BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 1952720 · Received January 4, 2011

    Report

    Report Number
    2210968-2011-00004
    Event Type
    Malfunction
    Date Received
    January 4, 2011
    Date of Event
    November 28, 2010
    Report Date
    December 6, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - MESH TO PLASTIC NEEDLE DETACHED. CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. IN ADDITION, 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 PATIENT UNDERWENT A SLING PROCEDURE ON (B)(6) 2010. WHEN THE SURGEON WENT THROUGH THE TISSUE WITH THE NEEDLE, THE PLASTIC TROCAR BROKE AND THE MESH SEPARATED FROM THE NEEDLE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA 3422100

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK