BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANCE MALE SLING SYSTEM

    MDR report key: 2081338 · Received April 27, 2011

    Report

    Report Number
    2183959-2011-00149
    Event Type
    Injury
    Date Received
    April 27, 2011
    Date of Event
    August 1, 2010
    Report Date
    March 30, 2011
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CLINICAL STUDY (B)(6). ON (B)(6) 2010, AN ADVANCE SLING SYSTEM WAS IMPLANTED, AT THE 6 MONTH F/U VISIT, PT REPORTED DE NOVO NOCTURNAL URGE INCONTINENCE. PT WAS TREATED WITH VESICARE 5MG QD. EVENT REPORTED AS RESOLVED ON (B)(6) 2011.

    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