BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOGRAPHY

    MDR report key: 8866504 · Received August 5, 2019

    Report

    Report Number
    MW5088846
    Event Type
    Injury
    Date Received
    August 5, 2019
    Date of Event
    January 11, 2019
    Report Date
    August 4, 2019
    Manufacturer
    UNK
    Product Code
    LHQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD A SELF DETECTED LUMP IN MY BREAST DESPITE A THERMOGRAPHY IN SEPTEMBER BEFORE TELLING ME I HAD LOW RISK OF CANCER. ON JANUARY 11, IN THE MORNING I HAD A THERMOGRAPHY AND EVEN POINTED TO THE LUMP. THE REPORT CAME BACK THAT I HAD A LOW RISK OF ANY CANCER. LUCKILY THAT AFTERNOON I HAD A DIAGNOSTIC MAMMOGRAM, THEN A SONOGRAM. A COUPLE DAYS LATER, I HAD A NEEDLE BIOPSY THAT PROVED INVASIVE BREAST CANCER. I URGE FDA TO MAKE THERMOGRAPHY ILLEGAL. ALL MY DRS AT (B)(6) CENTER AND (B)(6) CLINIC TOLD ME THEY WANTED IT OFF THE MARKET AND WE WOULD SAVE MANY BREASTS AND ALSO MANY WOMEN. THE COSTS OF LATE CARE IS MUCH HIGHER AS WELL. I HAVE COPIES OF BOTH TESTS AND WOULD BE WILLING TO DISCUSS. I AM CONVINCED THAT I WOULD NOT HAVE HAD TO LOSE LYMPH NODES AND RADIATION TREATMENT IF I HAD NOT BEEN TOLD THAT THERMOGRAPHY WAS FDA APPROVED FOR BREAST CANCER DETECTION. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654416 THERMOGRAPHY SYSTEM, TELETHERMOGRAPHIC (ADJUNCTIVE USE) LHQ UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Life Threatening| R