BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEBIRD SMART VISUAL EAR CLEANER

    MDR report key: 11628954 · Received April 6, 2021

    Report

    Report Number
    MW5100610
    Event Type
    Malfunction
    Date Received
    April 6, 2021
    Date of Event
    April 2, 2021
    Report Date
    April 2, 2021
    Manufacturer
    HEIFENG ZHIZAO(SHENZHEN) TECHNOLOGY CO., LTD.
    Product Code
    ERA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PURCHASED A PRODUCT AND OBSERVED THE FDA LOGO ON IT WHICH I KNOW ISN'T LEGAL. THE PRODUCT IS BEBIRD'S SMART VISUAL EAR CLEANER [HTTPS://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDRH/CFDOCS/CFRL/RL.CFM?LID=631017&LPCD=ERA]. I WORK IN THE MEDICAL DEVICE INDUSTRY WHICH IS HOW I'M FAMILIAR WITH FDA'S LOGO POLICY AND THAT MEDICAL DEVICES ARE NOT PERMITTED TO INCLUDE LABELS/LABELING CONTAINING THE FDA LOGO. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523001 BEBIRD SMART VISUAL EAR CLEANER OTOSCOPE ERA HEIFENG ZHIZAO(SHENZHEN) TECHNOLOGY CO., LTD. C3

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR