Case 1 On 05/08/10, a 32 yr.

old, mother of 4 children presented to the Sun clinic 1 year after IUD insertion with complaint of could not be detected the string. The doctor did the vaginal examination and string was not found. UCG test showed negative. The doctor referred the client for USG. The impression showed IUD is outside uterine cavity. The case was accidentally found out by Health Services Officer on 10/08/10 during monitoring visit.

1. What kind of problem is this? What will you do next? In what time frame? Uterine perforation (adverse event), referral ,inform to QA team within 24 hour. 2. Is the providers management complete or not? What do you think? The providers management is complete. It is urgent to report to HSO/QA/HSD. 3. How should this case be reported? Please draw the reporting process in diagram.
provider HSO QA QA MIS

4. Can this event be prevented in the future? If so, how? This event can be prevented by reminding providers to perform careful and gentle uterine sounding and uterine positioning. Reminding of determining for uterine position by VE is also essential.

5. How should it be discussed with external audiences?

Country Director is only spokesman for disclosing about AE.

6. Please write the complete report using the attached reporting form.
Date patient presented with problem: 5/8/10 Date of this Report: 10/8/10 Nature of Adverse Event: a. Unintened major surgery, including laparoscopy Type of event or problem ( check all that apply):

b. Complete Perforation or severe complication of insertion requiring surgery Provide details of Event or Problem: a. Missed string of IUD b. Occur after 1 year of IUD insertion c. Insertion date 5.7.09 Physical examination S/S ---Missed string only Vaginal examination was done Refer for USG Outcomes Provider didnt refer to OG. Treatment and Outcome USG resultIUD extra uterine UCG test (-). Past medical history NAD Contraceptive history IUD insertion last 1year Menstrual history -Normal For completion by PSI staff only: Date PSI informed:10/8/10 PSI actions taken related to patient care; a. reimburse for investigation fees and travel expense. b. Counsel to provider and client for other birth spacing method. c. Technical discussion with provider for slow and gentle uterine sounding for uttering positioning and proper IUD insertion.

Case 2 A 24 yr. old, mother of 2 children presented to the clinic on 22/10/11 with amenorrhoea for a month. She was inserted IUD last 3 months ago and regular menstruation for a month. She said to be checked the string regularly. She suspected of pregnancy and also did UCG test and showed positive. On speculum examination, string was seen and longer than at the time of insertion. The client

wanted to remove IUD. Removal was done. The doctor reported to PSI during monitoring visit of Health Services Officer.

1. What kind of problem is this? What will you do next and in what time frame? Complication (Pregnancy with IUD) reporting referral 2. Is the providers management complete or not? What do you think? Complete. Needed to report to PSI.

3. How should this event be reported? Please draw the reporting process in diagram.

Provider HSO

HSO MIS

QA

4. Can this event be prevented in the future? If so, how? This event can be prevented by exclusion of pregnancy with proper history taking and UCG testing.

5. How should it be discussed with external audiences?

Only CD has authorities for disclosing.

6. Please write the complete report using the attached reporting form.

Type of event or problem a. Pregnancy with IUD or implant in place

Amenorrhoea x 1mth 3mth after IUD insertion No other sign and symptom VE examination was done . UCG testing (positive) Provider remove IUD PSI reimburse Investigation fee and travel expense of client Provide technical discussion with provider