BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMERICAN MEDICAL SYSTEMS

    MDR report key: 472504 · Received July 18, 2003

    Report

    Report Number
    472504
    Event Type
    Injury
    Date Received
    July 18, 2003
    Date of Event
    June 18, 2003
    Report Date
    July 18, 2003
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    FHW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REMOVAL AND REPLACEMENT OF MALFUNCTIONING PENILE PROSTHESIS PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMERICAN MEDICAL SYSTEMS PENILE PROSTHESIS FHW AMERICAN MEDICAL SYSTEMS UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization