BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANCE MALE SLING SYSTEM

    MDR report key: 1915814 · Received November 30, 2010

    Report

    Report Number
    2183959-2010-00437
    Event Type
    Injury
    Date Received
    November 30, 2010
    Date of Event
    May 9, 2008
    Report Date
    September 30, 2008
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    (B)(4) PT WHO WAS IMPLANTED WITH ADVANCE DEVELOPED A PERITONEAL HEMATOMA THAT NEEDED TO BE SURGICALLY DRAINED. THE HEMATOMA WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANCE MALE SLING SYSTEM SURGICAL MESH FTL AMERICAN MEDICAL SYSTEMS, INC. 72404224 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Hospitalization| R