BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 1063124 · Received June 20, 2008

    Report

    Report Number
    2210968-2008-00429
    Event Type
    Injury
    Date Received
    June 20, 2008
    Date of Event
    May 20, 2008
    Report Date
    May 23, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K012628
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 A SLING PROCEDURE AND PERINEOPLASTY PROCEDURE IN 2008. THE PATIENT WAS DISCHARGED IN THE SAME DAY, AND HER VOIDING PATTERN WAS NORMAL AT THAT TIME. POST-OPERATIVELY 4 DAYS LATER, THE PATIENT WAS EXPERIENCING URINARY RETENTION. A BLADDER SCAN WAS PERFORMED TO CHECK THE PATIENT'S POST-VOID RESIDUAL. THIS WAS FOUND TO BE HIGH AND TRANSURETHRAL CATHETERIZATION WAS DONE AS A RESULT. AT ABOUT 2 DAYS LATER, THE PATIENT WAS BROUGHT TO THE OPERATING ROOM WHERE THE SLING WAS LOOSENED AND THE EVENT WAS RESOLVED.

    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 Required Intervention