BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OTOTEK

    MDR report key: 1964030 · Received January 11, 2011

    Report

    Report Number
    MW5019026
    Event Type
    Malfunction
    Date Received
    January 11, 2011
    Report Date
    January 11, 2011
    Manufacturer
    EAREST, INC
    Product Code
    JYQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE OTOTEK EARLOOP IS INHERENTLY UNSAFE. I AM A PRIMARY CARE PHYSICIAN. NONE OF MY PTS HAVE REPORTED USING THIS DEVICE. I SAW IT FOR SALE IN A (B)(6) PHARMACY. ITS PACKAGING SUGGESTS THAT IT IS FOR REMOVING EARWAX. IT CONSISTS OF A PLASTIC EAR CURETTE WITH A HILT TO KEEP FROM BEING INSERTED TOO FAR INTO THE EAR. WHILE IT WOULD PROBABLY BE IMPOSSIBLE TO REACH THE TYMPANIC MEMBRANE WITH THE DEVICE, IT CLEARLY IS LONG ENOUGH TO REACH THE DELICATE TISSUE OF THE BONY SECTION OF THE EXTERNAL EAR CANAL. THERE, IT WILL CAUSE ABRASIONS. EVEN AN EXPERIENCED PHYSICIAN OR AUDIOLOGIST HAS A HARD TIME NOT CAUSING ABRASIONS USING AN OTOSCOPE AND PROFESSIONAL GRADE CURETTES. ABRASIONS CAN LEAD TO INFECTIONS WITH POTENTIALLY DIRE CONSEQUENCES. TAKE THIS OFF THE MARKET RIGHT AWAY, PLEASE!

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OTOTEK OTOTEK LOOP JYQ EAREST, INC

    Patients

    Seq Age Sex Outcome Treatment
    1