BEUDAMED
    FDA Adverse Event Other Summary report: N

    FLEXART

    MDR report key: 131095 · Received November 7, 1997

    Report

    Report Number
    2936923-1997-00001
    Event Type
    Other
    Date Received
    November 7, 1997
    Date of Event
    October 31, 1997
    Report Date
    November 6, 1997
    Manufacturer
    TOSHIBA AMERICA MRI, INC.
    Product Code
    LNH
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER INVESTIGATION OF SUSPECT DEVICE THERE IS NO EVIDENCE SUGGESTING SUSPECT COILD COULD CAUSE THE DESCRIBED SKIN IRRITATION, NO INCREASE OF TEMPERATURE WAS DETECTED WHEN SCANNING UNDER CONDITIONS OF NORMAL OR MAXIMUM POWER. CAUSE OF IRRITATION UNKNOWN.

    Description of Event or Problem · 1

    ON 10/31/97, FEMALE PT WAS SCANNED IN A TOSHIBA FLEXART MRI SCANNER USING THE QD C-SPINE COIL. PT LEFT FACILITY AND WENT HOME, BETWEEN 30-60 MINUTES AFTER LEAVING FACILITY SHE FELT ITCHY SORE SENSATION. PT INFORMED FACILITY ON 11/3/97 AND WAS EXAMINED BY A DR. EXAM REVEALED A 5 INCH LONG 1/4 INCH WIDE RED MARK ACROSS THE BACK OF NECK. DR FELT IT COULD BE A BURN. PT ADVISED TO CONTINUE TREATING AREA WITH NEOSPORIN. SUSPECT COIL WAS REMOVED FROM SERVICE AND IS BEING SENT TO TOSHIBA FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXART 0.5T MRI SCANNER LNH TOSHIBA AMERICA MRI, INC. FLEXART (C-SPINE COIL) NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other