BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMS MALLEABLE

    MDR report key: 1052891 · Received May 15, 2008

    Report

    Report Number
    1052891
    Event Type
    Malfunction
    Date Received
    May 15, 2008
    Date of Event
    April 24, 2008
    Report Date
    May 15, 2008
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FAE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE IMPLANT BROKE WHILE THE PATIENT WAS AT HOME. IT REQUIRED SURGICAL REMOVAL AND REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMS MALLEABLE PENILE PROSTHESIS FAE AMERICAN MEDICAL SYSTEMS, INC. 16CM X 13 OR 11MM 340011007

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR