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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. COMPOSIX MESH SURGICAL MESH Back to Search Results
Catalog Number UNKAA018
Device Problems Defective Device (2588); Insufficient Information (3190)
Patient Problems Disability (2371); Impaired Healing (2378); Post Operative Wound Infection (2446)
Event Type  Injury  
Manufacturer Narrative

At this time no conclusions can be made to what extent the bard/davol composix mesh device may have caused or contributed to the reported event. The cause of the patient postoperative complications cannot be determined at this time. Regarding infection the warning section of the instructions-for-use states, ¿if an infection develops, treat the infection aggressively. The prosthesis may not have to be removed. An unresolved infection, however, may require removal of the prosthesis. ¿ information is limited at this time. Should additional information be provided a supplemental emdr will be submitted. Note: not returned.

 
Event Description

The following was alleged by the patient's attorney: (b)(6) 2013:the patient was diagnosed with a ventral hernia. On (b)(6) 2013:the patient underwent ventral hernia repair with an unspecified bard/davol composix product. In the months following and continuously to this day, patient continued to have an open wound and continues to experience chronic abdominal pain, and other medical issues including but not limited to: repeated infections in the mesh implant area which he currently is seeking additional medical treatments for. The patient was caused and in the future will be caused to suffer severe personal injuries, pain and suffering, and other damages. The patient has experienced mental and physical pain and suffering has sustained permanent injury, has undergone medical treatment and/or corrective surgery and hospitalization, and other damages due to the alleged defective composix bard mesh.

 
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Brand NameCOMPOSIX MESH
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
jan ling
100 crossings blvd.
warwick, RI 02886
8015652663
MDR Report Key8148197
MDR Text Key129876984
Report Number1213643-2018-04539
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK971745
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation
Type of Report Initial
Report Date 12/10/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/10/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNKAA018
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/26/2018
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
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 12/10/2018 Patient Sequence Number: 1
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