MAUDE Adverse Event Report: BARD COMPOSITE KUGEL MESH PATCHHERNIA PATCH

Event Date 01/01/2004

Event Type  No Answer Provided  

Event Description

Reporter is consumer who states that ever since he had the device used on him, he's had "trouble. " he had a 5 inch patch placed in his stomach area and a 1 inch patch placed in his groin. He's received notification via letter that others are suffering from the same problem. But his surgeon won't resolve his issues, since he has an outstanding medical balance (is unable to work, has applied for social security). In pain.

• Brand Name: BARD COMPOSITE KUGEL MESH PATCH
• Type of Device: HERNIA PATCH
• Device Event Key: 825826
• MDR Report Key: 817843
• Event Key: 801419
• Report Number: MW1041916
• Device Sequence Number: 1
• Product Code: FTL
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/08/2007

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 02/08/2007
• Is This An Adverse Event Report?: No
• Device Operator: Lay User/Patient
• Was Device Available For Evaluation?: No Answer Provided
• Is The Reporter A Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Home
• Was The Report Sent To Manufacturer?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Is the Device an Implant?: Yes
• Is this an Explanted Device?: No Answer Provided