BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAUN

    MDR report key: 5292511 · Received December 7, 2015

    Report

    Report Number
    1314800-2015-00081
    Event Type
    Malfunction
    Date Received
    December 7, 2015
    Date of Event
    September 1, 2015
    Manufacturer
    KAZ, INC.
    Product Code
    FLL
    PMA / PMN Number
    K103097
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CONSUMER REPORTED THEIR THEROMETER WAS GIVING FALSE NEGATIVE READINGS ON THEIR CHILD. THE DEVICE ALLEGEDLY WAS READING 3-4 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 FROM 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
    802674 BRAUN FLL KAZ, INC. IRT-3020 01911

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R