BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANCE MALE SLING SYSTEM

    MDR report key: 1760398 · Received July 13, 2010

    Report

    Report Number
    2183959-2010-00307
    Event Type
    Injury
    Date Received
    July 13, 2010
    Date of Event
    June 21, 2010
    Report Date
    June 21, 2010
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE MALFUNCTION WAS REPORTED AND DEVICE WAS NOT EXPLANTED. SERIAL NUMBER NOT PROVIDED FOR HISTORY REVIEW. THE OCCURRENCE OF THIS EVENT IS INCLUDED IN THE POTENTIAL ADVERSE EVENT SECTION OF THE DEVICE LABELING. THE FREQUENCY FOR THIS EVENT IS NOT GREATER THAN IS USUAL. THIS TYPE OF EVENT (ERECTILE DYSFUNCTION) IS NOT COVERED IN THE IFU. THE FREQUENCY OF OCCURRENCE IS RARE.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH ADVANCE ON (B)(6)2009. HE IS CLAIMING THAT "HIS VERY MILD INCONTINENCE HAS CONTINUED TO BE ABOUT 90-95% INCONTINENCE, CONSTANTLY REQUIRING TO WEAR A DIAPER, GO THROUGH 203 PADS DAILY, KIEGELIN ALMOST NON-EXISTENT WHERE PRIOR TO SLING SURGERY, I KIEGELED CONSTANTLY". HE STATES THAT SINCE THE ADVANCE IMPLANTATION HI IS IMPOTENT, HAS PAIN IN THE PERINEAL AREA. MEDICATION PRESCRIBED: CLOMAZAPAN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability