BEUDAMED
    FDA Adverse Event Death Summary report: N

    BIOTRON

    MDR report key: 404756 · Received July 3, 2002

    Report

    Report Number
    MW1025561
    Event Type
    Death
    Date Received
    July 3, 2002
    Date of Event
    August 1, 2000
    Report Date
    July 2, 2002
    Manufacturer
    BIOTRON
    Product Code
    GZO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    EVENT DATE APPROXIMATION OF DATE PT BEGAN SEEING A NURSE USING GALVANIC SKIN RESPONSE MEASUREMENT DEVICE MFG BY BIOTRON. SHE CLAIMED TO BE ABLE TO DETECT BOTH THE PRESENCE AND ABSENCE OF CANCER CELLS IN VARIOUS ORGANS AND THE LYMPHATIC SYSTEM WITH THIS MACHINE. PT WAS DIAGNOSED WITH MELANOMA. THEY DECLINED "TRADITIONAL" TREATMENT WITH HOSP AND WAS MONITORED AND TREATED BY NURSE WITH PREVIOUSLY MENTIONED DEVICE. WHEN THIS NURSE FIRST SAW PT, SHE TOLD PT THEY WERE CANCER-FREE. SHE INDICATED TO RPTR THAT SHE HAD DETECTED CANCER CELLS SEVERAL TIMES DURING THE 2-YEAR PERIOD OF VISITS, HOWEVER, SHE "GOT RID OF THEM". SAW HER APPROX 9 HRS PRIOR TO THEIR DEATH. SHE STATED THEN THAT SHE COULD NOT DETECT THE PRESENCE OF CANCER CELLS IN PT'S BODY, ONLY ARSENIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOTRON GALVANIC SKIN RESPONSE MEASUREMENT DEVICE GZO BIOTRON * *

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death