BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRAUN

    MDR report key: 4913014 · Received July 8, 2015

    Report

    Report Number
    1314800-2015-00056
    Event Type
    Injury
    Date Received
    July 8, 2015
    Date of Event
    June 22, 2015
    Report Date
    July 7, 2015
    Manufacturer
    KAZ USA, INC.
    Product Code
    FLL
    PMA / PMN Number
    K103097
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 5-8 DEGREES LOWER THAN THEN CHILD'S ACTUAL TEMPERATURE. THE CHILD SUFFERED A SEIZURE AND WAS TREATED AT A HOSPITAL, WHERE IT WAS CONFIRMED THAT THEY HAD A FEVER. THERE WERE NO COMPLICATIONS FROM THIS INCIDENT, AND THE PATIENT IS DING FINE NOW. 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
    441803 BRAUN THERMOMETER FLL KAZ USA, INC. IRT-3020 28912

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R