BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAUN

    MDR report key: 18191224 · Received November 22, 2023

    Report

    Report Number
    1314800-2023-00014
    Event Type
    Malfunction
    Date Received
    November 22, 2023
    Date of Event
    October 23, 2023
    Report Date
    November 21, 2023
    Manufacturer
    KAZ USA, INC., A HELEN OF TROY COMPANY
    Product Code
    FLL
    UDI-DI
    07630759300750
    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 HER THERMOMETER HAD ALLEGEDLY GIVEN FALSE NEGATIVE READINGS ON HER INFANT SON. THE DEVICE ALLEGEDLY GAVE MULTIPLE READINGS THAT WERE NEVER ABOVE 35°C, AND A FEVER OF 38.6°C WAS DETECTED WHEN THE CONSUMER USED A DIFFERENT STICK THERMOMETER THAT THEY HAD IN THEIR HOME. ABOUT AN HOUR LATER, A HOSPITAL MEASURED THE INFANTS' TEMPERATURE AS 39.8°C, AND HE WAS TREATED FOR SUSPECTED SEPSIS AND WAS TREATED WITH ANTIBIOTICS. 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
    880828 BRAUN EAR THERMOMETER FLL KAZ USA, INC., A HELEN OF TROY COMPANY IRT3030WE 35022FAM 07630759300750

    Patients

    Seq Age Sex Outcome Treatment
    1 11 WK Male Other