BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAUN

    MDR report key: 6188795 · Received December 20, 2016

    Report

    Report Number
    1314800-2016-00069
    Event Type
    Malfunction
    Date Received
    December 20, 2016
    Date of Event
    November 22, 2016
    Report Date
    December 20, 2016
    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
    NC, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT TWO OF THEIR THERMOMETERS WERE BOTH GIVING FALSE NEGATIVE READINGS ON THEIR CHILD. THE DEVICES ALLEGEDLY WERE BOTH READING 9 DEGREES LOWER THAN THE PATIENT'S ACTUAL TEMPERATURE. THE CHILD WAS BROUGHT TO A HOSPITAL, WHERE IT WAS CONFIRMED THAT SHE HAD A FEVER. NO ADVERSE EVENT OCCURRED, AND THE PATIENT IS DOING WELL. 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
    838888 BRAUN THERMOMETER FLL KAZ USA, INC., A HELEN OF TROY COMPANY NTF-3000 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other