BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVANCE MALE SLING SYSTEM

    MDR report key: 3185290 · Received June 7, 2013

    Report

    Report Number
    2183959-2013-00861
    Event Type
    Other
    Date Received
    June 7, 2013
    Report Date
    April 30, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    OTM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    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

    IT WAS REPORTED TO THE PT THAT HIS INCONTINENCE WAS WORSE NOW THAN BEFORE THE SLING WAS IMPLANTED. THE PT HAD ANOTHER DEVICE IMPLANTED ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254053 ADVANCE MALE SLING SYSTEM SURGICAL MESH, POLYMERIC OTM AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R