BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAUN

    MDR report key: 21182017 · Received January 17, 2025

    Report

    Report Number
    1314800-2025-00001
    Event Type
    Malfunction
    Date Received
    January 17, 2025
    Date of Event
    December 17, 2024
    Report Date
    January 17, 2025
    Manufacturer
    KAZ USA, INC., A HELEN OF TROY COMPANY
    Product Code
    FLL
    UDI-DI
    00032875000146
    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 FOR TESTING, BUT IT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 0

    A CONSUMER REPORTED THAT THEIR THERMOMETER HAD GIVEN FALSE NEGATIVE READINGS ON THEIR TWO BABIES. THE DEVICE ALLEGEDLY GAVE READINGS THAT WERE APPROXIMATELY 2.6°C-3.1°C LOWER THAN WHAT WAS LATER MEASURED BY A DOCTOR. THERE WERE NO REPORTED COMPLICATIONS FROM THIS INCIDENT. KAZ USA, INC. HAS REQUESTED THAT THE DEVICE BE RETURNED TO OUR COMPANY FOR TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1017696 BRAUN EAR THERMOMETER FLL KAZ USA, INC., A HELEN OF TROY COMPANY IRT3030 00032875000146

    Patients

    Seq Age Sex Outcome Treatment
    1 12 MO Prefer Not To Disclose Other