BEUDAMED
    FDA Adverse Event Summary report: N

    WAXTRACTOR EAR WAX REMOVAL KIT

    MDR report key: 8186564 · Received December 19, 2018

    Report

    Report Number
    MW5082377
    Date Received
    December 19, 2018
    Date of Event
    September 17, 2018
    Report Date
    September 30, 2018
    Manufacturer
    UNK
    Product Code
    OGQ
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I PURCHASED A WAXTRACTOR EAR WAX REMOVAL KIT FROM (B)(6) ON (B)(6) 2018. AFTER USING THIS PRODUCT, THE TIP ATTACHED TO THE HOSE CONNECTED TO THE WATER BOTTLE SHOT INTO MY EAR AFTER SQUEEZING THE BOTTLE TRIGGER. THE TIP LODGED INTO MY EAR CANAL CAUSING A SEVERE AND PAINFUL EAR INFECTION, THAT NOW HAS RESULTED INTO A RINGING IN MY RIGHT EAR. I HAVE CONTACTED BOTH (B)(6) AND KRUWORKS LLC THE VENDOR BUT TO NO AVAIL. DOCUMENT NUMBER: (B)(4). REPORT NUMBER: (B)(4). KRUWORKS LLC. EMAIL KRUWORKS ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1017760 WAXTRACTOR EAR WAX REMOVAL KIT WAXTRACTOR EAR WAX REMOVAL KIT OGQ UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR