VIGILENZ

Medical Devices
PRODUCT COMPLAINT FORM
Complaint Details
Date Customer
Patient Male Female Hospital & Department
Country Surgical Procedure
Product Code Quantity Supplied
Batch No. Quantity Complained

Product
Surgical Suture Surgical Hernia Mesh Vigisol Hydrocyn Others

Surgical Suture
Vigimesh
Thread Needle Packaging
Snapped Detached Contamination/ Dirt Incorrect Size
Rough Easily Bent Torn Contamination/ Dirt
Discoloration Broke Illegible Printing Stiffness
Fraying Not Sharp Wrong Batch No. Edge Security
Poor Knotting Wrong needle Discoloration Packaging
Incorrect Length Others Poor Dispensing Others
Others Others

Vigisol / Hydrocyn
Others
Solution Closure / Dispensing Packaging
Skin Irritation Functionality Damage / Dented
Please specify :
Sedimentation Less Volume Torn
Gluey/Gummy Poor Dispensing Wet _____________________________
Foreign Matters Leaking Contamination/ Dirt _____________________________
Discoloration Others Others
_____________________________
Others

Remarks / Comments from Customer For Internal Use

Date Complaint Received :

Complaint Registration No.

Complaint Registered by :
Date of Registration :

Containment Action :

Corrective Action Report No.

Internal Risk Class As Per QSP-22 Product Complaint Handling Procedure

Risk Class : 1 2 3 4

Response to complaint :

Doc. No: BD-CF001

Rev: 02