BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAUN

    MDR report key: 19082084 · Received April 10, 2024

    Report

    Report Number
    1314800-2024-00009
    Event Type
    Malfunction
    Date Received
    April 10, 2024
    Date of Event
    March 19, 2024
    Report Date
    April 10, 2024
    Manufacturer
    KAZ USA, INC., A HELEN OF TROY COMPANY
    Product Code
    FLL
    PMA / PMN Number
    K161933
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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

    CONSUMER CLAIMED THAT THE DEVICE GAVE INACCURATE MEASUREMENTS (TOO LOW). SINCE THE CONSUMER DID NOT PROVIDE MORE INFORMATION DESPITE OUR REQUEST WE DO NOT HAVE INFORMATION ON THE AGE/GENDER OF THE PATIENT INVOLVED. THE CUSTOMER IS CLAIMING THAT THE DEVICE WAS NOT TAKING ANY MEASUREMENT HIGHER THAN 34.8°C / 34.9°C. THIS WAS EVEN AFTER CHANGING THE BATTERIES TO RESET THE DEVICE. THE CONSUMER WENT TO THE DOCTOR (FOR HIM/HER OR A CHILD) WHERE A READING UP TO 38.1°C WAS ALLEGEDLY CONFIRMED. IT IS UNKNOWN IF THE CONSUMER TOOK A MEASUREMENT THE SAME DAY WITH THE THERMOMETER RESULTING IN A POTENTIAL FALSE NEGATIVE). 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
    1339621 BRAUN EAR THERMOMETER FLL KAZ USA, INC., A HELEN OF TROY COMPANY IRT3030WE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O