BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EARGO HEARING DEVICES

    MDR report key: 21179962 · Received January 17, 2025

    Report

    Report Number
    MW5164881
    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

    IT WAS REPORTED THAT THIS LEAD WAS EXPLANTED DUE TO UNKNOWN ISSUE. A NEW LEAD WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742428 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, OMEPRAZOLE PO 20MG| 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)