BEUDAMED
    FDA Adverse Event Other Summary report: N

    ARTIFICIAL URINARY SPHINCTER

    MDR report key: 35098 · Received August 8, 1996

    Report

    Report Number
    MW4001426
    Event Type
    Other
    Date Received
    August 8, 1996
    Date of Event
    June 3, 1996
    Report Date
    June 26, 1996
    Manufacturer
    AMERICAN MEDICAL SYSTEM
    Product Code
    EZY
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MALFUNCTIONING "GU SPHINCTER COMPONENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTIFICIAL URINARY SPHINCTER Implant ARTIFICIAL URINARY SPHINCTER EZY AMERICAN MEDICAL SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other