BEUDAMED
    FDA Adverse Event Injury Summary report: N

    100% BEESWAX EAR CANDLE

    MDR report key: 2834755 · Received November 10, 2012

    Report

    Report Number
    MW5027620
    Event Type
    Injury
    Date Received
    November 10, 2012
    Date of Event
    November 10, 2012
    Report Date
    November 10, 2012
    Manufacturer
    WALLY'S NATURAL PRODUCTS
    Product Code
    JYH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I WAS USING AN EAR CANDLE (NAME BRAND WALLY'S 100% BEESWAX EAR CANDLES) AS MY BOYFRIEND STOOD BY TO OBSERVE TO MAKE SURE NOTHING WENT WRONG. I FOLLOWED THE DIRECTIONS, USED A PLATE TO PREVENT BURNS, EXTINGUISHED THE FIRST ONE IN A BOWL OF WATER NEXT TO ME. I HAD DONE CANDLING BEFORE WITHOUT PROBLEMS. WHEN I WAS ABOUT HALF WAY THROUGH CANDLING MY LEFT EAR, BURNING HOT WAX DRIPPED INSIDE MY EAR. I IMMEDIATELY PULLED THE CANDLE OUT, ALSO BURNING MY THUMB ON THE HOT WAX AT THE TIP OF THE CANDLE. THIS IMMENSE PAIN INSIDE OF MY EAR LASTED FOR ABOUT THIRTY MINUTES BEFORE DISSIPATING SOME. MY HEARING IS COMPLETELY GONE IN THIS EAR. I HOPE THAT THE EAR WILL HEAL ON ITS OWN BECAUSE I DO NOT HAVE INSURANCE AND CANNOT AFFORD TO SEE SPECIALIST. I ALWAYS THOUGHT EAR CANDLES WERE SAFE. I MEAN, THEY SELL THEM IN THE HEALTH STORE! I WILL NEVER USE AN EAR CANDLE AGAIN. REASON FOR USE: EAR PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 100% BEESWAX EAR CANDLE EAR CANDLE JYH WALLY'S NATURAL PRODUCTS 609280300048

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other