BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 102991 · Received July 3, 1997

    Report

    Report Number
    MW1011626
    Event Type
    Injury
    Date Received
    July 3, 1997
    Report Date
    June 24, 1997
    Manufacturer
    NATURE'S WAY
    Product Code
    JYH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    RPTR NOTED AN ADD FOR EAR CANDLES AT A HEALTH FOOD STORE IN WEST COLUMBIA. AS NOTED FROM PERSONAL ENCOUNTERS AND FROM MEDICAL LITERATURE THESE DEVICES CAN DEPOSIT WAX IN EAR CANAL. REPORTER WANTS TO URGE THE FDA TO BAN THESE DEVICES. THEY ARE A HOAX. PLEASE STOP THIS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * EAR CANDLES JYH NATURE'S WAY * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention
    2