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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOHNSON AND JOHNSON URETEX SYNTHETIC SLING TRANSVAGINAL MESH

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JOHNSON AND JOHNSON URETEX SYNTHETIC SLING TRANSVAGINAL MESH Back to Search Results
Catalog Number 485031
Event Date 10/02/2011
Event Type  Death  
Event Description

My mother had the johnson and johnson gynecare prolift post repair system and the uretex synthetic sling implanted on (b)(6) 2008. Approximately four months ago, she started having problem such as erosion out of her vaginal with severe pain. She was going weekly to have her bladder flushed with antibiotics because of erosion into her bladder too. She was having severe constipation problems believed to be associated with the sling. She tried pain pills but they would not help with the pain. She would set up in bed laying across several pillows begging for relief. My mother was in such pain that she went in the backyard and shot herself. She is now gone due to the fda following this mesh to be put in women. Reason for use: prolapse. Just given a prescription for pain.

 
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Brand NameURETEX SYNTHETIC SLING
Type of DeviceTRANSVAGINAL MESH
Manufacturer (Section D)
JOHNSON AND JOHNSON
MDR Report Key2302230
Report NumberMW5022676
Device Sequence Number2
Product CodeFTL
Report Source Voluntary
Reporter Occupation Patient FAMILY MEMBER OR FRIEND
Type of Report Initial
Report Date 10/14/2011
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received10/14/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date02/12/2008
Device Catalogue Number485031
Device LOT NumberSGJ00478
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 10/14/2011 Patient Sequence Number: 1
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