BEUDAMED
    FDA Adverse Event Other Summary report: N

    ULTREX PENILE PROSTHESIS

    MDR report key: 14810 · Received July 21, 1994

    Report

    Report Number
    MW1002911
    Event Type
    Other
    Date Received
    July 21, 1994
    Date of Event
    November 4, 1993
    Report Date
    July 11, 1994
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FHW
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    REMOVAL OF CYLINDERS. LEFT CYLINDER ANEURYSM, REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTREX PENILE PROSTHESIS Implant PENILE PROSTHESIS FHW AMERICAN MEDICAL SYSTEMS, INC. 8355M005

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other