MAUDE Adverse Event Report: W. L. GORE AND ASSOCIATES, INC. MESH, SURGICAL

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

Strattice was used for an abdominal wall reconstruction procedure along with bioa.The strattice reinforced midline primary closure as intraperitoneal underlay to repair the thirteenth recurrence of incisional ventral hernia.Bio-a 9x15 fs0915 reinforced left lower quadrant primary closure as intra peritoneal underlay third recurrence of flank hernia.The patient reherniated in (b)(6) 2012.The left lower quadrant where the bio-a had been placed was the only recurrence site.It was reported that when the doctor re-operated, it was the bio-a that failed and not the strattice.L tm surgical mesh (strattice) (k070560) is manufactured by us, the lifecell? corporation, while the other product mentioned in the complaint, bioa, is manufactured by gore medical.The lifecell corporation has reviewed and evaluated this complaint, and affirms that our product, strattice, is not related to the event reported in the complaint.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: MESH, SURGICAL
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): W. L. GORE AND ASSOCIATES, INC.
• MDR Report Key: 17526971
• MDR Text Key: 321066129
• Report Number: MW5133908
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/30/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1