BEUDAMED
    FDA Adverse Event Other Summary report: N

    VARIAN 6/100

    MDR report key: 165709 · Received May 1, 1998

    Report

    Report Number
    MW1013707
    Event Type
    Other
    Date Received
    May 1, 1998
    Date of Event
    May 1, 1998
    Report Date
    May 1, 1998
    Manufacturer
    VARIAN ASSOC., INC.
    Product Code
    IYE
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    WHILE ROTATING THE MACHINE FROM 0 TO 180 DEGREES CLOCKWISE THE PORTAL IMAGING DEVICE BECAME DISENGAGED AND STRUCK THE PT IN THE FACE SPLITTING THE PT'S FACE OPEN & INJURING HIS SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VARIAN 6/100 LINEAR ACCELERATOR IYE VARIAN ASSOC., INC. VARIAN 6/100 S/N 358

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Other