BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EAR CANDLE

    MDR report key: 2108051 · Received May 24, 2011

    Report

    Report Number
    MW5020721
    Event Type
    Injury
    Date Received
    May 24, 2011
    Date of Event
    May 20, 2011
    Report Date
    May 24, 2011
    Product Code
    JYH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I WAS GETTING EAR CANDLING DONE FOR THE FIRST TIME AND THE FIRST SIDE (LEFT EAR) WENT FINE. ON THE RIGHT SIDE, AFTER 5 MINUTES, THE CANDLE EXPLODED IN MY EAR AND I STARTED SCREAMING. THE AESTHETICIAN BECAME OBVIOUSLY UPSET AND UNCOMFORTABLE AND TOLD ME THIS NEVER HAPPENS. SHE CLEANED MY EAR, PUT A PASTE FOR BURN VICTIMS IN IT AND GAVE ME A CREAM TO TAKE HOME AND APPLY. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EAR CANDLE BEES WAX JYH

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Hospitalization NONE THAT I AM AWARE OF