BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EARWAX CANDLE

    MDR report key: 1013928 · Received August 10, 2007

    Report

    Report Number
    MW5005889
    Event Type
    Injury
    Date Received
    August 10, 2007
    Report Date
    August 10, 2007
    Manufacturer
    *
    Product Code
    JYH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THIS PRODUCT WAS ADVERTIZED TO CURE SINUSITIS AND CLEAN EARWAX. PRODUCT IS MISLABELED AND FDA NEEDS TO INVESTIGATE. THIS PRODUCT IS A FRAUD. PATIENT WAS BURNT FROM USING THIS PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EARWAX CANDLE NONE JYH * UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Life Threatening