BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTIFICIAL URRINARY SPHINCTER

    MDR report key: 39216 · Received September 20, 1996

    Report

    Report Number
    2126328-1996-04399
    Event Type
    Injury
    Date Received
    September 20, 1996
    Date of Event
    June 3, 1996
    Report Date
    September 20, 1996
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    EZY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AN ANONYMOUS SOURCE REPORTS A MALFUNCTIONING AGUS "GU SPHINCTER COMPONENT." REFERENCE FDA ACCESS #4001426.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Hospitalization| R