BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAUN

    MDR report key: 15589543 · Received October 12, 2022

    Report

    Report Number
    1314800-2022-00016
    Event Type
    Malfunction
    Date Received
    October 12, 2022
    Date of Event
    September 9, 2022
    Report Date
    October 10, 2022
    Manufacturer
    KAZ USA, INC., A HELEN OF TROY COMPANY
    Product Code
    FLL
    UDI-DI
    00328785000146
    PMA / PMN Number
    K161933
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    A CONSUMER REPORTED THAT HER THERMOMETER HAD ALLEGEDLY GIVEN FALSE NEGATIVE READINGS ON HER BABY. IT WAS STATED THAT OUR DEVICE GAVE A READING OF 98.2°F, BUT THREE HOURS LATER A DIFFERENT HOUSEHOLD THERMOMETER READ 103.0°F. THE CHILD WAS LATER TAKEN TO THE DOCTOR WHERE A FEVER AND KIDNEY INFECTION WERE CONFIRMED. IT WAS STATED THAT THE LOW READINGS GIVEN BY OUR DEVICE ALLEGEDLY MAY HAVE CAUSED A DELAY IN MEDICAL ATTENTION. THERE WERE NO COMPLICATIONS FROM THIS INCIDENT, AND THE PATIENT IS DOING WELL NOW. KAZ USA, INC. HAD REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING, BUT THE DEVICE HAS NOT YET BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2744872 BRAUN EAR THERMOMETER FLL KAZ USA, INC., A HELEN OF TROY COMPANY IRT3030US UNKNOWN 00328785000146

    Patients

    Seq Age Sex Outcome Treatment
    1 12 MO Prefer Not To Disclose Required Intervention| O