BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIRITE POWERE WITH POWER DOME

    MDR report key: 2978604 · Received February 16, 2013

    Report

    Report Number
    MW5029103
    Event Type
    Injury
    Date Received
    February 16, 2013
    Date of Event
    February 15, 2013
    Report Date
    February 16, 2013
    Manufacturer
    OTICON, INC.
    Product Code
    ESD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    USING OTICON ¿MINIRITE POWER WITH POWER DOME¿ HEARING AID, A COUPLE OF WEEKS AGO, I NOTICED MISSING RUBBER TIP DOME IN THE RIGHT EAR DEVICE. I THOUGHT THAT THE TIP SIMPLY FELL OFF. AFTER REPLACING THE TIP, THE ATTEMPTS TO USE HEARING AID PRODUCED DISCOMFORT AND PAIN IN THE EAR. THE PAIN GOT PROGRESSIVELY WORSE, AND FINALLY, WITH SYMPTOMS OF OTITIS EXTERNA, I SOUGHT PROFESSIONAL HELP IN THE DOCTOR¿S URGENT CARE OFFICE IN (B)(6). ON (B)(6) 2013, PHYSICIAN DETECTED THE PRESENCE OF A FOREIGN BODY IN THE RIGHT EAR CANAL AND IN A PAINFUL PROCEDURE REMOVED THE RUBBER TIP, WHICH WAS STUCK IN THE EAR CANAL, NEXT TO THE EAR DRUM. IT SEEMS THAT THE OTICON ¿MINIRITE POWER WITH POWER DOME¿ DEVICE IS DEFECTIVE/POORLY DESIGNED. THE RUBBER TIP DOME SHOULD BE SECURELY LOCKED TO THE SPEAKER, AND SHOULD NOT BE ABLE TO SLIP OFF IN THE EAR CANAL. MEDICAL INTERVENTION OF REMOVAL OF THE TIP DOME STUCK IN THE EAR CANAL IS A PAINFUL PROCEDURE, AND THUS, PATIENTS USING OTICON ¿MINIRITE¿ POWER WITH POWER DOME¿ HEARING AID ARE AT RISK OF SUFFERING PAIN. DISCOMFORT AND UNNECESSARY EXPENSES. THIS RISK IS PREVENTABLE BY IMPROVING DESIGN OF THE DEVICE. DATES OF USE: (B)(6) 2012 - (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69985 MINIRITE POWERE WITH POWER DOME HEARING AID ESD OTICON, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR