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Adverse Event Report

BARD / DAVOL PERFIX MESH PLUG HERNIA MESH PLUG   back to search results
Patient Outcome  Other;
Event Description

Pt had bard-perfix mesh plug hernia repair with chronic pain, genitofemoral distribution since surgery. Mesh plug explanted. Genitofemoral entrapment found as well as chronic venous congestion of cord from stricture from keyhole.

 
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Brand NamePERFIX MESH PLUG
Type of DeviceHERNIA MESH PLUG
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section D)
BARD / DAVOL
p.o. box 8500
cranston RI 02920
Device Event Key500129
MDR Report Key511162
Event Key484943
Report NumberMW1031093
Device Sequence Number1
Product CodeFTL
Report Source Voluntary
Report Date 02/06/2004
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/06/2004
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Was Device Available For Evaluation? Yes
Is the Device an Implant? Yes
Is this an Explanted Device?

Database last updated on December 31, 2008

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