BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OTO-TIP EARWAX REMOVAL TOOL

    MDR report key: 24821164 · Received April 8, 2026

    Report

    Report Number
    MW5186484
    Event Type
    Injury
    Date Received
    April 8, 2026
    Date of Event
    January 16, 2026
    Report Date
    April 4, 2026
    Manufacturer
    PNEO LLC.
    Product Code
    KYZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    WAS USING THE OTO-TIP EARWAX REMOVAL TOOL WHEN THE PLASTIC TIP BROKE OFF IN MY EAR (SEE PICTURE). I WAS LUCKY IN THAT I WAS ABLE TO USE ANOTHER TOOL TO FISH THE TIP OUT, BUT IF I HADN'T BEEN ABLE TO IT WOULD HAVE REQUIRED A TRIP TO URGENT CARE OR THE HOSPITAL. SEE ONLINE REVIEWS OF THIS PRODUCT ON AMAZON ETC; OTHERS HAVE HAD THIS HAPPEN TO THEM (INCLUDING CHILDREN). THE DEVICE AND REPLACEMENT PARTS ARE READILY AVAILABLE ON SITES LIKE AMAZON. THIS IS A DEVICE WITH A DANGEROUS FLAW THAT SHOULD NOT BE ABLE TO BE SOLD TO THE PUBLIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    557399 OTO-TIP EARWAX REMOVAL TOOL SYRINGE, IRRIGATING (NON DENTAL) KYZ PNEO LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Male