BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EARPLANES+

    MDR report key: 18631048 · Received February 1, 2024

    Report

    Report Number
    MW5150999
    Event Type
    Injury
    Date Received
    February 1, 2024
    Date of Event
    November 20, 2023
    Report Date
    January 30, 2024
    Manufacturer
    CIRRUS HEALTCARE PRODUCTS, LLC / CIRRUS HEALTCARE PRODUCTS, LLC
    Product Code
    EWD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I RECENTLY PURCHASED "EARPLANES+" BY CIRRUS HEALTHCARE PRODUCTS, LLC (HTTPS://WWW.EARPLANES.COM) FOR AN AIRPLANE FLIGHT AND PUT THEM INTO MY EAR PRIOR TO TAKE OFF AND TO MY HORROR DISCOVERED THEY SHOT ALMOST ALL THE WAY INTO MY EAR CANAL AND I COULD NOT REMOVE THEM WITHOUT HELP. THEY BEGAN TO IMMEDIATELY CAUSE PAIN IN THE EAR DUE TO HOW DEEP THEY WERE LODGED INSIDE THE EAR AND BECAUSE OF THEIR TINY SHAPE AND SLIPPERY SILICONE MATERIAL JUST SLID FURTHER INTO THE EAR THE MORE I ATTEMPTED TO GRAB THEM AND EXTRACT THEM FROM MY EAR. THEY HAVE NO SAFETY DESIGN THAT STOPS THEM FROM SLIDING ALL OF THE WAY INTO THE EAR CANAL TOWARDS THE EAR DRUM AND NO WAY TO REMOVE THEM ONCE THEY ARE PAST THE OUTER EAR. LUCKILY, MY BROTHER WAS WITH ME AND HE HAD TO ASK THE STEWARDESS FOR A PAIR OF TWEEZERS TO CAREFULLY GRAB A HOLD OF THE END OF THE EARPLANES AND PULL THEM OUT OF MY EAR WHILE THE PLANE WAS ALREADY MID AIR. HAD MY BROTHER NOT BEEN WITH ME ON THE FLIGHT, I WOULD HAVE BEEN IN PAIN THE ENTIRE FLIGHT AND THEY MIGHT HAVE DAMAGED MY EAR CANAL OR EAR DRUM FROM THE CONSTANT PRESSURE CHANGES AS THE PLANE WENT UP AND DOWN IN ALTITUDE. THESE ARE A VERY DANGEROUS PRODUCT THAT SHOULD NOT BE ALLOWED FOR SALE AND SHOULD BE IMMEDIATELY RECALLED BEFORE THEY HURT MORE INNOCENT PEOPLE OR KIDS. I PURCHASED THE STYLE LABELS FOR "KIDS AND SMALLER EARS" WHICH ARE PRESUMABLY SMALLER THAN THE REGULAR VERSION BUT CLEARLY INDICATE THEY CAN BE USED BY ADULTS AND HAVE NO WARNINGS WHATSOEVER AS TO HOW DANGEROUS THEY ARE IF THEY SLIDE TOO FAR INTO THE EAR. IF I HADN'T BEEN CAREFUL THEY WOULD HAVE GONE EVEN FURTHER INTO MY EAR AND WOULD NOT HAVE BEEN REMOVABLE ON THE PLANE BY MY BROTHER AND WOULD HAVE REQUIRED A VISIT TO A HOSPITAL EMERGENCY ROOM WITH A DOCTOR TO REMOVE THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278553 EARPLANES+ PROTECTOR, HEARING (INSERT) EWD CIRRUS HEALTCARE PRODUCTS, LLC / CIRRUS HEALTCARE PRODUCTS, LLC FOR KIDS AND SMALLER EARS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| O