BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WIDEX

    MDR report key: 25095001 · Received May 6, 2026

    Report

    Report Number
    0002430101-2026-00003
    Event Type
    Injury
    Date Received
    May 6, 2026
    Date of Event
    January 15, 2026
    Report Date
    May 6, 2026
    Manufacturer
    WS AUDIOLOGY USA, INC.
    Product Code
    OSM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INPUT FROM RISK MANAGEMENT: AFTER MITIGATION: SEVERITY 2 (MODERATE) AND PROBABILITY B (IMPROBABLE) HAS RESIDUAL RISK RANGE CATEGORY II (ACCEPTABLE, RISK LEVEL MITIGATED AS LOW AS POSSIBLE).

    Description of Event or Problem · 0

    IN THIS EVENT, THE PATIENT WAS FITTED WITH BEHIND THE EAR HEARING AIDS WITH EARMOLDS ON (B)(6) 2024. PATIENT WAS PROVIDED A NEW LEFT EARMOLD ON (B)(6) 2026. BEGINNING IN (B)(6) 2026 THE PATIENT BEGAN EXPERIENCING ONGOING EAR INFECTIONS. THE INFECTIONS WERE TREATED WITH ANTIBIOTICS AND STEROIDS, AND THE PATIENT REPORTEDLY HAD MULTIPLE ENT DOCTOR VISITS DURING THIS PERIOD. THE PATIENT WAS EVALUATED BY AN ENT DOCTOR, WHO ADVISED THAT THE PATIENT WAS EXPERIENCING A SEVERE EAR INFECTION AND/OR POSSIBLE ALLERGIC REACTION TO THE EAR MOLDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479704 WIDEX EAR MOLD OSM WS AUDIOLOGY USA, INC. FLEX HARD SOLID P V2

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention