BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOGRAM

    MDR report key: 3084769 · Received April 25, 2013

    Report

    Report Number
    MW5029937
    Event Type
    Injury
    Date Received
    April 25, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 25, 2013
    Product Code
    LHQ
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE REPORTER IS A (B)(6), WHO WAS RECENTLY DIAGNOSED WITH BREAST CANCER (GRADE 3 DCSI) AND HAD A LUMPECTOMY. SHE FOUND OUT ABOUT THE CANCER A MONTH AGO AFTER HAVING MAMMOGRAM. THE LAST TIME SHE HAD A MAMMOGRAM WAS IN 2002 BECAUSE SHE HAS BEEN DOING HER YEARLY BREAST SCREENING IMAGING VIA THERMOGRAM. SHE IS APPEALING TO FDA NOT TO ACKNOWLEDGE A THERMOGRAM AS THE BEST WAY FOR BREAST EXAM AS IT DOES NOT REVEAL PRE CANCEROUS TISSUE. MAMMOGRAM IS FAR BETTER THAN THERMOGRAM. MAMMOGRAM DETECTS PRECANCEROUS TISSUE FASTER THAN THERMOGRAM. FDA PLEASE DO NOT APPROVE THIS DEVICE AS A SCREENING MECHANISM FOR WOMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179718 THERMOGRAM LHQ

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention