MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES,INC. GORE FLEX HD MESH IMPLANT; MESH, SURGICAL, POLYMERIC

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Failure of Implant (1924)

Event Date 01/03/2020

Event Type  Injury  

Event Description

Diaphragm hernia repair.Had diaphragm surgery on (b)(6) 2019 and gore flex hd mesh implant was placed.It failed in (b)(6) 2019.I had intestines push into my lungs.Needed another surgery on (b)(6) 2020.

• Brand Name: GORE FLEX HD MESH IMPLANT
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): W.L. GORE & ASSOCIATES,INC.
• MDR Report Key: 9948018
• MDR Text Key: 187542711
• Report Number: MW5094092
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Disability
• Patient Age: 57 YR
• Patient Weight: 51