BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTIFICIAL URINARY SPHINCTER

    MDR report key: 116374 · Received August 27, 1997

    Report

    Report Number
    2126328-1997-03852
    Event Type
    Injury
    Date Received
    August 27, 1997
    Date of Event
    July 22, 1997
    Report Date
    August 27, 1997
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    EZY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE BALLOON WAS REMOVED FROM THE PATIENT AND REPLACED DUE TO RECURRING INCONTINENCE. FLUID LOSS BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTIFICIAL URINARY SPHINCTER Implant AUS EZY AMERICAN MEDICAL SYSTEMS, INC. 800 8604P 003

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R