BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLINAC 2500 - 24 MV (VARIAN)

    MDR report key: 212331 · Received February 15, 1999

    Report

    Report Number
    MW1015762
    Event Type
    Injury
    Date Received
    February 15, 1999
    Date of Event
    June 12, 1995
    Report Date
    February 14, 1999
    Manufacturer
    VARIAN ASSOCIATES, INC.
    Product Code
    IYE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AFTER CANCER TREATMENT WITH RADIATION, SYMPTOMS WHICH BEGAN 4-97 AND HAVE PROGRESSED MODE IT APPEAR BY 5-98 THAT RPTR REC'D RADIATION OVER THE ENTIRE BACK SIDE OF THEIR BODY, THAT IS FROM THEIR HEAD TO THEIR TOES. SINCE MARCH 98 RPTR HAS FELT BURNED ON THE ENTIRE BACK SIDE OF BODY. RADIATION ONCOLOGIST SAID THIS SENSATION WOULD BE PRESENT IF NERVES WERE DAMAGED BY RADIATION. TESTS HAVE BEEN CONSISTENT WITH RADIATION DAMAGE TO SKIN, BLOOD VESSELS, NERVES, EYES, TONGUE, COGNITIVE CHANGES, INCREASING FATIGUE. THESE CHANGES ARE OUTSIDE OF THE RADIATION FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINAC 2500 - 24 MV (VARIAN) RADIATION ACCELERATOR IYE VARIAN ASSOCIATES, INC. CLINAC2500 - 24 MV *

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Disability