BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONING WORKS LLC

    MDR report key: 1800932 · Received August 9, 2010

    Report

    Report Number
    MW5017062
    Event Type
    Injury
    Date Received
    August 9, 2010
    Date of Event
    August 9, 2010
    Report Date
    August 9, 2010
    Manufacturer
    CONING WORKS, LLC
    Product Code
    KCN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    WIFE HAS USED EAR CANDLES FOR YEARS, WHICH HAVE ALWAYS SUCKED AN AMAZING AMOUNT OF WAX FROM HER EARS, AND NEVER CAUSED A PROBLEM. I FOOLISHLY CONSENTED TO HAVE HER TRY THIS PROCEDURE ON ME, WHICH RESULTED IN MELTING WAX DRIPPING ONTO MY EARDRUM AND BURNING IT. IN ADDITION TO THE BURN, I NOW HAVE WAX IMPACTED AGAINST MY EARDRUM, AFFECTING MY HEARING ON THAT SIDE - I DIDN'T HAVE THIS PROBLEM AT THE OUTSET, AND SHOULD HAVE LEFT WELL ENOUGH ALONE-. THE PAIN WAS EXTREME, AND I WILL NEVER LET HER APPROACH ME WITH ONE OF THESE INFERNAL DEVICES AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONING WORKS LLC EAR CONES KCN CONING WORKS, LLC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR