BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMERICAN MEDICAL SYSTEMS

    MDR report key: 110859 · Received July 10, 1997

    Report

    Report Number
    110859
    Event Type
    Injury
    Date Received
    July 10, 1997
    Date of Event
    March 25, 1997
    Report Date
    July 10, 1997
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    EZY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SURGICAL REMOVAL OF MALFUNCTIONING URINARY SPHINCTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMERICAN MEDICAL SYSTEMS Implant SPHINCTER 800 (TM) CONTROL PUMP EZY AMERICAN MEDICAL SYSTEMS, INC. * CI854009

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization