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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VAGINAL MESH MESH, SURGICAL, POLYMERIC

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VAGINAL MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Abdominal Pain (1685); Erosion (1750); Pain (1994)
Event Date 08/18/2020
Event Type  Injury  
Event Description

I had mesh implants that was not correct and have had severe rectal, tailbone, abdominal, vaginal pain along with that the vaginal mesh starting to erode through the vaginal tissue. I will be having some of the mesh removed (b)(6) 2021. Fda safety report id# (b)(4).

 
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Brand NameVAGINAL MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
MDR Report Key11596276
MDR Text Key243610191
Report NumberMW5100439
Device Sequence Number1
Product Code FTL
Combination Product (Y/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 03/26/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/30/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 03/30/2021 Patient Sequence Number: 1
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