BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMERICAN MEDICAL SYSTEMS

    MDR report key: 184358 · Received August 11, 1998

    Report

    Report Number
    MW1014477
    Event Type
    Injury
    Date Received
    August 11, 1998
    Date of Event
    August 4, 1998
    Report Date
    August 4, 1998
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FHW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON 8-4-98 AN AMS 700 PENILE PROSTHESIS WAS REMOVED BY DR, DUE TO PRODUCT MALFUNCTION. APPROX 2-3 WKS AGO, ACCORDING TO PTS HISTORY, THE PROSTHESIS MALFUNCTIONED. THE IMPLANT WAS PLACED IN 1994 IN REPORTING INSTITUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMERICAN MEDICAL SYSTEMS Implant PENILE PROSTHESIS FHW AMERICAN MEDICAL SYSTEMS, INC. AMS-700 *

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention