BEUDAMED
    FDA Adverse Event Other Summary report: N

    AMS 800

    MDR report key: 68808 · Received January 7, 1997

    Report

    Report Number
    68808
    Event Type
    Other
    Date Received
    January 7, 1997
    Date of Event
    September 9, 1996
    Report Date
    September 9, 1996
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    EZY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    MALFUNCTIONING URINARY SPHINCTER PROSTHESIS IS COMPLETELY FLACCID AND NEEDS REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMS 800 Implant URINARY PROSTHESIS EZY AMERICAN MEDICAL SYSTEMS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other