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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOHNSON & JOHNSON GYNECARE TVTO ABBREVO KIT CONTINENCE SYSTEM MESH SLING VAGINAL TAPE

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JOHNSON & JOHNSON GYNECARE TVTO ABBREVO KIT CONTINENCE SYSTEM MESH SLING VAGINAL TAPE Back to Search Results
Model Number TVT ABBREVO
Device Problem Material Erosion (1214)
Patient Problems Abdominal Pain (1685); Erosion (1750); Failure of Implant (1924)
Event Date 08/16/2012
Event Type  Injury  
Event Description
Patient had a laparoscopic bilateral salpingo-oophorectomy and tension-free vaginal tape tvto procedure last month. Patient reports constant vaginal stinging pain since surgery; pain progressing in intensity during the past week. She has strong stinging pain when she sits. Patient was taken to surgery for removal of polypropylene mesh which had eroded through the vagina. An extensive area of mesh erosion from 12:00 position clockwise to 3:00 position was eroded, approximately 1. 5 cm from the urethral meatus in the vagina. There were two 102 mm areas of protruding tvt polypropylene mesh tape exposed through the vagina wall. The surgeon dissected out the tvt tape, including the attached prolene tensioning suture at the distal end used during the insertion on 07/10/2012. Procedure was completed and patient was discharged home in good condition with no complications. The tvt mesh tape was submitted to pathology.
 
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Brand NameGYNECARE TVTO ABBREVO KIT CONTINENCE SYSTEM
Type of DeviceMESH SLING VAGINAL TAPE
Manufacturer (Section D)
JOHNSON & JOHNSON
route 22 west
somerville NJ 08876
MDR Report Key2715775
MDR Text Key22107445
Report Number2715775
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 User Facility
Source Type Unknown
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/21/2012
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/21/2012
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberTVT ABBREVO
Device Catalogue NumberTVTOML
Device Lot Number3609450
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/21/2012
Distributor Facility Aware Date08/16/2012
Device Age1 MO
Event Location Hospital
Date Report to Manufacturer08/21/2012
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 08/21/2012 Patient Sequence Number: 1
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