BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAUN

    MDR report key: 21999806 · Received May 11, 2025

    Report

    Report Number
    1314800-2025-00017
    Event Type
    Malfunction
    Date Received
    May 11, 2025
    Date of Event
    April 4, 2025
    Report Date
    May 11, 2025
    Manufacturer
    KAZ USA, INC., A HELEN OF TROY COMPANY
    Product Code
    FLL
    UDI-DI
    00328785001914
    PMA / PMN Number
    K103800
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 HOSPITAL REPORTED THAT THEIR THERMOMETER HAD ALLEGEDLY GIVEN A FALSE NEGATIVE READING ON A PATIENT WHO HAD ALREADY BEEN ADMITTED WITH A LUNG INFECTION. THE DEVICE ALLEGEDLY GAVE A READING OF 36.9°C, AND A FEVER OF 38.9°C WAS CONFIRMED BY A MEDICAL PROFESSIONAL USING A DIFFERENT EAR THERMOMETER. NO INFORMATION WAS PROVIDED ON THE DIAGNOSIS OR CURRENT STATUS OF THE PATIENT. THE ONLY KNOWN INFORMATION PROVIDED WAS THAT A FEVER WAS CONFIRMED BY A MEDICAL PROFESSIONAL, AND OUR DEVICE WAS GIVING FALSE NEGATIVE READINGS. 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
    1131162 BRAUN EAR THERMOMETER FLL KAZ USA, INC., A HELEN OF TROY COMPANY 00328785001914

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Female Hospitalization| R| O