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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON TVT OBTURATOR SLING MESH, SURGICAL
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ETHICON TVT OBTURATOR SLING MESH, SURGICAL Back to Search Results
Model Number 810081
Device Problem Insufficient Information (3190)
Patient Problems Incontinence (1928); Pain (1994); Burning Sensation (2146); Cramp(s) (2193)
Event Date 06/25/2014
Event Type  Injury  
Event Description
Urogynecology surgery to implant ethicon 810081 gynecare tvt obturator system for stress incontinence on (b)(6) 2014. I experienced pubic pelvic pain with inner groin thigh pain and i experienced terrible leg cramps. The tvt sling actually made my stress incontinence worse. It has taken me over 3 years to find another doctor to try to remove it. My symptoms are far worse. I now have terrible sharp pains in pubic area with sitting and getting up. Also sharp pain when bending down and squatting. Stress incontinence worst. Deterioration of pubic area tissue formed over clitoris and labia lips almost nonexistent. Burning vulva and nerve pain. Scheduled for tvt sling removal on (b)(6) 2017 in (b)(6). Warned it is a very risky surgery to remove it, but i cannot take the pain anymore.
 
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Brand NameTVT OBTURATOR SLING
Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
ETHICON
MDR Report Key7013520
MDR Text Key91741741
Report NumberMW5073194
Device Sequence Number1
Product Code FTM
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 11/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/09/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number810081
Was Device Available for Evaluation? No
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: 11/09/2017 Patient Sequence Number: 1
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