BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCE MALE SLING SYSTEM

    MDR report key: 2193089 · Received July 21, 2011

    Report

    Report Number
    2183959-2011-00266
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    July 6, 2011
    Report Date
    July 6, 2011
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFO BECOME AVAILABLE REGARDING THIS EVENT, IT WILL BE RE-EVALUATED AND A F/U REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2011, DURING AN ADVANCE SLING IMPLANT PROCEDURE, THE LEFT PLASTIC SHEATH COULD NOT BE REMOVED FROM THE MESH ARM BECAUSE IT WOULD NOT SEPARATE. THE AREA BETWEEN THE SHEATH AND MESH ARM WAS IRRIGATED TO ASSIST WITH REMOVAL, HOWEVER, IT WAS UNSUCCESSFUL. "THE OUTER SHEATH SIMPLY STRETCHED." THE CONTRA-LATERAL SHEATH EASILY REMOVED FROM THE MESH ARM. A "RIGID INSTRUMENT" WAS PASSED TO FREE UP THE OUTER SHEATH, WHICH WAS UNSUCCESSFUL. THE MESH ARM WAS PALPATED TO DETERMINE IF THERE WAS A TWIST IN THE MESH ARM, IT WAS FELT TO BE FLAT. APPROX 4 CM WAS REMOVED LEAVING A PORTION OF THE OUTER SLEEVE WITHIN THE PT. THE PROCEDURE WAS COMPLETED. THE PT WAS REPORTED TO BE DOING WELL WITH NO ADVERSE OUTCOME TO-DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANCE MALE SLING SYSTEM SURGICAL MESH FTL AMERICAN MEDICAL SYSTEMS, INC. 720088-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R