BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTIFICIAL URINARY SPHINCTER

    MDR report key: 125831 · Received October 9, 1997

    Report

    Report Number
    2126328-1997-04570
    Event Type
    Injury
    Date Received
    October 9, 1997
    Date of Event
    April 9, 1997
    Report Date
    October 9, 1997
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    EZY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON 9/20/94 AN AUS DEVICE WAS IMPLANTED. ON 1/31/95 THE CUFF AND PUMP WERE REVISED AND TANDEM CUFF IMPLANTED. THE TANDEM CUFF WAS REMOVED SOMETIME OIN 1996 DUE TO EROSION. ON 9/9/97 A TANDEM CUFF WAS IMPLANTED DUE TO RECURRING INCONTINENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTIFICIAL URINARY SPHINCTER Implant AUS EZY AMERICAN MEDICAL SYSTEMS, INC. 800 6443T 003,6721T 002,(MORE)

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R