BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 1040150 · Received May 9, 2008

    Report

    Report Number
    2210968-2008-00337
    Event Type
    Injury
    Date Received
    May 9, 2008
    Report Date
    April 8, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K052401
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADD'L INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT A SLING PROCEDURE IN THE HAMMOCK POSITION IN 2008. THE PT HAD BEEN ON COUMADIN WHICH WAS STOPPED. THE PT UNEVENTFULLY UNDERWENT THE PROCEDURE WHILE HEPARINIZED. THE SURGEON PLACED FLOSEAL AROUND THE DEVICE. THE PT WAS THEN RE-COUMADINIZED. THE PT'S INT'L NORMALIZED RATIO BECAME ELEVATED TO FOUR AND ONE HALF AND HER HEMATOCRIT DROPPED, THOUGH NO SOURCE OF BLEEDING WAS FOUND. ON AN UNK DATE, THE SUBURETHRAL INCISION OPENED EXPOSING THE MESH. THE SURGEON PLANS TO RE-CLOSE IT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention