BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OTICON OPN 1 MINIRITE

    MDR report key: 21850470 · Received April 16, 2025

    Report

    Report Number
    MW5169130
    Event Type
    Malfunction
    Date Received
    April 16, 2025
    Report Date
    April 15, 2025
    Manufacturer
    OTICON, INC.
    Product Code
    OSM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    A REPORTER CALLED TO SUBMIT A COMPLAINT ABOUT HER HEARING AIDS. REPORTER SAID SHE SPENT ABOUT (B)(6) DOLLARS FOR THE HEARING AIDS AND FOR INSURANCE ABOUT (B)(6). AFTER SHE SPENT THIS MUCH MONEY, SHE IS NOT GETTING THE THERAPEUTIC TREATMENT SHE PAID FOR FROM THE DEVICE. SHE IS HAVING ALL KINDS OF PROBLEMS WITH THE EQUIPMENT. SHE SAID IT TOOK 2 AND HALF YEARS TO FIX THE PROBLEMS. SHE SAID SHE CONTACTED THE MANUFACTURER SO MANY TIMES, BUT SHE DID NOT GET ANY EXPLANATION WHY THE DEVICE IS BREAKING AGAIN AND AGAIN. SHE SAID THE CUSTOMER SERVICE PEOPLE EITHER DO NOT KNOW ABOUT THE PRODUCT OR THEY ARE NOT HELPFUL AT ALL. SHE SAID THE DEVICE WAS SENT TO THE MANUFACTURER 2 OR 3 TIMES TO BE FIXED AND WHEN THEY COME BACK, THEY BREAK AGAIN. THE MAIN PROBLEM IS THE BLUETOOTH, IT WAS NOT PAIRING, IF IT DOES, IT IS INTERMITTENT. IT ALSO HAS STATIC; THE HEARING AIDS ARE LOUD, EVEN OTHER PEOPLE AROUND HER CAN HEART THEM. EVERY TIME THE DEVICES ARE SENT FOR A REPAIR, SHE DID NOT HAVE SUFFICIENT HEARING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133362 OTICON OPN 1 MINIRITE HEARING AID, AIR-CONDUCTION WITH WIRELESS TECHNOLOGY, PRESCRIPTION OSM OTICON, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Unknown