BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASCUSHUNT

    MDR report key: 46282 · Received November 1, 1996

    Report

    Report Number
    1713910-1996-00029
    Event Type
    Malfunction
    Date Received
    November 1, 1996
    Date of Event
    September 15, 1996
    Report Date
    November 1, 1996
    Manufacturer
    RESEARCH MEDICAL, INC.
    Product Code
    DQR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    UPON OPENING THE STERILE TRAY THE STOPCOCK SEPARATED FROM THE INFLATION LINE. THE PT WAS NOT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASCUSHUNT CAROTID SHUNT DQR RESEARCH MEDICAL, INC. NA 87934

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other