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U.S. Department of Health and Human Services

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

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BARD COMPOSIX KUGEL MESH PATCH KUGLE MESH PATCH   Back to Search Results
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.

 
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Brand NameBARD COMPOSIX KUGEL MESH PATCH
Type of DeviceKUGLE MESH PATCH
Device Event Key796546
MDR Report Key809049
Event Key772515
Report NumberMW1041684
Device Sequence Number1
Product CodeFTL
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 Received01/22/2007
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Lay User/Patient
Device LOT Number43CPTD365
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
#TreatmentTreatment Date
NONE
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