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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Failure of Implant (1924); Pain (1994); Urinary Frequency (2275); Prolapse (2475); Constipation (3274); Urinary Incontinence (4572)

Event Date 10/26/2021

Event Type  Injury  

Event Description

Immediately after surgery reporter has ongoing pain with the mesh implant on both sides.Reporter has had the following pain with walking, constipation, bladder prolapse, urinary frequency, and now has to were a panty liner for urinary incontinence.She has an ultrasound scheduled for (b)(6) 2022 and may have mesh removed.

• Brand Name: MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.
• MDR Report Key: 14684663
• MDR Text Key: 294022933
• Report Number: MW5110296
• Device Sequence Number: 2
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/13/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 96 KG