BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CINEMAVISION

    MDR report key: 2597436 · Received May 24, 2012

    Report

    Report Number
    MW5025600
    Event Type
    Injury
    Date Received
    May 24, 2012
    Date of Event
    April 17, 2008
    Report Date
    May 24, 2012
    Manufacturer
    RESONANCE TECHNOLOGY, INC
    Product Code
    HOY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2008, OUR DAUGHTER WAS OFFERED MRI APPROVED VIDEO GOGGLES TO WATCH A MOVIE DURING USER FACILITY'S MRI. THE GOGGLES MALFUNCTIONED AND PROJECTED A PIECE OF TUNGSTEN METAL FIBER INTO HER EYELID. THE USER FACILITY'S MRI TECH DID NOT HEAR HER CRIES FOR HELP AS THE PT MICROPHONE WAS TURNED DOWN AND THE MRI DID NOT HAVE A PANIC BUTTON. THE FIBER WAS CONFIRMED TO HAVE COME FROM THE GOGGLES BY THE USER FACILITY'S BIO MED DEPT. ADDITIONALLY, THE EVENT FACILITY'S MRI TECH PROVIDED A STATEMENT IN (B)(6) 2011, THAT THE GOGGLES HAD, PRIOR TO THIS INCIDENT, BEEN REPAIRED BY THE USER FACILITY'S BIO MED DEPT BECAUSE THE GOGGLES PLASTIC COVER HAS FALLEN OFF. OUR DAUGHTER'S INJURIES REQUIRED BOTH EMERGENCY AND F/U MEDICAL CARE TO PREVENT PERMANENT IMPAIRMENT AND/OR DAMAGE TO EYELID AND EYE. INITIAL EMERGENCY CARE REQUIRED AN EYE SURGEON TO REMOVE THE TUNGSTEN FIBER THAT HAD SOLDERED TO HER LEFT EYELID AND TREATMENT OF MULTIPLE EYELID LACERATIONS. F/U CARE REQUIRED REPEATED VISITS TO ASSURE NO INFECTION OR ADD'L VISION IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CINEMAVISION MRI VIDEO GOGGLES HOY RESONANCE TECHNOLOGY, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention