BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTIFICIAL URINARY SPHINCTER

    MDR report key: 117755 · Received September 4, 1997

    Report

    Report Number
    2126328-1997-03982
    Event Type
    Injury
    Date Received
    September 4, 1997
    Report Date
    September 4, 1997
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    EZY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON 01/24/83 THE AUS DEVICE WAS IMPLANTED. THE CONTROL ASSEMBLY WAS IMPLANTED, DATE NOT PROVIDED. THE CUFF AND PERINEAL CUFF ENCLOSURE WERE REMOVED FROM THE PATIENT AND REPLACED, REASON AND DATE NOT INDICATED. AMS HAS REQUESTED ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTIFICIAL URINARY SPHINCTER Implant AUS EZY AMERICAN MEDICAL SYSTEMS, INC. 800 3007B,1948B

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R