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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD COMPOSITE KUGEL MESH PATCH HERNIA PATCH

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BARD COMPOSITE KUGEL MESH PATCH HERNIA PATCH Back to Search Results
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.

 
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Brand NameBARD COMPOSITE KUGEL MESH PATCH
Type of DeviceHERNIA PATCH
Device Event Key825826
MDR Report Key817843
Event Key801419
Report NumberMW1041916
Device Sequence Number1
Product CodeFTL
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 Received02/08/2007
Is This An Adverse Event Report? No
Is This A Product Problem Report?
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

Patient TREATMENT DATA
Date Received: 02/08/2007 Patient Sequence Number: 1
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