BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 1040145 · Received May 9, 2008

    Report

    Report Number
    2210968-2008-00339
    Event Type
    Injury
    Date Received
    May 9, 2008
    Date of Event
    April 8, 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
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFO DERIVED FROM THE EVAL WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. 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 THE HAMMOCK POSITION IN 2008. DURING THE PROCEDURE, THE FINGER PAD FELL OFF AND THEN THE RELEASE WIRE CAME OUT OF ITS PLACE WHILE THE SURGEON WAS IN THE MIDDLE OF INSERTING IT. THERE WAS DOUBT ABOUT THE ATTACHMENT BETWEEN THE INSERTER AND THE IMPLANTED MESH. A SMALL TEAR IN THE VAGINAL WALL OCCURRED. A DIFFERENT TYPE OF SLING DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA 3079569

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention