BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD BREAST MRI AUXILIARY TABLE W/8CH COIL

    MDR report key: 2663058 · Received June 5, 2009

    Report

    Report Number
    3005748597-2009-00001
    Event Type
    Injury
    Date Received
    June 5, 2009
    Date of Event
    June 3, 2009
    Report Date
    June 5, 2009
    Manufacturer
    SENTINELLE MEDICAL, INC.
    Product Code
    MOS
    PMA / PMN Number
    K060873
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING ROUTINE BREAST SCREENING MRI EXAM, PATIENT COMPLAINED OF BURNING SENSATION AT STERNUM. AFTER LAST SCAN, PATIENT WAS REMOVED FROM SCANNER, AND EXAMINED BY THE CHARGE TECHNOLOGIST, WHO REPORTED REDNESS "LIKE SUNBURN" CONFINED TO THE PATIENT'S STERNUM. RADIOLOGIST EXAMINED THE PATIENT LATER THE SAME DAY AND SAID REDNESS HAD LARGELY RESOLVED AND HE COULDN'T TELL WHETHER THERE WAS A BURN. MANUFACTURER (SENTIELLE MEDICAL INC) ASKED THE CLINIC TO DISCONTINUE USE OF THE DEVICE PENDING INVESTIGATION, WHICH IS ONGOING. AT THIS TIME THERE IS NO EVIDENCE OF ABNORMAL OPERATION, OR PAST HEATING OF THE DEVICE. IT IS QUITE POSSIBLE THAT THE REDNESS AND BURNING SENSATION WAS CAUSED BY PATIENT WEIGHT BORNE BY STERNUM SUPPORT. SENTINELLE MEDICAL INC. IS CONTINUING TO INVESTIGATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VANGUARD BREAST MRI AUXILIARY TABLE W/8CH COIL VANGUARD FOR GE MRI MOS SENTINELLE MEDICAL, INC. 4000001-12

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR