BEUDAMED
    FDA Adverse Event Other Summary report: N

    ULTREX PENILE PROSTHESIS

    MDR report key: 560479 · Received December 15, 2004

    Report

    Report Number
    560479
    Event Type
    Other
    Date Received
    December 15, 2004
    Date of Event
    October 26, 2004
    Report Date
    December 15, 2004
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FHW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MALFUNCTIONING PENILE PROSTHESIS WITH SMALL BREACHES OF BOTH CYLINDERS, AND DISRUPTION OF THE RESERVOIR TUBING AT THE PUMP LEVEL, COMPLETE, AND DISRUPTION OF ONE CYLINDER AT THE PUMP LEVEL, PARTIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTREX PENILE PROSTHESIS ULTREX PENILE IMPLANT FHW AMERICAN MEDICAL SYSTEMS, INC. NOT REPORTED NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR