MAUDE Adverse Event Report: BARD COMPOSIX KUGEL MESH PATCHKUGLE MESH PATCH

Lot Number 43CPTD365

Event Date 07/01/2005

Event Type  Other   Patient Outcome  Other

Event Description

Had 2 surgeries for hernia's after a major surgery. They placed the bard composix kugel mesh inside me for the second surgery and had complained and visited the surgeon several times complaining about abdominal pains and swelling in the effected area. Had 2 cat scans with what the doctor called negative results for a new hernia, but nothing about the swelling and pain that i had. I heard about the recall for the mesh and after checking, i had one of the recalled meshes inside of me. Product code 0010208 lot number 43cptd365. Confirmed with bard about being part of the recall by the company, but was never notified, by either the company or the hospital, nor the doc's office.

• Brand Name: BARD COMPOSIX KUGEL MESH PATCH
• Type of Device: KUGLE MESH PATCH
• Device Event Key: 796546
• MDR Report Key: 809049
• Event Key: 772515
• Report Number: MW1041684
• Device Sequence Number: 1
• Product Code: FTL
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/22/2007

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 01/22/2007
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device LOT Number: 43CPTD365
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Home
• Was The Report Sent To Manufacturer?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Is the Device an Implant?: Yes
• Is this an Explanted Device?: No Answer Provided

Patient TREATMENT DATA

Date Received: 01/22/2007 Patient Sequence Number: 1

#	Treatment	Treatment Date
NONE