BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 3101312 · Received May 5, 2013

    Report

    Report Number
    MW5030080
    Event Type
    Injury
    Date Received
    May 5, 2013
    Date of Event
    April 19, 2013
    Report Date
    May 5, 2013
    Product Code
    HWA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    (B)(4). PT. STATES THAT THE HOSPITAL USED TITANIUM SCREWS IN THE ELEKTA HEAD FRAME INSTEAD OF INSULATED SCREWS, WHICH CAUSED THE MRI MACHINE TO ARC. PT. SUSTAINED 2ND DEGREE BURNS X 2, EYE SWELLING, AND FLUID AROUND THE EYES. FOUR SCREWS CAUSED 2ND DEGREE BURN (2). FORGOT TO USE INSULATED SCREWS, ARCING.

    Description of Event or Problem · 1

    SECOND DEGREE BURN TWO LOCATIONS FROM MRI BEFORE GAMMA KNIFE SURGERY FOR TRIGEMINAL NEURALGIA. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195958 UNKNOWN ELEKTA HEAD FRAM HWA
    195959 UNKNOWN ELEKTA HEAD FRAM HWA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention| S