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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN PARIETEX COMPOSITE MESH, SURGICAL, POLYMERIC

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COVIDIEN PARIETEX COMPOSITE MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number N/A
Event Date 04/30/2014
Event Type  Malfunction  
Event Description

The patient presents for evaluation of a draining abdominal wall sinus tract. The patient underwent radical cystoprostatectomy with neobladder formation about six years ago, after which he developed a wound infection and subsequent hernia. He then underwent laparoscopic converted to open ventral hernia repair with mesh. This was complicated by an abdominal wall abscess requiring opening of the wound. He ultimately ended up with a nonhealing wound with exposed mesh, which did not heal with conservative management with serial mesh debridement. About three years ago, the patient underwent mesh removal and ventral hernia repair with bilateral component separation and strattice mesh underlay. A portion of the wound opened after this operation but was closing steadily with wound care. However, he was subsequently found to have a sigmoid colon cancer after an admission for gi bleed. About two years ago, the patient underwent low anterior resection and excision of mesh. Since that time, he has gone back to the operating room on two occasions, both about a year ago, for non-healing wounds, associated with persistent mesh, which was excised at the time of surgery. The patient did well after his most recent operation but has developed a persistent draining sinus tract to the left of his lower midline incision.

 
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Brand NamePARIETEX COMPOSITE
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
COVIDIEN
60 middletown avenue
north haven CT 06473
MDR Report Key5418788
Report Number5418788
Device Sequence Number1
Product CodeFTL
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 11/19/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/09/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device MODEL NumberN/A
Device Catalogue NumberPCO3020
Device LOT NumberPIF00074
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/19/2015
Event Location Hospital
Date Report TO Manufacturer11/19/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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