BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOGRAPHY

    MDR report key: 8487644 · Received April 4, 2019

    Report

    Report Number
    MW5085624
    Event Type
    Injury
    Date Received
    April 4, 2019
    Date of Event
    January 8, 2019
    Report Date
    April 1, 2019
    Manufacturer
    UNK
    Product Code
    LHQ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    NEW PALPABLE BREAST LUMP, GOT THERMOGRAM (B)(6) 2019 AT (B)(6)/ INTERPRETED AS LOW RISK WITH RECOMMENDATION FOR 3 MONTH F/U. THE PT IS NOW HOSPITALIZED WITH WIDELY METASTATIC BREAST CANCER. IN A (B)(6) Y/O WOMAN WITH A PALPABLE MASS IN HER BREAST AND A POSITIVE FAMILY HISTORY, A MAMMOGRAM AND ULTRASOUND ARE INDICATED. THIS EXAM RESULT FALSELY REASSURED THE PT AND DELAYED DIAGNOSIS AND TREATMENT. NOW, THERE IS NO CURE FOR HER DISEASE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274903 THERMOGRAPHY SYSTEM, TELETHERMOGRAPHIC (ADJUNCTIVE USE) LHQ UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other