BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAUN

    MDR report key: 6356196 · Received February 24, 2017

    Report

    Report Number
    1314800-2017-00006
    Event Type
    Malfunction
    Date Received
    February 24, 2017
    Date of Event
    January 27, 2017
    Report Date
    February 24, 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
    CA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING, BUT IT HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT HER THERMOMETER HAD ALLEGEDLY GIVEN FALSE NEGATIVE READINGS ON HER INFANT. THE CONSUMER STATED THAT THEY HAD NOT YET SOUGHT MEDICAL ATTENTION, BUT THAT THE CHILD FELT FEVERISH AND WAS VOMITING. THEY STATED THAT THE THERMOMETER WAS GIVING READINGS OF 95°F ON THE INFANT, AND 96°F ON THEMSELF. IT IS UNKNOWN WHAT THE CHILD'S ACTUAL TEMPERATURE WAS, AS THEY HAD NOT YET RECEIVED MEDICAL ATTENTION. 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
    139339 BRAUN FOREHEAD THERMOMETER FLL KAZ USA, INC., A HELEN OF TROY COMPANY NTF-3000 11315TAV

    Patients

    Seq Age Sex Outcome Treatment
    1 12 MO Other