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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. MESH - COMPOSIX KUGEL SURGICAL MESH

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DAVOL INC., SUB. C.R. BARD, INC. MESH - COMPOSIX KUGEL SURGICAL MESH Back to Search Results
Catalog Number 0010204
Device Problem Insufficient Information (3190)
Patient Problems Abdominal Pain (1685); Pain (1994)
Event Type  Injury  
Manufacturer Narrative

Based on the limited information provided we are unable to determine to what extent, if any the bard devices may have caused or contributed to the events as alleged. To date no additional information has been provided. There have been no other reported complaints for this lot number. Based on the provided lot number the subject product is part of the composix kugel recall, initiated on (b)(6) 2005. Should additional information be provided, a supplemental emdr will be submitted. This emdr represents lot number 43bod272 (device #2) an additional emdr was submitted representing lot number 43dpd334 (device#1). Not returned.

 
Event Description

It was reported that approximately ten years ago (no date provided) the patient was implanted with two bard composix kugel hernia patch devices. The patient has recently presented to his physician alleging the devices are causing him "abdominal pain and problems" and wants to have the devices removed.

 
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Brand NameMESH - COMPOSIX KUGEL
Type of DeviceSURGICAL MESH
Manufacturer (Section D)
DAVOL INC., SUB. C.R. BARD, INC.
100 crossings blvd.
warwick RI 02886
Manufacturer (Section G)
BARD SHANNON LIMITED -3005636544
san geronimo industrial park
lot #1, road #3, km 79.7
humacao PR 00791
Manufacturer Contact
laura sundberg
100 crossings blvd.
warwick, RI 02886
4018258462
MDR Report Key7155231
MDR Text Key96062935
Report Number1213643-2017-01146
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
PMA/PMN NumberK003323
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup
Report Date 01/02/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/29/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/28/2009
Device Catalogue Number0010204
Device LOT Number43BOD272
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/29/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/28/2004
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-0761-06

Patient TREATMENT DATA
Date Received: 12/29/2017 Patient Sequence Number: 1
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