BEUDAMED
    FDA Adverse Event Other Summary report: N

    BRAUN

    MDR report key: 4811758 · Received May 27, 2015

    Report

    Report Number
    1314800-2015-00044
    Event Type
    Other
    Date Received
    May 27, 2015
    Date of Event
    March 1, 2015
    Report Date
    May 22, 2015
    Manufacturer
    KAZ USA, INC.
    Product Code
    FLL
    PMA / PMN Number
    K103097
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CONSUMER REPORTED THEIR THERMOMETER WAS GIVING FALSE NEGATIVE READINGS ON THEIR INFANT. THE DEVICE ALLEGEDLY WAS READING E TO 4 DEGREES FAHRENHEIT LOWER THAN THE PT'S ACTUAL TEMPERATURE. THE INFANT WAS SEEN BY A DOCTOR,WHERE E=A FEVER WAS CONFIRMED. THERE WERE NO COMPLICATIONS FROM THIS INCIDENT, AND THE PT IS DOING FINE NOW. KAZ USA, INC HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR CO FOR LAB ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343554 BRAUN THERMOMETER FLL KAZ USA, INC. IRT-3020 33813RAD

    Patients

    Seq Age Sex Outcome Treatment
    1 7 MO