BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTIFICIAL URINARY SPHINCTER

    MDR report key: 88328 · Received May 2, 1997

    Report

    Report Number
    2126328-1997-01971
    Event Type
    Injury
    Date Received
    May 2, 1997
    Date of Event
    March 31, 1997
    Report Date
    May 2, 1997
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    EZY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO RECEIVED ON 8/20/97 INDICATES THE CUFF WAS REMOVED FROM THE PT DUE TO INFECTION ON 1/27/97. FDA ACCESS #1011907.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTIFICIAL URINARY SPHINCTER Implant AUS EZY AMERICAN MEDICAL SYSTEMS, INC. 800 CQ895 009

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Hospitalization| R