GORE ENFORM Preperitoneal Biomaterial GBWR2025Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00733132644629), received between May 29, 2020 and May 29, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Material Separation” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 29, 2020Material Separation; Material Separation

  IT WAS REPORTED TO GORE THAT A PATIENT UNDERWENT A DEIP FLAP PROCEDURE USING GORE® ENFORM BIOMATERIAL. THE MESH WAS PLACED IN AN ONLAY FASHION TO REINFORCE THE DIEP FLAP. ONE MONTH LATER, THE PATIENT DEVELOPED A SEROMA THAT REQUIRED TWO ASPIRATIONS WITH RAPID ACCUMULATION OF FLUID. THE PHYSICIAN REPORTED A SURGICAL CORRECTION WAS PERFORMED ABOUT 2 MONTHS FOLLOWING THE INDEX PROCEDURE. UPON REOPERATION TO EVACUATE THE SEROMA, THE MESH WAS REPORTED TO BE LIKE TISSUE PAPER AND DISINTEGRATING. REPORTEDLY, THERE WAS NO INFECTION. THE MESH WAS REMOVED IN MULTIPLE FRAGMENTS.

  Patient problems: Seroma

  MAUDE report 10102045 ↗