BEUDAMED
    FDA Adverse Event Other Summary report: N

    ULTREX CYLINDER, & PUMP

    MDR report key: 438742 · Received January 21, 2003

    Report

    Report Number
    MW1027289
    Event Type
    Other
    Date Received
    January 21, 2003
    Report Date
    January 13, 2003
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FHW
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHEN PT PUMPS PROSTHESIS, GOES FLACID (FLUID LOSS). RESERVOIR REPLACED APPROX. 2 MONTHS BUT FLUID LOSS CONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTREX CYLINDER, & PUMP PENILE IMPLANT FHW AMERICAN MEDICAL SYSTEMS, INC. ULTREX PLUS *

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other