BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRAUN

    MDR report key: 5407103 · Received January 21, 2016

    Report

    Report Number
    1314800-2016-00005
    Event Type
    Injury
    Date Received
    January 21, 2016
    Date of Event
    December 21, 2015
    Report Date
    January 20, 2016
    Manufacturer
    KAZ USA,INC.
    Product Code
    FLL
    PMA / PMN Number
    K103097
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CONSUMER REPORTED THEIR THERMOMETER WAS GIVING FALSE NEGATIVE READINGS ON THEIR CHILD. THE DEVICE ALLEGEDLY WAS READING 4 DEGREES LOWER THAT THE CHILD'S ACTUAL TEMPERATURE. THE CHILD WAS TREATED AT AN EMERGENCY ROOM, WHERE IT WAS CONFIRMED THAT THEY HAD A FEVER. THE CONSUMER ALSO STATED THAT THE CHILD HAS A FEBRILE SEIZURE. KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR LAB ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41543 BRAUN THERMOMETER FLL KAZ USA,INC. IRT-3020 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Hospitalization| O| R