BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 434405 · Received December 20, 2002

    Report

    Report Number
    434405
    Event Type
    Malfunction
    Date Received
    December 20, 2002
    Date of Event
    December 9, 2002
    Report Date
    December 18, 2002
    Manufacturer
    AMERCIAN MEDICAL SYSTEMS, INC
    Product Code
    FHW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IN 1994, PT UNDERWENT PENILE IMPLANT-PROSTHESIS DISTRIBUTED BY AMERICAN MEDICAL SYSTEMS INC. PT RETURNED TO SURGERY IN 2002 FOR REPLACEMENT OF IMPLANT DUE TO MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * PENILE PROSTHESIS FHW AMERCIAN MEDICAL SYSTEMS, INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other