BEUDAMED
    FDA Adverse Event Other Summary report: N

    KAZ WARM STEAM VAPORIZER

    MDR report key: 3664684 · Received March 4, 2014

    Report

    Report Number
    MW5034808
    Event Type
    Other
    Date Received
    March 4, 2014
    Date of Event
    January 20, 2014
    Manufacturer
    KAZ
    Product Code
    BTT
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ((B)(6) 2014) THE CONSUMER IS CONCERNED THAT THE PRODUCT IS MISLABELED. SHE STATED THAT IT DOES NOT GIVE PROPER WARNING. THERE IS A SAMPLE PACK OF VICKS VAPOTAD INCLUDED. THERE ARE NO INSTRUCTIONS FOR USING THE TABLET. THE CONSUMER STATES THAT THE PICTURE OF A MOTHER AND INFANT ON THE BOX GIVES AN INDICATION THAT THE PRODUCT CAN BE USED FOR INFANTS. ((B)(6) 2014) THE CONSUMER STATED THAT SHE PURCHASED THE SAME PRODUCT BUT IT DOES NOT INCLUDE A SAMPLE OF THE VICKS VAPOTAD. THE BOX HAS THE WORD PEDIATRICS ON THE FRONT OF THE BOX. IT ALSO HAS A PICTURE OF THE MOTHER WITH AN INFANT. THERE IS A RECOMMENDATION ON THE BOX TO USE THE VICKS VAPOTAD. RETAILER: (B)(4). PURCHASE DATE: (B)(6) 2013 THIS DATE IS AN ESTIMATE. (B)(4). REPORT SUBMITTED DATE: (B)(4) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130429 KAZ WARM STEAM VAPORIZER HUMIDIFIER BTT KAZ V150SGN

    Patients

    Seq Age Sex Outcome Treatment
    1