BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEST SYSTEM MERIDIAN STRESS ASSESSMENT

    MDR report key: 245173 · Received October 8, 1999

    Report

    Report Number
    MW4002621
    Event Type
    Malfunction
    Date Received
    October 8, 1999
    Report Date
    October 5, 1999
    Manufacturer
    BIOMERIDIAN, INC.
    Product Code
    GZO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A COUNSELOR AND SUPERVISOR FROM THE VOCATIONAL REHABILITATION CALLED ASKING FOR INFO ABOUT FDA DEVICE CLASSIFICATION AND APPROVAL. THEY HAVE A CLIENT WITH MENTAL ILLNESS WHO IS ASKING THE STATE AGENCY TO PAY FOR THE BEST SYSTEM MERIDAN STRESS ASSESSMENT COMPUTERIZED DEVICE AND TRAINING. THEY FAXED A COPY OF THE 510(K) LETTER FOR THIS DEVICE AND THE PRODUCT BROCHURE. THE PRODUCT BROCHURE CLAIMS THAT BY USING THE SYSTEM "A TRAINED PRACTITIONER OR TECHNICIAN CAN THEN INTERPRET THE STRESS CONDITIONS OF A PARTICULAR ORGAN SYSTEM." THE DISTRIBUTOR VERBALLY CLAIMED THIS DEVICE CAN DIAGNOSE VARIOUS MEDICAL CONDITIONS INCLUDING CANCER. WHEN THE AGENCY E-MAILED THE DISTRIBUTOR ASKING ABOUT THE DEPTH OF TRAINING REQUIRED, ALL THEY LEARNED WAS THE COST WAS $20,000. DEVICE WAS NOT PURCHASED. UNKNOWN IF DEVICE IS IMPORTED. PROBLEM KEYWORD: FRAUD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BEST SYSTEM MERIDIAN STRESS ASSESSMENT GALVANIC SKIN RESPONSE DEVICE GZO BIOMERIDIAN, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO