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U.S. Department of Health and Human Services

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

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W. L. GORE & ASSOCIATES, INC. MESH MESH, SURGICAL, POLYMERIC Back to Search Results
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.
 
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Brand NameMESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
W. L. GORE & ASSOCIATES, INC.
MDR Report Key14684663
MDR Text Key294022933
Report NumberMW5110296
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Received06/13/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No

Patient Treatment Data
Date Received: 06/13/2022 Patient Sequence Number: 1
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