BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAUN

    MDR report key: 5407080 · Received January 21, 2016

    Report

    Report Number
    1314800-2016-00004
    Event Type
    Malfunction
    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
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CONSUMER REPORTED THEIR THERMOMETER WAS GIVING FALSE NEGATIVE READING ON THEIR CHILD. THE DEVICE ALLEGEDLY WAS READING 8 - 9 DEGREES LOWER THAN THE CHILD'S ACTUAL TEMPERATURE. THE CHILD WAS TREATED AT A HOSPITAL, WHERE IT WAS CONFIRMED THAT THEY HAD A FEVER. THERE WERE NO COMPLICATIONS FORM THIS INCIDENT, AND THE PATIENT IS DOING 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
    43260 BRAUN THERMOMETER FLL KAZ USA, INC. IRT-3020 23314

    Patients

    Seq Age Sex Outcome Treatment
    1