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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. COMPOSIX EX SURGICAL MESH Back to Search Results
Model Number 0123810
Device Problems Defective Device (2588); Insufficient Information (3190)
Patient Problems Pain (1994); Disability (2371); Obstruction/Occlusion (2422)
Event Date 11/19/2014
Event Type  Injury  
Manufacturer Narrative

Currently, it is unknown to what extent the device may have caused or contributed to the reported event. To date no medical records have been provided. Based on the information provided, it is alleged the patient underwent an additional surgery to repair a bowel obstruction. At this time it is unclear if the bowel obstruction was related to the implanted composix ex mesh. A manufacturing review was performed which found no anomalies during the manufacturing process of the device. If additional event and/or evaluation information is obtained, a follow up mdr will be submitted. Not returned to manufacturer.

 
Event Description

The following was reported to davol by the patient's attorney: (b)(6) 2005 - the patient underwent surgery for repair of a ventral hernia, a composix e/x hernia patch was implanted to repair the hernia defect. (b)(6) 2014 - the patient underwent an additional surgery to repair a bowel obstruction. The patient has suffered and will continue to suffer pain and was injured severely and permanently.

 
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Brand NameCOMPOSIX EX
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
steven figueroa
100 crossings blvd.
warwick, RI 02886
4018258460
MDR Report Key7140229
MDR Text Key95589197
Report Number1213643-2017-01089
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK002684
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation ATTORNEY
Type of Report Initial
Report Date 12/21/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/21/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/28/2008
Device MODEL Number0123810
Device Catalogue Number0123810
Device LOT Number43FND338
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/04/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/17/2003
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 12/21/2017 Patient Sequence Number: 1
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