BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTIFICIAL URINARY SPHINCTER

    MDR report key: 74494 · Received March 7, 1997

    Report

    Report Number
    2126328-1997-00837
    Event Type
    Injury
    Date Received
    March 7, 1997
    Date of Event
    February 3, 1997
    Report Date
    March 7, 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 8/8/97 INDICATES A REPORT SENT TO FDA WITH A 7-DIGIT ACCESS NUMBER 1011689.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTIFICIAL URINARY SPHINCTER Implant AUS EZY AMERICAN MEDICAL SYSTEMS, INC. 800 0857M 018,0825M 002,7357M 007

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| R