BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICKS

    MDR report key: 8417166 · Received March 13, 2019

    Report

    Report Number
    1314800-2019-00015
    Event Type
    Injury
    Date Received
    March 13, 2019
    Date of Event
    February 24, 2019
    Report Date
    March 13, 2019
    Manufacturer
    KAZ USA, INC., A HELEN OF TROY COMPANY
    Product Code
    FLL
    PMA / PMN Number
    K043110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING, BUT IT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT SHE LEFT HER CHILD UNATTENDED, TO MAKE BREAKFAST FOR 30 MINUTES, DURING WHICH TIME THE CHILD WAS LEFT TO PLAY WITH THE THERMOMETER. ACCORDING TO THE CONSUMER, THE CHILD CHEWED ON THE COVER OF THE THERMOMETER "LIKE A LOLLIPOP", AND SOMEHOW OPENED THE COVER OF THE UNIT. IN THE PROCESS, THE CHILD REMOVED THE BATTERY AND ACCIDENTALLY SWALLOWED IT. THE BATTERY CAUSED BURNS TO THE ESOPHAGUS, AND THE CHILD UNDERWENT SEVERAL SURGERIES TO REPAIR DAMAGE TO HIS ESOPHAGUS FROM THE INCIDENT. MORE MEDICAL INTERVENTION MAY BE REQUIRED. THE INSTRUCTIONS FOR USE HAVE CLEAR WARNINGS WHICH STATE, "DO NOT ALLOW CHILDREN TO TAKE THEIR TEMPERATURE UNATTENDED", "KEEP OUT OF REACH OF YOUNG CHILDREN, ELDERLY AND PETS", AS WELL AS A CLEAR INSTRUCTION TO "CAREFULLY REPLACE THE BATTERY COVER AND, USING A COIN, TIGHTEN THE COVER". IT IS UNCLEAR TO US HOW A SECURELY TIGHTENED BATTERY COMPARTMENT COULD HAVE BEEN OPENED BY A SMALL CHILD. KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED FOR TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208928 VICKS DIGITAL THERMOMETER FLL KAZ USA, INC., A HELEN OF TROY COMPANY V912US UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 13 MO Hospitalization| L| O