BEUDAMED
    FDA Adverse Event Summary report: N

    MEDICAL ADVANCES

    MDR report key: 841872 · Received March 22, 2007

    Report

    Report Number
    841872
    Date Received
    March 22, 2007
    Date of Event
    February 19, 2007
    Report Date
    March 22, 2007
    Manufacturer
    INVIVO RESEARCH, INC
    Product Code
    MOS
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    DURING THE MRI SCAN OF THIS PATIENT'S RIGHT HAND, THE FEMALE PATIENT RECEIVED A FIRST DEGREE BURN TO THE 2ND AND 3RD DISTAL PHALANGEAL JOINTS WITH REDNESS AND SWELLING. THIS WAS NOTICED AFTER THE MRI WAS COMPLETE. THE PATIENT'S HAND WAS POSITIONED BETWEEN THE PADDLE COILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDICAL ADVANCES MRI SURFACE COIL MOS INVIVO RESEARCH, INC * *
    2 * MRI LNH GE MEDICAL SYSTEMS, LLC GE 1.5T *

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR NO OTHER THERAPIES