07-Nov-2012 Preferred Term Deep vein thrombosis Pulmonary embolism Case # 8896473 Case Type DIRECT Product NUVARING Health Professional Outcomes HO,DS,LT,OT Role Route S VAGINAL Dosage Text Manufacturer Control # Age 54 YR Duration 75 DAY Sex Female Country USA

Manufacturer

8722677 Date FDA Received

08-Nov-2012

Case # 8722677

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,DS,OT

Manufacturer Control # US-009507513-2011SP0 31111 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism Bronchitis Coagulopathy Influenza Pneumonia

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

8861207 Date FDA Received

08-Nov-2012

Case # 8861207

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO

Manufacturer Control # PT-009507513-1210PRT 009310 Dosage Text UNK UNK

Age 31 YR

Sex Female

Country PRT

Preferred Term Abortion spontaneous Respiratory disorder Unintended pregnancy

Product NUVARING amoxicillin (+) clavulanic acid

Role Route S C

Duration

Manufacturer MERCK

8894092 Date FDA Received

08-Nov-2012

Case # 8894092

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1211USA 002727

Age

Sex Female

Country USA

Preferred Term Metrorrhagia

Product NUVARING LEXAPRO

Role Route S C VAGINAL

Dosage Text

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,297 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8894104 Date FDA Received
08-Nov-2012 Case # 8894104 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1210USA 013646 Role Route S Health Professional VAGINAL Dosage Text strength: 0.015/0.12 , 1 ring Manufacturer Control # US-009507513-1211USA 001377 Role Route S Health Professional Outcomes HO Dosage Text UNK Manufacturer Control # US-009507513-1211USA 001369 Dosage Text UNK Age 17 YR Sex Female Age 30 YR Sex Female Duration Age Sex Female Country USA

Preferred Term Adverse event

Product NUVARING Case # 8894155 Case Type NON-EXPEDITED

Manufacturer MERCK Country USA

8894155 Date FDA Received

08-Nov-2012

Outcomes

Preferred Term Device expulsion

Product NUVARING Case # 8894157 Case Type EXPEDITED (15-DAY)

Duration

Manufacturer MERCK Country USA

8894157 Date FDA Received

08-Nov-2012

Preferred Term Cerebrovascular accident Product quality issue

Product NUVARING

Role Route S

Duration

Manufacturer MERCK

8894429 Date FDA Received

08-Nov-2012

Case # 8894429

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1211USA 002632

Age

Sex Female

Country USA

Preferred Term Inappropriate schedule of drug administration No adverse event

Product NUVARING

Role Route S VAGINAL

Dosage Text UNK

Duration

Manufacturer MERCK

8895690 Date FDA Received

08-Nov-2012

Case # 8895690

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1211USA 002783

Age

Sex Female

Country USA

Preferred Term Acne

Product NUVARING

Role Route S

Dosage Text 1 UNK, UNK

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,298 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8895802 Date FDA Received
08-Nov-2012 Case # 8895802 Case Type EXPEDITED (15-DAY) Health Professional Outcomes DS,OT Manufacturer Control # US-009507513-1211USA 000370 Dosage Text UNK Manufacturer Control # US-009507513-1211USA 003729 Dosage Text UNK Duration Age Sex Unknown Duration Age Sex Unknown Country USA

Preferred Term Pulmonary embolism

Product NUVARING Case # 8895925 Case Type EXPEDITED (15-DAY) Health Professional

Role Route S VAGINAL

Manufacturer MERCK Country USA

8895925 Date FDA Received

08-Nov-2012

Outcomes OT

Preferred Term Cerebrovascular accident Emotional disorder Thrombosis

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

8898646 Date FDA Received

08-Nov-2012

Case # 8898646

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes OT

Manufacturer Control # US-009507513-1211USA 003738 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Cerebrovascular accident Pulmonary embolism Thrombosis

Product NUVARING

Role Route S

Duration

Manufacturer MERCK

8901495 Date FDA Received

08-Nov-2012

Case # 8901495

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO

Manufacturer Control # US-009507513-1211USA 000394 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Deep vein thrombosis

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,299 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8858415 Date FDA Received
09-Nov-2012 Case # 8858415 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,LT Manufacturer Control # US-009507513-1210USA 010492 Dosage Text 0.120mg/0.015mg, qd/ 21 days Manufacturer Control # US-009507513-1210USA 010935 Dosage Text UNK Manufacturer Control # US-009507513-1211USA 002212 Role Route S VAGINAL Dosage Text UNK Duration Age Sex Female Duration Age Sex Female Age 20 YR Sex Female Country USA

Preferred Term Deep vein thrombosis

Product NUVARING Case # 8858432 Case Type EXPEDITED (15-DAY) Health Professional

Role Route S VAGINAL

Duration

Manufacturer MERCK Country USA

8858432 Date FDA Received

09-Nov-2012

Outcomes HO

Preferred Term Deep vein thrombosis

Product NUVARING Case # 8898001 Case Type NON-EXPEDITED Health Professional

Role Route S VAGINAL

Manufacturer MERCK Country USA

8898001 Date FDA Received

09-Nov-2012

Outcomes

Preferred Term Device expulsion No adverse event

Product NUVARING

Manufacturer MERCK

8900587 Date FDA Received

09-Nov-2012

Case # 8900587

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes DE,OT

Manufacturer Control # US-009507513-1211USA 003741 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Death Pulmonary embolism

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

8900593 Date FDA Received

09-Nov-2012

Case # 8900593

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1211USA 000141

Age

Sex Female

Country USA

Preferred Term Inappropriate schedule of drug administration

Product NUVARING

Role Route S VAGINAL

Dosage Text 3 weeks in, 1 week out

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,300 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8900745 Date FDA Received
09-Nov-2012 Case # 8900745 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO Manufacturer Control # US-009507513-1210USA 008056 Dosage Text UNK Manufacturer Control # US-009507513-1211USA 000400 Dosage Text Duration Age Sex Unknown Age 18 YR Sex Female Country USA

Preferred Term Cerebral artery embolism

Product NUVARING Case # 8901124 Case Type EXPEDITED (15-DAY) Health Professional

Role Route S VAGINAL

Duration

Manufacturer MERCK Country USA

8901124 Date FDA Received

09-Nov-2012

Outcomes OT

Preferred Term Myocardial infarction

Product NUVARING Case # 8901520 Case Type EXPEDITED (15-DAY) Health Professional

Role Route S Outcomes HO,OT

Manufacturer MERCK

8901520 Date FDA Received

09-Nov-2012

Manufacturer Control # US-009507513-2009SP0 17666 Dosage Text 1 DF, QM PRN

Age

Sex Unknown

Country USA

Preferred Term Lung infiltration Pulmonary embolism Headache Pain Pityriasis rosea Pleural effusion

Product NUVARING LODINE

Role Route S C VAGINAL ORAL

Duration

Manufacturer MERCK

8901918 Date FDA Received

09-Nov-2012 Preferred Term Chest pain Gallbladder disorder

Case # 8901918

Case Type DIRECT Product NUVARING

Health Professional

Outcomes OT,RI Role Route S VAGINAL

Manufacturer Control #

Age 42 YR

Sex Female

Country USA

Dosage Text monthly vag

Duration

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,301 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8904462 Date FDA Received
10-Nov-2012 Case # 8904462 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1211USA 003507 Role Route S VAGINAL Dosage Text 3 weeks in one week ring free week Manufacturer Control # US-009507513-1211USA 002208 Role Route S Health Professional VAGINAL Dosage Text UNK Manufacturer Control # US-009507513-1211USA 000492 Role Route S C C Health Professional Outcomes HO,LT Manufacturer Control # DE-009507513-1211DEU 003543 Dosage Text Age 22 YR Sex Female Country DEU VAGINAL Dosage Text 1 DF, qm Duration Age Sex Female Duration Age Sex Female Age 27 YR Sex Female Country USA

Preferred Term Metrorrhagia

Product NUVARING

Duration

Manufacturer MERCK

8903428 Date FDA Received

11-Nov-2012

Case # 8903428

Case Type NON-EXPEDITED

Health Professional

Outcomes

Country USA

Preferred Term Device expulsion

Product NUVARING Case # 8905348 Case Type NON-EXPEDITED

Manufacturer MERCK Country USA

8905348 Date FDA Received

11-Nov-2012

Outcomes

Preferred Term Unintended pregnancy No adverse event

Product NUVARING EFFEXOR VALIUM

Manufacturer MERCK

8905989 Date FDA Received

11-Nov-2012

Case # 8905989

Case Type EXPEDITED (15-DAY)

Preferred Term Dyspnoea Deep vein thrombosis Dizziness Oedema peripheral Pulmonary embolism Thrombosis

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,302 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8902919 Date FDA Received
12-Nov-2012 Case # 8902919 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1211USA 004302 Role Route S Health Professional VAGINAL Dosage Text 3 weeks in, 1 week out Manufacturer Control # US-009507513-1211USA 003074 Dosage Text UNK Duration Age Sex Unknown Age 28 YR Sex Unknown Country USA

Preferred Term Inappropriate schedule of drug administration

Product NUVARING

Duration

Manufacturer MERCK Country USA

8904417 Date FDA Received

12-Nov-2012

Case # 8904417

Case Type EXPEDITED (15-DAY)

Outcomes OT

Preferred Term Pulmonary embolism Deep vein thrombosis

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

8904520 Date FDA Received

12-Nov-2012

Case # 8904520

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1210USA 013796

Age 38 YR

Sex Female

Country USA

Preferred Term Drug administration error Polymorphonuclear chromatin clumping

Product NUVARING

Role Route S VAGINAL

Dosage Text 3 weeks in, 1 week out

Duration

Manufacturer MERCK

8906120 Date FDA Received

12-Nov-2012

Case # 8906120

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1210USA 014173

Age

Sex Female

Country USA

Preferred Term Metrorrhagia

Product NUVARING

Role Route S VAGINAL

Dosage Text 1 ring for 3 week use

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,303 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8906121 Date FDA Received
12-Nov-2012 Case # 8906121 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # SE-009507513-1211SW E003577 Dosage Text 0.120mg/0.015mg per 24 hours Age 26 YR Sex Female Country SWE

Preferred Term Cerebral infarction Headache Hemiparesis VIIth nerve paralysis

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

8694574 Date FDA Received

13-Nov-2012

Case # 8694574

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,OT

Manufacturer Control # US-009507513-2011SP0 56192 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Hypercoagulation Cerebrovascular accident Drug abuse Embolism Hyperhomocysteinaemia Ovarian cyst Pre-eclampsia Thrombosis Transient ischaemic attack

Product NUVARING

Role Route S

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,304 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8785020 Date FDA Received
13-Nov-2012 Case # 8785020 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,LT,OT Manufacturer Control # US-009507513-2011SP0 37379 Dosage Text UNK UNK Duration Age Sex Unknown Country USA

Preferred Term Pulmonary embolism Iliac vein occlusion Chest pain Cognitive disorder Cystic fibrosis Emotional disorder Headache Hypertension Hypokalaemia Mental disorder Migraine Nephrolithiasis Peritonsillar abscess Polycystic ovaries Renal stone removal Tonsillitis Ureteral stent insertion Urinary tract infection Vena cava embolism

Product NUVARING NUVARING

Role Route S S

Manufacturer MERCK MERCK

8903587 Date FDA Received

13-Nov-2012

Case # 8903587

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,DS

Manufacturer Control # US-009507513-1211USA 004968 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Deep vein thrombosis

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,305 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8903590 Date FDA Received
13-Nov-2012 Case # 8903590 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-1211USA 004965 Dosage Text UNK Manufacturer Control # IE-009507513-1211GBR 004764 Dosage Text 1 ring/21 days 1 ring/21 days 1 TDS (1 DOSAGE FORM, 3 IN 1 D) 100 Microgram, UNK Manufacturer Control # US-009507513-1211USA 003079 Dosage Text UNK Manufacturer Control # US-009507513-2012SP0 28987 Dosage Text UNK Duration Age Sex Unknown Duration Age Sex Unknown Country USA Age 39 YR Sex Female Duration Age Sex Unknown Country USA

Preferred Term Pulmonary embolism

Product NUVARING Case # 8903777 Case Type EXPEDITED (15-DAY) Health Professional

Role Route S Outcomes OT

Manufacturer MERCK Country GBR

8903777 Date FDA Received

13-Nov-2012

Preferred Term Sinusitis Nasal congestion

Product NUVARING NUVARING URSOFALK ELTROXIN

Role Route S S C C Health Professional Outcomes HO VAGINAL VAGINAL

Duration

Manufacturer MERCK MERCK

8903817 Date FDA Received

13-Nov-2012

Case # 8903817

Case Type EXPEDITED (15-DAY)

Preferred Term Intracranial venous sinus thrombosis

Product NUVARING Case Type EXPEDITED (15-DAY) Health Professional

Role Route S VAGINAL

Manufacturer MERCK Country USA

8903843 Date FDA Received

13-Nov-2012

Case # 8903843

Outcomes HO

Preferred Term Deep vein thrombosis

Product NUVARING

Role Route S

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,306 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8905162 Date FDA Received
13-Nov-2012 Case # 8905162 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1211USA 005090 Role Route S Health Professional Outcomes Manufacturer Control # US-009507513-1211USA 005092 Role Route S Health Professional Outcomes Manufacturer Control # US-009507513-1210USA 014665 Role Route S VAGINAL Dosage Text 3 weeks in, 1 week out Age 32 YR Sex Female Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term Vulvovaginal discomfort

Product NUVARING Case # 8905183 Case Type NON-EXPEDITED

Manufacturer MERCK Country USA

8905183 Date FDA Received

13-Nov-2012

Preferred Term Device expulsion

Product NUVARING Case # 8905207 Case Type NON-EXPEDITED

Manufacturer MERCK Country USA

8905207 Date FDA Received

13-Nov-2012

Preferred Term Device expulsion Vaginal haemorrhage

Product NUVARING

Duration

Manufacturer MERCK

8905228 Date FDA Received

13-Nov-2012

Case # 8905228

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO

Manufacturer Control # IT-009507513-1211ITA00 4221 Dosage Text 11.7mg+2.7mg

Age

Sex Female

Country ITA

Preferred Term Chalazion Chalazion Eye abscess Eyelid pain Lacrimation increased Malaise Pain in jaw Rhinalgia

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,307 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8905695 Date FDA Received
13-Nov-2012 Case # 8905695 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,DS,OT Manufacturer Control # US-009507513-2011SP0 27264 Dosage Text Duration Age Sex Unknown Country USA

Preferred Term Lobar pneumonia Deep vein thrombosis Aortic dissection Asthma Depression Gastroenteritis Hypertension Influenza Migraine Off label use Pulmonary embolism Pulmonary infarction

Product NUVARING NUVARING

Role Route S S

Manufacturer MERCK MERCK

8907149 Date FDA Received

14-Nov-2012

Case # 8907149

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1211USA 005097

Age

Sex Female

Country USA

Preferred Term Migraine

Product NUVARING Case # 8907450 Case Type NON-EXPEDITED Health Professional

Role Route S Outcomes

Dosage Text UNK Manufacturer Control # US-009507513-1211USA 003297

Duration

Manufacturer MERCK

8907450 Date FDA Received

14-Nov-2012

Age 26 YR

Sex Female

Country USA

Preferred Term Nausea

Product NUVARING

Role Route S VAGINAL

Dosage Text 3 weeks in 1 week out, qm

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,308 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8654678 Date FDA Received
15-Nov-2012 Case # 8654678 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2012SP0 05867 Dosage Text UNK Duration Age Sex Unknown Country USA

Preferred Term Anaemia Deep vein thrombosis Escherichia urinary tract infection Nephrolithiasis Pulmonary embolism

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

8824245 Date FDA Received

15-Nov-2012

Case # 8824245

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,OT

Manufacturer Control # US-009507513-2012SP0 34969 Dosage Text UNK 20 mg, qd

Age

Sex Unknown

Country USA

Preferred Term Atrial fibrillation Pulmonary embolism Anxiety Coital bleeding Hypertension Menorrhagia Nausea Pneumonia Vomiting Vulvovaginal mycotic infection

Product NUVARING CELEXA

Role Route S C VAGINAL

Duration

Manufacturer MERCK

8909497 Date FDA Received

15-Nov-2012

Case # 8909497

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1211USA 005390

Age 17 YR

Sex Female

Country USA

Preferred Term Inappropriate schedule of drug administration

Product NUVARING

Role Route S VAGINAL

Dosage Text 1 ring for 3 weeks followed by a week free break

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,309 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8910149 Date FDA Received
15-Nov-2012 Case # 8910149 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1211USA 004670 Role Route S Health Professional Outcomes Dosage Text UNK Manufacturer Control # US-009507513-1211USA 004851 Role Route S Health Professional Outcomes OT Dosage Text UNK Manufacturer Control # US-009507513-1211USA 004967 Dosage Text UNK Manufacturer Control # US-009507513-1211USA 002513 Role Route S C C C C C C UNK UNK, qw VAGINAL Dosage Text 1 DF, UNK Duration Age Sex Female Duration Age Sex Unknown Age 28 YR Sex Female Duration Age Sex Female Country USA

Preferred Term Metrorrhagia

Product NUVARING Case # 8910740 Case Type NON-EXPEDITED

Manufacturer MERCK Country USA

8910740 Date FDA Received

15-Nov-2012

Preferred Term Discomfort

Product NUVARING Case # 8910824 Case Type EXPEDITED (15-DAY)

Duration

Manufacturer MERCK Country USA

8910824 Date FDA Received

15-Nov-2012

Preferred Term Pulmonary embolism

Product NUVARING Case # 8911255 Case Type NON-EXPEDITED Health Professional

Role Route S VAGINAL

Manufacturer MERCK Country USA

8911255 Date FDA Received

15-Nov-2012

Outcomes

Preferred Term Menorrhagia Dysmenorrhoea Menorrhagia Inappropriate schedule of drug administration

Product NUVARING DIOVAN metoprolol vitamin D (unspecified) methotrexate PLAQUENIL vitamin E

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,310 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8911311 Date FDA Received
15-Nov-2012 Case # 8911311 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1211USA 004009 Role Route S C VAGINAL Dosage Text 3 weeks in 1 week out UNK Age 19 YR Sex Female Country USA

Preferred Term Metrorrhagia Breast tenderness Dizziness Fatigue Headache

Product NUVARING minocycline

Duration

Manufacturer MERCK

8911473 Date FDA Received

15-Nov-2012

Case # 8911473

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1211USA 005927

Age

Sex Unknown

Country USA

Preferred Term Deep vein thrombosis

Product NUVARING Case # 8911973 Case Type EXPEDITED (15-DAY) Health Professional

Role Route S Outcomes HO,OT

Dosage Text UNK Manufacturer Control # US-009507513-1211USA 003078 Dosage Text UNK

Duration

Manufacturer MERCK

8911973 Date FDA Received

15-Nov-2012

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism Deep vein thrombosis

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

8912056 Date FDA Received

15-Nov-2012

Case # 8912056

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO

Manufacturer Control # US-009507513-1211USA 005926 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Intracranial venous sinus thrombosis

Product NUVARING

Role Route S

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,311 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8912058 Date FDA Received
15-Nov-2012 Case # 8912058 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1211USA 003786 Role Route S S VAGINAL VAGINAL Dosage Text UNK UNK Age 24 YR Sex Female Country USA

Preferred Term Metrorrhagia Feeling abnormal Device expulsion Incorrect drug administration duration

Product NUVARING NUVARING

Duration

Manufacturer MERCK MERCK

8912137 Date FDA Received

15-Nov-2012

Case # 8912137

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1211USA 005465

Age

Sex Female

Country USA

Preferred Term Vomiting Headache Nausea

Product NUVARING

Role Route S VAGINAL

Dosage Text UNK

Duration

Manufacturer MERCK

8664827 Date FDA Received

16-Nov-2012

Case # 8664827

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,OT

Manufacturer Control # US-009507513-2012SP0 22824 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism Dyspnoea Cervical dysplasia Chest pain Fatigue Nausea Syncope Trichomoniasis

Product NUVARING ONE-A-DAY ESSENTIAL VITAMINS

Role Route S C VAGINAL

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,312 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8708937 Date FDA Received
16-Nov-2012 Case # 8708937 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-1208USA 000214 Dosage Text UNK UNK UNK, qd Duration Age Sex Unknown Country USA

Preferred Term Ischaemic stroke Pulmonary embolism Deep vein thrombosis Cognitive disorder Transient ischaemic attack Vaginal infection Vulvovaginal mycotic infection

Product NUVARING NUVARING ORTHO TRI-CYCLEN

Role Route S S S VAGINAL VAGINAL ORAL

Manufacturer MERCK MERCK

8910919 Date FDA Received

16-Nov-2012

Case # 8910919

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1211USA 004375

Age 25 YR

Sex Female

Country USA

Preferred Term Food craving Metrorrhagia Muscle spasms

Product NUVARING

Role Route S VAGINAL

Dosage Text 1 ring 3 weeks / followed 1 week free break

Duration

Manufacturer MERCK

8911353 Date FDA Received

16-Nov-2012

Case # 8911353

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1211USA 004456

Age

Sex Female

Country USA

Preferred Term Device breakage Vulvovaginal pain

Product NUVARING

Role Route S

Dosage Text

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,313 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8911537 Date FDA Received
16-Nov-2012 Case # 8911537 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1211USA 003823 Role Route S Dosage Text Duration Age Sex Female Country USA

Preferred Term Vulvovaginal pain Device breakage

Product NUVARING

Manufacturer MERCK

8911904 Date FDA Received

16-Nov-2012

Case # 8911904

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,OT

Manufacturer Control # US-009507513-1211USA 004969 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism Deep vein thrombosis

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

8566257 Date FDA Received

19-Nov-2012

Case # 8566257

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,DS,OT

Manufacturer Control # US-009507513-2011SP0 58947 Dosage Text

Age

Sex Unknown

Country USA

Preferred Term Renal injury Renal failure chronic Abdominal pain Anaemia Anxiety Asthma Avulsion fracture Back pain Bronchitis Cellulitis Cervical dysplasia Cervix carcinoma Deep vein thrombosis Dermoid cyst

Product NUVARING NUVARING

Role Route S S

Duration

Manufacturer MERCK MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,314 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8566257
Preferred Term Dyspnoea Endometriosis Fear Gastrooesophageal reflux disease Headache Hydronephrosis Hypoglycaemia Metabolic acidosis Musculoskeletal chest pain Myomectomy Nasopharyngitis Obstructive airways disorder Oedema peripheral Oropharyngeal pain Paranasal sinus hypersecretion Paranoia Pulmonary embolism Rash Renal cyst Rhinitis seasonal Sinusitis Sinus tachycardia Syncope Urinary tract infection Uterine leiomyoma Product Role Route Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,315 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8708284 Date FDA Received
19-Nov-2012 Case # 8708284 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-1208USA 000198 Dosage Text 1 DF, qm Duration Age Sex Unknown Country USA

Preferred Term Portal vein thrombosis Adverse drug reaction Deep vein thrombosis Gastritis Head injury Hypercoagulation Pulmonary embolism Rhinitis Urinary tract infection

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,316 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8740279 Date FDA Received
19-Nov-2012 Case # 8740279 Case Type EXPEDITED (15-DAY) Health Professional Outcomes OT Manufacturer Control # US-009507513-2011SP0 27261 Dosage Text Duration Age Sex Unknown Country USA

Preferred Term Cholecystectomy Cholecystitis chronic Abdominal pain Back disorder Diarrhoea Hangover Intervertebral disc protrusion Joint injury Limb injury Mental disorder Mental status changes Nausea Neck injury Road traffic accident Vomiting

Product NUVARING NUVARING

Role Route S S

Manufacturer MERCK MERCK

8913778 Date FDA Received

19-Nov-2012

Case # 8913778

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1208USA 008468

Age

Sex Unknown

Country USA

Preferred Term Deep vein thrombosis

Product NUVARING Case # 8914160 Case Type EXPEDITED (15-DAY) Health Professional

Role Route S Outcomes HO

Dosage Text UNK Manufacturer Control # DE-009507513-1211DEU 005086 Dosage Text deliver 0.2mg/0.015 mg daily, q3w

Duration

Manufacturer MERCK

8914160 Date FDA Received

19-Nov-2012

Age 26 YR

Sex Female

Country DEU

Preferred Term Arrhythmia

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,317 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8914163 Date FDA Received
19-Nov-2012 Case # 8914163 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1211USA 005631 Role Route S VAGINAL Dosage Text 1 ring for 3 weeks followed by a week free break Manufacturer Control # US-009507513-1211USA 006925 Role Route S Health Professional Outcomes OT Dosage Text 1 DF, UNK Manufacturer Control # US-009507513-1211USA 005866 Dosage Text UNK Manufacturer Control # US-009507513-1211USA 003917 Role Route S VAGINAL Dosage Text 1 ring every 28 days Duration Age Sex Female Age 39 YR Sex Female Duration Age Sex Female Duration Age Sex Female Country USA

Preferred Term Inappropriate schedule of drug administration

Product NUVARING

Manufacturer MERCK

8914468 Date FDA Received

19-Nov-2012

Case # 8914468

Case Type NON-EXPEDITED

Health Professional

Outcomes

Country USA

Preferred Term Metrorrhagia

Product NUVARING Case # 8914718 Case Type EXPEDITED (15-DAY)

Manufacturer MERCK Country USA

8914718 Date FDA Received

19-Nov-2012

Preferred Term Rash generalised

Product NUVARING Case # 8914725 Case Type NON-EXPEDITED Health Professional

Role Route S VAGINAL

Duration

Manufacturer MERCK Country USA

8914725 Date FDA Received

19-Nov-2012

Outcomes

Preferred Term Device expulsion No adverse event

Product NUVARING

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,318 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8914813 Date FDA Received
19-Nov-2012 Case # 8914813 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1211USA 006015 Role Route S C VAGINAL ORAL Dosage Text 1 ring for 3 week use 1 tablet a day Duration Age Sex Female Country USA

Preferred Term Abdominal pain lower Vulvovaginal discomfort Vulvovaginal pain

Product NUVARING vitamins (unspecified)

Manufacturer MERCK

8914831 Date FDA Received

19-Nov-2012

Case # 8914831

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1211USA 007090

Age

Sex Female

Country USA

Preferred Term Fungal infection

Product NUVARING Case # 8915741 Case Type EXPEDITED (15-DAY) Health Professional

Role Route S VAGINAL

Dosage Text 0.015/0.012 Manufacturer Control # US-009507513-2009-195 832-NL Dosage Text CONTINUING: NO UNK UNK, QD

Duration

Manufacturer MERCK

8915741 Date FDA Received

19-Nov-2012

Outcomes HO,OT

Age

Sex Unknown

Country USA

Preferred Term Deep vein thrombosis Pulmonary embolism Thrombophlebitis Tendonitis Haemangioma of liver Upper respiratory tract infection

Product NUVARING CALCIUM (UNSPECIFIED) OMEGA-3 MARINE TRIGLYCERIDES SYNTHROID

Role Route S C C C VAGINAL

Duration

Manufacturer MERCK

8917485 Date FDA Received

19-Nov-2012

Case # 8917485

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1211USA 006388

Age

Sex Unknown

Country USA

Preferred Term Deep vein thrombosis

Product NUVARING

Role Route S

Dosage Text

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,319 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8917616 Date FDA Received
19-Nov-2012 Case # 8917616 Case Type EXPEDITED (15-DAY) Health Professional Outcomes DE,OT Manufacturer Control # US-009507513-1211USA 006390 Dosage Text UNK Duration Age Sex Unknown Country USA

Preferred Term Cerebrovascular accident Coagulopathy

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

8916346 Date FDA Received

20-Nov-2012

Case # 8916346

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,OT

Manufacturer Control # US-009507513-1211USA 007534 Dosage Text UNK Manufacturer Control # US-009507513-1211USA 008010

Age 32 YR

Sex Female

Country USA

Preferred Term Myocardial infarction

Product NUVARING Case # 8916352 Case Type NON-EXPEDITED Health Professional

Role Route S VAGINAL

Duration

Manufacturer MERCK

8916352 Date FDA Received

20-Nov-2012

Outcomes

Age

Sex Unknown

Country USA

Preferred Term Deep vein thrombosis

Product NUVARING Case # 8916661 Case Type NON-EXPEDITED Health Professional

Role Route S Outcomes

Dosage Text UNK Manufacturer Control # US-009507513-1211USA 006489

Duration

Manufacturer MERCK

8916661 Date FDA Received

20-Nov-2012

Age

Sex Female

Country USA

Preferred Term Unintended pregnancy

Product NUVARING Case # 8916828 Case Type NON-EXPEDITED Health Professional

Role Route S VAGINAL

Dosage Text UNK Manufacturer Control # US-009507513-1211USA 006567

Duration

Manufacturer MERCK

8916828 Date FDA Received

20-Nov-2012

Outcomes

Age 19 YR

Sex Female

Country USA

Preferred Term Vaginal flatulence

Product NUVARING

Role Route S VAGINAL

Dosage Text

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,320 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8916958 Date FDA Received
20-Nov-2012 Case # 8916958 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1211USA 007031 Role Route S Health Professional VAGINAL Dosage Text 1 ring every 3 weeks and off 1 week Manufacturer Control # US-009507513-1211USA 005638 Role Route S VAGINAL Dosage Text 1 ring for 3 weeks followed by a ring free break UNK, prn Duration Age Sex Female Duration Age Sex Female Country USA

Preferred Term Incorrect storage of drug

Product NUVARING Case # 8916963 Case Type NON-EXPEDITED

Manufacturer MERCK Country USA

8916963 Date FDA Received

20-Nov-2012

Outcomes

Preferred Term Metrorrhagia

Product NUVARING

Manufacturer MERCK

ibuprofen TYLENOL iron (unspecified) (+) vitamins (unspecified)

C C C Outcomes

8916993 Date FDA Received

20-Nov-2012

Case # 8916993

Case Type NON-EXPEDITED

Health Professional

Manufacturer Control # US-009507513-1211USA 006569

Age 38 YR

Sex Female

Country USA

Preferred Term Device difficult to use

Product NUVARING Case # 8918030 Case Type NON-EXPEDITED Health Professional

Role Route S VAGINAL

Dosage Text

Duration

Manufacturer MERCK

8918030 Date FDA Received

20-Nov-2012

Outcomes

Manufacturer Control # US-009507513-1211USA 007525

Age

Sex Unknown

Country USA

Preferred Term Deep vein thrombosis

Product NUVARING

Role Route S VAGINAL

Dosage Text UNK

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,321 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8918258 Date FDA Received
20-Nov-2012 Case # 8918258 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1211USA 006592 Role Route S VAGINAL Dosage Text 1 ring for 3 weeks followed by a week free break Duration Age Sex Female Country USA

Preferred Term Vulvovaginal pruritus

Product NUVARING

Manufacturer MERCK

Fungal infection Incorrect drug administration duration Vaginal discharge

amoxicillin

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,322 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8610540 Date FDA Received
21-Nov-2012 Case # 8610540 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,DS,OT Manufacturer Control # US-009507513-2012SP0 03425 Dosage Text Duration Age Sex Unknown Country USA

Preferred Term Pancreatitis Back pain Carotidynia Cervical dysplasia Chest pain Deep vein thrombosis Disturbance in attention Dizziness Hypokalaemia Liposuction Liver disorder Local swelling Muscle strain Neck pain Oedema peripheral Pain in extremity Pulmonary embolism Systemic lupus erythematosus Urinary tract infection Vomiting Weight increased

Product NUVARING

Role Route S

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,323 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8667676 Date FDA Received
21-Nov-2012 Case # 8667676 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-1207USA 004149 Dosage Text UNK UNK, prn Duration Age Sex Unknown Country USA

Preferred Term Pulmonary embolism Deep vein thrombosis Hypertension Abdominal pain lower Chest pain Muscle rupture Off label use Palpitations Sinus tachycardia

Product NUVARING NUVARING VENTOLIN (albuterol)

Role Route S S C VAGINAL

Manufacturer MERCK MERCK

8815840 Date FDA Received

21-Nov-2012

Case # 8815840

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,OT

Manufacturer Control # US-009507513-2012SP0 34972 Dosage Text 0.12-0.015 mg/24 hr x 3 weeks per month 0.12-0.015 mg/24 hr every 3 weeks UNK UNK

Age

Sex Unknown

Country USA

Preferred Term Lung neoplasm Pulmonary embolism Leukocytosis Withdrawal bleed Amenorrhoea Anogenital warts Cervical dysplasia Hypersensitivity Limb injury

Product NUVARING NUVARING vitamins (unspecified) ibuprofen

Role Route S S C C VAGINAL VAGINAL

Duration

Manufacturer MERCK MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,324 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8817243 Date FDA Received
21-Nov-2012 Case # 8817243 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2012SP0 36116 Dosage Text UNK Duration Age Sex Unknown Country USA

Preferred Term Abortion spontaneous Deep vein thrombosis Depression Female sterilisation Gestational diabetes Knee operation Mammoplasty Pregnancy

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

8821788 Date FDA Received

21-Nov-2012

Case # 8821788

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO

Manufacturer Control # US-009507513-2012SP0 06669 Dosage Text

Age

Sex Unknown

Country USA

Preferred Term Intracranial venous sinus thrombosis Cerebrovascular disorder Dermatitis contact Headache Migraine Nausea Obesity Pregnancy on contraceptive Sinusitis Vomiting

Product NUVARING

Role Route S

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,325 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8919906 Date FDA Received
21-Nov-2012 Case # 8919906 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1211USA 006318 Role Route S VAGINAL Dosage Text 3 week ring Duration Age Sex Female Country USA

Preferred Term Mood swings Device expulsion Headache Muscle spasms Product shape issue

Product NUVARING

Manufacturer MERCK

8920265 Date FDA Received

21-Nov-2012

Case # 8920265

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,OT

Manufacturer Control # US-009507513-2011SP0 17556 Dosage Text

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism Candidiasis

Product NUVARING NUVARING Case # 8920964 Case Type EXPEDITED (15-DAY) Health Professional

Role Route S S VAGINAL VAGINAL

Duration

Manufacturer MERCK MERCK

8920964 Date FDA Received

21-Nov-2012

Outcomes DS

Manufacturer Control # US-009507513-1211USA 007523 Dosage Text UNK Manufacturer Control # US-009507513-1211USA 007535 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Deep vein thrombosis

Product NUVARING Case # 8921026 Case Type EXPEDITED (15-DAY) Health Professional

Role Route S Outcomes OT

Duration

Manufacturer MERCK

8921026 Date FDA Received

21-Nov-2012

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,326 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8824989 Date FDA Received
22-Nov-2012 Case # 8824989 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1209USA 003061 Role Route S VAGINAL Dosage Text 1 DF, UNK Duration Age Sex Female Country USA

Preferred Term Withdrawal bleed Inappropriate schedule of drug administration Incorrect drug administration duration

Product NUVARING

Manufacturer MERCK

8912164 Date FDA Received

22-Nov-2012

Case # 8912164

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1211USA 006548

Age

Sex Female

Country USA

Preferred Term Vulvitis Product quality issue

Product NUVARING

Role Route S VAGINAL

Dosage Text UNK

Duration

Manufacturer MERCK

8921321 Date FDA Received

22-Nov-2012

Case # 8921321

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1211USA 005501

Age

Sex Female

Country USA

Preferred Term Polymenorrhoea

Product NUVARING Case # 8920994 Case Type NON-EXPEDITED Health Professional

Role Route S VAGINAL

Dosage Text 3 weeks in 1 week out Manufacturer Control # US-009507513-1211USA 006228

Duration

Manufacturer MERCK

8920994 Date FDA Received

23-Nov-2012

Outcomes

Age

Sex Female

Country USA

Preferred Term Fungal infection Device breakage Device expulsion Vulvovaginal discomfort

Product NUVARING

Role Route S VAGINAL

Dosage Text 1 ring/every 28 days

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,327 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8921094 Date FDA Received
23-Nov-2012 Case # 8921094 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1211USA 002455 Role Route S C Outcomes Manufacturer Control # US-009507513-1211USA 008885 Role Route S Dosage Text UNK Duration Age Sex Female Country USA VAGINAL Dosage Text 1 DF, UNK Duration Age Sex Female Country USA

Preferred Term Muscle spasms Metrorrhagia

Product NUVARING levothyroxine sodium Case # 8922079 Case Type NON-EXPEDITED Health Professional

Manufacturer MERCK

8922079 Date FDA Received

23-Nov-2012

Preferred Term Vulvitis Product quality issue

Product NUVARING

Manufacturer MERCK

8922130 Date FDA Received

23-Nov-2012

Case # 8922130

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1211USA 008886

Age

Sex Female

Country USA

Preferred Term Vulvitis Product quality issue

Product NUVARING

Role Route S

Dosage Text UNK

Duration

Manufacturer MERCK

8922134 Date FDA Received

23-Nov-2012

Case # 8922134

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1211USA 008887

Age

Sex Female

Country USA

Preferred Term Vulvitis Product quality issue

Product NUVARING

Role Route S

Dosage Text UNK

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,328 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8922155 Date FDA Received
23-Nov-2012 Case # 8922155 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1211USA 007278 Role Route S VAGINAL Dosage Text 3 weeks inserted one week ring free break Age 23 YR Sex Female Country USA

Preferred Term Withdrawal bleed Device expulsion

Product NUVARING

Duration

Manufacturer MERCK

8796595 Date FDA Received

24-Nov-2012

Case # 8796595

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1209USA 006913

Age

Sex Female

Country USA

Preferred Term Nasopharyngitis Vaginal discharge Vulvovaginal discomfort

Product NUVARING

Role Route S VAGINAL

Dosage Text UNK

Duration

Manufacturer MERCK

8923437 Date FDA Received

24-Nov-2012

Case # 8923437

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,LT

Manufacturer Control # US-009507513-1211USA 008412 Dosage Text 0.015/0.12 units unspecified, 1 ring for 3 weeks on and 1week off 20 mg, UNK

Age

Sex Female

Country USA

Preferred Term Cerebrovascular accident

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

CELEXA

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,329 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8709785 Date FDA Received
26-Nov-2012 Case # 8709785 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-1208USA 000245 Dosage Text UNK UNK 20 mg, bid 50 mg, prn 800 mg, prn Duration Age Sex Unknown Country USA

Preferred Term Aortic embolus Deep vein thrombosis Sacroiliitis Off label use Seronegative arthritis Cough Hypoxia Loss of consciousness Nasopharyngitis Oropharyngeal pain Rheumatic disorder Syncope Ulcer haemorrhage Urinary tract infection Wisdom teeth removal

Product NUVARING NUVARING prednisone tramadol hydrochloride ibuprofen

Role Route S S C C C VAGINAL VAGINAL ORAL

Manufacturer MERCK MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,330 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8716270 Date FDA Received
26-Nov-2012 Case # 8716270 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2012SP0 22602 Dosage Text 1 DF, qm 1 DF, qm 1 DF, UNK Duration Age Sex Unknown Country USA

Preferred Term Chest pain Pulmonary embolism Deep vein thrombosis Back pain Blood cholesterol increased Dyspnoea Herpes simplex Hypoglycaemia Metrorrhagia Oligomenorrhoea

Product NUVARING NUVARING NUVARING

Role Route S S S VAGINAL VAGINAL VAGINAL

Manufacturer MERCK MERCK MERCK

8815552 Date FDA Received

26-Nov-2012

Case # 8815552

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO

Manufacturer Control # US-009507513-2011SP0 05535 Dosage Text

Age

Sex Unknown

Country USA

Preferred Term Deep vein thrombosis Emotional disorder Mental disorder Angina pectoris Fatigue Head injury Musculoskeletal chest pain Oedema peripheral Sinus disorder Vaginal infection Weight increased

Product NUVARING NUVARING ACETAMINOPHEN (+) HYDROCODONE BITARTRATE

Role Route S S C ORAL

Duration

Manufacturer MERCK MERCK

UNK UNK, PRN

8823894
Date - Time: 02-04-2013 9:43:10 AM EST Note: If the field is blank, there is no data Page: 1,331 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8823894
FDA Received Date 26-Nov-2012 Case # 8823894 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2011SP0 57243 Dosage Text UNK Duration Age Sex Unknown Country USA

Preferred Term Aortic embolus Adenoidectomy Anticoagulation drug level below therapeutic Anxiety Appendicectomy Appendicitis Catheter removal Chest pain Deep vein thrombosis Depression Diabetes mellitus Dyspnoea Fibrin D dimer increased Furuncle Glucose tolerance impaired Haemorrhage Haemorrhoids Hypoaesthesia Implantable defibrillator insertion Intracranial pressure increased Irritability Migraine Pancreatic disorder Pleurisy Pleuritic pain Post-traumatic stress disorder Pulmonary embolism

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,332 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8823894
Preferred Term Rectal haemorrhage Tension headache Treatment noncompliance Varicose vein Vein disorder Vena cava filter insertion Viral upper respiratory tract infection Product Role Route Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,333 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8846482 Date FDA Received
26-Nov-2012 Case # 8846482 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2010SP0 56217 Dosage Text Duration Age Sex Unknown Country USA

Preferred Term Uterine leiomyoma Arachnoid cyst Deep vein thrombosis Pelvic venous thrombosis Blood cholesterol increased Breast cyst Bronchitis Coagulopathy Congenital arterial malformation Embolism venous Fibrocystic breast disease Haemangioma of liver Hypoprothrombinaemia Nervous system disorder Pulmonary embolism Sinusitis Spider vein Urinary tract infection Vascular operation Vena cava filter insertion

Product NUVARING NUVARING NUVARING SYNTHROID

Role Route S S S C VAGINAL

Manufacturer MERCK MERCK MERCK

112 ?g, QD

8922544 Date FDA Received

26-Nov-2012

Case # 8922544

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1211USA 008208

Age 39 YR

Sex Female

Country USA

Preferred Term Menstruation delayed

Product NUVARING

Role Route S VAGINAL

Dosage Text 1 ring for 3 weeks followed by a week free break

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,334 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8922551 Date FDA Received
26-Nov-2012 Case # 8922551 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1211USA 002488 Role Route S VAGINAL Dosage Text 3 weeks in, 1 week out Age 27 YR Sex Female Country USA

Preferred Term Weight decreased Alopecia Menstruation irregular

Product NUVARING

Duration

Manufacturer MERCK

8924410 Date FDA Received

26-Nov-2012

Case # 8924410

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes OT

Manufacturer Control # BR-009507513-1211BRA 010252 Dosage Text UNK

Age

Sex Female

Country BRA

Preferred Term Mammoplasty Drug administration error Liposuction Metrorrhagia Oesophagitis Reflux gastritis

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

8924706 Date FDA Received

26-Nov-2012

Case # 8924706

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes OT

Manufacturer Control # US-009507513-2010SP0 20840 Dosage Text

Age

Sex Unknown

Country USA

Preferred Term Deep vein thrombosis Thrombophlebitis Chest pain Abdominal pain Vaginal discharge

Product NUVARING NUVARING RISPERIDONE ZOLOFT

Role Route S S C C

Duration

Manufacturer MERCK MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,335 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8924745 Date FDA Received
26-Nov-2012 Case # 8924745 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1211USA 008559 Role Route S S S Health Professional Outcomes HO,OT Dosage Text UNK UNK UNK Manufacturer Control # US-009507513-2009-201 021-NL Dosage Text CONTINUING: NO Duration Age Sex Female Duration Age Sex Unknown Country USA

Preferred Term Pregnancy

Product NUVARING NUVARING NUVARING

Manufacturer MERCK MERCK MERCK Country USA

8925380 Date FDA Received

26-Nov-2012

Case # 8925380

Case Type EXPEDITED (15-DAY)

Preferred Term Pulmonary embolism Deep vein thrombosis Pulmonary infarction Pharyngitis Dermatitis Lymphadenopathy Blood disorder Menstruation delayed Acne Abortion induced

Product NUVARING COUMADIN LOVENOX HEPARIN HYDRO.C.SOD.SUC. METROGEL (METRONIDAZOLE) AZITHROMYCIN BENZACLIN LIQUIBID NASONEX DIFLUCAN

Role Route S S S S C C C C C C C Health Professional ORAL INHALATION ORAL TOPICAL VAGINAL

Manufacturer MERCK

0.2% CREAM 0.75% VAGINAL GEL 250 MG DOSE D1200 2 SPRAYS TO EACH NOSTRIL 150 mg, ONCE Manufacturer Control # US-009507513-1211USA 010222 Age Sex Unknown Country USA MERCK

8925703 Date FDA Received

26-Nov-2012

Case # 8925703

Case Type NON-EXPEDITED

Outcomes

Preferred Term Thrombosis

Product NUVARING

Role Route S VAGINAL

Dosage Text UNK

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,336 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8925894 Date FDA Received
26-Nov-2012 Case # 8925894 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2010SP0 55017 Dosage Text Duration Age Sex Unknown Country USA

Preferred Term Pulmonary embolism Cognitive disorder Deep vein thrombosis Depression Emotional disorder Mental disorder Pulmonary infarction Sciatica Urinary tract infection

Product NUVARING

Role Route S

Manufacturer MERCK

8926093 Date FDA Received

26-Nov-2012

Case # 8926093

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1211USA 005999

Age

Sex Female

Country USA

Preferred Term Vulvovaginal discomfort Product quality issue

Product NUVARING

Role Route S VAGINAL

Dosage Text 1 ring for 3 weeks on and 1 week off

Duration

Manufacturer MERCK

8926428 Date FDA Received

26-Nov-2012

Case # 8926428

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1211USA 008090

Age 25 YR

Sex Female

Country USA

Preferred Term Alopecia Weight increased Nausea

Product NUVARING NUVARING

Role Route S S VAGINAL

Dosage Text Every 3 weeks in, 1 week out

Duration

Manufacturer MERCK MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,337 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8928671 Date FDA Received
26-Nov-2012 Preferred Term Visual impairment Balance disorder Diplopia Ischaemic stroke Case # 8928671 Case Type DIRECT Product NUVARING MERCK Health Professional Outcomes DE,HO,DS,LT,CA,OT,RI Role Route S Dosage Text Manufacturer Control # Age 32 YR Duration Sex Female Country USA

Manufacturer

8927144 Date FDA Received

27-Nov-2012

Case # 8927144

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1211USA 010219

Age

Sex Unknown

Country USA

Preferred Term Intracardiac thrombus

Product NUVARING Case # 8927306 Case Type EXPEDITED (15-DAY) Health Professional

Role Route S VAGINAL

Dosage Text UNK Manufacturer Control # CH-009507513-1211CHE 005649 Dosage Text 11.7/2.7 mg

Duration

Manufacturer MERCK

8927306 Date FDA Received

27-Nov-2012

Outcomes HO

Age 29 YR

Sex Female

Country CHE

Preferred Term Delivery Unintended pregnancy

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

8898626 Date FDA Received

28-Nov-2012

Case # 8898626

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes OT

Manufacturer Control # US-009507513-1211USA 003735 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism

Product NUVARING

Role Route S

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,338 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8929149 Date FDA Received
28-Nov-2012 Case # 8929149 Case Type EXPEDITED (15-DAY) Health Professional Outcomes OT Manufacturer Control # CH-009507513-1211CHE 005675 Dosage Text 11.7/2.7 mg Age 29 YR Sex Female Country CHE

Preferred Term Abortion missed Unintended pregnancy

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

8930259 Date FDA Received

28-Nov-2012

Case # 8930259

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes OT

Manufacturer Control # US-009507513-1211USA 010213 Dosage Text UNK Manufacturer Control # US-009507513-1211USA 010220 Dosage Text UNK Manufacturer Control # US-009507513-2012SP0 06354 Dosage Text

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism

Product NUVARING Case # 8930474 Case Type EXPEDITED (15-DAY) Health Professional

Role Route S Outcomes OT

Duration

Manufacturer MERCK

8930474 Date FDA Received

28-Nov-2012

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism

Product NUVARING Case # 8930487 Case Type EXPEDITED (15-DAY) Health Professional

Role Route S VAGINAL

Duration

Manufacturer MERCK

8930487 Date FDA Received

28-Nov-2012

Outcomes HO,OT

Age

Sex Unknown

Country USA

Preferred Term Left ventricular hypertrophy Back pain Gastrooesophageal reflux disease Haemangioma of liver Pleuritic pain Pulmonary embolism Pulmonary infarction Pyrexia Thyroid neoplasm

Product NUVARING

Role Route S

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,339 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8932169 Date FDA Received
28-Nov-2012 Case # 8932169 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1211USA 011356 Role Route S Health Professional VAGINAL Dosage Text UNK Manufacturer Control # US-009507513-1211USA 010215 Dosage Text UNK UNK Manufacturer Control # US-009507513-1211USA 010778 Role Route S VAGINAL Dosage Text Duration Age Sex Female Duration Age Sex Unknown Duration Age Sex Unknown Country USA

Preferred Term Device expulsion

Product NUVARING Case # 8932385 Case Type EXPEDITED (15-DAY)

Manufacturer MERCK Country USA

8932385 Date FDA Received

28-Nov-2012

Outcomes OT

Preferred Term Pulmonary embolism

Product NUVARING NUVARING

Role Route S S Health Professional VAGINAL VAGINAL

Manufacturer MERCK MERCK Country USA

8934447 Date FDA Received

28-Nov-2012

Case # 8934447

Case Type NON-EXPEDITED

Outcomes

Preferred Term Device expulsion Product quality issue

Product NUVARING

Manufacturer MERCK

8705238 Date FDA Received

29-Nov-2012

Case # 8705238

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,OT

Manufacturer Control # US-009507513-1208USA 000208

Age

Sex Unknown

Country USA

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,340 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8705238
Preferred Term Respiratory failure Amnesia Anxiety Cardiac arrest Cardiac disorder Cognitive disorder Coma Convulsion Deep vein thrombosis Depression Fall Haemangioma of liver Hepatic enzyme increased Hyperglycaemia Hypokalaemia Hypotension Insomnia Joint instability Motor dysfunction Pneumonia Post thrombotic syndrome Pulmonary embolism Pulmonary infarction Shock Stress Transaminases increased Treatment noncompliance Varicose vein Vascular insufficiency Venous insufficiency Product NUVARING Role Route S VAGINAL Dosage Text In 3 weeks, out 1 week Duration Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,341 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8711794 Date FDA Received
29-Nov-2012 Case # 8711794 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO Manufacturer Control # US-009507513-1208USA 000212 Dosage Text UNK Duration Age Sex Unknown Country USA

Preferred Term Papilloedema Anxiety Benign intracranial hypertension Cerebral venous thrombosis Cranial nerve disorder Migraine

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

8846712 Date FDA Received

29-Nov-2012

Case # 8846712

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,DS,OT

Manufacturer Control # US-009507513-2012SP0 36104 Dosage Text UNK UNK 1 ring weekly

Age

Sex Unknown

Country USA

Preferred Term Road traffic accident Pulmonary embolism Deep vein thrombosis Atelectasis Drug abuse Drug prescribing error Dyspareunia Maternal exposure before pregnancy Menometrorrhagia Migraine Off label use Ovarian cyst Polycystic ovaries Skin papilloma Urinary tract infection

Product NUVARING NUVARING NUVARING

Role Route S S S VAGINAL VAGINAL VAGINAL

Duration

Manufacturer MERCK MERCK MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,342 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8933351 Date FDA Received
29-Nov-2012 Case # 8933351 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1211USA 009320 Role Route S Health Professional VAGINAL Dosage Text UNK Manufacturer Control # US-009507513-1211USA 010849 Dosage Text UNK Manufacturer Control # US-009507513-1211USA 010834 Dosage Text UNK Manufacturer Control # US-009507513-1211USA 010845 Dosage Text UNK Duration Age Sex Unknown Duration Age Sex Unknown Duration Age Sex Unknown Duration Age Sex Unknown Country USA

Preferred Term Device expulsion

Product NUVARING Case # 8934036 Case Type EXPEDITED (15-DAY)

Manufacturer MERCK Country USA

8934036 Date FDA Received

29-Nov-2012

Outcomes HO,OT

Preferred Term Pulmonary embolism

Product NUVARING Case # 8934162 Case Type EXPEDITED (15-DAY) Health Professional

Role Route S VAGINAL

Manufacturer MERCK Country USA

8934162 Date FDA Received

29-Nov-2012

Outcomes OT

Preferred Term Pulmonary embolism

Product NUVARING Case # 8934223 Case Type EXPEDITED (15-DAY) Health Professional

Role Route S VAGINAL

Manufacturer MERCK Country USA

8934223 Date FDA Received

29-Nov-2012

Outcomes OT

Preferred Term Pulmonary embolism Deep vein thrombosis

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

8934224 Date FDA Received

29-Nov-2012

Case # 8934224

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1211USA 010842

Age

Sex Unknown

Country USA

Preferred Term Deep vein thrombosis Thrombosis

Product NUVARING

Role Route S VAGINAL

Dosage Text UNK

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,343 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8934240 Date FDA Received
29-Nov-2012 Case # 8934240 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-1211USA 010236 Dosage Text UNK Manufacturer Control # US-009507513-1211USA 010865 Dosage Text UNK Manufacturer Control # US-009507513-1211USA 010853 Dosage Text UNK Duration Age Sex Unknown Duration Age Sex Unknown Duration Age Sex Unknown Country USA

Preferred Term Pulmonary embolism

Product NUVARING Case # 8934572 Case Type EXPEDITED (15-DAY) Health Professional

Role Route S VAGINAL

Manufacturer MERCK Country USA

8934572 Date FDA Received

29-Nov-2012

Outcomes DS,OT

Preferred Term Pulmonary embolism

Product NUVARING Case # 8934915 Case Type EXPEDITED (15-DAY) Health Professional

Role Route S VAGINAL

Manufacturer MERCK Country USA

8934915 Date FDA Received

29-Nov-2012

Outcomes HO

Preferred Term Deep vein thrombosis

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,344 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8054562 Date FDA Received
30-Nov-2012 Case # 8054562 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,DS,OT Manufacturer Control # US-009507513-2011SP0 06459 Dosage Text UNK 12.5 mg, qam 25 mg, QD Duration Age Sex Unknown Country USA

Preferred Term Hypokalaemia Hypercoagulation Deep vein thrombosis Costochondritis Dysmenorrhoea Essential hypertension Head injury Menorrhagia Migraine Pain in extremity Phlebitis Plantar fasciitis Pulmonary embolism Road traffic accident Uterine leiomyoma Venous insufficiency

Product NUVARING HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE

Role Route S C C VAGINAL ORAL ORAL

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,345 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8708303 Date FDA Received
30-Nov-2012 Case # 8708303 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-1208USA 000228 Dosage Text 3 weeks in 1 week out Duration Age Sex Unknown Country USA

Preferred Term Pulmonary infarction Pulmonary embolism Abdominal pain Adverse drug reaction Anaemia Angina pectoris Arthropod bite Breast tenderness Deep vein thrombosis Depression Nausea Pharyngitis Pregnancy Protein S deficiency Sinusitis Urinary tract infection Vomiting

Product NUVARING NUVARING

Role Route S S VAGINAL

Manufacturer MERCK MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,346 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8740575 Date FDA Received
30-Nov-2012 Case # 8740575 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-1208USA 007411 Dosage Text UNK ORAL od Duration Age Sex Unknown Country USA

Preferred Term Pulmonary embolism Off label use Anxiety Atrial fibrillation Back pain Constipation Depression Device dislocation Dyspnoea Hypercholesterolaemia Hypothyroidism Musculoskeletal pain Surgery Thyroid neoplasm Tricuspid valve incompetence

Product NUVARING CRESTOR

Role Route S C

Manufacturer MERCK

8763414 Date FDA Received

30-Nov-2012

Case # 8763414

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO

Manufacturer Control # US-009507513-1208USA 007414 Dosage Text 0.12-0.015 mg/ 24 hr

Age

Sex Unknown

Country USA

Preferred Term Deep vein thrombosis Anaemia Coagulopathy Haematochezia Obesity

Product NUVARING

Role Route S

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,347 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8936209 Date FDA Received
30-Nov-2012 Case # 8936209 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1211USA 011906 Role Route S VAGINAL Dosage Text 3 week in, 1 week out Age 23 YR Sex Female Country USA

Preferred Term Unintended pregnancy Inappropriate schedule of drug administration Incorrect drug administration duration

Product NUVARING

Duration

Manufacturer MERCK

8936360 Date FDA Received

30-Nov-2012

Case # 8936360

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes DS,OT

Manufacturer Control # US-009507513-1211USA 010855 Dosage Text UNK Manufacturer Control # US-009507513-1211USA 011750 Dosage Text UNK Manufacturer Control # US-009507513-1211USA 010861 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism

Product NUVARING Case # 8937047 Case Type EXPEDITED (15-DAY) Health Professional

Role Route S VAGINAL

Duration

Manufacturer MERCK

8937047 Date FDA Received

30-Nov-2012

Outcomes OT

Age 20 YR

Sex Female

Country USA

Preferred Term Pulmonary embolism

Product NUVARING Case # 8939896 Case Type EXPEDITED (15-DAY) Health Professional

Role Route S VAGINAL

Duration

Manufacturer MERCK

8939896 Date FDA Received

30-Nov-2012

Outcomes OT

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism Thrombosis

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

8939904 Date FDA Received

30-Nov-2012

Case # 8939904

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes OT

Manufacturer Control # US-009507513-1211USA 010859 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,348 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8942182 Date FDA Received
02-Dec-2012 Case # 8942182 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1211USA 007648 Role Route S Health Professional VAGINAL Dosage Text 1 ring for 3 weeks Manufacturer Control # USMERCK-2012SP036942 Dosage Text UNK Duration Age Sex Unknown Age 40 YR Sex Female Country USA

Preferred Term Metrorrhagia

Product NUVARING Case # 8654136 Case Type EXPEDITED (15-DAY)

Duration

Manufacturer MERCK Country USA

8654136 Date FDA Received

03-Dec-2012

Outcomes HO

Preferred Term Vena cava filter insertion Angioplasty Anxiety Breast cyst excision Deep vein thrombosis Depression Fibrocystic breast disease Irritability Post thrombotic syndrome Thrombophlebitis Treatment failure Venous occlusion Venous stent insertion Weight decreased

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

8669656 Date FDA Received

03-Dec-2012

Case # 8669656

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes LT

Manufacturer Control # IT-009507513-2012SP03 4155

Age 40 YR

Sex Female

Country ITA

Preferred Term Deep vein thrombosis

Product NUVARING

Role Route S VAGINAL

Dosage Text 1 DF, UNK

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,349 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8740562 Date FDA Received
03-Dec-2012 Case # 8740562 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-1208USA 007401 Dosage Text UNK UNK, prn Manufacturer Control # US-009507513-1208USA 007434 Dosage Text UNK UNK Duration Age Sex Unknown Country USA Duration Age Sex Unknown Country USA

Preferred Term Pulmonary embolism

Product NUVARING nonsteroidal anti-inflammatory drug (unspecified)

Role Route S C Outcomes HO,OT VAGINAL

Manufacturer MERCK

8740567 Date FDA Received

03-Dec-2012

Case # 8740567

Case Type EXPEDITED (15-DAY)

Health Professional

Preferred Term Hypokalaemia Pulmonary embolism Hypertension

Product NUVARING NUVARING

Role Route S S VAGINAL VAGINAL

Manufacturer MERCK MERCK

8740587 Date FDA Received

03-Dec-2012

Case # 8740587

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,OT

Manufacturer Control # US-009507513-1208USA 007473 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Proteinuria Dysuria Essential tremor Hyperlipidaemia Hypokalaemia Migraine Pulmonary embolism

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,350 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8921442 Date FDA Received
03-Dec-2012 Case # 8921442 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,DS,OT Manufacturer Control # US-009507513-1211USA 007589 Dosage Text in 3 weeks, out 1 week Duration Age Sex Unknown Country USA

Preferred Term Intracranial venous sinus thrombosis Headache Adverse drug reaction Anxiety Constipation Depression Drug prescribing error Dural fistula Dysmenorrhoea Fatigue Headache Insomnia Irritable bowel syndrome Nausea Off label use Ovarian cyst Therapeutic response unexpected Vision blurred

Product NUVARING NUVARING

Role Route S S VAGINAL

Manufacturer MERCK MERCK

8939909 Date FDA Received

03-Dec-2012

Case # 8939909

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1211USA 012511

Age

Sex Female

Country USA

Preferred Term Inappropriate schedule of drug administration

Product NUVARING

Role Route S VAGINAL

Dosage Text Every 3 weeks in, 1 week out

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,351 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8940009 Date FDA Received
03-Dec-2012 Case # 8940009 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1211USA 012748 Role Route S Health Professional Outcomes Dosage Text UNK Manufacturer Control # US-009507513-1211USA 009177 Role Route S Health Professional VAGINAL Dosage Text UNK Manufacturer Control # US-009507513-1211USA 012908 Role Route S Health Professional VAGINAL Dosage Text UNK Manufacturer Control # US-009507513-1212USA 000047 Dosage Text UNK Duration Age Sex Female Duration Age Sex Unknown Age 37 YR Sex Female Duration Age Sex Female Country USA

Preferred Term Device expulsion

Product NUVARING Case # 8940096 Case Type NON-EXPEDITED

Manufacturer MERCK Country USA

8940096 Date FDA Received

03-Dec-2012

Preferred Term Inappropriate schedule of drug administration

Product NUVARING

Duration

Manufacturer MERCK Country USA

8940853 Date FDA Received

03-Dec-2012

Case # 8940853

Case Type NON-EXPEDITED

Outcomes

Preferred Term High risk pregnancy

Product NUVARING Case # 8941556 Case Type EXPEDITED (15-DAY)

Manufacturer MERCK Country USA

8941556 Date FDA Received

03-Dec-2012

Outcomes HO

Preferred Term Cerebrovascular accident Confusional state Headache

Product NUVARING

Role Route S

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,352 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8941724 Date FDA Received
03-Dec-2012 Case # 8941724 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1211USA 012295 Role Route S VAGINAL Dosage Text UNK, 3 weeks in, 1 week out Age 21 YR Sex Female Country USA

Preferred Term Inappropriate schedule of drug administration Incorrect drug administration duration

Product NUVARING

Duration

Manufacturer MERCK

8941768 Date FDA Received

03-Dec-2012

Case # 8941768

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO

Manufacturer Control # US-009507513-1211USA 010850 Dosage Text UNK Manufacturer Control # US-009507513-1211USA 012530

Age

Sex Unknown

Country USA

Preferred Term Deep vein thrombosis

Product NUVARING Case # 8941861 Case Type NON-EXPEDITED Health Professional

Role Route S Outcomes

Duration

Manufacturer MERCK

8941861 Date FDA Received

03-Dec-2012

Age 27 YR

Sex Female

Country USA

Preferred Term Cyanosis

Product NUVARING

Role Route S VAGINAL

Dosage Text delivers 0.015 etonogestrel/0.012 ethinyl estradiol Manufacturer Control # US-009507513-1211USA 012321

Duration

Manufacturer MERCK

8943387 Date FDA Received

03-Dec-2012

Case # 8943387

Case Type NON-EXPEDITED

Health Professional

Outcomes

Age 19 YR

Sex Female

Country USA

Preferred Term Inappropriate schedule of drug administration

Product NUVARING Health Professional

Role Route S VAGINAL

Dosage Text 3 weeks in, 1 week out Manufacturer Control # US-009507513-2012SP0 17429

Duration

Manufacturer MERCK

8711834 Date FDA Received

04-Dec-2012

Case # 8711834

Case Type EXPEDITED (15-DAY)

Outcomes HO,DS,OT

Age

Sex Unknown

Country USA

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,353 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8711834
Preferred Term Deafness unilateral Abdominal pain lower Anticoagulation drug level below therapeutic Anxiety Attention deficit/hyperactivity disorder Blood disorder Cerebral infarction Colon injury Constipation Cyst Deep vein thrombosis Depression Dysfunctional uterine bleeding Dyslipidaemia Endometriosis Haemorrhagic stroke Headache Hyperlipidaemia Joint injury Jugular vein thrombosis Migraine Oedema peripheral Pain in extremity Pulmonary embolism Surgery Thrombosis Transient ischaemic attack Urinary hesitation Vitamin D deficiency Product NUVARING Role Route S Dosage Text UNK Duration Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,354 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8879873 Date FDA Received
04-Dec-2012 Case # 8879873 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,LT,OT Manufacturer Control # US-009507513-1210USA 011439 Dosage Text UNK Duration Age Sex Female Country USA

Preferred Term Post procedural complication Pulmonary embolism Deep vein thrombosis Deep vein thrombosis

Product NUVARING EFFEXOR TOPAMAX

Role Route S C C VAGINAL

Manufacturer MERCK

8944824 Date FDA Received

04-Dec-2012

Case # 8944824

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1212USA 000455

Age 28 YR

Sex Female

Country USA

Preferred Term Uterine inflammation Hypersensitivity

Product NUVARING

Role Route S VAGINAL

Dosage Text UNK

Duration

Manufacturer MERCK

8944914 Date FDA Received

04-Dec-2012

Case # 8944914

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1211USA 012328

Age 17 YR

Sex Female

Country USA

Preferred Term Inappropriate schedule of drug administration Amenorrhoea Metrorrhagia

Product NUVARING

Role Route S VAGINAL

Dosage Text UNK

Duration

Manufacturer MERCK

8762275 Date FDA Received

05-Dec-2012

Case # 8762275

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,DS,OT

Manufacturer Control # US-009507513-2011SP0 16567

Age

Sex Unknown

Country USA

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,355 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8762275
Preferred Term Carotid artery dissection Ischaemic stroke Cerebral infarction Cerebral artery thrombosis Haemorrhagic stroke Anxiety Breast discharge Breast mass Calculus ureteric Cognitive disorder Cranioplasty Depression Dysfunctional uterine bleeding Endometrial ablation Female sterilisation Headache Hydronephrosis Hypertonic bladder Insomnia Lithotripsy Menorrhagia Migraine Obesity Oral candidiasis Quality of life decreased Renal cyst Stress Tenderness Upper-airway cough syndrome Urinary tract infection Product NUVARING NUVARING NUVARING SYNTHROID VITAMINS (UNSPECIFIED) Role Route S S S C C UNK UNK, QD UNK Dosage Text Duration Manufacturer MERCK MERCK MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,356 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8916343 Date FDA Received
05-Dec-2012 Case # 8916343 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-1211USA 008011 Dosage Text UNK Manufacturer Control # US-009507513-1212USA 000800 Role Route S Health Professional VAGINAL Dosage Text UNK Manufacturer Control # US-009507513-1212USA 000425 Dosage Text Duration Age Sex Unknown Duration Age Sex Female Duration Age Sex Unknown Country USA

Preferred Term Pulmonary embolism

Product NUVARING Case # 8945380 Case Type NON-EXPEDITED Health Professional

Role Route S Outcomes

Manufacturer MERCK Country USA

8945380 Date FDA Received

05-Dec-2012

Preferred Term Alopecia

Product NUVARING Case # 8947109 Case Type EXPEDITED (15-DAY)

Manufacturer MERCK Country USA

8947109 Date FDA Received

05-Dec-2012

Outcomes HO,DS

Preferred Term Vascular injury Deep vein thrombosis

Product NUVARING

Role Route S

Manufacturer MERCK

8949917 Date FDA Received

05-Dec-2012

Case # 8949917

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1212USA 001058

Age

Sex Female

Country USA

Preferred Term Incorrect storage of drug

Product NUVARING

Role Route S VAGINAL

Dosage Text

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,357 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8952283 Date FDA Received
05-Dec-2012 Case # 8952283 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1212USA 000774 Role Route S S VAGINAL Dosage Text up to 3 weeks with one week ring free break UNK Duration Age Sex Female Country USA

Preferred Term Abnormal withdrawal bleeding Incorrect drug administration duration Inappropriate schedule of drug administration

Product NUVARING NUVARING

Manufacturer MERCK MERCK

8952308 Date FDA Received

05-Dec-2012

Case # 8952308

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1211USA 011740

Age 24 YR

Sex Female

Country USA

Preferred Term Mobility decreased Fall Crying Dyspareunia Medical device discomfort Pain Vaginal discharge Vulval disorder Vulvovaginal discomfort

Product NUVARING vitamins (unspecified)

Role Route S C VAGINAL

Dosage Text UNK

Duration

Manufacturer MERCK

8952616 Date FDA Received

05-Dec-2012

Case # 8952616

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1212USA 001388

Age

Sex Female

Country USA

Preferred Term Vulvovaginal discomfort Product quality issue Vulvovaginal rash

Product NUVARING

Role Route S VAGINAL

Dosage Text UNK

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,358 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6973407 Date FDA Received
06-Dec-2012 Case # 6973407 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,DS,OT Manufacturer Control # US-009507513-2008-188 696-NL Dosage Text CONTINUING: NO DOSE TEXT: 1 TAB OD PRN, FREQUENCY: PRN 180 20 mg, QD Duration Age Sex Unknown Country USA

Preferred Term Pulmonary embolism Fibrocystic breast disease Pulmonary infarction

Product NUVARING NUVARING IBUPROFEN

Role Route S S C

Manufacturer MERCK MERCK

Hypophosphataemia Sinus disorder Adverse drug reaction Carpal tunnel decompression Carpal tunnel syndrome Deep vein thrombosis Dyspnoea Encephalopathy Hypercoagulation Hysterectomy Liver function test abnormal Nasal obstruction Off label use Presyncope Rhinitis Upper extremity mass

ALLEGRA CELEXA

C C

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,359 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8696887 Date FDA Received
06-Dec-2012 Case # 8696887 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2011SP0 32589 Dosage Text UNK Duration Age Sex Unknown Country USA

Preferred Term Pulmonary embolism Blood cholesterol increased Cervical dysplasia Conjunctival haemorrhage Deep vein thrombosis Facial bones fracture Hypercoagulation Metrorrhagia Papilloma viral infection Skin disorder Urinary tract infection

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

8755879 Date FDA Received

06-Dec-2012

Case # 8755879

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,OT

Manufacturer Control # US-009507513-2012SP0 22368 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism Abdominal pain Coagulopathy Coeliac disease Diarrhoea Haematochezia Headache Papilloma viral infection Urethral dilation procedure Urinary tract infection Weight decreased

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,360 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8949469 Date FDA Received
06-Dec-2012 Case # 8949469 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1212USA 001094 Role Route S Health Professional Outcomes HO,LT Manufacturer Control # US-009507513-1212USA 002018 Dosage Text 0.120 mg/day of etonogestrel and 0. 015 mg/day of ethinyl estradiol/21 days Manufacturer Control # US-009507513-1212USA 001377 Dosage Text 0.120 mg/day of etonogestrel and 0. 015 mg/day of ethinyl estradiol/21 days Manufacturer Control # US-009507513-1211USA 012289 Role Route S VAGINAL Dosage Text 1 ring for 3 weeks Age 19 YR Sex Female Duration Age Sex Female Duration Age Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term Device expulsion

Product NUVARING Case # 8949663 Case Type EXPEDITED (15-DAY)

Manufacturer MERCK Country USA

8949663 Date FDA Received

06-Dec-2012

Preferred Term Pulmonary embolism

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

8949677 Date FDA Received

06-Dec-2012

Case # 8949677

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,LT

Country USA

Preferred Term Pulmonary embolism

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

8953193 Date FDA Received

06-Dec-2012

Case # 8953193

Case Type NON-EXPEDITED

Health Professional

Outcomes

Country USA

Preferred Term Metrorrhagia

Product NUVARING

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,361 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8953221 Date FDA Received
06-Dec-2012 Case # 8953221 Case Type EXPEDITED (15-DAY) Health Professional Outcomes OT Manufacturer Control # GR-009507513-1212GR C001497 Dosage Text UNK Duration Age Sex Female Country GRC

Preferred Term Complex regional pain syndrome Drug intolerance Erythema Product quality issue

Product NUVARING

Role Route S

Manufacturer MERCK

8953241 Date FDA Received

06-Dec-2012

Case # 8953241

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1212USA 000198

Age

Sex Female

Country USA

Preferred Term Menorrhagia Amenorrhoea

Product NUVARING

Role Route S VAGINAL

Dosage Text UNK

Duration

Manufacturer MERCK

8953832 Date FDA Received

06-Dec-2012

Case # 8953832

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes OT

Manufacturer Control # US-009507513-1212USA 001127 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism

Product NUVARING

Role Route S

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,362 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8688772 Date FDA Received
07-Dec-2012 Case # 8688772 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2012SP0 17341 Dosage Text UNK Duration Age Sex Female Country USA

Preferred Term Pulmonary embolism Acute tonsillitis Adenoidectomy Anxiety Arthralgia Deep vein thrombosis Headache Major depression Mitral valve incompetence Nausea Overdose Pain Pharyngitis Pulmonary valve incompetence Sialoadenitis Sinusitis Tonsillar hypertrophy Tonsillectomy Tricuspid valve incompetence Upper airway obstruction Upper respiratory tract infection Vomiting

Product NUVARING

Role Route S

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,363 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8708729 Date FDA Received
07-Dec-2012 Case # 8708729 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,DS,OT Manufacturer Control # US-009507513-1208USA 000207 Dosage Text in 3 weeks/out 1 week Duration Age Sex Unknown Country USA

Preferred Term Pulmonary embolism Ovarian cyst Antiphospholipid syndrome Allergy to metals Headache Hypertriglyceridaemia Lung disorder Nausea Vomiting

Product NUVARING NUVARING NUVARING

Role Route S S S VAGINAL

Manufacturer MERCK MERCK MERCK

8773533 Date FDA Received

07-Dec-2012

Case # 8773533

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,DS,OT

Manufacturer Control # US-009507513-2009-198 049-NL Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Hypokalaemia Hypothyroidism Intracranial venous sinus thrombosis Migraine Vertigo positional Diplopia Papilloedema Sinusitis Rosacea Adenoidectomy Anaemia Anxiety Constipation Contusion

Product NUVARING HORMONES (UNSPECIFIED) TYLENOL IMITREX (SUMATRIPTAN) ROBITUSSIN SUDAFED PROVENTIL PULMICORT ADVAIR

Role Route S S C C C C C C C VAGINAL

Duration

Manufacturer MERCK

MERCK 1 DF, BID

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,364 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8773533
Preferred Term Cyst Depression Diarrhoea Dizziness Dyspnoea Ear pain Epistaxis Fatigue Gallbladder enlargement Gastrooesophageal reflux disease Haematoma Headache Irritability Irritable bowel syndrome Lipoma Nausea Sleep disorder Urinary tract infection Weight increased Product Role Route Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,365 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8866461 Date FDA Received
07-Dec-2012 Case # 8866461 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2012SP0 00999 Dosage Text UNK Duration Age Sex Unknown Country USA

Preferred Term Pulmonary embolism Deep vein thrombosis Asthma Cervical dysplasia Cervicitis Dyspnoea Dyspnoea exertional Embolism venous Fatigue Gastrooesophageal reflux disease Ovarian cyst Papilloma viral infection Pregnancy

Product NUVARING NUVARING

Role Route S S VAGINAL VAGINAL

Manufacturer MERCK MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,366 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8881062 Date FDA Received
07-Dec-2012 Case # 8881062 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,DS,OT Manufacturer Control # US-009507513-2012SP0 25954 Dosage Text UNK Duration Age Sex Unknown Country USA

Preferred Term Aneurysm Arthralgia Arthritis Back disorder Back pain Cardiac operation Cerebrovascular accident Coagulopathy Cough C-reactive protein increased Haemoptysis Heart rate irregular Intervertebral disc degeneration Narcolepsy Nervous system disorder Oropharyngeal pain Pulmonary embolism Respiratory tract congestion Road traffic accident Sleep disorder Spinal column stenosis Spinal fusion surgery Thrombosis Transient ischaemic attack

Product NUVARING

Role Route S

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,367 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8951222 Date FDA Received
07-Dec-2012 Case # 8951222 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1212USA 000747 Role Route S Health Professional VAGINAL Dosage Text 3 week in, 1 week out Manufacturer Control # US-009507513-1212USA 001349 Role Route S VAGINAL Dosage Text UNK Age 16 YR Sex Female Age 22 YR Sex Female Country USA

Preferred Term Overdose

Product NUVARING Case # 8954642 Case Type NON-EXPEDITED

Duration

Manufacturer MERCK Country USA

8954642 Date FDA Received

07-Dec-2012

Outcomes

Preferred Term Rash generalised Oedema mouth

Product NUVARING

Duration

Manufacturer MERCK

8955083 Date FDA Received

07-Dec-2012

Case # 8955083

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1212USA 001348

Age

Sex Female

Country USA

Preferred Term Genital discomfort

Product NUVARING Case # 8955346 Case Type EXPEDITED (15-DAY) Health Professional

Role Route S VAGINAL

Dosage Text UNK .015/.012 UNK Manufacturer Control # DE-009507513-1211DEU 008844 Dosage Text 1 ring per menstrual cycle

Duration

Manufacturer MERCK

8955346 Date FDA Received

07-Dec-2012

Outcomes HO

Age 46 YR

Sex Female

Country DEU

Preferred Term Pain in extremity Pain in extremity Withdrawal bleed

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,368 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8955470 Date FDA Received
07-Dec-2012 Case # 8955470 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1212USA 000201 Role Route S S Outcomes Manufacturer Control # US-009507513-1212USA 001821 Role Route S Health Professional VAGINAL Dosage Text 1 ringUNK Manufacturer Control # US-009507513-2012SP0 11814 Dosage Text UNK Duration Age Sex Unknown Duration Age Sex Female Country USA VAGINAL Dosage Text One ring, qm Age 32 YR Sex Female Country USA

Preferred Term Bone density increased Skin discolouration

Product NUVARING ORTHO TRI-CYCLEN Case # 8955671 Case Type NON-EXPEDITED Health Professional

Duration

Manufacturer MERCK

8955671 Date FDA Received

07-Dec-2012

Preferred Term Eye pruritus

Product NUVARING Case # 8666398 Case Type EXPEDITED (15-DAY)

Manufacturer MERCK Country USA

8666398 Date FDA Received

10-Dec-2012

Outcomes HO,OT

Preferred Term Pulmonary embolism Bronchitis Cyst Depression Headache Melanocytic naevus Myalgia Osteopenia Pharyngitis Pulmonary infarction Seborrhoeic keratosis Sinus polyp Synovial cyst Vaginitis bacterial

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,369 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8954295 Date FDA Received
10-Dec-2012 Case # 8954295 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1212USA 002036 Role Route S Health Professional VAGINAL Dosage Text 3 weeks in, 1 week out Manufacturer Control # US-009507513-1212USA 002253 Dosage Text UNK Manufacturer Control # US-009507513-1211USA 011751 Role Route S Dosage Text Age 31 YR Sex Male Duration Age Sex Unknown Duration Age Sex Female Country USA

Preferred Term Device expulsion

Product NUVARING Case # 8955738 Case Type EXPEDITED (15-DAY)

Manufacturer MERCK Country USA

8955738 Date FDA Received

10-Dec-2012

Outcomes OT

Preferred Term Pulmonary embolism

Product NUVARING Case # 8955832 Case Type NON-EXPEDITED Health Professional

Role Route S VAGINAL

Manufacturer MERCK Country USA

8955832 Date FDA Received

10-Dec-2012

Outcomes

Preferred Term Penile pain Medical device discomfort

Product NUVARING

Duration

Manufacturer MERCK

8956326 Date FDA Received

10-Dec-2012

Case # 8956326

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,DS,OT

Manufacturer Control # US-009507513-2012SP0 05874 Dosage Text

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism Anxiety Asthma Depression Type 2 diabetes mellitus

Product NUVARING

Role Route S

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,370 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8957040 Date FDA Received
10-Dec-2012 Case # 8957040 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,DS,OT Manufacturer Control # US-009507513-2011SP0 14788 Dosage Text UNK UNK, QM Duration Age Sex Unknown Country USA

Preferred Term Amnesia Aphasia Meningitis viral Abdominal pain upper Anxiety Blood pressure decreased Cerebral thrombosis Depression Headache Intracranial venous sinus thrombosis Mastoiditis Off label use Overdose Pleocytosis Road traffic accident Transverse sinus thrombosis Tremor Urinary tract infection

Product NUVARING NUVARING PHENELZINE SULFATE

Role Route S S S

Manufacturer MERCK MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,371 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8660475 Date FDA Received
11-Dec-2012 Case # 8660475 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2012SP0 36875 Dosage Text UNK UNK Duration Age Sex Unknown Country USA

Preferred Term Cerebellar infarction Cerebrovascular accident Bronchitis Fall Female sterilisation Inflammation Migraine Off label use Pain in extremity Sleep apnoea syndrome

Product NUVARING NUVARING

Role Route S S VAGINAL

Manufacturer MERCK MERCK

8771979 Date FDA Received

11-Dec-2012

Case # 8771979

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1209USA 001030

Age

Sex Female

Country USA

Preferred Term Device expulsion

Product NUVARING Case # 8819916 Case Type EXPEDITED (15-DAY) Health Professional

Role Route S Outcomes HO

Dosage Text UNK Manufacturer Control # US-009507513-2012SP0 24525 Dosage Text UNK

Duration

Manufacturer MERCK

8819916 Date FDA Received

11-Dec-2012

Age

Sex Unknown

Country USA

Preferred Term Venous stent insertion Deep vein thrombosis General physical condition abnormal Stent embolisation Thrombolysis Vena cava filter insertion

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,372 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8957093 Date FDA Received
11-Dec-2012 Case # 8957093 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1212USA 001289 Role Route S Dosage Text Duration Age Sex Female Country USA

Preferred Term Device expulsion Product quality issue

Product NUVARING

Manufacturer MERCK

8957143 Date FDA Received

11-Dec-2012

Case # 8957143

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1212USA 002574

Age

Sex Female

Country USA

Preferred Term Unintended pregnancy Amenorrhoea

Product NUVARING

Role Route S VAGINAL

Dosage Text UNK

Duration

Manufacturer MERCK

8958275 Date FDA Received

11-Dec-2012 Preferred Term Hypersensitivity Eczema Pruritus Rash

Case # 8958275

Case Type EXPEDITED (15-DAY) Product QLAIRA NuvaRing

Health Professional

Outcomes DS Role Route S S ORAL VAGINAL

Manufacturer Control # CH-BAYER-2012-125705 Dosage Text UNK UNK

Age

Sex Female

Country CHE

Duration

Manufacturer BAYER

8660457 Date FDA Received

12-Dec-2012

Case # 8660457

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO

Manufacturer Control # US-009507513-2012SP0 36939 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Deep vein thrombosis Cognitive disorder Emotional disorder Mental disorder

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,373 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8916090 Date FDA Received
12-Dec-2012 Case # 8916090 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-1211USA 006987 Dosage Text UNK Duration Age Sex Unknown Country USA

Preferred Term Deep vein thrombosis Pulmonary embolism

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

8958700 Date FDA Received

12-Dec-2012

Case # 8958700

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1212USA 003537

Age 40 YR

Sex Female

Country USA

Preferred Term Unintended pregnancy Metrorrhagia Vaginal haemorrhage

Product NUVARING

Role Route S

Dosage Text

Duration

Manufacturer MERCK

8958782 Date FDA Received

12-Dec-2012

Case # 8958782

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes OT

Manufacturer Control # US-009507513-1212USA 003970 Dosage Text UNK Manufacturer Control # US-009507513-1212USA 002137

Age

Sex Unknown

Country USA

Preferred Term Cerebrovascular accident

Product NUVARING Case Type NON-EXPEDITED Health Professional

Role Route S VAGINAL

Duration

Manufacturer MERCK

8959077 Date FDA Received

12-Dec-2012

Case # 8959077

Outcomes

Age

Sex Female

Country USA

Preferred Term Dyspareunia

Product NUVARING

Role Route S

Dosage Text UNK

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,374 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8959133 Date FDA Received
12-Dec-2012 Case # 8959133 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1212USA 003099 Role Route S VAGINAL Dosage Text 0.015 etonogestrel/0.12 ethinyl estradiol one ring every three or four weeks UNK Duration Age Sex Female Country USA

Preferred Term Metrorrhagia

Product NUVARING

Manufacturer MERCK

Incorrect drug administration duration Product quality issue

NUVARING PROTONIX

S C Health Professional Outcomes

MERCK

8959532 Date FDA Received

12-Dec-2012

Case # 8959532

Case Type NON-EXPEDITED

Manufacturer Control # US-009507513-1212USA 003138

Age

Sex Unknown

Country USA

Preferred Term Device expulsion

Product NUVARING Case # 8959661 Case Type NON-EXPEDITED Health Professional

Role Route S Outcomes

Dosage Text 1 ring for three week use Manufacturer Control # US-009507513-1212USA 003110

Duration

Manufacturer MERCK

8959661 Date FDA Received

12-Dec-2012

Age

Sex Female

Country USA

Preferred Term Device expulsion

Product NUVARING

Role Route S VAGINAL

Dosage Text 0.015 etonogestrel/0.12 mg ethinyl estradiol,every three weeks vaginally as directed

Duration

Manufacturer MERCK

Product quality issue

8961372 Date FDA Received

12-Dec-2012

Case # 8961372

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1212USA 002438

Age

Sex Female

Country USA

Preferred Term Metrorrhagia Medical device complication

Product NUVARING

Role Route S VAGINAL

Dosage Text UNK

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,375 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8961375 Date FDA Received
12-Dec-2012 Case # 8961375 Case Type EXPEDITED (15-DAY) Health Professional Outcomes DE,HO,OT Manufacturer Control # US-009507513-1212USA 003967 Dosage Text UNK Manufacturer Control # US-009507513-1212USA 004043 Role Route S VAGINAL Dosage Text 3 weeks in, 1 week out Age 34 YR Sex Female Duration Age Sex Unknown Country USA

Preferred Term Pulmonary embolism

Product NUVARING Case # 8962142 Case Type NON-EXPEDITED Health Professional

Role Route S VAGINAL

Manufacturer MERCK Country USA

8962142 Date FDA Received

12-Dec-2012

Outcomes

Preferred Term Menstruation irregular

Product NUVARING

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,376 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8812711 Date FDA Received
13-Dec-2012 Case # 8812711 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2008-188 129-NL Dosage Text DOSE TEXT: 3 WEEKS INSERTED AND 1 WEEK OUT, CONTINUING: NO DOSE TEXT: CONTINUOUSLY, CONTINUING: NO 40 mg, QD 150 mg, QD 300 mg, QD 325 mg, QD DOSE TEXT: DAILY DOSE TEXT: UNCERTAIN OF DOSAGE 50 mg, QD 1 CUP 3 X/WEEK Duration Age Sex Unknown Country USA

Preferred Term Pulmonary embolism

Product NUVARING

Role Route S

Manufacturer MERCK

Lung disorder

NUVARING

MERCK

Off label use Anxiety Muscle spasms Deep vein thrombosis Depression Sinusitis

PROZAC WELLBUTRIN WELLBUTRIN MOL-IRON VITAMINS (UNSPECIFIED) CALCIUM (UNSPECIFIED) (+) CHOLECALCIFEROL IRON (UNSPECIFIED) TEA

C C C C C C

Cellulitis Skin lesion excision Acrochordon Cyst Cyst removal Ear disorder Endometriosis Ovarian cyst Skin lesion Smear cervix abnormal Tonsillectomy

C C

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,377 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8961791 Date FDA Received
13-Dec-2012 Case # 8961791 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1212USA 004323 Role Route S VAGINAL Dosage Text Duration Age Sex Female Country USA

Preferred Term Device expulsion No adverse event

Product NUVARING

Manufacturer MERCK

8961921 Date FDA Received

13-Dec-2012

Case # 8961921

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1212USA 004013

Age 35 YR

Sex Female

Country USA

Preferred Term Unintended pregnancy Inappropriate schedule of drug administration

Product NUVARING

Role Route S VAGINAL

Dosage Text 3 weeks in, 1 week out

Duration

Manufacturer MERCK

8962871 Date FDA Received

13-Dec-2012

Case # 8962871

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes DS,OT

Manufacturer Control # US-009507513-1212USA 004746 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism Deep vein thrombosis

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

8962949 Date FDA Received

13-Dec-2012

Case # 8962949

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,DS

Manufacturer Control # US-009507513-1212USA 003601 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Deep vein thrombosis

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,378 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8963915 Date FDA Received
13-Dec-2012 Case # 8963915 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-1212USA 003599 Dosage Text DF,, qm Duration Age Sex Unknown Country USA

Preferred Term Pulmonary embolism Deep vein thrombosis

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

8964793 Date FDA Received

13-Dec-2012

Case # 8964793

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO

Manufacturer Control # US-009507513-1212USA 004609 Dosage Text UNK Manufacturer Control # US-009507513-1212USA 002254 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Deep vein thrombosis

Product NUVARING Case # 8964820 Case Type EXPEDITED (15-DAY) Health Professional

Role Route S Outcomes HO,OT

Duration

Manufacturer MERCK

8964820 Date FDA Received

13-Dec-2012

Age

Sex Unknown

Country USA

Preferred Term Deep vein thrombosis Pulmonary embolism

Product NUVARING

Role Route S

Duration

Manufacturer MERCK

8838631 Date FDA Received

14-Dec-2012

Case # 8838631

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1210USA 001602

Age

Sex Unknown

Country USA

Preferred Term Vaginal discharge Vaginal odour Device expulsion

Product NUVARING NUVARING [therapy unspecified]

Role Route S S C VAGINAL VAGINAL

Dosage Text 0.015mg 0.015mg

Duration

Manufacturer MERCK MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,379 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8911962 Date FDA Received
14-Dec-2012 Case # 8911962 Case Type EXPEDITED (15-DAY) Health Professional Outcomes OT Manufacturer Control # US-009507513-1211USA 006226 Dosage Text 1 Ring UNK Manufacturer Control # US-009507513-1212USA 002699 Role Route S Health Professional VAGINAL Dosage Text UNK Manufacturer Control # FR-009507513-1212FRA 002210 Dosage Text UNK Age 18 YR Sex Female Age 45 YR Sex Female Duration Age Sex Female Country USA

Preferred Term Abortion spontaneous Unintended pregnancy

Product NUVARING NUVARING Case # 8963665 Case Type NON-EXPEDITED Health Professional

Role Route S S Outcomes VAGINAL

Manufacturer MERCK MERCK Country USA

8963665 Date FDA Received

14-Dec-2012

Preferred Term Menorrhagia

Product NUVARING Case # 8963678 Case Type EXPEDITED (15-DAY)

Duration

Manufacturer MERCK Country FRA

8963678 Date FDA Received

14-Dec-2012

Outcomes OT

Preferred Term Accommodation disorder Blood glucose increased

Product NUVARING ACTIFED Case # 8963707 Case Type NON-EXPEDITED Health Professional

Role Route S S Outcomes VAGINAL

Duration

Manufacturer MERCK

8963707 Date FDA Received

14-Dec-2012

Manufacturer Control # US-009507513-1212USA 005447

Age

Sex Female

Country USA

Preferred Term Pain Device breakage Product quality issue

Product NUVARING

Role Route S VAGINAL

Dosage Text 0.015mg etonogestrel/ 0.12 mg ethinyl estradiol

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,380 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8963981 Date FDA Received
14-Dec-2012 Case # 8963981 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1212USA 002948 Role Route S VAGINAL Dosage Text 0.120 mgetomogestrel/ 0.015 mg/ ethinyl estradiol Manufacturer Control # US-009507513-1212USA 004754 Dosage Text UNK Duration Age Sex Unknown Age 17 YR Sex Female Country USA

Preferred Term Urticaria

Product NUVARING

Duration

Manufacturer MERCK

8963984 Date FDA Received

14-Dec-2012

Case # 8963984

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes DS,OT

Country USA

Preferred Term Pulmonary embolism Thrombosis

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

8966525 Date FDA Received

14-Dec-2012

Case # 8966525

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1212USA 003740

Age

Sex Female

Country USA

Preferred Term Burning sensation

Product NUVARING Case # 8966651 Case Type NON-EXPEDITED Health Professional

Role Route S VAGINAL

Dosage Text UNK Manufacturer Control # US-009507513-1212USA 004702

Duration

Manufacturer MERCK

8966651 Date FDA Received

14-Dec-2012

Outcomes

Age 23 YR

Sex Female

Country USA

Preferred Term Device expulsion Inappropriate schedule of drug administration Metrorrhagia

Product NUVARING

Role Route S VAGINAL

Dosage Text UNK

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,381 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8966806 Date FDA Received
14-Dec-2012 Case # 8966806 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1212USA 005188 Role Route S C VAGINAL Dosage Text UNK, 3 weeks in 1 week out UNK Age 21 YR Sex Female Country USA

Preferred Term Unintended pregnancy Polymenorrhoea Menstruation delayed

Product NUVARING ZOLOFT

Duration

Manufacturer MERCK

8878941 Date FDA Received

17-Dec-2012

Case # 8878941

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,OT

Manufacturer Control # US-009507513-2012SP0 36112 Dosage Text UNK UNK, qm

Age

Sex Unknown

Country USA

Preferred Term Pleurisy Bronchitis Chloasma Deep vein thrombosis Fatigue Headache Nausea Ovarian cyst Papilloma viral infection Pelvic pain Pneumonia Pulmonary embolism Pulmonary granuloma Varicose vein Vertigo

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,382 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8969153 Date FDA Received
17-Dec-2012 Case # 8969153 Case Type EXPEDITED (15-DAY) Health Professional Outcomes OT Manufacturer Control # US-009507513-1212USA 004643 Dosage Text UNK Manufacturer Control # US-009507513-1212USA 003600 Dosage Text UNK Manufacturer Control # US-009507513-1212USA 005712 Dosage Text UNK Manufacturer Control # US-009507513-2012SP0 36941 Dosage Text UNK Duration Age Sex Unknown Duration Age Sex Unknown Duration Age Sex Unknown Duration Age Sex Unknown Country USA

Preferred Term Pulmonary embolism

Product NUVARING Case # 8969817 Case Type EXPEDITED (15-DAY) Health Professional

Role Route S Outcomes DS,OT

Manufacturer MERCK Country USA

8969817 Date FDA Received

17-Dec-2012

Preferred Term Pulmonary embolism

Product NUVARING Case # 8971520 Case Type EXPEDITED (15-DAY) Health Professional

Role Route S VAGINAL

Manufacturer MERCK Country USA

8971520 Date FDA Received

17-Dec-2012

Outcomes HO

Preferred Term Deep vein thrombosis

Product NUVARING Case # 8660454 Case Type EXPEDITED (15-DAY) Health Professional

Role Route S VAGINAL

Manufacturer MERCK Country USA

8660454 Date FDA Received

18-Dec-2012

Outcomes HO,OT

Preferred Term Pulmonary embolism Deep vein thrombosis Dizziness Dysmenorrhoea Heart rate irregular Hernia repair Palpitations Sleep apnoea syndrome Sneezing Viral infection

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,383 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8940013 Date FDA Received
18-Dec-2012 Case # 8940013 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1211USA 010224 Role Route S Health Professional VAGINAL Dosage Text UNK Manufacturer Control # US-009507513-1212USA 005427 Role Route S VAGINAL Dosage Text 1 ring up to 3 weeks with one ring free break Age 21 YR Sex Female Duration Age Sex Unknown Country USA

Preferred Term Thrombosis

Product NUVARING Case # 8969147 Case Type NON-EXPEDITED

Manufacturer MERCK Country USA

8969147 Date FDA Received

18-Dec-2012

Outcomes

Preferred Term Unintended pregnancy Abnormal withdrawal bleeding Device expulsion Inappropriate schedule of drug administration

Product NUVARING

Duration

Manufacturer MERCK

8971247 Date FDA Received

18-Dec-2012

Case # 8971247

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,OT

Manufacturer Control # US-009507513-1212USA 005710 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism Deep vein thrombosis

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

8972516 Date FDA Received

18-Dec-2012

Case # 8972516

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes OT

Manufacturer Control # US-009507513-1212USA 004753 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism Deep vein thrombosis

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,384 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8972814 Date FDA Received
18-Dec-2012 Case # 8972814 Case Type EXPEDITED (15-DAY) Health Professional Outcomes OT Manufacturer Control # US-009507513-1212USA 006738 Dosage Text 4 weeks in Age 45 YR Sex Female Country USA

Preferred Term Convulsion Incorrect drug administration duration

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

8972932 Date FDA Received

18-Dec-2012

Case # 8972932

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1212USA 004453

Age

Sex Female

Country USA

Preferred Term Migraine

Product NUVARING Case # 8973173 Case Type EXPEDITED (15-DAY) Health Professional

Role Route S VAGINAL

Dosage Text Continously up to 4 weeks Manufacturer Control # US-009507513-2010SP0 07773 Dosage Text

Duration

Manufacturer MERCK

8973173 Date FDA Received

18-Dec-2012

Outcomes HO,OT

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism Chest pain Diabetes mellitus Endometriosis Foot deformity Headache Hyperlipidaemia Hypertension Menorrhagia Paraesthesia Pelvic pain

Product NUVARING

Role Route S

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,385 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 7284807 Date FDA Received
19-Dec-2012 Case # 7284807 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2009-200 466-NL Dosage Text CONTINUING: NO Duration Age Sex Unknown Country USA

Preferred Term Haemoptysis Adjustment disorder Analgesic drug level increased Blood alcohol increased Haematuria Intentional overdose Nausea Pulmonary embolism Suicidal behaviour Suicidal ideation Thyroid disorder

Product NUVARING

Role Route S

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,386 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8775997 Date FDA Received
19-Dec-2012 Case # 8775997 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-1209USA 001494 Dosage Text UNK UNK, qd UNK Duration Age Sex Unknown Country USA

Preferred Term Road traffic accident Cerebrovascular accident Pain in extremity Acne Adverse drug reaction Anxiety Confusional state Coordination abnormal Depression Endometrial ablation Headache Migraine Oedema peripheral Tinnitus Trichotillomania

Product NUVARING YAZ ibuprofen

Role Route S C C

Manufacturer MERCK

8934922 Date FDA Received

19-Dec-2012

Case # 8934922

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes OT

Manufacturer Control # US-009507513-1211USA 010839 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,387 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8972795 Date FDA Received
19-Dec-2012 Case # 8972795 Case Type EXPEDITED (15-DAY) Health Professional Outcomes OT Manufacturer Control # US-009507513-1212USA 005981 Dosage Text UNK Age 21 YR Sex Female Country USA

Preferred Term Complication of device insertion Arthralgia Cystoscopy Incorrect route of drug administration Micturition urgency Removal of foreign body Suprapubic pain Vaginal discharge

Product NUVARING

Role Route S URETHRAL

Duration

Manufacturer MERCK

8973212 Date FDA Received

19-Dec-2012

Case # 8973212

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes OT

Manufacturer Control # US-009507513-1212USA 004748 Dosage Text UNK Manufacturer Control # US-009507513-1207USA 004138 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism

Product NUVARING Case # 8667674 Case Type EXPEDITED (15-DAY) Health Professional

Role Route S VAGINAL

Duration

Manufacturer MERCK

8667674 Date FDA Received

20-Dec-2012

Outcomes HO

Age

Sex Unknown

Country USA

Preferred Term Embolism venous Cerebral venous thrombosis Headache Nausea Superior sagittal sinus thrombosis Vomiting

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,388 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8900612 Date FDA Received
20-Dec-2012 Case # 8900612 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,LT,OT Manufacturer Control # US-009507513-1211USA 001415 Dosage Text UNK Duration Age Sex Female Country USA

Preferred Term Cerebrovascular accident Cerebral thrombosis

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

8976296 Date FDA Received

20-Dec-2012

Case # 8976296

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes DS,OT

Manufacturer Control # US-009507513-1212USA 004633 Dosage Text UNK Manufacturer Control # US-009507513-1212USA 007774

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism

Product NUVARING Case # 8976320 Case Type NON-EXPEDITED Health Professional

Role Route S VAGINAL

Duration

Manufacturer MERCK

8976320 Date FDA Received

20-Dec-2012

Outcomes

Age

Sex Female

Country USA

Preferred Term Device expulsion Device breakage Drug dose omission Product quality issue

Product NUVARING

Role Route S VAGINAL

Dosage Text 1 DF, every 28 days

Duration

Manufacturer MERCK

8976724 Date FDA Received

20-Dec-2012

Case # 8976724

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1212USA 006975

Age 24 YR

Sex Female

Country USA

Preferred Term Acne

Product NUVARING

Role Route S VAGINAL

Dosage Text UNK

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,389 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8976755 Date FDA Received
20-Dec-2012 Case # 8976755 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,DS Manufacturer Control # US-009507513-2012SP0 11820 Dosage Text Duration Age Sex Unknown Country USA

Preferred Term Deep vein thrombosis Cervical dysplasia Coccydynia Dizziness Dysfunctional uterine bleeding Fall Headache Menstruation irregular Muscle spasms Off label use Ovarian cyst Papilloma viral infection Polycystic ovaries Venous insufficiency

Product NUVARING

Role Route S

Manufacturer MERCK

8977572 Date FDA Received

20-Dec-2012

Case # 8977572

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes OT

Manufacturer Control # USGLAXOSMITHKLINEA0890356A Dosage Text

Age

Sex Female

Country USA

Preferred Term Unintended pregnancy Asthenia Fatigue Gait disturbance Malaise Hepatic pain Maternal exposure during pregnancy Renal pain

Product Soriatane Contraceptive NuvaRing Enbrel Prozac

Role Route S S S C C ORAL

Duration

Manufacturer GLAXOSMITHKLINE

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,390 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8977739 Date FDA Received
20-Dec-2012 Case # 8977739 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1212USA 006766 Role Route S Dosage Text 1 DF, UNK Duration Age Sex Female Country USA

Preferred Term Device breakage No adverse event Product quality issue

Product NUVARING

Manufacturer MERCK

8978108 Date FDA Received

20-Dec-2012

Case # 8978108

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1212USA 004257

Age

Sex Female

Country USA

Preferred Term Wrong technique in drug usage process Device expulsion No adverse event

Product NUVARING

Role Route S VAGINAL

Dosage Text 1 DF, UNK

Duration

Manufacturer MERCK

8978432 Date FDA Received

20-Dec-2012

Case # 8978432

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1212USA 006965

Age

Sex Female

Country USA

Preferred Term Inappropriate schedule of drug administration

Product NUVARING

Role Route S VAGINAL

Dosage Text three weeks in one week

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,391 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8825334 Date FDA Received
21-Dec-2012 Case # 8825334 Case Type EXPEDITED (15-DAY) Health Professional Outcomes OT Manufacturer Control # US-009507513-2012SP0 34975 Dosage Text UNK UNK Duration Age Sex Unknown Country USA

Preferred Term Cerebrovascular accident Back disorder Cervical dysplasia Colposcopy Cystocele Otorhinolaryngological surgery Papilloma viral infection Rectocele Seasonal allergy Uterine prolapse

Product NUVARING NUVARING

Role Route S S VAGINAL VAGINAL

Manufacturer MERCK MERCK

8978301 Date FDA Received

21-Dec-2012

Case # 8978301

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1212USA 007458

Age

Sex Unknown

Country USA

Preferred Term Metrorrhagia

Product NUVARING Case # 8979420 Case Type EXPEDITED (15-DAY) Health Professional

Role Route S Outcomes DS

Dosage Text UNK Manufacturer Control # US-009507513-2012SP0 00445 Dosage Text UNK

Duration

Manufacturer MERCK

8979420 Date FDA Received

21-Dec-2012

Age

Sex Female

Country USA

Preferred Term Palpitations Anxiety Deep vein thrombosis Phlebitis Post thrombotic syndrome

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,392 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8980979 Date FDA Received
21-Dec-2012 Case # 8980979 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1212USA 007519 Role Route S Health Professional Outcomes Dosage Text 1 ring for 3 week use Manufacturer Control # US-009507513-1212USA 007898 Role Route S Health Professional Outcomes HO Manufacturer Control # DE-009507513-1212DEU 006207 Dosage Text UNK Duration Age Sex Female Dosage Text Duration Age Sex Unknown Age 23 YR Sex Female Country USA

Preferred Term Medical device complication

Product NUVARING Case Type NON-EXPEDITED

Duration

Manufacturer MERCK Country USA

8981271 Date FDA Received

21-Dec-2012

Case # 8981271

Preferred Term Thrombosis

Product NUVARING Case # 8982316 Case Type EXPEDITED (15-DAY)

Manufacturer MERCK Country DEU

8982316 Date FDA Received

22-Dec-2012

Preferred Term Appendicitis Metrorrhagia

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

8983094 Date FDA Received

23-Dec-2012

Case # 8983094

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1212USA 008693

Age

Sex Female

Country USA

Preferred Term Inappropriate schedule of drug administration

Product NUVARING Health Professional

Role Route S VAGINAL

Dosage Text 3 weeks in, 1 week out Manufacturer Control # US-009507513-1212USA 008818

Duration

Manufacturer MERCK

8983309 Date FDA Received

24-Dec-2012

Case # 8983309

Case Type NON-EXPEDITED

Outcomes

Age

Sex Female

Country USA

Preferred Term Menstruation delayed Hypomenorrhoea

Product NUVARING NUVARING

Role Route S S

Dosage Text 1 ring, q3w

Duration

Manufacturer MERCK MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,393 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8984305 Date FDA Received
26-Dec-2012 Case # 8984305 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO Manufacturer Control # US-009507513-1212USA 008190 Dosage Text UNK Manufacturer Control # US-009507513-2011SP0 51290 Dosage Text Duration Age Sex Unknown Duration Age Sex Unknown Country USA

Preferred Term Cerebral artery thrombosis

Product NUVARING Case Type EXPEDITED (15-DAY) Health Professional

Role Route S Outcomes HO

Manufacturer MERCK Country USA

8984525 Date FDA Received

26-Dec-2012

Case # 8984525

Preferred Term Hiatus hernia Asthma Chest pain Deep vein thrombosis Diabetes mellitus Migraine Thrombosis

Product NUVARING

Role Route S

Manufacturer MERCK

8985639 Date FDA Received

26-Dec-2012

Case # 8985639

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1212USA 007066

Age

Sex Female

Country USA

Preferred Term Menorrhagia Product quality control issue

Product NUVARING

Role Route S VAGINAL

Dosage Text UNK

Duration

Manufacturer MERCK

8985843 Date FDA Received

26-Dec-2012

Case # 8985843

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1212USA 008960

Age

Sex Unknown

Country USA

Preferred Term Injury

Product NUVARING

Role Route S VAGINAL

Dosage Text

Duration

Manufacturer MERCK

8986557
Date - Time: 02-04-2013 9:43:10 AM EST Note: If the field is blank, there is no data Page: 1,394 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8986557
FDA Received Date 26-Dec-2012 Case # 8986557 Case Type EXPEDITED (15-DAY) Health Professional Outcomes OT Manufacturer Control # US-009507513-2009SP0 38965 Dosage Text Duration Age Sex Unknown Country USA

Preferred Term Suicidal ideation Ovarian cyst ruptured Bacterial pyelonephritis Asthma Abdominal pain Abnormal withdrawal bleeding Amenorrhoea Anxiety Cervical dysplasia Constipation Deep vein thrombosis Depressed mood Gastritis Gastroenteritis viral Haemorrhoids Inappropriate schedule of drug administration Maternal exposure before pregnancy Migraine Off label use Pain Panic attack Parotitis Pneumonia Proctalgia Pulmonary embolism Renal vein thrombosis Rhinitis allergic

Product NUVARING NUVARING LORTAB PROVENTIL

Role Route S S S C

Manufacturer MERCK MERCK MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,395 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8986557
Preferred Term Sinusitis Urinary tract infection Urinary tract infection bacterial Vulvovaginal burning sensation Vulvovaginal candidiasis Vulvovaginal pruritus Product Role Route Dosage Text Duration Manufacturer

8709356 Date FDA Received

27-Dec-2012

Case # 8709356

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,DS,OT

Manufacturer Control # US-009507513-1208USA 000232 Dosage Text UNK UNK, qd UNK, qd UNK

Age

Sex Unknown

Country USA

Preferred Term Coagulopathy Pulmonary embolism Migraine Mood swings Fall Anxiety Computerised tomogram abnormal Deep vein thrombosis Dizziness Fatigue Hormone level abnormal Musculoskeletal chest pain Musculoskeletal pain Neck pain Off label use Presyncope Sleep disorder

Product NUVARING NUVARING vitamins (unspecified) chondroitin sulfate sodium (+) glucosamine sulfate ARMOUR THYROID TABLETS

Role Route S S C C C

Duration

Manufacturer MERCK MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,396 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8724400 Date FDA Received
27-Dec-2012 Case # 8724400 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2012SP0 11795 Dosage Text UNK Duration Age Sex Unknown Country USA

Preferred Term Pulmonary embolism Anxiety Atrial fibrillation Chest discomfort Chest pain Cough Deep vein thrombosis Diarrhoea Dyspepsia Dyspnoea exertional Eye haemorrhage Lung neoplasm Oedema peripheral Pain in extremity Peripheral embolism Phlebitis Rhinitis allergic Tricuspid valve incompetence Vulvovaginal candidiasis

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,397 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8772336 Date FDA Received
27-Dec-2012 Case # 8772336 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-1208USA 010973 Dosage Text UNK UNK Duration Age Sex Unknown Country USA

Preferred Term Cardiac aneurysm Ischaemic cerebral infarction Cerebral artery occlusion Atrial septal defect Chest pain Local swelling Maternal exposure before pregnancy Methylenetetrahydrofolate reductase deficiency Pneumothorax

Product NUVARING NUVARING cough, cold, and flu therapies (unspecified)

Role Route S S C

Manufacturer MERCK MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,398 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8857708 Date FDA Received
27-Dec-2012 Case # 8857708 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,DS,OT Manufacturer Control # US-009507513-2012SP0 13041 Dosage Text UNK UNK, qd Duration Age Sex Unknown Country USA

Preferred Term Cervix carcinoma Pulmonary embolism Adverse drug reaction Brachytherapy Chest pain Cystoscopy Discomfort Dysmenorrhoea Dyspepsia Gastrointestinal motility disorder Gastrooesophageal reflux disease Haemorrhoids Hand fracture Headache Hyperaesthesia Infusion site swelling Ovarian cyst Proctoscopy Seasonal allergy Sinus disorder Vulvovaginal swelling

Product NUVARING WELLBUTRIN XL

Role Route S C VAGINAL

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,399 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8952994 Date FDA Received
27-Dec-2012 Case # 8952994 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,DS,OT Manufacturer Control # US-009507513-2009SP0 35995 Dosage Text UNK Duration Age Sex Unknown Country USA

Preferred Term Tachycardia Chest pain Anxiety Hypothyroidism Anaemia Cardiomyopathy Cerebrovascular accident Coagulopathy Deep vein thrombosis Dizziness Dyspnoea Left ventricular hypertrophy Maternal exposure before pregnancy Migraine Nausea Pelvic discomfort Pulmonary embolism Transient ischaemic attack

Product NUVARING EXCEDRIN MIGRAINE TYLENOL MIRENA

Role Route S C C S

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,400 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8976236 Date FDA Received
27-Dec-2012 Case # 8976236 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2011SP0 37380 Dosage Text UNK Duration Age Sex Unknown Country USA

Preferred Term Pulmonary embolism Abnormal loss of weight Anxiety Chest pain Depression Fatigue Pleurisy

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

8987150 Date FDA Received

27-Dec-2012

Case # 8987150

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO

Manufacturer Control # US-009507513-1212USA 008611 Dosage Text UNK

Age

Sex Female

Country USA

Preferred Term Pulmonary thrombosis Blood disorder Female sterilisation Hormone level abnormal Pneumonia Unintended pregnancy Vitamin D deficiency

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

8987356 Date FDA Received

27-Dec-2012

Case # 8987356

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1212USA 009524

Age 22 YR

Sex Female

Country USA

Preferred Term Metrorrhagia Incorrect drug administration duration

Product NUVARING

Role Route S VAGINAL

Dosage Text 4 weeks in, 1 week out

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,401 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8987569 Date FDA Received
27-Dec-2012 Case # 8987569 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1212USA 009859 Role Route S Health Professional VAGINAL Dosage Text 1 DF for 3 weeks Manufacturer Control # US-009507513-1207USA 008761 Dosage Text UNK Duration Age Sex Unknown Duration Age Sex Female Country USA

Preferred Term Overdose

Product NUVARING Case # 8683013 Case Type EXPEDITED (15-DAY)

Manufacturer MERCK Country USA

8683013 Date FDA Received

28-Dec-2012

Outcomes HO,OT

Preferred Term Pulmonary embolism Cognitive disorder Deep vein thrombosis Emotional disorder Mental disorder

Product NUVARING

Role Route S

Manufacturer MERCK

8692597 Date FDA Received

28-Dec-2012

Case # 8692597

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,OT

Manufacturer Control # US-009507513-1207USA 008775 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Pulmonary infarction Allergic sinusitis Deep vein thrombosis Female sterilisation Fibroma Migraine Ovarian cyst Pulmonary embolism

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,402 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8981282 Date FDA Received
28-Dec-2012 Case # 8981282 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-1212USA 008186 Dosage Text UNK Manufacturer Control # US-009507513-1212USA 008618 Role Route S VAGINAL Dosage Text 1 ring for 3 weeks followed by a week free break Manufacturer Control # US-009507513-1212USA 008972 Role Route S C Health Professional Outcomes DS Manufacturer Control # US-009507513-1212USA 010548 Dosage Text Duration Age Sex Female Country USA VAGINAL Dosage Text UNK Duration Age Sex Unknown Age 20 YR Sex Female Duration Age Sex Unknown Country USA

Preferred Term Pulmonary embolism

Product NUVARING Case # 8989643 Case Type NON-EXPEDITED Health Professional

Role Route S Outcomes

Manufacturer MERCK Country USA

8989643 Date FDA Received

28-Dec-2012

Preferred Term Device expulsion

Product NUVARING

Duration

Manufacturer MERCK

8990022 Date FDA Received

28-Dec-2012

Case # 8990022

Case Type NON-EXPEDITED

Health Professional

Outcomes

Country USA

Preferred Term Medical device discomfort Product quality issue

Product NUVARING CYMBALTA Case # 8990040 Case Type EXPEDITED (15-DAY)

Manufacturer MERCK

8990040 Date FDA Received

28-Dec-2012

Preferred Term Deep vein thrombosis

Product NUVARING Case # 8991412 Case Type NON-EXPEDITED Health Professional

Role Route S Outcomes

Manufacturer MERCK

8991412 Date FDA Received

28-Dec-2012

Manufacturer Control # US-009507513-1212USA 008534

Age 23 YR

Sex Female

Country USA

Preferred Term Infertility female

Product NUVARING

Role Route S VAGINAL

Dosage Text UNK

Duration

Manufacturer MERCK

8688114
Date - Time: 02-04-2013 9:43:10 AM EST Note: If the field is blank, there is no data Page: 1,403 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8688114
FDA Received Date 31-Dec-2012 Case # 8688114 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2012SP0 17141 Dosage Text UNK UNK UNK UNK UNK Duration Age Sex Unknown Country USA

Preferred Term Acute respiratory failure Pulmonary embolism Ovarian cyst Hypertension Pneumonia Adverse drug reaction Anxiety Asthma Attention deficit/hyperactivity disorder Biopsy lung Blood cholesterol increased Cardiac neoplasm unspecified Chest pain Cholelithiasis Chronic obstructive pulmonary disease Cor pulmonale Depression Diabetes mellitus Dyspnoea Endocervical curettage Endometrial ablation Fibromyalgia Gastroenteritis Gastrooesophageal reflux disease Headache Hernia repair Hypertension

Product NUVARING NUVARING CATAPRES NORVASC COUMADIN

Role Route S S C C S

Manufacturer MERCK MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,404 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8688114
Preferred Term Insomnia Intervertebral disc degeneration Lobar pneumonia Menorrhagia Migraine Multiple allergies Obesity Osteoporosis Peptic ulcer Personality disorder Pulmonary embolism Radiculopathy Sarcoidosis Sleep apnoea syndrome Sleep paralysis Tricuspid valve incompetence Urinary tract infection Uterine dilation and curettage Uterine leiomyoma Product Role Route Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,405 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8774545 Date FDA Received
31-Dec-2012 Case # 8774545 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2012SP0 07965 Dosage Text Duration Age Sex Unknown Country USA

Preferred Term Small intestinal resection Abdominal pain Gastritis Gastrointestinal stoma complication Gastrooesophageal reflux disease Intestinal ischaemia Intestinal obstruction Jejunostomy Mesenteric vein thrombosis Pain Thrombectomy Urine output decreased

Product NUVARING

Role Route S

Manufacturer MERCK

8846976 Date FDA Received

31-Dec-2012

Case # 8846976

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,LT

Manufacturer Control # US-009507513-1210USA 007536 Dosage Text 0.120 mg/day of etonogestrel and 0.015 mg/day of ethinyl estradiol over 21 days Manufacturer Control # US-009507513-1212USA 001640 Dosage Text UNK

Age

Sex Female

Country USA

Preferred Term Cerebrovascular accident

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

8954136 Date FDA Received

31-Dec-2012

Case # 8954136

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,OT

Age

Sex Female

Country USA

Preferred Term Pulmonary embolism

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,406 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8682832 Date FDA Received
02-Jan-2013 Case # 8682832 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO Manufacturer Control # US-009507513-1207USA 008767 Dosage Text UNK Duration Age Sex Unknown Country USA

Preferred Term Deep vein thrombosis Anxiety Coagulopathy Depression Oedema peripheral

Product NUVARING

Role Route S

Manufacturer MERCK

8818051 Date FDA Received

02-Jan-2013

Case # 8818051

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,OT

Manufacturer Control # US-009507513-2012SP0 34974 Dosage Text

Age

Sex Unknown

Country USA

Preferred Term Thrombectomy Deep vein thrombosis Limb operation Pregnancy Pulmonary embolism Urinary tract infection Vena cava filter insertion Venous stenosis

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

8838747 Date FDA Received

02-Jan-2013

Case # 8838747

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1210USA 001605

Age

Sex Female

Country USA

Preferred Term Drug dose omission No adverse event Product shape issue

Product NUVARING

Role Route S VAGINAL

Dosage Text 0.015 daily

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,407 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8978931 Date FDA Received
02-Jan-2013 Case # 8978931 Case Type EXPEDITED (15-DAY) Health Professional Outcomes DE,OT Manufacturer Control # US-009507513-1212USA 007834 Dosage Text UNK Duration Age Sex Unknown Country USA

Preferred Term Pulmonary embolism Cardiac arrest

Product NUVARING

Role Route S

Manufacturer MERCK

8992820 Date FDA Received

02-Jan-2013

Case # 8992820

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1212USA 010615

Age 19 YR

Sex Female

Country USA

Preferred Term Vulvovaginal dryness Dyspareunia Vulvovaginal burning sensation Weight increased

Product NUVARING

Role Route S VAGINAL

Dosage Text 1 DF, 3 weeks followed by a week free break

Duration

Manufacturer MERCK

8993549 Date FDA Received

02-Jan-2013

Case # 8993549

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes DS,OT

Manufacturer Control # US-009507513-1301USA 000384 Dosage Text UNK Manufacturer Control # US-009507513-1212USA 008597

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism

Product NUVARING Case # 8995347 Case Type NON-EXPEDITED Health Professional

Role Route S VAGINAL

Duration

Manufacturer MERCK

8995347 Date FDA Received

02-Jan-2013

Outcomes

Age 36 YR

Sex Female

Country USA

Preferred Term Inappropriate schedule of drug administration

Product NUVARING

Role Route S VAGINAL

Dosage Text 3 weeks in, 1 week out

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,408 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8999811 Date FDA Received
02-Jan-2013 Case # 8999811 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1301USA 000021 Role Route S Health Professional VAGINAL Dosage Text UNK Manufacturer Control # US-009507513-1208USA 000234 Dosage Text UNK UNK UNK Duration Age Sex Unknown Duration Age Sex Female Country USA

Preferred Term Device expulsion

Product NUVARING Case # 8708932 Case Type EXPEDITED (15-DAY)

Manufacturer MERCK Country USA

8708932 Date FDA Received

03-Jan-2013

Outcomes HO,OT

Preferred Term Abortion spontaneous Pulmonary embolism Uterine dilation and curettage Back pain Hypercoagulation Obesity Vulvovaginal candidiasis

Product NUVARING NUVARING NUVARING

Role Route S S S

Manufacturer MERCK MERCK MERCK

8995914 Date FDA Received

03-Jan-2013

Case # 8995914

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,DS,OT

Manufacturer Control # US-009507513-2010SP0 63654 Dosage Text

Age

Sex Unknown

Country USA

Preferred Term Hypercoagulation Muscle strain Fibromyalgia Pulmonary embolism Cerebellar haemorrhage Vertigo Epstein-Barr virus infection Dyspnoea Acute sinusitis Back pain

Product NUVARING NUVARING NUVARING NUVARING LEXAPRO REGLAN COUMADIN COUMADIN

Role Route S S S S S S S S

Duration

Manufacturer MERCK MERCK MERCK MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,409 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8995914
Preferred Term Breast disorder Bursitis Depression Drug intolerance Dystonia Fatigue Feeling jittery Folate deficiency Gastrooesophageal reflux disease Genital discharge Headache Herpes simplex Inappropriate schedule of drug administration Influenza like illness Insomnia Iron deficiency anaemia Lichenoid keratosis Lymphadenectomy Mastoptosis Metrorrhagia Migraine Off label use Ovarian cyst Pain Pelvic pain Pharyngitis Sleep apnoea syndrome Viral infection Vitamin B12 deficiency Product Role Route Dosage Text Duration Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,410 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8998645 Date FDA Received
03-Jan-2013 Case # 8998645 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1212USA 011061 Role Route S Health Professional VAGINAL Dosage Text UNK, qm Manufacturer Control # US-009507513-1212USA 010634 Role Route S Health Professional VAGINAL Dosage Text 3 weeks in, 1 week out Manufacturer Control # US-009507513-1301USA 000500 Role Route S Health Professional Outcomes Dosage Text UNK Manufacturer Control # US-009507513-1212USA 008542 Role Route S VAGINAL Dosage Text 1 ring for 3 weeks followed by a week free break 800 mg, UNK Duration Age Sex Female Duration Age Sex Unknown Age 50 YR Sex Female Duration Age Sex Female Country USA

Preferred Term Inappropriate schedule of drug administration

Product NUVARING

Manufacturer MERCK Country USA

8998654 Date FDA Received

03-Jan-2013

Case # 8998654

Case Type NON-EXPEDITED

Outcomes

Preferred Term Menstrual disorder

Product NUVARING Case # 8998662 Case Type NON-EXPEDITED

Duration

Manufacturer MERCK Country USA

8998662 Date FDA Received

03-Jan-2013

Outcomes

Preferred Term Menorrhagia

Product NUVARING Case # 8998669 Case Type NON-EXPEDITED

Manufacturer MERCK Country USA

8998669 Date FDA Received

03-Jan-2013

Preferred Term Chest pain

Product NUVARING

Manufacturer MERCK

Pain in extremity Back pain Fatigue Insomnia

ibuprofen

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,411 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8998689 Date FDA Received
03-Jan-2013 Case # 8998689 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1301USA 000304 Role Route S Health Professional VAGINAL Dosage Text 3 weeks in, 1 week out Manufacturer Control # US-009507513-1212USA 011099 Role Route S VAGINAL Dosage Text UNK Duration Age Sex Female Duration Age Sex Female Country USA

Preferred Term Vulvovaginal discomfort

Product NUVARING Case # 8998723 Case Type NON-EXPEDITED

Manufacturer MERCK Country USA

8998723 Date FDA Received

03-Jan-2013

Outcomes

Preferred Term Device expulsion Inappropriate schedule of drug administration No adverse event

Product NUVARING

Manufacturer MERCK

8998941 Date FDA Received

03-Jan-2013

Case # 8998941

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1301USA 000036

Age 25 YR

Sex Female

Country USA

Preferred Term Inappropriate schedule of drug administration

Product NUVARING Health Professional

Role Route S VAGINAL

Dosage Text UNK, qm, 3 weeks in, 1 week out Manufacturer Control # US-009507513-1301USA 000496

Duration

Manufacturer MERCK

8998966 Date FDA Received

03-Jan-2013

Case # 8998966

Case Type NON-EXPEDITED

Outcomes

Age

Sex Female

Country USA

Preferred Term Menstrual disorder Abnormal withdrawal bleeding

Product NUVARING

Role Route S VAGINAL

Dosage Text 3 weeks in, 1 week out

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,412 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8998967 Date FDA Received
03-Jan-2013 Case # 8998967 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1212USA 010054 Role Route S VAGINAL Dosage Text UNK, qm Age 19 YR Sex Female Country USA

Preferred Term Device expulsion Inappropriate schedule of drug administration

Product NUVARING

Duration

Manufacturer MERCK

8999333 Date FDA Received

03-Jan-2013

Case # 8999333

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1301USA 000490

Age

Sex Female

Country USA

Preferred Term Hypomenorrhoea Inappropriate schedule of drug administration

Product NUVARING

Role Route S

Dosage Text

Duration

Manufacturer MERCK

8999373 Date FDA Received

03-Jan-2013

Case # 8999373

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,OT

Manufacturer Control # US-009507513-1301USA 000317 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism Deep vein thrombosis

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

8740577 Date FDA Received

04-Jan-2013

Case # 8740577

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO

Manufacturer Control # US-009507513-1208USA 007468 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Hypokalaemia Cystitis Deep vein thrombosis Menstruation delayed Oedema peripheral

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,413 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8769336 Date FDA Received
04-Jan-2013 Case # 8769336 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,DS,OT Manufacturer Control # US-009507513-1208USA 012636 Dosage Text UNK Duration Age Sex Unknown Country USA

Preferred Term Cerebrovascular accident Adjustment disorder with depressed mood Anxiety Migraine

Product NUVARING

Role Route S

Manufacturer MERCK

8819927 Date FDA Received

04-Jan-2013

Case # 8819927

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,OT

Manufacturer Control # US-009507513-2012SP0 29904 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Asthma Pulmonary embolism Female sterilisation Headache Amenorrhoea Chest pain Constipation Dental operation Device expulsion Menometrorrhagia Palpitations Rash Sinus disorder Skin graft

Product NUVARING sertraline hydrochloride sertraline hydrochloride ESTROGENS

Role Route S C C S

Duration

Manufacturer MERCK

UNK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,414 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8912570 Date FDA Received
04-Jan-2013 Case # 8912570 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO Manufacturer Control # DE-009507513-1211DEU 005603 Dosage Text 11.7mg/2.7mg, q3w Age 29 YR Sex Female Country DEU

Preferred Term Pancreatitis Infection Pancreatitis

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,415 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8937580 Date FDA Received
04-Jan-2013 Case # 8937580 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,DS,LT,OT Manufacturer Control # US-009507513-2012SP0 32595 Dosage Text UNK UNK UNK Duration Age Sex Unknown Country USA

Preferred Term Cardiac failure congestive Pulmonary embolism Deep vein thrombosis Anaemia Aneurysm Anxiety Cardiac arrest Cardiomegaly Chest pain Depression Fibromyalgia Gastric haemorrhage Gastrointestinal haemorrhage Hypotension Leukocytosis Migraine Nausea Nerve injury Pain Pleural effusion Sleep disorder Sternotomy Thromboembolectomy Vena cava filter insertion

Product NUVARING gabapentin TOPAMAX

Role Route S C C VAGINAL

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,416 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8953320 Date FDA Received
04-Jan-2013 Case # 8953320 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1212USA 001430 Role Route S VAGINAL Dosage Text 3 weeks in, 1 week out, qm Age 21 YR Sex Female Country USA

Preferred Term Inappropriate schedule of drug administration Incorrect drug administration duration

Product NUVARING

Duration

Manufacturer MERCK

8992803 Date FDA Received

04-Jan-2013

Case # 8992803

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1212USA 010612

Age 19 YR

Sex Female

Country USA

Preferred Term Device expulsion

Product NUVARING Case # 8996326 Case Type NON-EXPEDITED Health Professional

Role Route S VAGINAL

Dosage Text 1 ring for 3 weeks Manufacturer Control # US-009507513-1301USA 000022

Duration

Manufacturer MERCK

8996326 Date FDA Received

04-Jan-2013

Outcomes

Age 25 YR

Sex Female

Country USA

Preferred Term Inappropriate schedule of drug administration

Product NUVARING Health Professional

Role Route S VAGINAL

Dosage Text 3 weeks in, 1 week out , qm Manufacturer Control # US-009507513-1212USA 006206

Duration

Manufacturer MERCK

8996333 Date FDA Received

04-Jan-2013

Case # 8996333

Case Type NON-EXPEDITED

Outcomes

Age

Sex Unknown

Country USA

Preferred Term Drug dose omission No adverse event Product quality issue

Product NUVARING

Role Route S VAGINAL

Dosage Text UNK

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,417 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8996346 Date FDA Received
04-Jan-2013 Case # 8996346 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1212USA 010608 Role Route S Health Professional VAGINAL Dosage Text UNK UNK, qm Manufacturer Control # US-009507513-1212USA 010617 Role Route S Health Professional Outcomes LT Dosage Text UNK Manufacturer Control # US-009507513-1301USA 000385 Role Route S VAGINAL Dosage Text UNK Duration Age Sex Unknown Duration Age Sex Female Duration Age Sex Female Country USA

Preferred Term Inappropriate schedule of drug administration

Product NUVARING

Manufacturer MERCK Country USA

8996498 Date FDA Received

04-Jan-2013

Case # 8996498

Case Type NON-EXPEDITED

Outcomes

Preferred Term Device expulsion

Product NUVARING Case # 8997048 Case Type EXPEDITED (15-DAY)

Manufacturer MERCK Country USA

8997048 Date FDA Received

04-Jan-2013

Preferred Term Deep vein thrombosis Thrombophlebitis superficial

Product NUVARING

Manufacturer MERCK

8997226 Date FDA Received

04-Jan-2013

Case # 8997226

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1301USA 000283

Age 40 YR

Sex Female

Country USA

Preferred Term Inappropriate schedule of drug administration

Product NUVARING Health Professional

Role Route S VAGINAL

Dosage Text 1 DF, 3weeks in, 1 week out Manufacturer Control # US-009507513-1301USA 000323 Dosage Text UNK

Duration

Manufacturer MERCK

8997319 Date FDA Received

04-Jan-2013

Case # 8997319

Case Type EXPEDITED (15-DAY)

Outcomes HO,OT

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism Deep vein thrombosis

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,418 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8997576 Date FDA Received
04-Jan-2013 Case # 8997576 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1301USA 000280 Role Route S Health Professional VAGINAL Dosage Text 1 DF, 3 weeks in, 1 week out Manufacturer Control # US-009507513-1212USA 011202 Role Route S C Outcomes DS Manufacturer Control # US-009507513-1301USA 000371 Dosage Text UNK Manufacturer Control # US-009507513-1301USA 000368 Dosage Text UNK Manufacturer Control # US-009507513-1301USA 001790 Dosage Text UNK Duration Age Sex Unknown Duration Age Sex Female Duration Age Sex Unknown Country USA VAGINAL Dosage Text UNK Duration Age Sex Female Age 23 YR Sex Female Country USA

Preferred Term Inappropriate schedule of drug administration

Product NUVARING

Duration

Manufacturer MERCK Country USA

8997614 Date FDA Received

04-Jan-2013

Case # 8997614

Case Type NON-EXPEDITED

Outcomes

Preferred Term Device expulsion Device physical property issue

Product NUVARING dicyclomine hydrochloride Case Type EXPEDITED (15-DAY) Health Professional

Manufacturer MERCK

8997643 Date FDA Received

04-Jan-2013

Case # 8997643

Preferred Term Thrombosis

Product NUVARING Case # 8998014 Case Type EXPEDITED (15-DAY) Health Professional

Role Route S Outcomes DS,OT

Manufacturer MERCK Country USA

8998014 Date FDA Received

04-Jan-2013

Preferred Term Pulmonary embolism

Product NUVARING Case # 8998140 Case Type EXPEDITED (15-DAY) Health Professional

Role Route S VAGINAL

Manufacturer MERCK Country USA

8998140 Date FDA Received

04-Jan-2013

Outcomes HO

Preferred Term Deep vein thrombosis

Product NUVARING

Role Route S

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,419 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8998185 Date FDA Received
04-Jan-2013 Case # 8998185 Case Type EXPEDITED (15-DAY) Health Professional Outcomes DS,OT Manufacturer Control # US-009507513-1301USA 000383 Dosage Text Duration Age Sex Unknown Country USA

Preferred Term Pulmonary embolism

Product NUVARING Case # 8998020 Case Type NON-EXPEDITED Health Professional

Role Route S Outcomes

Manufacturer MERCK

8998020 Date FDA Received

05-Jan-2013

Manufacturer Control # US-009507513-1212USA 010836

Age

Sex Female

Country USA

Preferred Term Irritability Abdominal distension

Product NUVARING

Role Route S VAGINAL

Dosage Text 0.012/0.015

Duration

Manufacturer MERCK

9000326 Date FDA Received

06-Jan-2013

Case # 9000326

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1212USA 011065

Age

Sex Female

Country USA

Preferred Term Inappropriate schedule of drug administration

Product NUVARING Health Professional

Role Route S VAGINAL

Dosage Text UNK Manufacturer Control # US-009507513-1212USA 011067

Duration

Manufacturer MERCK

9000332 Date FDA Received

07-Jan-2013

Case # 9000332

Case Type NON-EXPEDITED

Outcomes

Age

Sex Female

Country USA

Preferred Term Abnormal withdrawal bleeding

Product NUVARING BACTRIM

Role Route S C Health Professional Outcomes VAGINAL

Dosage Text UNK, qm

Duration

Manufacturer MERCK

9000632 Date FDA Received

07-Jan-2013

Case # 9000632

Case Type NON-EXPEDITED

Manufacturer Control # US-009507513-1301USA 001890

Age

Sex Female

Country USA

Preferred Term Device expulsion

Product NUVARING

Role Route S VAGINAL

Dosage Text 3 weeks in, 1 week out

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,420 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 9001129 Date FDA Received
07-Jan-2013 Case # 9001129 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1301USA 001877 Role Route S Health Professional Outcomes HO,OT Dosage Text 1 ring for 3 week use Manufacturer Control # US-009507513-1301USA 000320 Dosage Text UNK Manufacturer Control # US-009507513-1212USA 010646 Role Route S VAGINAL Dosage Text 3 weeks in, 1 week out Age 21 YR Sex Female Duration Age Sex Unknown Duration Age Sex Female Country USA

Preferred Term Vaginal infection

Product NUVARING Case # 9001500 Case Type EXPEDITED (15-DAY)

Manufacturer MERCK Country USA

9001500 Date FDA Received

07-Jan-2013

Preferred Term Pulmonary embolism

Product NUVARING Case # 9001650 Case Type NON-EXPEDITED Health Professional

Role Route S Outcomes

Manufacturer MERCK Country USA

9001650 Date FDA Received

07-Jan-2013

Preferred Term Inappropriate schedule of drug administration Unintended pregnancy

Product NUVARING

Duration

Manufacturer MERCK

9001851 Date FDA Received

07-Jan-2013

Case # 9001851

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1212USA 010675

Age

Sex Female

Country USA

Preferred Term Metrorrhagia Incorrect drug administration duration

Product NUVARING

Role Route S VAGINAL

Dosage Text 4 weeks in, back to back

Duration

Manufacturer MERCK

9002185 Date FDA Received

07-Jan-2013

Case # 9002185

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1301USA 001857

Age

Sex Female

Country USA

Preferred Term Inappropriate schedule of drug administration

Product NUVARING

Role Route S VAGINAL

Dosage Text 3 weeks in, 1 week out

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,421 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 9002192 Date FDA Received
07-Jan-2013 Case # 9002192 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1212USA 010824 Role Route S VAGINAL Dosage Text 1 ring for 3 weeks followed by a week free break Duration Age Sex Female Country USA

Preferred Term Urinary tract infection

Product NUVARING

Manufacturer MERCK

Fungal infection Abdominal distension Abnormal withdrawal bleeding Breast tenderness Dysmenorrhoea Vaginal discharge

ALLEGRA

9002197 Date FDA Received

07-Jan-2013

Case # 9002197

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1301USA 001361

Age

Sex Female

Country USA

Preferred Term Device expulsion

Product NUVARING Case # 9002206 Case Type NON-EXPEDITED Health Professional

Role Route S VAGINAL

Dosage Text

Duration

Manufacturer MERCK

9002206 Date FDA Received

07-Jan-2013

Outcomes

Manufacturer Control # US-009507513-1301USA 001298

Age

Sex Female

Country USA

Preferred Term Metrorrhagia

Product NUVARING Case # 9002813 Case Type NON-EXPEDITED Health Professional

Role Route S Outcomes

Dosage Text

Duration

Manufacturer MERCK

9002813 Date FDA Received

07-Jan-2013

Manufacturer Control # US-009507513-1301USA 000313

Age

Sex Unknown

Country USA

Preferred Term Deep vein thrombosis

Product NUVARING

Role Route S VAGINAL

Dosage Text UNK

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,422 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 6784013 Date FDA Received
08-Jan-2013 Case # 6784013 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,DS,LT,OT Manufacturer Control # US-009507513-2008-183 939-NL Dosage Text DOSE TEXT: 3 WEEKS IN; 1 WEEK OUT, CONTINUING: NO Duration Age Sex Unknown Country USA

Preferred Term Pulmonary embolism

Product NUVARING

Role Route S

Manufacturer MERCK

Deep vein thrombosis Candidiasis Weight increased

ADVIL

8781507 Date FDA Received

08-Jan-2013

Case # 8781507

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,OT

Manufacturer Control # US-009507513-1209USA 003603 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism Cardiolipin antibody Emotional disorder Gastrooesophageal reflux disease Subcutaneous haematoma Vaginitis bacterial

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,423 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8815977 Date FDA Received
08-Jan-2013 Case # 8815977 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2012SP0 34978 Dosage Text UNK UNK UNK 1000 mg, bid Duration Age Sex Unknown Country USA

Preferred Term Intestinal resection Intracranial venous sinus thrombosis Jugular vein thrombosis Headache Ear pain Crohn's disease Erythema nodosum Ileal stenosis Lymphadenopathy Nausea Open wound Perineal operation Photosensitivity reaction Pneumonia Skin mass Small intestinal obstruction Tendon sheath lesion excision Vaginal fistula Vaginal fistula repair Viral rash Vomiting

Product NUVARING NUVARING NUVARING PENTASA REMICADE

Role Route S S S C C VAGINAL VAGINAL VAGINAL

Manufacturer MERCK MERCK MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,424 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8906041 Date FDA Received
08-Jan-2013 Case # 8906041 Case Type EXPEDITED (15-DAY) Health Professional Outcomes OT Manufacturer Control # BR-009507513-2012SP0 28810 Dosage Text UNK UNK, Unknown UNK Duration Age Sex Female Country BRA

Preferred Term Abortion spontaneous Metrorrhagia Abdominal pain Candidiasis Decreased appetite Diarrhoea Dizziness Dysmenorrhoea Headache Inappropriate schedule of drug administration Malaise Maternal exposure during pregnancy Metrorrhagia Nausea Pain in extremity Uterine dilation and curettage Vaginal discharge Vomiting Vulvovaginal discomfort Vulvovaginal dryness Vulvovaginal pruritus

Product NUVARING NUVARING

Role Route S S VAGINAL VAGINAL

Manufacturer MERCK MERCK

9001859 Date FDA Received

08-Jan-2013

Case # 9001859

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1301USA 001108

Age 23 YR

Sex Female

Country USA

Preferred Term Abdominal discomfort Headache

Product NUVARING

Role Route S VAGINAL

Dosage Text 3 weeks in, 3 weeks in

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,425 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 9004020 Date FDA Received
08-Jan-2013 Case # 9004020 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,DS,OT Manufacturer Control # US-009507513-2010SP0 28345 Dosage Text Duration Age Sex Unknown Country USA

Preferred Term Hypercoagulation Pneumonia Anaemia Antiphospholipid syndrome Deep vein thrombosis Dehydration Hepatic lesion Muscle spasms Off label use Pulmonary embolism

Product NUVARING CODEINE PHOSPHATE

Role Route S C

Manufacturer MERCK

9004023 Date FDA Received

08-Jan-2013

Case # 9004023

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,OT

Manufacturer Control # US-009507513-1301USA 000325 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism Deep vein thrombosis

Product NUVARING

Role Route S

Duration

Manufacturer MERCK

9004495 Date FDA Received

08-Jan-2013

Case # 9004495

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes OT

Manufacturer Control # US-009507513-1301USA 000309 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,426 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8796828 Date FDA Received
09-Jan-2013 Case # 8796828 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2012SP0 29908 Dosage Text 1 DF, qm for 28 days Duration Age Sex Unknown Country USA

Preferred Term Vena cava filter insertion Abortion missed Aortic arteriosclerosis Deep vein thrombosis Drug prescribing error Malaise Menstrual disorder Phlebitis Pulmonary embolism Pulmonary hypertension Thrombosis Unintended pregnancy Uterine dilation and curettage Uterine leiomyoma Vaginitis gardnerella

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

9004054 Date FDA Received

09-Jan-2013

Case # 9004054

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1301USA 002667

Age 22 YR

Sex Female

Country USA

Preferred Term Inappropriate schedule of drug administration

Product NUVARING Health Professional

Role Route S VAGINAL

Dosage Text 3 weeks in, 1 week out Manufacturer Control # US-009507513-1301USA 002438 Dosage Text UNK UNK

Duration

Manufacturer MERCK

9005516 Date FDA Received

09-Jan-2013

Case # 9005516

Case Type EXPEDITED (15-DAY)

Outcomes HO,OT

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism Deep vein thrombosis

Product NUVARING NUVARING

Role Route S S VAGINAL

Duration

Manufacturer MERCK MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,427 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 9005597 Date FDA Received
09-Jan-2013 Case # 9005597 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,DS,OT Manufacturer Control # US-009507513-2010SP0 45172 Dosage Text Duration Age Sex Unknown Country USA

Preferred Term Hepatic lesion Anxiety Headache Pulmonary embolism Pulmonary mass

Product NUVARING

Role Route S

Manufacturer MERCK

9005612 Date FDA Received

09-Jan-2013

Case # 9005612

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1301USA 001686

Age

Sex Female

Country USA

Preferred Term Inappropriate schedule of drug administration

Product NUVARING

Role Route S VAGINAL

Dosage Text 1 DF, 1 ring up to 3 weeks with one week ring free break

Duration

Manufacturer MERCK

Device expulsion Unintended pregnancy

9010571 Date FDA Received

09-Jan-2013

Case # 9010571

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO

Manufacturer Control # US-009507513-1301USA 002410 Dosage Text UNK Manufacturer Control # US-009507513-1301USA 002431 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Deep vein thrombosis

Product NUVARING Case # 9010582 Case Type EXPEDITED (15-DAY) Health Professional

Role Route S VAGINAL

Duration

Manufacturer MERCK

9010582 Date FDA Received

09-Jan-2013

Outcomes HO,DS,OT

Age

Sex Unknown

Country USA

Preferred Term Cerebrovascular accident

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,428 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 9010913 Date FDA Received
09-Jan-2013 Case # 9010913 Case Type EXPEDITED (15-DAY) Health Professional Outcomes DS Manufacturer Control # US-009507513-1301USA 002429 Dosage Text UNK Manufacturer Control # US-009507513-1301USA 002433 Dosage Text UNK Manufacturer Control # US-009507513-1301USA 001768 Role Route S VAGINAL Dosage Text 1 ring every 3 weeks followed by a week free Duration Age Sex Female Duration Age Sex Unknown Duration Age Sex Unknown Country USA

Preferred Term Injury

Product NUVARING Case # 9010973 Case Type EXPEDITED (15-DAY) Health Professional

Role Route S VAGINAL

Manufacturer MERCK Country USA

9010973 Date FDA Received

09-Jan-2013

Outcomes HO,OT

Preferred Term Pulmonary embolism

Product NUVARING Case # 9011097 Case Type NON-EXPEDITED Health Professional

Role Route S VAGINAL

Manufacturer MERCK Country USA

9011097 Date FDA Received

09-Jan-2013

Outcomes

Preferred Term Device expulsion Product quality issue

Product NUVARING

Manufacturer MERCK

8767862 Date FDA Received

10-Jan-2013

Case # 8767862

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes OT

Manufacturer Control # US-009507513-1208USA 012641 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Cerebrovascular accident Complicated migraine Dizziness Headache Low density lipoprotein increased Major depression Nasopharyngitis Vertigo

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,429 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8769726 Date FDA Received
10-Jan-2013 Case # 8769726 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1208USA 011069 Role Route S VAGINAL Dosage Text 1 DF, 1 ring for 3 weeks then a break and resinsert after period stops Age 23 YR Sex Female Country USA

Preferred Term Unintended pregnancy

Product NUVARING

Duration

Manufacturer MERCK

Withdrawal bleed Inappropriate schedule of drug administration

loratadine

8771436 Date FDA Received

10-Jan-2013

Case # 8771436

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,DS,OT

Manufacturer Control # US-009507513-1208USA 012635 Dosage Text UNK UNK

Age

Sex Unknown

Country USA

Preferred Term Surgery Deep vein thrombosis Thrombosis

Product NUVARING ibuprofen

Role Route S C

Duration

Manufacturer MERCK

8841757 Date FDA Received

10-Jan-2013

Case # 8841757

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1210USA 003569

Age

Sex Female

Country USA

Preferred Term Vulvovaginal discomfort Device expulsion

Product NUVARING vitamin B (unspecified) levothyroxine sodium PRILOSEC alprazolam

Role Route S C C C C Health Professional Outcomes HO,OT VAGINAL

Dosage Text UNK

Duration

Manufacturer MERCK

UNK, prn Manufacturer Control # US-009507513-2010SP0 40146 Dosage Text Duration Age Sex Unknown Country USA

8963000 Date FDA Received

10-Jan-2013

Case # 8963000

Case Type EXPEDITED (15-DAY)

Preferred Term

Product

Role Route

Manufacturer

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,430 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8963000
Preferred Term Loss of consciousness Abdominal pain lower Abortion spontaneous Acne Alopecia Anogenital warts Apparent death Chest discomfort Coagulopathy Concussion Contusion Dyspnoea Dyspnoea exertional Fall Haematemesis Headache Head injury Hypertension Inappropriate schedule of drug administration Jaw operation Limb injury Lymphadenopathy Major depression Maternal exposure during pregnancy Nasal operation Nausea Nephrolithiasis Pharyngitis Physical assault Polycystic ovaries Psoriasis Product NUVARING Role Route S VAGINAL Dosage Text UNK Duration Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,431 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8963000
Preferred Term Pulmonary embolism Pulmonary hypertension Rash pustular Vaginal haemorrhage Product Role Route Dosage Text Duration Manufacturer

8988264 Date FDA Received

10-Jan-2013

Case # 8988264

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,OT

Manufacturer Control # US-009507513-2012SP0 04596 Dosage Text UNK UNK UNK

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism Chest pain Off label use Pain in extremity Back injury Back pain Chest pain Fall Neck injury Road traffic accident

Product NUVARING NUVARING ascorbic acid vitamin B complex

Role Route S S C C

Duration

Manufacturer MERCK MERCK

9006382 Date FDA Received

10-Jan-2013

Case # 9006382

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO

Manufacturer Control # DE-009507513-1301CHN 003369 Dosage Text

Age

Sex Female

Country CHN

Preferred Term Adverse event

Product NUVARING Case # 9006393 Case Type NON-EXPEDITED Health Professional

Role Route S VAGINAL

Duration

Manufacturer MERCK

9006393 Date FDA Received

10-Jan-2013

Outcomes

Manufacturer Control # US-009507513-1301USA 001284

Age

Sex Unknown

Country USA

Preferred Term Metrorrhagia

Product NUVARING

Role Route S

Dosage Text UNK

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,432 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 9007846 Date FDA Received
10-Jan-2013 Case # 9007846 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-1301USA 002436 Dosage Text UNK Manufacturer Control # US-009507513-1301USA 002437 Dosage Text UNK Manufacturer Control # US-009507513-1208USA 012645 Dosage Text UNK UNK Duration Age Sex Unknown Duration Age Sex Unknown Duration Age Sex Unknown Country USA

Preferred Term Pulmonary embolism

Product NUVARING Case # 9009716 Case Type EXPEDITED (15-DAY) Health Professional

Role Route S Outcomes HO,OT

Manufacturer MERCK Country USA

9009716 Date FDA Received

10-Jan-2013

Preferred Term Pulmonary embolism

Product NUVARING Case # 8765900 Case Type EXPEDITED (15-DAY) Health Professional

Role Route S VAGINAL

Manufacturer MERCK Country USA

8765900 Date FDA Received

11-Jan-2013

Outcomes HO,DS,OT

Preferred Term Pulmonary embolism Left ventricular dysfunction Cardiac arrest Convulsion Ovarian cyst Tonsillectomy

Product NUVARING VENTOLIN HFA

Role Route S C

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,433 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8772129 Date FDA Received
11-Jan-2013 Case # 8772129 Case Type EXPEDITED (15-DAY) Health Professional Outcomes DS Manufacturer Control # US-009507513-2012SP0 05291 Dosage Text 0.12 MG-0.015 MG/3 WEEKS IN ONE WEEK OUT PER MONTH, 0.12-0.015 MG/ 24 HR Duration Age Sex Female Country USA

Preferred Term Optic neuritis

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

Clinically isolated syndrome Intervertebral disc degeneration Vitamin B12 deficiency Vitamin D deficiency Rash Arthralgia

PAXIL PRILOSEC ascorbic acid thiamine hydrochloride KLONOPIN

C C C C C UNK UNK, PRN

8890690 Date FDA Received

11-Jan-2013

Case # 8890690

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes OT

Manufacturer Control # US-009507513-1211USA 001026 Dosage Text 0.120 mg/day of etonogestrel and 0.015mg/day of ethinyl estradiol

Age 38 YR

Sex Female

Country USA

Preferred Term Abortion spontaneous

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

Maternal exposure during pregnancy

8924333 Date FDA Received

11-Jan-2013

Case # 8924333

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,OT

Manufacturer Control # US-009507513-2010SP0 51431 Dosage Text UNK UNK, QM

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism Asthma Migraine

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,434 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 9007776 Date FDA Received
11-Jan-2013 Case # 9007776 Case Type EXPEDITED (15-DAY) Health Professional Outcomes OT Manufacturer Control # SK-009507513-1212SVK 001351 Dosage Text UNK Manufacturer Control # FR-009507513-2012SP0 36902 Dosage Text UNK 2 g, bid Duration Age Sex Female Duration Age Sex Female Country SVK

Preferred Term Vitiligo

Product NUVARING Case # 9007816 Case Type EXPEDITED (15-DAY) Health Professional

Role Route S VAGINAL

Manufacturer MERCK Country FRA

9007816 Date FDA Received

11-Jan-2013

Outcomes HO

Preferred Term Enterocolitis haemorrhagic Diarrhoea Abdominal pain

Product NUVARING PENTASA

Role Route S C VAGINAL ORAL

Manufacturer MERCK

9008525 Date FDA Received

11-Jan-2013

Case # 9008525

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes CA

Manufacturer Control # US-009507513-1301USA 002983 Dosage Text

Age

Sex

Country USA

121 DAY Male

Preferred Term Penis disorder Exposure during breast feeding

Product NUVARING

Role Route S TRANSAMMMARY

Duration

Manufacturer MERCK

9009204 Date FDA Received

11-Jan-2013

Case # 9009204

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes OT

Manufacturer Control # BR-009507513-2011SP0 32178 Dosage Text UNK 10 mg, qd

Age

Sex Female

Country BRA

Preferred Term Breast prosthesis implantation Inappropriate schedule of drug administration Drug administration error

Product NUVARING fluoxetine

Role Route S C VAGINAL ORAL

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,435 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 9011433 Date FDA Received
11-Jan-2013 Case # 9011433 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1301USA 004636 Role Route S Health Professional VAGINAL Manufacturer Control # US-009507513-1301USA 003259 Role Route S Health Professional VAGINAL Dosage Text UNK Manufacturer Control # US-009507513-1207USA 001105 Dosage Text UNK Duration Age Sex Unknown Duration Age Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term Hypersensitivity

Product NUVARING Case # 9011760 Case Type NON-EXPEDITED

Manufacturer MERCK Country USA

9011760 Date FDA Received

13-Jan-2013

Outcomes

Preferred Term Pelvic pain

Product NUVARING Case # 8663986 Case Type EXPEDITED (15-DAY)

Manufacturer MERCK Country USA

8663986 Date FDA Received

14-Jan-2013

Outcomes HO,OT

Preferred Term Pulmonary embolism Multiple injuries Off label use Type 2 diabetes mellitus

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,436 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8770198 Date FDA Received
14-Jan-2013 Case # 8770198 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-1209USA 001498 Dosage Text UNK Duration Age Sex Unknown Country USA

Preferred Term Pulmonary embolism Deep vein thrombosis Non-cardiac chest pain Anaemia Asthma Bronchitis Cellulitis Deep vein thrombosis Dyspnoea Haemorrhagic anaemia Hyperlipidaemia Melaena Off label use Ovarian cyst Pain in extremity Pulmonary embolism Transfusion

Product NUVARING NUVARING NUVARING

Role Route S S S VAGINAL

Manufacturer MERCK MERCK MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,437 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8815383 Date FDA Received
14-Jan-2013 Case # 8815383 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2012SP0 24805 Dosage Text in for 3 weeks, out for 1 week UNK Duration Age Sex Unknown Country USA

Preferred Term Palpitations Pulmonary infarction Abortion spontaneous Anticoagulation drug level below therapeutic Chest pain Dyspnoea International normalised ratio decreased Pain in extremity Paraesthesia Pericardial effusion Pulmonary embolism Tachycardia

Product NUVARING PROVENTIL

Role Route S C VAGINAL

Manufacturer MERCK

8853062 Date FDA Received

14-Jan-2013

Case # 8853062

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1210USA 008756

Age

Sex Female

Country USA

Preferred Term Dysmenorrhoea Drug dose omission Metrorrhagia

Product NUVARING

Role Route S VAGINAL

Dosage Text 1 ring,every 28 days

Duration

Manufacturer MERCK

8976185 Date FDA Received

14-Jan-2013

Case # 8976185

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes DE,OT

Manufacturer Control # US-009507513-2011SP0 50707 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism Migraine

Product NUVARING

Role Route S

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,438 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 9012203 Date FDA Received
14-Jan-2013 Case # 9012203 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1301USA 003385 Role Route S Health Professional VAGINAL Dosage Text 1 DF 3 weeks in, 1 week out Manufacturer Control # US-009507513-1301USA 005171 Dosage Text UNK Duration Age Sex Unknown Duration Age Sex Female Country USA

Preferred Term Inappropriate schedule of drug administration

Product NUVARING

Manufacturer MERCK Country USA

9012317 Date FDA Received

14-Jan-2013

Case # 9012317

Case Type EXPEDITED (15-DAY)

Outcomes OT

Preferred Term Pulmonary embolism Coagulopathy Deep vein thrombosis

Product NUVARING

Role Route S

Manufacturer MERCK

9012321 Date FDA Received

14-Jan-2013

Case # 9012321

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes OT

Manufacturer Control # US-009507513-1301USA 005209 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism Coagulopathy Deep vein thrombosis

Product NUVARING

Role Route S

Duration

Manufacturer MERCK

9012527 Date FDA Received

14-Jan-2013

Case # 9012527

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes OT

Manufacturer Control # US-009507513-1301USA 005202 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism Coagulopathy Deep vein thrombosis

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,439 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 9012539 Date FDA Received
14-Jan-2013 Case # 9012539 Case Type EXPEDITED (15-DAY) Health Professional Outcomes OT Manufacturer Control # US-009507513-1301USA 005244 Dosage Text UNK Duration Age Sex Unknown Country USA

Preferred Term Pulmonary embolism Coagulopathy Deep vein thrombosis

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

9012541 Date FDA Received

14-Jan-2013

Case # 9012541

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes OT

Manufacturer Control # US-009507513-1301USA 005128 Dosage Text UNK

Age

Sex Female

Country USA

Preferred Term Pulmonary embolism Coagulopathy Deep vein thrombosis

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

9012576 Date FDA Received

14-Jan-2013

Case # 9012576

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes OT

Manufacturer Control # US-009507513-1301USA 005258 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism Coagulopathy Deep vein thrombosis

Product NUVARING

Role Route S

Duration

Manufacturer MERCK

9012676 Date FDA Received

14-Jan-2013

Case # 9012676

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes OT

Manufacturer Control # US-009507513-1301USA 005194 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism Coagulopathy Deep vein thrombosis

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,440 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 9012682 Date FDA Received
14-Jan-2013 Case # 9012682 Case Type EXPEDITED (15-DAY) Health Professional Outcomes OT Manufacturer Control # US-009507513-1301USA 005237 Dosage Text UNK Duration Age Sex Unknown Country USA

Preferred Term Pulmonary embolism Coagulopathy Deep vein thrombosis

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

9012685 Date FDA Received

14-Jan-2013

Case # 9012685

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes OT

Manufacturer Control # US-009507513-1301USA 005118 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism Coagulopathy Deep vein thrombosis

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

9012688 Date FDA Received

14-Jan-2013

Case # 9012688

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes OT

Manufacturer Control # US-009507513-1301USA 005269 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism Coagulopathy Deep vein thrombosis

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

9012689 Date FDA Received

14-Jan-2013

Case # 9012689

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes OT

Manufacturer Control # US-009507513-1301USA 005187 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism Coagulopathy Deep vein thrombosis

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,441 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 9012700 Date FDA Received
14-Jan-2013 Case # 9012700 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1301USA 004444 Role Route S VAGINAL Dosage Text UNK Duration Age Sex Unknown Country USA

Preferred Term Inappropriate schedule of drug administration No adverse event

Product NUVARING

Manufacturer MERCK

9012727 Date FDA Received

14-Jan-2013

Case # 9012727

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes OT

Manufacturer Control # US-009507513-1301USA 005246 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism Coagulopathy Deep vein thrombosis

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

9012729 Date FDA Received

14-Jan-2013

Case # 9012729

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes OT

Manufacturer Control # US-009507513-1301USA 005216 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Coagulopathy Deep vein thrombosis Pulmonary embolism

Product NUVARING

Role Route S

Duration

Manufacturer MERCK

9012736 Date FDA Received

14-Jan-2013

Case # 9012736

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes OT

Manufacturer Control # US-009507513-1301USA 005260 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Coagulopathy Deep vein thrombosis Pulmonary embolism

Product NUVARING

Role Route S

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,442 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 9012738 Date FDA Received
14-Jan-2013 Case # 9012738 Case Type EXPEDITED (15-DAY) Health Professional Outcomes OT Manufacturer Control # US-009507513-1301USA 005281 Dosage Text UNK Duration Age Sex Unknown Country USA

Preferred Term Coagulopathy Deep vein thrombosis Pulmonary embolism

Product NUVARING

Role Route S

Manufacturer MERCK

9012859 Date FDA Received

14-Jan-2013

Case # 9012859

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes OT

Manufacturer Control # US-009507513-1301USA 005206 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism Coagulopathy Deep vein thrombosis

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

9012860 Date FDA Received

14-Jan-2013

Case # 9012860

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes OT

Manufacturer Control # US-009507513-1301USA 005280 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism Coagulopathy Deep vein thrombosis

Product NUVARING

Role Route S

Duration

Manufacturer MERCK

9012864 Date FDA Received

14-Jan-2013

Case # 9012864

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes OT

Manufacturer Control # US-009507513-1301USA 005267 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism Coagulopathy Deep vein thrombosis

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,443 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 9012999 Date FDA Received
14-Jan-2013 Case # 9012999 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1301USA 003960 Role Route S Health Professional VAGINAL Dosage Text UNK Manufacturer Control # US-009507513-1301USA 005110 Dosage Text UNK Duration Age Sex Unknown Duration Age Sex Female Country USA

Preferred Term Inappropriate schedule of drug administration

Product NUVARING

Manufacturer MERCK Country USA

9013031 Date FDA Received

14-Jan-2013

Case # 9013031

Case Type EXPEDITED (15-DAY)

Outcomes OT

Preferred Term Pulmonary embolism Coagulopathy Deep vein thrombosis

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

9013059 Date FDA Received

14-Jan-2013

Case # 9013059

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes OT

Manufacturer Control # US-009507513-1301USA 005177 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Coagulopathy Deep vein thrombosis Pulmonary embolism

Product NUVARING

Role Route S

Duration

Manufacturer MERCK

9013254 Date FDA Received

14-Jan-2013

Case # 9013254

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes OT

Manufacturer Control # US-009507513-1301USA 005168 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism Coagulopathy Deep vein thrombosis

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,444 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 9013255 Date FDA Received
14-Jan-2013 Case # 9013255 Case Type EXPEDITED (15-DAY) Health Professional Outcomes OT Manufacturer Control # US-009507513-1301USA 005235 Dosage Text UNK Duration Age Sex Unknown Country USA

Preferred Term Pulmonary embolism Coagulopathy Deep vein thrombosis

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

9013259 Date FDA Received

14-Jan-2013

Case # 9013259

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes OT

Manufacturer Control # US-009507513-1301USA 005192 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism Coagulopathy Deep vein thrombosis

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

9013260 Date FDA Received

14-Jan-2013

Case # 9013260

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes OT

Manufacturer Control # US-009507513-1301USA 005247 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism Coagulopathy Deep vein thrombosis

Product NUVARING

Role Route S

Duration

Manufacturer MERCK

9013262 Date FDA Received

14-Jan-2013

Case # 9013262

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes OT

Manufacturer Control # US-009507513-1301USA 005277 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism Coagulopathy Deep vein thrombosis

Product NUVARING

Role Route S

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,445 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 9013412 Date FDA Received
14-Jan-2013 Case # 9013412 Case Type EXPEDITED (15-DAY) Health Professional Outcomes OT Manufacturer Control # US-009507513-1301USA 005248 Dosage Text UNK Duration Age Sex Unknown Country USA

Preferred Term Pulmonary embolism Coagulopathy Deep vein thrombosis

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

9013430 Date FDA Received

14-Jan-2013

Case # 9013430

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes OT

Manufacturer Control # US-009507513-1301USA 005172 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism Coagulopathy Deep vein thrombosis

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

9013438 Date FDA Received

14-Jan-2013

Case # 9013438

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes OT

Manufacturer Control # US-009507513-1301USA 005211 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism Coagulopathy Deep vein thrombosis

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

9013446 Date FDA Received

14-Jan-2013

Case # 9013446

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes OT

Manufacturer Control # US-009507513-1301USA 005279 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism Coagulopathy Deep vein thrombosis

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,446 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8716479 Date FDA Received
15-Jan-2013 Case # 8716479 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,DS,OT Manufacturer Control # US-009507513-2012SP0 23050 Dosage Text UNK Duration Age Sex Unknown Country USA

Preferred Term Heart rate irregular Depression Economic problem Emotional disorder Impaired work ability Insomnia Pulmonary embolism

Product NUVARING

Role Route S

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,447 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8782646 Date FDA Received
15-Jan-2013 Case # 8782646 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2012SP0 28679 Dosage Text UNK UNK, qm UNK Duration Age Sex Unknown Country USA

Preferred Term Venous stent insertion Pulmonary embolism Abdominal distension Abscess Adjustment disorder Anaemia Decreased appetite Deep vein thrombosis Diarrhoea Dysmenorrhoea Dyspnoea Gastrooesophageal reflux disease Helicobacter infection Hypoaesthesia Leukocytosis Lymphadenopathy Nausea Nephrolithiasis Post thrombotic syndrome Surgical failure Swelling face Syncope Thrombectomy Urinary tract infection Varicose vein Vena cava filter insertion Venous stenosis Weight decreased

Product NUVARING NUVARING

Role Route S S VAGINAL VAGINAL

Manufacturer MERCK MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,448 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8857238 Date FDA Received
15-Jan-2013 Case # 8857238 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-1210USA 009020 Dosage Text UNK Duration Age Sex Unknown Country USA

Preferred Term Palpitations Pain in extremity Pulmonary embolism Pulmonary hypertension

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

8882059 Date FDA Received

15-Jan-2013

Case # 8882059

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1210USA 013529

Age

Sex Female

Country USA

Preferred Term Sensory disturbance Hyperhidrosis Growth retardation Pain Palpitations Vaginal discharge

Product NUVARING CYMBALTA CELEBREX PLAQUENIL PROTONIX MEDROL Case # 8963839 Case Type NON-EXPEDITED Health Professional

Role Route S C C C C C Outcomes VAGINAL

Dosage Text 1 ring for 3 weeks then 1 week break UNK UNK UNK UNK UNK Manufacturer Control # US-009507513-1212USA 004788

Duration

Manufacturer MERCK

8963839 Date FDA Received

15-Jan-2013

Age

Sex Female

Country USA

Preferred Term Vaginal infection

Product NUVARING

Role Route S VAGINAL

Dosage Text UNK

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,449 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8967888 Date FDA Received
15-Jan-2013 Case # 8967888 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1212USA 005757 Role Route S Dosage Text Duration Age Sex Female Country USA

Preferred Term Device breakage No adverse event

Product NUVARING

Manufacturer MERCK

9001607 Date FDA Received

15-Jan-2013

Case # 9001607

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1301USA 000642

Age

Sex Female

Country USA

Preferred Term Metrorrhagia

Product NUVARING Case # 9002196 Case Type EXPEDITED (15-DAY) Health Professional

Role Route S VAGINAL

Dosage Text 3 week ring Manufacturer Control # US-009507513-1301USA 000376 Dosage Text UNK Manufacturer Control # US-009507513-1301USA 004757

Duration

Manufacturer MERCK

9002196 Date FDA Received

15-Jan-2013

Outcomes DS

Age

Sex Unknown

Country USA

Preferred Term Deep vein thrombosis

Product NUVARING Case # 9013077 Case Type NON-EXPEDITED Health Professional

Role Route S VAGINAL

Duration

Manufacturer MERCK

9013077 Date FDA Received

15-Jan-2013

Outcomes

Age

Sex Female

Country USA

Preferred Term Unintended pregnancy

Product NUVARING Case # 9013079 Case Type NON-EXPEDITED Health Professional

Role Route S Outcomes

Dosage Text

Duration

Manufacturer MERCK

9013079 Date FDA Received

15-Jan-2013

Manufacturer Control # US-009507513-1301USA 004767

Age

Sex Female

Country USA

Preferred Term Adverse event

Product NUVARING

Role Route S VAGINAL

Dosage Text

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,450 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 9013285 Date FDA Received
15-Jan-2013 Case # 9013285 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1301USA 003441 Role Route S VAGINAL Dosage Text 1 ring for 3 weeks followed by week free break Manufacturer Control # US-009507513-1301USA 005125 Dosage Text UNK Duration Age Sex Unknown Duration Age Sex Female Country USA

Preferred Term Device expulsion

Product NUVARING

Manufacturer MERCK

9014045 Date FDA Received

15-Jan-2013

Case # 9014045

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes OT

Country USA

Preferred Term Pulmonary embolism Coagulopathy Deep vein thrombosis

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

9014046 Date FDA Received

15-Jan-2013

Case # 9014046

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes OT

Manufacturer Control # US-009507513-1301USA 005176 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism Coagulopathy Deep vein thrombosis

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

9014047 Date FDA Received

15-Jan-2013

Case # 9014047

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes OT

Manufacturer Control # US-009507513-1301USA 005242 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism Coagulopathy Deep vein thrombosis

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,451 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 9014073 Date FDA Received
15-Jan-2013 Case # 9014073 Case Type EXPEDITED (15-DAY) Health Professional Outcomes OT Manufacturer Control # US-009507513-1301USA 005195 Dosage Text UNK Duration Age Sex Unknown Country USA

Preferred Term Pulmonary embolism Coagulopathy Deep vein thrombosis

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

9014146 Date FDA Received

15-Jan-2013

Case # 9014146

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes OT

Manufacturer Control # US-009507513-1301USA 005230 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism Coagulopathy Deep vein thrombosis

Product NUVARING

Role Route S

Duration

Manufacturer MERCK

9014217 Date FDA Received

15-Jan-2013

Case # 9014217

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes OT

Manufacturer Control # US-009507513-1301USA 005265 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism Coagulopathy Deep vein thrombosis

Product NUVARING

Role Route S

Duration

Manufacturer MERCK

9014219 Date FDA Received

15-Jan-2013

Case # 9014219

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes OT

Manufacturer Control # US-009507513-1301USA 005197 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism Coagulopathy Deep vein thrombosis

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,452 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 9014221 Date FDA Received
15-Jan-2013 Case # 9014221 Case Type EXPEDITED (15-DAY) Health Professional Outcomes OT Manufacturer Control # US-009507513-1301USA 005273 Dosage Text UNK Duration Age Sex Unknown Country USA

Preferred Term Pulmonary embolism Coagulopathy Deep vein thrombosis

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

9014284 Date FDA Received

15-Jan-2013

Case # 9014284

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes OT

Manufacturer Control # US-009507513-1301USA 005274 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism Coagulopathy Deep vein thrombosis

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

9014334 Date FDA Received

15-Jan-2013

Case # 9014334

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes OT

Manufacturer Control # US-009507513-1301USA 005275 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism Coagulopathy Deep vein thrombosis

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

9014675 Date FDA Received

15-Jan-2013

Case # 9014675

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes OT

Manufacturer Control # US-009507513-1301USA 005240 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism Coagulopathy Deep vein thrombosis

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,453 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 9014706 Date FDA Received
15-Jan-2013 Case # 9014706 Case Type EXPEDITED (15-DAY) Health Professional Outcomes OT Manufacturer Control # US-009507513-1301USA 005185 Dosage Text UNK Duration Age Sex Unknown Country USA

Preferred Term Pulmonary embolism Coagulopathy Deep vein thrombosis

Product NUVARING

Role Route S

Manufacturer MERCK

9014722 Date FDA Received

15-Jan-2013

Case # 9014722

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes OT

Manufacturer Control # BR-009507513-1301BRA 005692 Dosage Text UNK

Age

Sex Female

Country BRA

Preferred Term Renal surgery Menstruation irregular Nephrolithiasis Papilloma viral infection

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

9014783 Date FDA Received

15-Jan-2013

Case # 9014783

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,OT

Manufacturer Control # US-009507513-2011SP0 48397 Dosage Text

Age

Sex Unknown

Country USA

Preferred Term Tachycardia Influenza Constipation Pulmonary embolism

Product NUVARING NUVARING

Role Route S S VAGINAL

Duration

Manufacturer MERCK MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,454 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 9015172 Date FDA Received
15-Jan-2013 Case # 9015172 Case Type EXPEDITED (15-DAY) Health Professional Outcomes OT Manufacturer Control # US-009507513-1301USA 005107 Dosage Text UNK Duration Age Sex Unknown Country USA

Preferred Term Pulmonary embolism Coagulopathy Deep vein thrombosis

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,455 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8660474 Date FDA Received
16-Jan-2013 Case # 8660474 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2012SP0 36872 Dosage Text UNK Duration Age Sex Unknown Country USA

Preferred Term Pulmonary embolism Anaemia Anticoagulation drug level below therapeutic Biopsy bone Bronchial hyperreactivity Bronchitis Chest pain Conjunctivitis Contusion Dyspnoea Hallucination Ligament sprain Menorrhagia Migraine with aura Orthostatic hypotension Paraesthesia Pleurisy Pneumonia Rhinitis allergic Tachycardia Vertigo

Product NUVARING

Role Route S

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,456 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8687606 Date FDA Received
16-Jan-2013 Case # 8687606 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-1207USA 008748 Dosage Text UNK Duration Age Sex Unknown Country USA

Preferred Term Pulmonary embolism Deep vein thrombosis Arthralgia

Product NUVARING ibuprofen ibuprofen Case # 8706091 Case Type EXPEDITED (15-DAY) Health Professional

Role Route S C C Outcomes HO,DS,OT

Manufacturer MERCK

8706091 Date FDA Received

16-Jan-2013

Manufacturer Control # US-009507513-1208USA 000205 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Abortion spontaneous Dysuria Maternal exposure during pregnancy Musculoskeletal chest pain Nausea Pulmonary embolism Vomiting

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

9016157 Date FDA Received

16-Jan-2013

Case # 9016157

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,OT

Manufacturer Control # US-009507513-2009-196 598-NL Dosage Text 1 DF, qm 600 mg, ONCE

Age

Sex Unknown

Country USA

Preferred Term Deep vein thrombosis Pulmonary embolism Hepatic cyst Deep vein thrombosis Nausea Off label use

Product NUVARING NUVARING ibuprofen

Role Route S S C VAGINAL

Duration

Manufacturer MERCK MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,457 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 9016185 Date FDA Received
16-Jan-2013 Case # 9016185 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,DS,OT Manufacturer Control # US-009507513-1301USA 007528 Dosage Text UNK Duration Age Sex Unknown Country USA

Preferred Term Pulmonary embolism Deep vein thrombosis Thrombophlebitis superficial

Product NUVARING

Role Route S

Manufacturer MERCK

9016373 Date FDA Received

16-Jan-2013

Case # 9016373

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1301USA 005878

Age

Sex Female

Country USA

Preferred Term Palpitations

Product NUVARING Case # 9016470 Case Type NON-EXPEDITED Health Professional

Role Route S VAGINAL

Dosage Text

Duration

Manufacturer MERCK

9016470 Date FDA Received

16-Jan-2013

Outcomes

Manufacturer Control # US-009507513-1301USA 006380

Age

Sex Female

Country USA

Preferred Term Vulvovaginal mycotic infection

Product NUVARING Case Type EXPEDITED (15-DAY) Health Professional

Role Route S VAGINAL

Dosage Text UNK Manufacturer Control # DE-009507513-1301DEU 005895 Dosage Text

Duration

Manufacturer MERCK

9016473 Date FDA Received

16-Jan-2013

Case # 9016473

Outcomes OT

Age

Sex Female

Country DEU

Preferred Term Surgery

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,458 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 9016702 Date FDA Received
16-Jan-2013 Case # 9016702 Case Type EXPEDITED (15-DAY) Health Professional Outcomes OT Manufacturer Control # US-009507513-1301USA 005264 Dosage Text UNK Duration Age Sex Unknown Country USA

Preferred Term Pulmonary embolism Coagulopathy Deep vein thrombosis

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

9016733 Date FDA Received

16-Jan-2013

Case # 9016733

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes OT

Manufacturer Control # US-009507513-1301USA 005220 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism Coagulopathy Deep vein thrombosis

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

9016779 Date FDA Received

16-Jan-2013

Case # 9016779

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes OT

Manufacturer Control # US-009507513-1301USA 005104 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism Coagulopathy Deep vein thrombosis

Product NUVARING

Role Route S

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,459 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8798677 Date FDA Received
17-Jan-2013 Case # 8798677 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,DS,OT Manufacturer Control # US-009507513-2012SP0 22366 Dosage Text UNK 10 mg, UNK Duration Age Sex Unknown Country USA

Preferred Term Pulmonary embolism Gastrooesophageal reflux disease Anxiety Arthralgia Asthenia Blood cholesterol increased Blood triglycerides increased Constipation Cough Deep vein thrombosis Gastritis Hypertension Insomnia Metrorrhagia Musculoskeletal pain Oedema peripheral Palpitations Respiratory distress Restlessness Sinusitis Urinary tract infection

Product NUVARING LEXAPRO

Role Route S C

Manufacturer MERCK

8847665 Date FDA Received

17-Jan-2013

Case # 8847665

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1210USA 007874

Age

Sex Female

Country USA

Preferred Term Hypomenorrhoea

Product NUVARING

Role Route S VAGINAL

Dosage Text 3 weeks in, one week ring free

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,460 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8898638 Date FDA Received
17-Jan-2013 Case # 8898638 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1211USA 003128 Role Route S Health Professional VAGINAL Dosage Text UNK Manufacturer Control # DE-009507513-1301DEU 007327 Dosage Text Age 25 YR Sex Female Duration Age Sex Female Country USA

Preferred Term Vulvovaginal discomfort

Product NUVARING Case # 9016660 Case Type EXPEDITED (15-DAY)

Manufacturer MERCK Country DEU

9016660 Date FDA Received

17-Jan-2013

Outcomes HO

Preferred Term Infection Menstruation irregular

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

9016671 Date FDA Received

17-Jan-2013

Case # 9016671

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1301USA 004222

Age 40 YR

Sex Female

Country USA

Preferred Term Thrombosis

Product NUVARING Case # 9017007 Case Type NON-EXPEDITED Health Professional

Role Route S VAGINAL

Dosage Text

Duration

Manufacturer MERCK

9017007 Date FDA Received

17-Jan-2013

Outcomes

Manufacturer Control # US-009507513-1301USA 005644

Age 26 YR

Sex Female

Country USA

Preferred Term Unintended pregnancy

Product NUVARING Case # 9017008 Case Type NON-EXPEDITED Health Professional

Role Route S VAGINAL

Dosage Text

Duration

Manufacturer MERCK

9017008 Date FDA Received

17-Jan-2013

Outcomes

Manufacturer Control # US-009507513-1301USA 005544

Age

Sex Female

Country USA

Preferred Term Metrorrhagia

Product NUVARING

Role Route S VAGINAL

Dosage Text 1 ring 3 week use

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,461 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 9017204 Date FDA Received
17-Jan-2013 Case # 9017204 Case Type EXPEDITED (15-DAY) Health Professional Outcomes DE,OT Manufacturer Control # US-009507513-1301USA 005182 Dosage Text UNK Duration Age Sex Unknown Country USA

Preferred Term Death Coagulopathy Deep vein thrombosis Pulmonary embolism

Product NUVARING

Role Route S

Manufacturer MERCK

9017219 Date FDA Received

17-Jan-2013

Case # 9017219

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1301USA 006533

Age

Sex Unknown

Country USA

Preferred Term Maternal exposure before pregnancy

Product NUVARING Case Type EXPEDITED (15-DAY) Health Professional

Role Route S Outcomes OT

Dosage Text

Duration

Manufacturer MERCK

9017261 Date FDA Received

17-Jan-2013

Case # 9017261

Manufacturer Control # US-009507513-1301USA 007533 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism Deep vein thrombosis

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,462 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 9017413 Date FDA Received
17-Jan-2013 Case # 9017413 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2011SP0 17555 Dosage Text UNK UNK, QM Duration Age Sex Unknown Country USA

Preferred Term Hypercoagulation Hallucination Cervix carcinoma Pulmonary embolism Dysfunctional uterine bleeding Nasopharyngitis Kidney infection Cervical dysplasia Cervix operation Inappropriate schedule of drug administration Insomnia Maternal exposure before pregnancy Off label use Substance abuse Vulvovaginal candidiasis Vulvovaginal discomfort

Product NUVARING NUVARING NUVARING NUVARING COUGH, COLD, AND FLU THERAPIES (UNSPECIFIED) LORAZEPAM SERTRALINE HYDROCHLORIDE

Role Route S S S S C C C VAGINAL

Manufacturer MERCK MERCK MERCK MERCK

50 mg, QD 0.5 mg, QD 100 mg, QD

9017645 Date FDA Received

17-Jan-2013

Case # 9017645

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes OT

Manufacturer Control # US-009507513-1301USA 005217 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism Coagulopathy Deep vein thrombosis

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,463 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 9017650 Date FDA Received
17-Jan-2013 Case # 9017650 Case Type EXPEDITED (15-DAY) Health Professional Outcomes OT Manufacturer Control # US-009507513-1301USA 005261 Dosage Text UNK Duration Age Sex Unknown Country USA

Preferred Term Pulmonary embolism Coagulopathy Deep vein thrombosis

Product NUVARING

Role Route S

Manufacturer MERCK

9017651 Date FDA Received

17-Jan-2013

Case # 9017651

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes OT

Manufacturer Control # US-009507513-1301USA 005282 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism Coagulopathy Deep vein thrombosis

Product NUVARING

Role Route S

Duration

Manufacturer MERCK

9018124 Date FDA Received

17-Jan-2013

Case # 9018124

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1301USA 004788

Age

Sex Female

Country USA

Preferred Term Adverse event

Product NUVARING Case # 8674251 Case Type EXPEDITED (15-DAY) Health Professional

Role Route S VAGINAL

Dosage Text

Duration

Manufacturer MERCK

8674251 Date FDA Received

18-Jan-2013

Outcomes HO,OT

Manufacturer Control # US-009507513-1207USA 004221 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Cerebral venous thrombosis Bronchitis Melanocytic naevus Rosacea Seborrhoeic keratosis Sinusitis

Product NUVARING

Role Route S

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,464 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8740586 Date FDA Received
18-Jan-2013 Case # 8740586 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-1208USA 007405 Dosage Text UNK 0.3 mg, UNK Duration Age Sex Unknown Country USA

Preferred Term Pleural effusion Pulmonary embolism Thrombosis Pulmonary infarction

Product NUVARING NUVARING YASMIN

Role Route S S S ORAL VAGINAL

Manufacturer MERCK MERCK

8810245 Date FDA Received

18-Jan-2013

Case # 8810245

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1209USA 006440

Age

Sex Female

Country USA

Preferred Term Device difficult to use Medical device discomfort

Product NUVARING

Role Route S VAGINAL

Dosage Text 3 weeks in 1 week out, qm

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,465 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8845888 Date FDA Received
18-Jan-2013 Case # 8845888 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-1210USA 005846 Dosage Text 1 ring/month Duration Age Sex Unknown Country USA

Preferred Term Ovarian cystectomy Pulmonary embolism Adverse drug reaction Appendicectomy Appendix disorder Biopsy breast Chest pain Costochondritis Depressed mood Diarrhoea Headache Myalgia Off label use Pain Pleurisy Rash Vaginal haemorrhage Vitamin D deficiency

Product NUVARING NUVARING

Role Route S S VAGINAL

Manufacturer MERCK MERCK

8985121 Date FDA Received

18-Jan-2013

Case # 8985121

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,LT

Manufacturer Control # US-009507513-1212USA 008615 Dosage Text strength reported as 0.15/0.12

Age

Sex Female

Country USA

Preferred Term Thrombosis

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,466 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 9017666 Date FDA Received
18-Jan-2013 Case # 9017666 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1301USA 005394 Role Route S VAGINAL Dosage Text UNK Duration Age Sex Female Country USA

Preferred Term Vaginal discharge Vulvovaginal discomfort

Product NUVARING

Manufacturer MERCK

9017997 Date FDA Received

18-Jan-2013

Case # 9017997

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1301USA 006167

Age

Sex Female

Country USA

Preferred Term Unintended pregnancy Device expulsion

Product NUVARING

Role Route S VAGINAL

Dosage Text

Duration

Manufacturer MERCK

9018372 Date FDA Received

18-Jan-2013

Case # 9018372

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1301USA 007386

Age

Sex Female

Country USA

Preferred Term Metrorrhagia

Product NUVARING

Role Route S

Dosage Text

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,467 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 9018857 Date FDA Received
18-Jan-2013 Case # 9018857 Case Type EXPEDITED (15-DAY) Health Professional Outcomes DE,OT Manufacturer Control # US-009507513-2011SP0 28094 Dosage Text UNK Duration Age Sex Unknown Country USA

Preferred Term Pulmonary embolism Abdominal pain Cardiac arrest Cardiac failure acute Contracted bladder Dilatation ventricular Pericardial effusion Pleural adhesion Pleural effusion Pulmonary haemorrhage Pulmonary infarction

Product NUVARING

Role Route S

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,468 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 9019477 Date FDA Received
18-Jan-2013 Case # 9019477 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2010SP0 62584 Dosage Text Duration Age Sex Unknown Country USA

Preferred Term Nephrolithiasis Abdominal pain Angiomyolipoma Arthralgia Blood cholesterol increased Cholecystectomy Cholecystitis chronic Constipation Flank pain Gastric bypass Gastric disorder Gastrooesophageal reflux disease Haemorrhoids Hepatic cyst Liver function test abnormal Portal vein thrombosis Protein S decreased Renal cyst Sleep disorder Trichomoniasis

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,469 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 9019796 Date FDA Received
18-Jan-2013 Case # 9019796 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,DS,OT Manufacturer Control # US-009507513-2012SP0 26570 Dosage Text UNK Duration Age Sex Unknown Country USA

Preferred Term Abdominoplasty Autoimmune thyroiditis Pulmonary embolism Pulmonary infarction

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

9022190 Date FDA Received

18-Jan-2013

Case # 9022190

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes OT

Manufacturer Control # US-009507513-1301USA 007530 Dosage Text UNK Manufacturer Control # US-009507513-2011SP0 57246 Dosage Text UNK UNK

Age

Sex Female

Country USA

Preferred Term Pulmonary embolism

Product NUVARING Case # 9022490 Case Type EXPEDITED (15-DAY) Health Professional

Role Route S Outcomes HO,OT

Duration

Manufacturer MERCK

9022490 Date FDA Received

18-Jan-2013

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism Deep vein thrombosis Anxiety Dyspnoea

Product NUVARING NUVARING tizanidine hydrochloride tizanidine hydrochloride [therapy unspecified]

Role Route S S C C C Outcomes HO,OT VAGINAL VAGINAL

Duration

Manufacturer MERCK MERCK

9022619 Date FDA Received

18-Jan-2013

Case # 9022619

Case Type EXPEDITED (15-DAY)

Health Professional

Manufacturer Control # US-009507513-2012SP0 05871 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism Thrombosis

Product NUVARING NUVARING [therapy unspecified]

Role Route S S C VAGINAL VAGINAL ORAL

Duration

Manufacturer MERCK MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,470 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8828784 Date FDA Received
19-Jan-2013 Case # 8828784 Case Type EXPEDITED (15-DAY) Health Professional Outcomes DE,OT Manufacturer Control # US-009507513-2012SP0 23090 Dosage Text UNK Duration Age Sex Unknown Country USA

Preferred Term Pulmonary embolism Abdominal pain Cardiac arrest Mental status changes Syncope Ventricular fibrillation

Product NUVARING

Role Route S

Manufacturer MERCK

8888097 Date FDA Received

21-Jan-2013

Case # 8888097

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1210USA 010550

Age

Sex Female

Country USA

Preferred Term Decidual cast

Product NUVARING Case # 9023502 Case Type NON-EXPEDITED Health Professional

Role Route S VAGINAL

Dosage Text UNK Manufacturer Control # US-009507513-1301USA 009027

Duration

Manufacturer MERCK

9023502 Date FDA Received

21-Jan-2013

Outcomes

Age

Sex Female

Country USA

Preferred Term Medical device discomfort No adverse event

Product NUVARING

Role Route S VAGINAL

Dosage Text UNK

Duration

Manufacturer MERCK

9024593 Date FDA Received

21-Jan-2013

Case # 9024593

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1301USA 007926

Age

Sex Female

Country USA

Preferred Term Thrombosis

Product NUVARING

Role Route S VAGINAL

Dosage Text

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,471 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 9024596 Date FDA Received
21-Jan-2013 Case # 9024596 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1301USA 007925 Role Route S Health Professional VAGINAL Manufacturer Control # US-009507513-1301USA 007730 Role Route S Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-1207USA 002370 Dosage Text 0.120 mg/0.015 mg per day, once monthly Duration Age Sex Unknown Dosage Text Duration Age Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term Thrombosis

Product NUVARING Case # 9024742 Case Type NON-EXPEDITED

Manufacturer MERCK Country USA

9024742 Date FDA Received

21-Jan-2013

Outcomes

Preferred Term Unintended pregnancy

Product NUVARING Case # 8674089 Case Type EXPEDITED (15-DAY)

Manufacturer MERCK Country USA

8674089 Date FDA Received

22-Jan-2013

Preferred Term Cardiac ablation Anxiety Atrial fibrillation Blood potassium decreased Cardioversion Drug ineffective Maternal exposure before pregnancy Musculoskeletal discomfort No therapeutic response Off label use Pulmonary embolism Puncture site pain Tachycardia

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,472 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8675544 Date FDA Received
22-Jan-2013 Case # 8675544 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2012SP0 06666 Dosage Text UNK Duration Age Sex Unknown Country USA

Preferred Term Pulmonary embolism Arthropod bite Asthenia Asthma Deep vein thrombosis Dysfunctional uterine bleeding Dyspnoea Varicose vein

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

8830430 Date FDA Received

22-Jan-2013

Case # 8830430

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,OT

Manufacturer Control # US-009507513-1210USA 003277 Dosage Text UNK 81 mg, qd

Age

Sex Unknown

Country USA

Preferred Term Thyroidectomy Deep vein thrombosis Cholelithiasis Goitre Hypertensive crisis Leiomyoma Menstruation irregular Oedema peripheral Renal failure chronic Thyroid adenoma Thyroid cancer

Product NUVARING aspirin

Role Route S C VAGINAL ORAL

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,473 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8978474 Date FDA Received
22-Jan-2013 Case # 8978474 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2012SP0 21506 Dosage Text Duration Age Sex Unknown Country USA

Preferred Term Tricuspid valve disease Pulmonary embolism Costochondritis Deep vein thrombosis Eczema Extravasation Heart rate irregular Intervertebral disc protrusion Lung neoplasm Migraine Necrosis Ovarian cystectomy Pericarditis Pulmonary infarction Sinus tachycardia Tonsillitis Urticaria

Product NUVARING NUVARING

Role Route S S VAGINAL

Manufacturer MERCK MERCK

9005281 Date FDA Received

22-Jan-2013

Case # 9005281

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1301USA 001415

Age

Sex Unknown

Country USA

Preferred Term Vomiting Dysmenorrhoea Skin discolouration

Product NUVARING

Role Route S VAGINAL

Dosage Text UNK

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,474 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 9008038 Date FDA Received
22-Jan-2013 Case # 9008038 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1301USA 001282 Role Route S C C Health Professional Outcomes Manufacturer Control # US-009507513-1211USA 006928 Role Route S VAGINAL Dosage Text Duration Age Sex Unknown Country USA Dosage Text 1 ring for 3 week use Duration Age Sex Female Country USA

Preferred Term Vaginal infection

Product NUVARING cyanocobalamin SYNTHROID

Manufacturer MERCK

9023978 Date FDA Received

22-Jan-2013

Case # 9023978

Case Type NON-EXPEDITED

Preferred Term Inappropriate schedule of drug administration No adverse event

Product NUVARING

Manufacturer MERCK

9024039 Date FDA Received

22-Jan-2013

Case # 9024039

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1301USA 005369

Age

Sex Female

Country USA

Preferred Term Cervix oedema

Product NUVARING

Role Route S VAGINAL

Dosage Text 0.120 mg/ day of etonogestrel and 0.015 mg/day of ethinyl estradiol / 21days

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,475 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 9025128 Date FDA Received
22-Jan-2013 Case # 9025128 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,LT,OT Manufacturer Control # US-009507513-2010SP0 41567 Dosage Text 0.120 mg/0.015 mg/day, qm 30 mg, qw Duration Age Sex Unknown Country USA

Preferred Term Subdural haematoma Pulmonary embolism Cerebral thrombosis Fall Antiphospholipid antibodies positive Craniotomy Deep vein thrombosis Drug hypersensitivity Hand fracture Head injury Hyperlipidaemia Hypertension Hypotension Myocardial infarction Pulmonary hypertension Pulmonary infarction Right ventricular dysfunction Tachycardia

Product NUVARING AVONEX cholecalciferol calcium (unspecified)

Role Route S C C C VAGINAL

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,476 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 9025152 Date FDA Received
22-Jan-2013 Case # 9025152 Case Type EXPEDITED (15-DAY) Health Professional Outcomes OT Manufacturer Control # US-009507513-1301USA 008177 Dosage Text 1 ring for 3 weeks followed by a week free break Duration Age Sex Female Country USA

Preferred Term Ectopic pregnancy

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

Abortion of ectopic pregnancy Unintended pregnancy

iron (unspecified) TYLENOL ADVIL MOTRIN

C C C C

9025170 Date FDA Received

22-Jan-2013

Case # 9025170

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,OT

Manufacturer Control # US-009507513-2012SP0 12813 Dosage Text UNK

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism Benign breast neoplasm Breast mass Carpal tunnel syndrome Cervical dysplasia Deep vein thrombosis Depression Diverticulum Hiatus hernia Pancreatic disorder Substance abuse Substance use

Product NUVARING

Role Route S

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,477 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 9025204 Date FDA Received
22-Jan-2013 Case # 9025204 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1301USA 009008 Role Route S VAGINAL Dosage Text 3 weeks in 1 week out Age 21 YR Sex Female Country USA

Preferred Term Device dislocation Device misuse Metrorrhagia

Product NUVARING

Duration

Manufacturer MERCK

9025317 Date FDA Received

22-Jan-2013

Case # 9025317

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1301USA 008997

Age 21 YR

Sex Female

Country USA

Preferred Term Metrorrhagia

Product NUVARING Case # 9032188 Case Type NON-EXPEDITED Health Professional

Role Route S VAGINAL

Dosage Text 3 weeks in, 3 weeks out Manufacturer Control # US-009507513-1301USA 006409

Duration

Manufacturer MERCK

9032188 Date FDA Received

22-Jan-2013

Outcomes

Age

Sex Female

Country USA

Preferred Term Product quality issue

Product NUVARING

Role Route S VAGINAL

Dosage Text 3 weeks in 1 week ring free break

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,478 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8740294 Date FDA Received
23-Jan-2013 Case # 8740294 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,DS Manufacturer Control # US-009507513-1208USA 002606 Dosage Text UNK Duration Age Sex Unknown Country USA

Preferred Term Hypokalaemia Abortion spontaneous Abscess Back pain Deep vein thrombosis Heart rate irregular Migraine Mitral valve incompetence Papule Pulmonary valve incompetence Rash Sleep apnoea syndrome Tricuspid valve incompetence

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

8801271 Date FDA Received

23-Jan-2013

Case # 8801271

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1209USA 007459

Age

Sex Female

Country USA

Preferred Term Inappropriate schedule of drug administration

Product NUVARING

Role Route S VAGINAL

Dosage Text 1 DF, UNK

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,479 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8838729 Date FDA Received
23-Jan-2013 Case # 8838729 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-1210USA 003273 Dosage Text UNK Duration Age Sex Unknown Country USA

Preferred Term Deep vein thrombosis Abortion spontaneous Substance use Treatment noncompliance Unintended pregnancy

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

8842462 Date FDA Received

23-Jan-2013

Case # 8842462

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes DS,OT

Manufacturer Control # US-009507513-2012SP0 35539 Dosage Text UNK UNK UNK UNK UNK

Age

Sex Unknown

Country USA

Preferred Term Relapsing-remitting multiple sclerosis Cerebrovascular accident Pregnancy Gastroenteritis Dizziness Type 2 diabetes mellitus Abnormal weight gain Bacterial toxaemia Blood pressure increased Hypertonic bladder Hysterectomy Menorrhagia Migraine Nasopharyngitis Pelvic inflammatory disease Restless legs syndrome Sleep disorder Wisdom teeth removal

Product NUVARING SEROQUEL LORTAB buspirone hydrochloride omeprazole omeprazole

Role Route S C C C C C

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,480 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8846811 Date FDA Received
23-Jan-2013 Case # 8846811 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-1210USA 003278 Dosage Text UNK Duration Age Sex Unknown Country USA

Preferred Term Pulmonary embolism Abdominal pain lower Anaemia Bronchitis Chest pain

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

8879715 Date FDA Received

23-Jan-2013

Case # 8879715

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO

Manufacturer Control # US-009507513-1210USA 011116 Dosage Text UNK UNK

Age

Sex Unknown

Country USA

Preferred Term Deep vein thrombosis Injury Depression Fall Fibula fracture

Product NUVARING NUVARING

Role Route S S VAGINAL VAGINAL

Duration

Manufacturer MERCK MERCK

9014782 Date FDA Received

23-Jan-2013

Case # 9014782

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,OT

Manufacturer Control # US-009507513-2012SP0 19296 Dosage Text 3 weeks/remove 1 week 75 mg, UNK

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism Lung neoplasm Dizziness Anaemia Deep vein thrombosis Depression Hypertension Rash

Product NUVARING ZOLOFT ZOLOFT

Role Route S C C VAGINAL ORAL

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,481 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 9025643 Date FDA Received
23-Jan-2013 Case # 9025643 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1301USA 004770 Role Route S Dosage Text UNK Duration Age Sex Female Country USA

Preferred Term Pyrexia Abdominal pain Headache Hypoaesthesia Nausea

Product NUVARING

Manufacturer MERCK

9026615 Date FDA Received

23-Jan-2013

Case # 9026615

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1301USA 007041

Age 28 YR

Sex Female

Country USA

Preferred Term Inappropriate schedule of drug administration

Product NUVARING

Role Route S VAGINAL

Dosage Text 1 ring for 3 weeks followed by a week free break Manufacturer Control # US-009507513-2011SP0 16572 Dosage Text UNK

Duration

Manufacturer MERCK

9026655 Date FDA Received

23-Jan-2013

Case # 9026655

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,OT

Age

Sex Unknown

Country USA

Preferred Term Hypercoagulation Deep vein thrombosis Incorrect drug administration duration Pulmonary embolism

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

9027344 Date FDA Received

23-Jan-2013

Case # 9027344

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1301USA 007718

Age 28 YR

Sex Female

Country USA

Preferred Term Inappropriate schedule of drug administration

Product NUVARING

Role Route S VAGINAL

Dosage Text 3 weeks in, 1 week out

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,482 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 9028176 Date FDA Received
23-Jan-2013 Case # 9028176 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1301USA 007044 Role Route S VAGINAL Dosage Text 3weeks insertion, one week ring free Manufacturer Control # US-009507513-1208USA 012644 Dosage Text Duration Age Sex Unknown Duration Age Sex Female Country USA

Preferred Term Metrorrhagia

Product NUVARING

Manufacturer MERCK

8765921 Date FDA Received

24-Jan-2013

Case # 8765921

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,OT

Country USA

Preferred Term Simple partial seizures Back pain Cerebral infarction Cerebral ischaemia Depression Incorrect drug administration duration Intracranial venous sinus thrombosis Metrorrhagia Nausea Neck pain Paraesthesia Smear cervix abnormal Subarachnoid haemorrhage Vomiting

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,483 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8771736 Date FDA Received
24-Jan-2013 Case # 8771736 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,DS,OT Manufacturer Control # US-009507513-1208USA 012650 Dosage Text UNK 20 mg, qd 40 mg, qd 100 mg, qd 0.2 mg, bid Duration Age Sex Unknown Country USA

Preferred Term Deep vein thrombosis Pulmonary embolism Cardiac flutter Renal cyst Off label use

Product NUVARING NUVARING PROZAC NEXIUM PROVIGIL ARTHROTEC

Role Route S S C C C C VAGINAL

Manufacturer MERCK MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,484 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8831596 Date FDA Received
24-Jan-2013 Case # 8831596 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-1210USA 002343 Dosage Text UNK UNK Duration Age Sex Unknown Country USA

Preferred Term Cholecystectomy Pulmonary embolism Cholelithiasis Constipation C-reactive protein increased Deep vein thrombosis Depression Dyspareunia Fall Fatigue Hypercoagulation Hyperglycaemia Hypothyroidism Incorrect drug administration duration Leukocytosis Libido decreased Menstruation irregular Muscle spasms Musculoskeletal pain Neck pain Oophorectomy Ovarian cyst Ovarian neoplasm Premenstrual syndrome Vaginal discharge Varicose vein Weight increased

Product NUVARING NUVARING

Role Route S S VAGINAL VAGINAL

Manufacturer MERCK MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,485 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8837742 Date FDA Received
24-Jan-2013 Case # 8837742 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO Manufacturer Control # US-009507513-1210USA 004388 Dosage Text 0.120mg/0.015 mg Duration Age Sex Female Country USA

Preferred Term Deep vein thrombosis Anxiety Pulmonary embolism

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

8859605 Date FDA Received

24-Jan-2013

Case # 8859605

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1210USA 010517

Age

Sex Female

Country USA

Preferred Term Metrorrhagia Abnormal withdrawal bleeding

Product NUVARING CORTIZONE 10 Case Type EXPEDITED (15-DAY) Health Professional

Role Route S C Outcomes HO,DS,OT VAGINAL

Dosage Text 3 weeks in, one week out

Duration

Manufacturer MERCK

8876274 Date FDA Received

24-Jan-2013

Case # 8876274

Manufacturer Control # US-009507513-2012SP0 20669 Dosage Text UNK 20 mg, UNK

Age

Sex Unknown

Country USA

Preferred Term Bronchitis chronic Pulmonary embolism Anxiety Drug dose omission Dysfunctional uterine bleeding Galactorrhoea Hypertension Pulmonary embolism

Product NUVARING ADDERALL TABLETS

Role Route S C ORAL

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,486 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8920253 Date FDA Received
24-Jan-2013 Case # 8920253 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-1211USA 008015 Dosage Text 0.015 mg/0.120 mg, q 4 weeks Duration Age Sex Unknown Country USA

Preferred Term Sinus tachycardia Anxiety Atrial flutter Depression Headache Pulmonary embolism Thyroxine increased Upper respiratory tract infection

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,487 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8960657 Date FDA Received
24-Jan-2013 Case # 8960657 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,DS,OT Manufacturer Control # US-009507513-2011SP0 57738 Dosage Text DF, qm Duration Age Sex Unknown Country USA

Preferred Term Rhabdomyolysis Abdominal discomfort Antiphospholipid antibodies positive Blood thyroid stimulating hormone increased Cholecystectomy Drug hypersensitivity Dyspnoea Headache Hirsutism Hyperhomocysteinaemia Hyperlipidaemia Hypothyroidism Nephrolithiasis Nodule Pain in extremity Pelvic inflammatory disease Pleuritic pain Polycystic ovaries Pulmonary embolism Spinal osteoarthritis Urinary tract infection

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,488 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 9028943 Date FDA Received
24-Jan-2013 Case # 9028943 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1301USA 008876 Role Route S VAGINAL Dosage Text Duration Age Sex Female Country USA

Preferred Term Device difficult to use No adverse event Product shape issue

Product NUVARING

Manufacturer MERCK

9029319 Date FDA Received

24-Jan-2013

Case # 9029319

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,OT

Manufacturer Control # US-009507513-2009SP0 17682 Dosage Text 1 DF, QD 160/25 MG

Age

Sex Unknown

Country USA

Preferred Term Pulmonary hypertension Acidosis Pulmonary embolism Deep vein thrombosis Deep vein thrombosis Hepatic cyst Hypersensitivity Hypertension Sleep apnoea syndrome Thrombophlebitis superficial

Product NUVARING TETRACYCLINE DIOVAN HCT WELLBUTRIN

Role Route S C C C

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,489 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 9029838 Date FDA Received
24-Jan-2013 Case # 9029838 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-2011SP0 40942 Dosage Text Duration Age Sex Unknown Country USA

Preferred Term Dyspnoea Lung disorder Pleuritic pain

Product NUVARING NUVARING YASMIN

Role Route S S C

Manufacturer MERCK MERCK

28'S GREEN PACKAGE; SAMPLES GIVEN 20JUN07 AND PRESCRIPTION UNTIL SEP2009 ORAL 1 g, QD

Exercise tolerance decreased Back pain Acne Anxiety Depression Headache Nausea Off label use Pulmonary embolism Pulmonary infarction Stress Vomiting

VALTREX IMITREX (SUMATRIPTAN)

C C

9031292 Date FDA Received

24-Jan-2013

Case # 9031292

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1301USA 008218

Age

Sex Female

Country USA

Preferred Term Device expulsion Inappropriate schedule of drug administration

Product NUVARING

Role Route S VAGINAL

Dosage Text 3 weeks in with 1 week ring free break

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,490 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 9031344 Date FDA Received
24-Jan-2013 Case # 9031344 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1301USA 006364 Role Route S Health Professional VAGINAL Manufacturer Control # US-009507513-1301USA 008243 Role Route S VAGINAL Dosage Text 3 weeks in 1 week out Age 38 YR Sex Female Dosage Text Duration Age Sex Female Country USA

Preferred Term Malaise

Product NUVARING Case # 9031443 Case Type NON-EXPEDITED

Manufacturer MERCK Country USA

9031443 Date FDA Received

24-Jan-2013

Outcomes

Preferred Term Abdominal pain Metrorrhagia Product physical issue

Product NUVARING

Duration

Manufacturer MERCK

8694573 Date FDA Received

25-Jan-2013

Case # 8694573

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,DS,OT

Manufacturer Control # US-009507513-1207USA 008786 Dosage Text UNK .125 mg, qd Manufacturer Control # US-009507513-1212USA 003990

Age

Sex Unknown

Country USA

Preferred Term Pulmonary embolism Pneumonia

Product NUVARING SYNTHROID Case # 8996617 Case Type NON-EXPEDITED Health Professional

Role Route S C VAGINAL ORAL

Duration

Manufacturer MERCK

8996617 Date FDA Received

25-Jan-2013

Outcomes

Age

Sex Female

Country USA

Preferred Term Inappropriate schedule of drug administration Device expulsion Incorrect drug administration duration

Product NUVARING

Role Route S VAGINAL

Dosage Text

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,491 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 9032639 Date FDA Received
26-Jan-2013 Case # 9032639 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1301USA 007163 Role Route S VAGINAL Dosage Text 1 ring for 3 weeks followed by week free break Age 22 YR Sex Female Country USA

Preferred Term Inappropriate schedule of drug administration

Product NUVARING

Duration

Manufacturer MERCK

Incorrect drug administration duration

9032677 Date FDA Received

26-Jan-2013

Case # 9032677

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1301USA 007166

Age

Sex Female

Country USA

Preferred Term Inappropriate schedule of drug administration

Product NUVARING Health Professional

Role Route S Outcomes

Dosage Text

Duration

Manufacturer MERCK

9032680 Date FDA Received

27-Jan-2013

Case # 9032680

Case Type NON-EXPEDITED

Manufacturer Control # US-009507513-1301USA 011142

Age 21 YR

Sex Female

Country USA

Preferred Term Abdominal discomfort

Product NUVARING anesthetic (unspecified)

Role Route S C VAGINAL

Dosage Text UNK every 3 weeks in, 1 week out

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,492 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8771096 Date FDA Received
28-Jan-2013 Case # 8771096 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-1209USA 001489 Dosage Text UNK Duration Age Sex Female Country USA

Preferred Term Pulmonary embolism Anxiety Blood cortisol decreased Blood potassium decreased Blood sodium decreased Heart rate increased Thrombosis

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

8831516 Date FDA Received

28-Jan-2013

Case # 8831516

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,DS,OT

Manufacturer Control # US-009507513-1210USA 002354 Dosage Text UNK Manufacturer Control # US-009507513-1301USA 004230 Dosage Text

Age

Sex Female

Country USA

Preferred Term Pulmonary embolism

Product NUVARING Case # 9013237 Case Type EXPEDITED (15-DAY) Health Professional

Role Route S VAGINAL

Duration

Manufacturer MERCK

9013237 Date FDA Received

28-Jan-2013

Outcomes OT

Age

Sex Female

Country USA

Preferred Term Ectopic pregnancy Unintended pregnancy Pain

Product NUVARING antimicrobial (unspecified)

Role Route S C

Duration

Manufacturer MERCK

9032686 Date FDA Received

28-Jan-2013

Case # 9032686

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1301USA 007720

Age 23 YR

Sex Female

Country USA

Preferred Term Incorrect drug administration duration Inappropriate schedule of drug administration

Product NUVARING

Role Route S VAGINAL

Dosage Text 3 weeks in, 1 week out

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,493 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 9033291 Date FDA Received
28-Jan-2013 Case # 9033291 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1301USA 011562 Role Route S Health Professional VAGINAL Dosage Text UNK Manufacturer Control # US-009507513-2012SP0 03424 Dosage Text leave in 3 weeks/remove 1 week Duration Age Sex Female Duration Age Sex Female Country USA

Preferred Term Deep vein thrombosis

Product NUVARING Case # 9033380 Case Type EXPEDITED (15-DAY)

Manufacturer MERCK Country USA

9033380 Date FDA Received

28-Jan-2013

Outcomes HO,OT

Preferred Term Tachycardia Anxiety Arthralgia Bipolar disorder Chest discomfort Chest pain Convulsion Depression Female sterilisation Otitis externa Pulmonary embolism Substance abuse Toothache Tooth fracture Wrist fracture

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,494 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8691983 Date FDA Received
29-Jan-2013 Case # 8691983 Case Type EXPEDITED (15-DAY) Health Professional Outcomes DE,OT Manufacturer Control # US-009507513-1207USA 010403 Dosage Text UNK Duration Age Sex Female Country USA

Preferred Term Cardio-respiratory arrest Pulmonary embolism

Product NUVARING

Role Route S

Manufacturer MERCK

9037097 Date FDA Received

29-Jan-2013

Case # 9037097

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO,LT,OT

Manufacturer Control # US-009507513-1301USA 011647 Dosage Text 0.015/0.12MG Manufacturer Control # US-009507513-1301USA 012380

Age 30 YR

Sex Female

Country USA

Preferred Term Pulmonary embolism

Product NUVARING Case # 9037140 Case Type NON-EXPEDITED Health Professional

Role Route S VAGINAL

Duration

Manufacturer MERCK

9037140 Date FDA Received

29-Jan-2013

Outcomes

Age 24 YR

Sex Female

Country USA

Preferred Term Nausea

Product NUVARING Case # 9037751 Case Type NON-EXPEDITED Health Professional

Role Route S VAGINAL

Dosage Text UNK Manufacturer Control # US-009507513-1301USA 008382

Duration

Manufacturer MERCK

9037751 Date FDA Received

29-Jan-2013

Outcomes

Age 20 YR

Sex Female

Country USA

Preferred Term Menstrual disorder

Product NUVARING LAMISIL (terbinafine hydrochloride) ZOLOFT trazodone hydrochloride

Role Route S C C C VAGINAL

Dosage Text

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,495 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 9038885 Date FDA Received
29-Jan-2013 Case # 9038885 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,OT Manufacturer Control # US-009507513-1301USA 013262 Dosage Text UNK Duration Age Sex Female Country USA

Preferred Term Deep vein thrombosis Pulmonary embolism

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

9039064 Date FDA Received

29-Jan-2013

Case # 9039064

Case Type EXPEDITED (15-DAY)

Health Professional

Outcomes HO

Manufacturer Control # US-009507513-1301USA 013273 Dosage Text

Age 37 YR

Sex Female

Country USA

Preferred Term Deep vein thrombosis

Product NUVARING Case # 9039546 Case Type EXPEDITED (15-DAY) Health Professional

Role Route S VAGINAL

Duration

Manufacturer MERCK

9039546 Date FDA Received

29-Jan-2013

Outcomes HO

Manufacturer Control # US-009507513-1301USA 012172 Dosage Text UNK

Age

Sex Female

Country USA

Preferred Term Deep vein thrombosis Headache Ligament sprain Pain in extremity

Product NUVARING

Role Route S VAGINAL

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,496 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 8838657 Date FDA Received
30-Jan-2013 Case # 8838657 Case Type EXPEDITED (15-DAY) Health Professional Outcomes HO,DS,OT Manufacturer Control # US-009507513-1210USA 003274 Dosage Text UNK, in 3 weeks, out 1 week Duration Age Sex Female Country USA

Preferred Term Deep vein thrombosis Pulmonary embolism Deep vein thrombosis Depression Diabetes mellitus Hypertension Hypothyroidism Neuropathy peripheral Off label use

Product NUVARING NUVARING

Role Route S S VAGINAL

Manufacturer MERCK MERCK

9013829 Date FDA Received

30-Jan-2013

Case # 9013829

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1301USA 004211

Age 33 YR

Sex Female

Country USA

Preferred Term Medical device discomfort Product quality issue

Product NUVARING

Role Route S VAGINAL

Dosage Text 3 weeks in, 1 week out

Duration

Manufacturer MERCK

9039749 Date FDA Received

30-Jan-2013

Case # 9039749

Case Type NON-EXPEDITED

Health Professional

Outcomes

Manufacturer Control # US-009507513-1301USA 012881

Age

Sex Female

Country USA

Preferred Term Paraesthesia

Product NUVARING

Role Route S VAGINAL

Dosage Text 1 DF, q3w

Duration

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,497 of 1,498

FDA Adverse Event Reporting System (FAERS) Freedom of Information Act (FOIA) Detailed Report 9039944 Date FDA Received
30-Jan-2013 Case # 9039944 Case Type NON-EXPEDITED Health Professional Outcomes Manufacturer Control # US-009507513-1301USA 013564 Role Route S Health Professional VAGINAL Dosage Text 3weeks in ,1week ring free break Manufacturer Control # US-009507513-1301USA 013383 Dosage Text UNK Duration Age Sex Female Age 24 YR Sex Female Country USA

Preferred Term Device expulsion

Product NUVARING Case # 9045054 Case Type EXPEDITED (15-DAY)

Duration

Manufacturer MERCK Country USA

9045054 Date FDA Received

30-Jan-2013

Outcomes OT

Preferred Term Pulmonary embolism

Product NUVARING

Role Route S VAGINAL

Manufacturer MERCK

Date - Time: 02-04-2013 9:43:10 AM EST

Note: If the field is blank, there is no data

Page: 1,498 of 1,498