BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 1082419 · Received July 21, 2008

    Report

    Report Number
    2210968-2008-00584
    Event Type
    Malfunction
    Date Received
    July 21, 2008
    Date of Event
    March 28, 2008
    Report Date
    June 24, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K052401
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    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. A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED, AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SLING PROCEDURE, THE MESH PULLED AWAY FROM THE INSERTER. THE SURGEON USED A SECOND DEVICE TO COMPLETE THE CASE WITH NO ADVERSE PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA 3065831

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK