BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLY NATURAL PRODUCTS

    MDR report key: 970302 · Received December 20, 2007

    Report

    Report Number
    MW5004776
    Event Type
    Injury
    Date Received
    December 20, 2007
    Date of Event
    December 10, 2007
    Report Date
    December 20, 2007
    Product Code
    JYH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    MY BOYFRIEND WANTED TO TRY EAR CANDLING. I THINK THAT THESE SHOULD BE BANNED OR AT LEAST A VERY HAZARDOUS WARNING PUT ON PACKAGING. THE PACKAGING WAS ALL CUTE. IT ENDED UP THAT THE HOT WAX WENT DOWN HIS EAR AND BURNT A HOLE THROUGH HIS EAR DRUM. THE FDA NEEDS TO GET MORE INVOLVED WITH THE SELLING -OR RATHER NON-DISTRIBUTION- OF EAR CANDLES. THESE ARE VERY DANGEROUS TO SAY THE LEAST. DATES OF USE: ONE TIME USE AND STOPPED. IN 2007. DIAGNOSIS OR REASON FOR USE: TO CLEAR OUT EAR WAX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLY NATURAL PRODUCTS WALLY JOES' EAR CANDLES JYH

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR WALLY'S NATURAL EAR CANDLES