BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 1974325 · Received January 21, 2011

    Report

    Report Number
    2210968-2011-00069
    Event Type
    Injury
    Date Received
    January 21, 2011
    Date of Event
    December 22, 2010
    Report Date
    December 22, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K100485
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: 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 ON (B)(6) 2010. DURING THE PROCEDURE, WHILE THE SURGEON WAS TENSIONING THE TAPE, THE SCRUB NURSE WAS DIRECTED TO CLAMP THE MESH WHICH HAS A PLASTIC SLEEVE OVER IT AND CUT THE PLASTIC TROCAR SHEATH FROM THE MESH. THE SCRUB NURSE CLAMPED THE MESH AND PLASTIC SLEEVE BUT INSTEAD OF CUTTING ABOVE THE CLAMP, SHE CUT THE MESH BELOW THE CLAMP AT THE SKIN LEVEL. THIS WAS IMMEDIATELY NOTICED BY THE SURGEON. SINCE THE PLASTIC SLEEVE WAS STILL ON THE MESH, THE MESH RESEEDED INTO THE PATIENT. THE SURGEON THEN HAD TO CUT THE PATIENT PARTLY OPEN IN ORDER TO RETRIEVE THE MESH SO THE PLASTIC SLEEVE COULD BE REMOVED. ANOTHER SURGEON HAD TO BE CALLED IN TO ASSIST IN THE MESH AND PLASTIC SLEEVE RETRIEVAL. ONCE THE MESH AND PLASTIC HAD BEEN LOCATED AND CLAMPED, THE SURGEON COULD THEN TENSION THE TAPE AND 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention