BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAUN

    MDR report key: 5427316 · Received February 2, 2016

    Report

    Report Number
    1314800-2016-00009
    Event Type
    Malfunction
    Date Received
    February 2, 2016
    Date of Event
    December 1, 2015
    Report Date
    February 2, 2016
    Manufacturer
    KAZ USA, INC.
    Product Code
    FLL
    PMA / PMN Number
    K103800
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT SHE HAS TWO THERMOMETERS, AND THAT BOTH OF THEM HAD ALLEGEDLY GIVEN FALSE NEGATIVE READINGS ON THEIR SON. THE DEVICE BOTH ALLEGEDLY GAVE READINGS 4-5 DEGREES LOWER THAN THE PATIENT'S ACTUAL TEMPERATURE. THE PATIENT WAS BROUGHT TO A HOSPITAL AND A FEVER STREPTOCOCCUS WERE CONFIRMED. KAZ USA, INC. HAS REQUESTED THAT BOTH DEVICES BE RETURNED TO OUR COMPANY FOR FURTHER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64127 BRAUN THERMOMETER FLL KAZ USA, INC. IRT-4520 02913 & 27712

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R