BEUDAMED
    FDA Adverse Event Other Summary report: N

    ULTREX

    MDR report key: 25792 · Received January 19, 1995

    Report

    Report Number
    25792
    Event Type
    Other
    Date Received
    January 19, 1995
    Date of Event
    November 4, 1993
    Report Date
    July 11, 1994
    Manufacturer
    AMS
    Product Code
    FAE
    Report Source
    User Facility report
    Reporter Location
    LA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    REMOVAL OF ULTREX CYLENDERS. L. CYLENDER ANEURYOM REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTREX Implant PENILE PROSTHESIS FAE AMS CYLINDER 5303M001 RESERVOIR LOT # 8355M005

    Patients

    Seq Age Sex Outcome Treatment
    1 52 * Other