BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMERICAN MEDICAL SYSTEMS

    MDR report key: 510824 · Received February 2, 2004

    Report

    Report Number
    MW1031039
    Event Type
    Malfunction
    Date Received
    February 2, 2004
    Date of Event
    September 12, 2003
    Report Date
    January 28, 2004
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    FHW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD AMS AMBICOR TWO PIECE PENILE IMPLANT WITHOUT COMPLICATIONS. POSTOP, THE INFLATE AND DEFLATE PART OF THE AMBICOR IMPLANT BECAME VERY PROBLEMATIC. IMPLANT MALFUNCTION - DEFLATION OF THE IMPLANT WAS ALWAYS PROBLEMATIC. THE DEFECTIVE IMPLANT WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMERICAN MEDICAL SYSTEMS AMBICOR 16CM X 11MM PENILE IMPLANT FHW AMERICAN MEDICAL SYSTEMS * 367539005

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR