BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EAR AND FOREHEAD THERMOMETER

    MDR report key: 6957392 · Received October 18, 2017

    Report

    Report Number
    3005170249-2017-00017
    Event Type
    Malfunction
    Date Received
    October 18, 2017
    Report Date
    February 6, 2017
    Manufacturer
    SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD.
    Product Code
    FLL
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE ANALYSIS, THE THERMOMETER IS NOT ACCURATE DUE TO THE DIRTY PROBE TIP. AFTER THE PURITY OF THE DEVICE, CAN BE MEASURED ACCURATELY.

    Description of Event or Problem · 1

    THE CONSUMER CLAIMS THE DEVICE WAS GIVING INACCURATE MEASUREMENTS. THE CUSTOMER'S GRANDMOTHER HAD A FEVER AND GO TO THE HOSPITAL, THEN FIND THE THERMOMETER WAS GIVING INACCURATE MEASUREMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736814 EAR AND FOREHEAD THERMOMETER EAR AND FOREHEAD THERMOMETER FLL SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD. TH1003A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other