BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANCE MALE SLING SYSTEM

    MDR report key: 2161778 · Received July 7, 2011

    Report

    Report Number
    2183959-2011-00241
    Event Type
    Injury
    Date Received
    July 7, 2011
    Report Date
    June 16, 2011
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADD'L 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

    CLINICAL STUDY PT. AN ADVANCE SLING WAS IMPLANTED ON (B)(6) 2008 FOR INCONTINENCE. INFO RECEIVED ON (B)(6) 2011 INDICATES THAT THE PT EXPERIENCED DE NOVO URGE INCONTINENCE, WITH ONSET OF (B)(6) 2011 AND WORSENING INCONTINENCE WITH AN ONSET OF (B)(6) 2009 SEVERITY WAS RATED AS MODERATE. EVENT STATUS WAS REPORTED AS CONTINUING. INTERVENTION WAS WITH MEDICATION, TOLTRODINE. THE DEVICE REMAINS IMPLANTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability