BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTIFICIAL URINARY SPHINCTER

    MDR report key: 97877 · Received June 11, 1997

    Report

    Report Number
    2126328-1997-02607
    Event Type
    Injury
    Date Received
    June 11, 1997
    Date of Event
    May 6, 1997
    Report Date
    June 11, 1997
    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

    ADDITIONAL INFO RECEIVED 2/12/1998 INDICATES ONLY THE PUMP WAS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTIFICIAL URINARY SPHINCTER Implant AUS EZY AMERICAN MEDICAL SYSTEMS, INC. 800 0423J 008, 1168T 012,(MORE)

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R