BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMERICAN MEDICAL SYSTEMS INC. PENILE PROSTHESIS PUMP

    MDR report key: 2748021 · Received September 12, 2012

    Report

    Report Number
    MW5026936
    Event Type
    Malfunction
    Date Received
    September 12, 2012
    Manufacturer
    AMS
    Product Code
    FAE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PER PHYSICIAN "PRODUCT MALFUNCTIONING" (LEAKING).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMERICAN MEDICAL SYSTEMS INC. PENILE PROSTHESIS PUMP PUMP FAE AMS CV599001

    Patients

    Seq Age Sex Outcome Treatment
    1