BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VICKS

    MDR report key: 2255604 · Received September 13, 2011

    Report

    Report Number
    1314800-2011-00039
    Event Type
    Malfunction
    Date Received
    September 13, 2011
    Date of Event
    August 18, 2011
    Report Date
    September 1, 2011
    Manufacturer
    KAZ, INC.
    Product Code
    FLL
    PMA / PMN Number
    033820
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CONSUMER REPORTED THE FOREHEAD THERMOMETER HE WAS USING TO TAKE HIS DAUGHTERS TEMPERATURE WAS GIVING A NORMAL TEMPERATURE READING. WHEN HE TOOK THE CHILD TO THE EMERGENCY ROOM, HER TEMPERATURE WAS HIGH AND HAD TO BE TREATED. THE CONSUMER IS CLAIMING THE FALSE NEGATIVE READING DELAYED TREATMENT. THIS IS AN ISOLATED CASE WITH NO SUCH TREND SEEN IN THIS THERMOMETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VICKS THERMOMETER FLL KAZ, INC. V977 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO Hospitalization