BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAUN

    MDR report key: 9157710 · Received October 4, 2019

    Report

    Report Number
    1314800-2019-00046
    Event Type
    Malfunction
    Date Received
    October 4, 2019
    Date of Event
    September 4, 2019
    Report Date
    October 4, 2019
    Manufacturer
    KAZ USA, INC., A HELEN OF TROY COMPANY
    Product Code
    FLL
    PMA / PMN Number
    K033820
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    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 · 1

    A CONSUMER REPORTED THAT HER THERMOMETER HAD ALLEGEDLY GIVEN AN ERROR MESSAGE AND SEVERAL FALSE NEGATIVE READINGS ON HER DAUGHTER. THE DEVICE ALLEGEDLY GAVE A READING THAT WAS 7.3°F LOWER THAN THE PATIENTS ACTUAL TEMPERATURE WHEN MEASURED AT A LATER TIME IN THE HOSPITAL. THE CHILD WAS SEEN AT A HOSPITAL OVERNIGHT, AND THEN WENT BACK TWO DAYS LATER AND A FEVER OF 103°F WAS CONFIRMED. THERE WERE NO COMPLICATIONS FROM THIS INCIDENT, AND THE PATIENT IS DOING WELL NOW. 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
    952173 BRAUN FOREHEAD THERMOMETER FLL KAZ USA, INC., A HELEN OF TROY COMPANY BFH125 12817ONB

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Hospitalization| O