BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EAR CANDLE

    MDR report key: 1276183 · Received December 30, 2008

    Report

    Report Number
    MW5009478
    Event Type
    Injury
    Date Received
    December 30, 2008
    Date of Event
    December 7, 2008
    Report Date
    December 30, 2008
    Manufacturer
    LOCAL HEALTH FOOD STORE
    Product Code
    JYH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    USED "EAR CANDLE" FROM HEALTH FOOD STORE. WAX DRIPPED INTO MY EAR CAUSING BURNING & WAX BLOCKED MY EARDRUM. EXPERIENCED SEVERE PAIN & IMPAIRED HEARING. I USED THIS PRODUCT PER PACKAGE INSTRUCTIONS. DEFECTIVE PRODUCT CAUSED HOT WAS TO ENTER MY EAR CANAL - BURNING AND BLOCKAGE RESULTED. PRESCRIPTION EAR DROPS 2008. EAR FLUSH PERFORMED BY RN AND Z-PACK ANTIBIOTIC PRESCRIBED FIVE DAYS LATER. OUT PT SURGERY TO REMOVE BLOCKAGE IN THE SAME MONTH. DOSE OR AMOUNT: 1 CANDLE PER EAR. FREQUENCY: ONCE. ROUTE: DATES OF USE: 2008.(1 TIME ONLY). REASON FOR USE: CLEAN EARS. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EAR CANDLE JYH LOCAL HEALTH FOOD STORE

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| S