BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMERICAN MEDICAL SYSTEMS

    MDR report key: 221446 · Received April 29, 1999

    Report

    Report Number
    MW1016224
    Event Type
    Injury
    Date Received
    April 29, 1999
    Date of Event
    April 8, 1999
    Report Date
    April 9, 1999
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FHW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WITH PENILE PROSTHESIS FOR APPROXIMATELY 10 YEARS, PRESENTS FOR REMOVAL OF PROSTHESIS ON 4/8/99. DR REMOVED PROSTHESIS DUE TO NON FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMERICAN MEDICAL SYSTEMS Implant PENILE PROSTHESIS FHW AMERICAN MEDICAL SYSTEMS, INC. DYNAFLEX UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention