BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 1150510 · Received September 4, 2008

    Report

    Report Number
    2210968-2008-00778
    Event Type
    Injury
    Date Received
    September 4, 2008
    Date of Event
    July 19, 2008
    Report Date
    August 5, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K974098
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION CODES: 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 IN 2008. POST-OPERATIVELY AT FOUR DAYS LATER, THE PATIENT DEVELOPED PAIN IN THE AREA OF THE INSERTION OF THE ADDUCTOR MUSCLES ON THE LEFT SIDE. THE PATIENT WAS GIVEN LOCAL ANESTHESIA OF PRILOCAIN ONE PERCENT AND PREDNISOLONE FIVE HUNDRED MILLIGRAMS.

    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