BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTIFICIAL URINARY SPHINCTER

    MDR report key: 128393 · Received October 24, 1997

    Report

    Report Number
    2126328-1997-04853
    Event Type
    Injury
    Date Received
    October 24, 1997
    Date of Event
    September 10, 1997
    Report Date
    October 24, 1997
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    EZY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AN AUS DEVICE WAS IMPLANTED ON 5/9/1994. ON 6/10/1996 AN ATTEMPTED REVISION TO ADD A SECOND CUFF. ON 9/10/1997 A TANDEM CUFF WAS IMPLANTED. NO COMPONENTS WERE REVMOVED OR REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTIFICIAL URINARY SPHINCTER Implant AUS EZY AMERICAN MEDICAL SYSTEMS, INC. 800 AD028 002

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R