BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMEDICS BUBBLE BLISS ELITE FOOTBATH

    MDR report key: 15891332 · Received November 30, 2022

    Report

    Report Number
    3011108694-2022-00002
    Event Type
    Malfunction
    Date Received
    November 30, 2022
    Report Date
    November 30, 2022
    Manufacturer
    NINGBO LONGFU ELECTRICAL APPLIANCES&TOOL CO.,LTD
    Product Code
    ISA
    UDI-DI
    00031262082268
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    CONSUMER REPORTED HE SOMETIMES WILL DOZE OFF WHILE USING THE SPA BECAUSE IT'S SO RELAXING. ON THIS NIGHT, HE WAS CLOSE TO DOZING OFF, BUT NOTICED A FUNNY SMELL, FOLLOWED BY SMOKE. HE SAW THE SMOKEY BUBBLES COMING OUT OF THE WATER AND NOTICED THE WATER WAS BURNING HIS FEET. HE PULLED HIS FEET OUT, SMOKE WAS FILLING THE ROOM. HE UNPLUGGED THE DEVICE AND RAN IT OUTSIDE. WHEN THE SMOKE CLEARED, HE FOUND A BURN IN HIS FLOOR. HE LOOKED AT THE FOOT SPA AND IT WAS CLEARLY BURNED. PHOTOGRAPHS OF THE FOOTBATH WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2123953 HOMEDICS BUBBLE BLISS ELITE FOOTBATH FOOT BATH ISA NINGBO LONGFU ELECTRICAL APPLIANCES&TOOL CO.,LTD FB-380HJ 00031262082268

    Patients

    Seq Age Sex Outcome Treatment
    1 Male