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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE DUALMESH BIOMATERIAL MESH, SURGICAL, POLYMERIC

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W. L. GORE & ASSOCIATES, INC. GORE DUALMESH BIOMATERIAL MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Post Operative Wound Infection (2446)
Event Date 06/30/1998
Event Type  Injury  
Manufacturer Narrative

The device(s) are unavailable, so no product evaluation can be performed. A review of the manufacturing records for the device(s) could not be conducted because the serial numbers remain unknown. Patient mean gender: female. Patient median age: 65 (28-87). Patient id: case number. Event date: study was closed in (b)(6) 1998. The author was contacted in order to get additional information for the reported wound infections with consequent device removal.

 
Event Description

Within the article ¿surgical repair of incisional ventral hernias: tension-free technique using prosthetic materials (expanded polytetrafluoroethylene gore-tex dual mesh)¿, published by emmanuel chrysos et al, within the journal the americal surgeon, volume 66, july 2000, page 679-682, the article indicates the following: the purpose of the study was to report the results of a tension-free repair technique using expanded polytetrafluoroethylene gore-tex dual mesh (gore-tex soft tissue patch, w. L. Gore and associates inc, flagstaff, az) in patients with primary or recurrent incisional ventral hernias. From june 1995, through june 1998, 52 patients with incisional hernias have undergone this procedure in the clinic. Fourteen of them had recurrent hernias which had been primarily repaired by mayo hernioplasty. Six of the patients had irreducible hernias preoperatively. Twenty-five patients had hernias on midline incisions, and the rest of them had hernias on transverse abdominal incisions. Four of the patients experienced wound infection and were treated by mesh removal.

 
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Brand NameGORE DUALMESH BIOMATERIAL
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
W. L. GORE & ASSOCIATES, INC.
1505 n. fourth street
flagstaff AZ 86004
Manufacturer (Section G)
MPD APC B/P
p.o. box 1408
elkton MD 21922 1408
Manufacturer Contact
barbara ulrich
1505 n. fourth street
flagstaff, AZ 86004
9285263030
MDR Report Key10829376
MDR Text Key215943021
Report Number3003910212-2020-01134
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeGR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type LITERATURE
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/06/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/12/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
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 Received12/06/2020
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?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 11/12/2020 Patient Sequence Number: 1
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