BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BEBIRD R1

    MDR report key: 23615941 · Received November 21, 2025

    Report

    Report Number
    MW5179214
    Event Type
    Injury
    Date Received
    November 21, 2025
    Date of Event
    November 17, 2025
    Report Date
    November 19, 2025
    Manufacturer
    HEIFENG ZHIZAO (SHENZHEN) TECHNOLOGY CO.,LTD
    Product Code
    ERA
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THIS BEBIRD R1 WAX REMOVAL TOOL FOR EAR STRAIGHT UP BLEW UP ON ME THE SECOND TIME I CHARGED IT. THIS MORNING I HAD IT SITTING ON THE LITTLE SHELF BY THE BATHROOM SINK CHARGING, I WAS JUST FINISHING UP SHAVING (LIKE 3 MINS) AND I STARTED SMELLING SOMETHING BURNT. WHEN I UNPLUGGED IT, IT POPPED AND CAUGHT FIRE RIGHT THERE. THE BACK OF MY HAND GOT BURNED, I JUST CAME BACK FROM URGENT CARE WHERE THEY WRAPPED IT UP. HERE'S THE INFO: ORDER #: (B)(6). PRODUCT: BEBIRD R1 WAX REMOVAL TOOL FOR EAR - SPADE EAR CANAL CLEANER WITH CAMERA 1080P EARSCOPE, WAX REMOVE EAR PICKER WITH VARI REPLACEMENT TIPS, CAMERA WITH 6LED LIGHT FOR EAR/NOSE/THROAT EXAMINATION, BLACK SELLER: BEBIRD OFFICIAL US LINK: HTTPS://WWW.AMAZON.COM/DP/ B08M9G18H3?REF_=PPX_HZOD _TITLE_DT_B_FED_ASIN_TITLE_0_1 THIS ISN¿T JUST A QUALITY ISSUE, IT'S A STRAIGHT SAFETY HAZARD. I NEED THIS REPORTED TO YOUR SAFETY TEAM, NOT JUST TOSSED IN AS A NORMAL REFUND THING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2560302 BEBIRD R1 OTOSCOPE ERA HEIFENG ZHIZAO (SHENZHEN) TECHNOLOGY CO.,LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Life Threatening