BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 1062186 · Received June 13, 2008

    Report

    Report Number
    2210968-2008-00427
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    May 20, 2008
    Report Date
    May 20, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 06/16/2008. SHEATH SPLITS/CRACKS/BREAKS - 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 A PT UNDERWENT A SLING PROCEDURE IN 2008. DURING THE PROCEDURE, THE AREA ON THE SHEATH THAT WAS CLIPPED BY THE HEMOSTAT LIKELY PULLED OFF WHEN THE PHYSICIAN TRIED TO REMOVE THE SHEATH. THE SURGEON THEN GRABBED THE OTHER SIDE OF THE SAME SHEATH AND WAS ABLE TO SUCCESSFULLY REMOVE IT. THE DEVICE WAS IMPLANTED SUCCESSFULLY WITH NO ADVERSE PT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA 3108479

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK