MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE ENFORM PREPERITONEAL BIOMATERIAL; MESH, SURGICAL, ABSORBABLE. PLASTIC AND RECONSTRUCTIVE SURGERY

Model Number	GBWR2025
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Seroma (2069)
Date of Event	02/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information including id, age, and weight were requested but the information is not available.The explant date is an estimated date based on the information provided.The explanted device was requested for return, however the device was not returned.
Event or Problem Description
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.

• Brand Name: GORE ENFORM PREPERITONEAL BIOMATERIAL
• Common Device Name: MESH, SURGICAL, ABSORBABLE. PLASTIC AND RECONSTRUCTIVE SURGERY
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 10102045
• Report Number: 3003910212-2020-00104
• Device Sequence Number: 19722972
• Product Code: OXF
• UDI-Device Identifier: 00733132644629
• UDI-Public: 00733132644629
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K173333
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/12/2021
• Device Model Number: GBWR2025
• Device Catalogue Number: GBWR2025
• Device Lot Number: 18643885
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention