BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CINEMAVISION20/20 MRI VIDEO GOGGLES

    MDR report key: 23827812 · Received December 17, 2025

    Report

    Report Number
    23827812
    Event Type
    Malfunction
    Date Received
    December 17, 2025
    Date of Event
    September 23, 2025
    Report Date
    October 2, 2025
    Manufacturer
    RESONANCE TECHNOLOGY, INC.
    Product Code
    LHN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE PATIENT WAS IN MRI WEARING THE GOGGLES WHEN THEY BEGAN COMPLAINING OF PAIN AND BURNING. ON INSPECTION, THE SILICONE NOSE BRIDGE HAD FALLEN OFF THE GOGGLES AND LED TO A PARTIAL THICKNESS BURN ON THE PATIENT'S NOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2320288 CINEMAVISION20/20 MRI VIDEO GOGGLES SYSTEM, RADIATION THERAPY, CHARGED-PARTICLE, MEDICAL LHN RESONANCE TECHNOLOGY, INC. CV2020

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Male