BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EAR CANDLE

    MDR report key: 6604693 · Received May 18, 2017

    Report

    Report Number
    MW5070129
    Event Type
    Injury
    Date Received
    May 18, 2017
    Date of Event
    May 16, 2017
    Report Date
    May 18, 2017
    Manufacturer
    UNK
    Product Code
    JYT
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A (B)(6) YEAR OLD FEMALE PRESENTED WITH EAR PAIN RESULTING FROM USE OF EAR CANDLING; MILD INFLAMMATION OF THE EAR CANAL. IS THE PRODUCT OVER-THE-COUNTER: YES. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357278 EAR CANDLE EAR CANDLE JYT UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Other