BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAUN

    MDR report key: 21056772 · Received January 2, 2025

    Report

    Report Number
    1314800-2024-00026
    Event Type
    Malfunction
    Date Received
    January 2, 2025
    Date of Event
    November 28, 2024
    Report Date
    January 2, 2025
    Manufacturer
    KAZ USA, INC., A HELEN OF TROY COMPANY
    Product Code
    FLL
    PMA / PMN Number
    K161933
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING, BUT IT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 0

    A CONSUMER REPORTED THAT THEIR THERMOMETER HAD ALLEGEDLY GIVEN FALSE NEGATIVE READINGS ON THEIR ONE-YEAR-OLD INFANT. THE DEVICE ALLEGEDLY GAVE READINGS OF 36°C FOR TWO DAYS, AND A FEVER OF 40°C WAS LATER MEASURED BY A DOCTOR. IT IS UNKNOWN WHETHER THE CONSUMER TOOK A MEASUREMENT ON THE SAME DAY THEY BROUGHT THE CHILD TO A HOSPITAL, WHERE A FEVER WAS CONFIRMED. THE CHILD HAS BEEN HOSPITALIZED WITH A VIRAL INFECTION FOR FOUR DAYS AND THEIR CURRENT HEALTH STATUS IS UNKNOWN. KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1911267 BRAUN EAR THERMOMETER FLL KAZ USA, INC., A HELEN OF TROY COMPANY IRT3030WE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 12 MO Unknown Hospitalization| O