BEUDAMED
    FDA Adverse Event Other Summary report: N

    ULTREX

    MDR report key: 560541 · Received December 15, 2004

    Report

    Report Number
    560541
    Event Type
    Other
    Date Received
    December 15, 2004
    Date of Event
    August 30, 2004
    Report Date
    December 15, 2004
    Manufacturer
    AMERICAN MEDICAL SYSTEMS INC.
    Product Code
    FHW
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS HAVING SURGERY FOR IMPLANTATION OF DEVICE. INTRA-OPERATIVELY, THERE WAS SIGNIFICANT CYLINDER LEAK WHICH LIMITED THE UTILITY OF THIS DEVICE. THE DEVICE WAS REMOVED DURING IMPLANTATION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTREX PENILE IMPLANT FHW AMERICAN MEDICAL SYSTEMS INC. 700 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR