BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KAZ

    MDR report key: 5580906 · Received April 13, 2016

    Report

    Report Number
    MW5061714
    Event Type
    Injury
    Date Received
    April 13, 2016
    Date of Event
    February 28, 2016
    Report Date
    March 4, 2016
    Manufacturer
    KAZ USA, INC.
    Product Code
    KFZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS CONSUMER IS REPORTING HER STEAM VAPORIZER PURCHASED (B)(6) 2015, CALLER PLACED ON HER ANTIQUE STAND WITH GLASS COVER. THE HEAT FROM THE UNIT CAUSED THE GLASS TO BREAK ON (B)(6) 2016. SHE IS REPORTING THIS INCIDENT AS A BURN HAZARD DUE TO THE UNIT HEATING TO THE HIGH ENOUGH TEMPERATURE TO BREAK 1/2 INCH TEMPERED GLASS. THE LABEL ON THE UNIT READS THAT IT IS LINED WITH TRIPLE WALL INSULATION TO PREVENT THE OUTSIDE FROM BECOMING DANGEROUSLY HOT AND DOES NOT INSTRUCT USER TO AVOID PLACING IT ON GLASS. SHE CONTACTED THE MANUFACTURER (B)(6) 2016, SHE SPOKE WITH A REPRESENTATIVE (NO NAME OBTAINED) WHO TOLD HER THAT IN THE FUTURE SHE COULD CONTACT (B)(4) THEN THE REP INFORMED HER THAT HE WOULD SEND HER A LABEL TO ENSURE RETURN OF VAPORIZER TO THE MANUFACTURER. THERE ARE NO INJURIES BEING REPORTED. (B)(6). PURCHASE DATE: (B)(6) 2015. THIS DATE IS AN ESTIMATE. THE PRODUCT WAS DAMAGED BEFORE THE INCIDENT: NO. THE PRODUCT WAS MODIFIED BEFORE THE INCIDENT: NO. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230124 KAZ STEAM VAPORIZER KFZ KAZ USA, INC. V150SGN

    Patients

    Seq Age Sex Outcome Treatment
    1