BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAUN

    MDR report key: 7049677 · Received November 21, 2017

    Report

    Report Number
    1314800-2017-00044
    Event Type
    Malfunction
    Date Received
    November 21, 2017
    Date of Event
    October 25, 2017
    Report Date
    November 21, 2017
    Manufacturer
    KAZ USA, INC., A HELEN OF TROY COMPANY
    Product Code
    FLL
    PMA / PMN Number
    K134043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    KAZ USA, INC. HAS REQUESTED THAT THE PRODUCTS BE RETURNED TO OUR COMPANY FOR TESTING, BUT THEY HAVE NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT SHE HAS TWO THERMOMETERS WHICH HAD ALLEGEDLY GIVEN FALSE NEGATIVE READINGS ON HER SON. THE DEVICES ALLEGEDLY CONSISTENTLY GAVE READINGS THAT WERE 3.9 F DEGREES LOWER THAN THE PATIENTS ACTUAL TEMPERATURE. THE CHILD WAS TAKEN TO SEE A PEDIATRICIAN WHERE A FEVER WAS CONFIRMED. IT WAS ALSO ALLEGED THAT A SIMILAR INCIDENT OCCURRED WITH HER THREE YEAR OLD EARLIER THAT WEEK. THERE WERE NO COMPLICATIONS FROM EITHER INCIDENT, NO ADVERSE EVENT OCCURRED, AND BOTH PATIENTS ARE DOING WELL NOW. KAZ USA, INC. HAS REQUESTED THAT THE PRODUCTS BE RETURNED TO OUR COMPANY FOR TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828898 BRAUN FOREHEAD THERMOMETER FLL KAZ USA, INC., A HELEN OF TROY COMPANY NTF-3000 02515TAV, 17414TAV

    Patients

    Seq Age Sex Outcome Treatment
    1 12 MO Other