BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EARGO HEARING DEVICES

    MDR report key: 21179984 · Received January 17, 2025

    Report

    Report Number
    MW5164882
    Event Type
    Injury
    Date Received
    January 17, 2025
    Date of Event
    October 24, 2024
    Report Date
    January 14, 2025
    Manufacturer
    EARGO, INC.
    Product Code
    QUH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    COMPLAINT AGAINST EARGO HEARING AID DEVICE. FAILURE OF PRODUCT TO MAINTAIN CHARGE. NUMEROUS COMPLAINTS TO CUSTOMER SERVICE . ALL INDICATOR LIGHTS (4) ILLUMINATED SHOWING FULLY CHARGED. I WAS SENT NEW REPLACEMENTS X3 AND ALL DEVELOPED SAME PROBLEM IN A SHORT PERIOD OF TIME. I WOULD BE AT A MEETING WHERE I REALLY NEEDED TO HEAR AND LOW BATTERY WARNING WAS ISSUED. SOMETIMES ONLY 1/2 HOUR USE. NOT ONLY IS THIS COMPLAINT BEING SUBMITTED AS A FAULTY PRODUCT BUT ALSO DESIGN HAZARDS. UPON REMOVAL OF EARBUD, IT CAME APART IN MY EAR. I WAS UNABLE TO REMOVE THE PIECE RETAINED IN MY EAR, BUT ALSO COULDN'T WITH ASSISTANCE FOR FEAR OF PUNCTURING MY EARDRUM. HAD TO MAKE AN APPOINTMENT WITH MY DOCTOR AND HE HAD ME COME IN IMMEDIATELY. WAS UNABLE TO RETRIEVE EARBUD WITH FORCEPS AND SO NECESSITATED TO BE VACUUMED OUT. THE EAR WAS INFLAMED AND REQUIRED TOPICAL ANTIBIOTIC APPLICATION. I HAVE A COPY OF PHYSICIANS' EXAMINATION. I NOTIFIED EARGO SUPPORT WITH COPY OF PHYSICIAN REPORT REQUESTING REFUND. THEY FAILED TO RESPOND. HAVE EXAMINATION REPORT FROM MEDICAL PHYSICIAN. REFERENCE REPORTS MW5164881, MW5164883.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722077 EARGO HEARING DEVICES SELF-FITTING AIR-CONDUCTION HEARING AID, OVER THE COUNTER QUH EARGO, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Required Intervention AMBIANCE 10MG AS NEEDED HS SLEEP | ASPIRIN| CYMBALTA 90 MG PO DAILY| FLEXERIL 10MG BID IF NEEDED FOR BACK PAIN, | IBUPROFEN| LATANOPROST OPTHALMIC SOLUTION BOTH EYES HS,| MULTIPLE VITAMINS | OMEPRAZOLE PO 20MG | PROGESTERONE 100MG PO HS| TIMOLOL OPTHTHALMIC SOLUTION BOTH EYES BID| TRAMADOL 10 MG PO AS NEEDED FOR PAIN. (BACK PAIN ARTHRITIS)