BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 1211135 · Received October 24, 2008

    Report

    Report Number
    2210968-2008-01025
    Event Type
    Injury
    Date Received
    October 24, 2008
    Report Date
    October 1, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 10/23/2008. DYSPAREUNIA OCCURRED. MESH EXPOSURE OCCURRED, - MESH EXPOSURE OCCURRED, CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNEVENTFUL OBTURATOR SLING PROCEDURE IN 2007. AT THE PATIENT'S POST-OPERATIVE VISIT, NO ABNORMALITIES WERE NOTED. THE PATIENT WAS CONTINENT AND HAPPY UNTIL APPROXIMATELY THREE MONTHS AGO WHEN SHE BECAME SEXUALLY ACTIVE. BOTH THE PATIENT AND HER PARTNER HAD DISCOMFORT WITH INTERCOURSE AND THE PATIENT COULD FEEL EXPOSED MESH IN THE SUBURETHRAL AREA WITH HER FINGER. THE PATIENT WAS SEEN BY THE SURGEON IN 2008, WHO CONFIRMED A HALF INCH OF EXPOSED TAPE IN THE SUBURETHRAL AREA. THE SURGEON OPINES THAT THE BEST APPROACH WOULD TO BE TRY TO RE-COVER THE EXPOSED MESH AFTER FRESHENING THE VAGINAL EDGES.

    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