BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTHERM IRIS

    MDR report key: 9621778 · Received January 22, 2020

    Report

    Report Number
    MW5092408
    Event Type
    Malfunction
    Date Received
    January 22, 2020
    Date of Event
    January 15, 2020
    Report Date
    January 21, 2020
    Manufacturer
    MEDITHERM INC.
    Product Code
    LHQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    LONGEVITY THERMOGRAPHY IS A COMPANY PRACTICING THERMOGRAPHY AND OFFERING ULTRASOUND IN MANY EASTERN STATES, WITHOUT ANY KIND OF BUSINESS LICENSE. THE WEBSITE IS VERY MISLEADING AND IS CAUSING WOMEN TO AVOID MAMMOGRAMS. THEIR CAMERAS ARE NOT RECENTLY CALIBRATED AND AS SUCH CANNOT BE RELIED ON TO ACCURATELY PERFORM THE SCANS THEY SAY THEY CAN. WITH OUT DATED AND UNCALIBRATED EQUIPMENT THIS COMPANY IS A RISK TO THOUSANDS OF LIVES. PLEASE DO SOMETHING. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82233 MEDTHERM IRIS SYSTEM, TELETHERMOGRAPHIC (ADJUNCTIVE USE) LHQ MEDITHERM INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other