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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VAGINAL MESH

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VAGINAL MESH Back to Search Results
Device Problem Material Protrusion/Extrusion (2979)
Patient Problems Impaired Healing (2378); Prolapse (2475)
Event Date 11/22/2016
Event Type  Injury  
Event Description

I had a grade 2 uterine prolapse with no other symptoms. I had a uterine ablation years before that stopped my menstrual cycle. My dr insisted i have a cystocele/rectocele/ hysterectomy. I had continued problems with healing and exposed mesh. I had a second surgery the following (b)(6) 2017 to resize the mesh. The dr also performed a vaginal closure. I'm not sure why i did not heal. I later sought a new physician and currently trying to complete treatment.

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Type of DeviceVAGINAL MESH
MDR Report Key7150599
MDR Text Key96018887
Report NumberMW5074267
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 12/25/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/27/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
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

Date Received: 12/27/2017 Patient Sequence Number: 1