GORE ENFORM Intraperitoneal Biomaterial GBFR1620Recalls & reported problems
W. L. Gore & Associates, Inc. · ENFORM INTRAPERITONEAL 16cmX20cm Biomaterial · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00733132644704), received between Apr 14, 2021 and Apr 14, 2021 — classified as 1 injury.
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
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Seroma1
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE INFORMATION WAS RECEIVED AS A PRE-PUBLICATION UN-TITLED LITERATURE DRAFT: BY (HOWARD LEVINSON, MD, FACS) REGARDING THE USE OF GORE® ENFORM INTRAPERITONEAL BIOMATERIAL FOR VENTRAL HERNIA REPAIR. THE PRE-PUBLISHED ARTICLE WAS SUBMITTED TO THE PRODUCT SPECIALIST ON (03/16/2021). IN A TOTAL POPULATION OF 12 PATIENTS, ALL PATIENTS HAD A (VENTRAL HERNIA REPAIR) WITH (GORE® ENFORM INTRAPERITONEAL BIOMATERIAL). THE ARTICLE STATES PATIENT 4 WAS A (B)(6) MALE WITH PAST MEDICAL HISTORY INCLUDING IBD, THERAPEUTIC ANTICOAGULATION, AND PREVIOUS ILEOSTOMY. HE WAS TAKEN TO THE OPERATING ROOM IN CONJUNCTION WITH THE COLORECTAL SURGERY TEAM FOR LOA AND OSTOMY REVERSAL WITH BILATERAL COMPONENT SEPARATION AND ONLAY MESH RECONSTRUCTION. HE PRESENTED TO THE EMERGENCY DEPARTMENT SIX WEEKS POSTOPERATIVELY COMPLAINING OF FEVERS AND PURULENT DRAINAGE FROM PREVIOUS DRAIN SITES. CT ABDOMEN WAS OBTAINED THAT DEMONSTRATED LARGE FLUID COLLECTION ADJACENT TO THE MESH CONCERNING FOR ABSCESS AND ACTIVE MESH INFECTION. THE PATIENT WAS STARTED ON EMPIRIC IV ANTIBIOTICS AND TAKEN TO THE OPERATING ROOM FOR ABDOMINAL WASHOUT. IN THE OPERATING ROOM THE PATIENT WAS FOUND TO HAVE LARGE POCKET OF PURULENT FLUID, UNINCOR
Patient problems: Seroma; Unspecified Infection
MAUDE report 11667360 ↗
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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