BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTIFICIAL URINARY SPHINCTER

    MDR report key: 46503 · Received November 1, 1996

    Report

    Report Number
    2126328-1996-05116
    Event Type
    Injury
    Date Received
    November 1, 1996
    Date of Event
    July 17, 1996
    Report Date
    November 1, 1996
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    EZY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE CUFF WAS REMOVED FROM THE PT AND REPLACED DUE TO COMPRESSION OF CUFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTIFICIAL URINARY SPHINCTER Implant AUS EZY AMERICAN MEDICAL SYSTEMS, INC. 800 8657J 012

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R