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Adverse Event Report

DAVOL, INC., SUB. C.R. BARD, INC. MESH PERFIX PLUG SURGICAL MESH   back to search results
Catalog Number 00000000
Event Date 02/06/2004
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

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

 
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Brand NameMESH PERFIX PLUG
Type of DeviceSURGICAL MESH
Baseline Brand NameMESH COMPOSIX KUGEL
Baseline Generic NameSURGICAL MESH
Baseline Catalogue Number00000000
Baseline Device FamilyMESH-COMPOSITE KUGEL
Baseline Device 510(K) NumberK003323
Baseline Device PMA Number
Baseline Shelf Life Information Yes
Baseline Preamendment? Yes
Transitional? No
510(K) Exempt? No
Shelf Life(Months)60
Date First Marketed02/09/2001
Manufacturer (Section F)
DAVOL, INC., SUB. C.R. BARD, INC.
100 sockanossett crossroad
cranston RI 02920
Manufacturer (Section D)
DAVOL, INC., SUB. C.R. BARD, INC.
100 sockanossett crossroad
cranston RI 02920
Manufacturer (Section G)
BARD PUERTO RICO
las piedras industrial park
lot #5, p.o. box 2001
las piedras PR 00671
Manufacturer Contact
thomas swanson
100 sockanossett crossroad
cranston , RI 02920
(401) 463 -7000
Device Event Key522256
MDR Report Key532984
Event Key506028
Report Number1213643-2004-00057
Device Sequence Number1
Product CodeFTL
Report Source Manufacturer
Source Type User facility
Reporter Occupation Other
Type of Report Initial
Report Date 06/17/2004
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/02/2004
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Invalid Data
Device Catalogue Number00000000
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received06/17/2004
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? 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
Type of Device Usage Initial

Database last updated on December 31, 2008

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