BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 1141047 · Received August 27, 2008

    Report

    Report Number
    2210968-2008-00728
    Event Type
    Injury
    Date Received
    August 27, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 28, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION CODE: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADD'L INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOOD RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT AN OBTURATOR SLING PROCEDURE IN 2008. ABOUT 3 DAYS LATER, THE PT SAW THE SURGEON FOR SEVERE THIGH PAIN AND THE SURGEON PRESCRIBED ANTIBIOTICS. AT ABOUT 5 DAYS LATER, THE PT WAS ADMITTED TO THE HOSP AND THE TAPE WAS REMOVED BY ANOTHER SURGEON. THE UROLOGIC SURGEON THAT REMOVED THE TAPE ALSO REMOVED A LOT OF NECROSED TISSUE AS LOW AS THE CALVES. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA 3135653

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R