BEUDAMED
    FDA Adverse Event Other Summary report: N

    AMS PRESSURE REGULATING BALLOON

    MDR report key: 17629 · Received October 3, 1994

    Report

    Report Number
    17629
    Event Type
    Other
    Date Received
    October 3, 1994
    Date of Event
    September 28, 1994
    Report Date
    September 28, 1994
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    EZY
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    URINARY INCONTINENCE IN SPITE OF URINARY SPHINCTER AT LOW PRESSURE 61-70. REPLACED WITH A HIGHER PRESSURE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMS PRESSURE REGULATING BALLOON Implant URINARY SPHINCTER PROTHESIS EZY AMERICAN MEDICAL SYSTEMS, INC. 4015M010

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other AMS ST. CUFF 4.5 CM 72400161, AMS AUS 72400002,| AMS CONTROL PUMP 72400098.