BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTIFICIAL URINARY SPHINCTER

    MDR report key: 79796 · Received March 27, 1997

    Report

    Report Number
    2126328-1997-01216
    Event Type
    Injury
    Date Received
    March 27, 1997
    Date of Event
    December 11, 1996
    Report Date
    March 27, 1997
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    EXY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A CONNECTOR WAS REMOVED FROM THE PT, DUE TO FLUID LOSS, AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTIFICIAL URINARY SPHINCTER Implant AUS EXY AMERICAN MEDICAL SYSTEMS, INC. 800 7218T 007

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R