BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFRARED NO-TOUCH FOREHEAD THERMOMETER

    MDR report key: 16818108 · Received April 25, 2023

    Report

    Report Number
    MW5117061
    Event Type
    Malfunction
    Date Received
    April 25, 2023
    Report Date
    April 21, 2023
    Manufacturer
    ANDON HEALTH CO., LTD.
    Product Code
    FLL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THIS IS REGARDING PT3 REMOTE MEASUREMENT PRODUCTS FROM IHEALTH LAB AND ALL THE CONSUMER PRODUCTS THAT HAVE INFRARED LIGHT. ALL THESE PRODUCTS MUST CLEARLY DISPLAY THAT LOOKING AT THE RED LIGHT CAN DAMAGE YOUR EYES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1336703 INFRARED NO-TOUCH FOREHEAD THERMOMETER THERMOMETER, ELECTRONIC, CLINICAL FLL ANDON HEALTH CO., LTD. PT3

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown