BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUNBEAM SERIES 001388-800 WARM MIST VAPORIZER

    MDR report key: 8577931 · Received May 2, 2019

    Report

    Report Number
    MW5086366
    Event Type
    Injury
    Date Received
    May 2, 2019
    Date of Event
    April 3, 2019
    Report Date
    April 9, 2019
    Manufacturer
    JARDEN CONSUMER SOLUTIONS / SUNBEAM PRODUCTS, INC.
    Product Code
    KFZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAVE USED THIS MODEL VAPORIZER FOR TWO YEARS. HOWEVER, I WAS NEVER AWARE OF ITS SCALDING POTENTIAL. THE DEVICE RUNS NEXT TO MY BED: APPROX 1.5 TO 2 FEET FROM ME. ONE NIGHT LAST WEEK, MY ARM DECIDED TO FLOP OUT OF BED DURING SLEEP AND THE LOWER PART OF MY ARM CAME TO REST ON THE HUMIDIFIER. I SOON AWOKE IN GREAT PAIN. THE DEVICE HAD SCALED ME SEVERELY. THERE ARE NO WARNINGS ABOUT SCALDING ON THE BOX OR IN THE INSTRUCTIONS. ONLY REGARDING ELECTRICAL HAZARDS. THERE IS A SMALL PRINT "CAUTION" ON THE DEVICE ITSELF THAT WARNS ABOUT "MIST CAN BE HOT. KEEP FROM CHILDREN". IT DOES NOT WARN OF SCALDING OR TELLS THE USER TO KEEP SEVERAL FEET AWAY FROM BEDSIDE. IN FACT, THE BOX IS SOMEWHAT MISLEADING. IT STATES THE MIST IS "WARM AND SOOTHING". THIS DEVICE IS MFG DIFFERENTLY THAN VICKS. THE SUNBEAM STEAM EXHAUST VENTS ACTUALLY RISE. THE VICKS MODEL HAS ITS STEAM VENT RECESSED. RETAILER: (B)(6); RETAILER STATE: ONLINE. PURCHASE DATE: (B)(6) 2019. DOCUMENT NUMBER: (B)(4). REPORT NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369579 SUNBEAM SERIES 001388-800 WARM MIST VAPORIZER HUMIDIFIER, NON-DIRECT PATIENT INTERFACE (HOME USE) KFZ JARDEN CONSUMER SOLUTIONS / SUNBEAM PRODUCTS, INC. 001388-800

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR