BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELATE 5.0 RIC R

    MDR report key: 25160952 · Received May 13, 2026

    Report

    Report Number
    MW5188125
    Event Type
    Injury
    Date Received
    May 13, 2026
    Date of Event
    May 8, 2026
    Report Date
    May 8, 2026
    Manufacturer
    SONOVA USA INC.
    Product Code
    OSM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    BECAME FIRST TIME WEARER/OWNER OF HEARING AIDS ON (B)(6) 2026. THE DEVICES ARE FROM MANUFACTURER IS SONOVA. MINE ARE RELATE 5.0 RIC R. ON THE EVENING OF (B)(6) 2026 THE RUBBER DOME TIP BECAME LODGED IN MY RIGHT EAR WHICH REQUIRED AN URGENT CARE VISIT THE NEXT DAY AS IT WAS CAUSING PAIN. IT WAS REMOVED AFTER DELICATE ATTEMPTS ABOUT ONE HALF HOUR. NEEDLESS TO SAY, I HAVE RESERVATIONS OF PUTTING THEM IN AGAIN. PT: 1994. DEVICE: 2923. REF: MW5188126.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4381 RELATE 5.0 RIC R HEARING AID, AIR-CONDUCTION WITH WIRELESS TECHNOLOGY, PRESCRIPTION OSM SONOVA USA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Required Intervention