BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 1040152 · Received May 9, 2008

    Report

    Report Number
    2210968-2008-00332
    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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL 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 ON AN UNK DATE. TWO WEEKS AFTER THE PROCEDURE, THE PT WAS NOT LEAKING URINE. SIX WEEKS AFTER THE PROCEDURE, THE MESH WAS FOUND TO BE EXPOSED AT THE INCISION SITE. ON AN UNK DATE, THE SURGEON TRIMMED THE EXPOSED MESH. THE SURGEON OPINES THAT THE LASER CUT MAY MAKE THE MESH TOO RIGID AND PROMOTE REJECTION. SIX MOS AFTER THE INITIAL PROCEDURE, THE PT WAS LEAKING URINE. CURRENTLY, THE PT IS NOT CURED OF STRESS URINARY INCONTINENCE.

    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