BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EAR CANDLE

    MDR report key: 1916499 · Received November 27, 2010

    Report

    Report Number
    MW5018334
    Event Type
    Injury
    Date Received
    November 27, 2010
    Date of Event
    October 9, 2010
    Report Date
    November 27, 2010
    Manufacturer
    UNK
    Product Code
    JYH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    EAR CANDLING 09/10 AND 10/10 BY (B)(6). REMNANTS OF THE EAR CANDLE WAX IMPACTED RIGHT EARDRUM, RESTRICTING MOVEMENT OF THE EARDRUM AND CAUSING INFLAMMATION OF THE SURROUNDING AREA. OWNERS OF (B)(6) REFUSED TO PROVIDE ANY INSURANCE INFO. ANOTHER CUSTOMER HAD THE WAX DRIP INTO HER EAR AND COMPLAINED OF A BURN IN THE EAR. WHEN I CALLED THEM, THEY SAID TO COME IN AND KIM WELLS PUT ME IN A FOOT BATH THAT SHE CLAIMED PULLED TOXINS FROM ALL MAJOR ORGANS OF THE BODY AND SAID, IT WOULD HELP RELIEVE THE PRESSURE IN MY EARS. I THEN WENT TO SEEK MEDICAL HELP FROM A LICENSED PHYSICIAN WHO SAID TO STAY AWAY FROM THEM AND REPORT WHAT HAPPENED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention