LARGE BORE MRI

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-02 for LARGE BORE MRI manufactured by Unk.

Event Text Entries

[116205350] Had mri low back at (b)(6) at 6pm (b)(6) 2018 in their large bore machine. I am not new to mri as i've had about 6 in the last 20 yrs or so and have never had any negative response to the machine, as the mri started i realized i had left my sterling silver wedding band on my hand because it was buzzing and warming up. Removed it gave it to the tech (their paperwork did not mention wedding rings, and sadly it never occurred to me i had it on. ) had about a 15 min scan during which time i noted that when the magnets were active my skin, particularly from about the xyphoid superior to the top of my head were getting warm and "itchy" to the point i was ready to call an end to the exam when i was notified it about to complete. When i got out of the tube my head, chest check, shoulders, and arms were reddened and covered in sweat. I mentioned it to the tech who said "you must be really sensitive. " and sent me to change and go home. I was full body in the tube. I am (b)(6) and about (b)(6). It took about 45 mins for the upper portion of my body to stop sweating and cool down. Beside the skin discomfort, my old mercury fillings were warm and (for lack of better word) tasteable. These are old fillings and i have not noticed them in many years. They still are testable i have no obvious skin color changes or burns but i notice the skin of my face, and neck remain tingling and i have a low level residue headache. On the good side my sinus have cleared up. I am a nurse practioner with many years of inpatient and in office work. I have never heard of this type reaction. I also am a licensed general level amateur radio operator and this felt like i was too close to a radio antenna.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5078857
MDR Report Key7746889
Date Received2018-08-02
Date of Report2018-07-31
Date of Event2018-07-30
Date Added to Maude2018-08-03
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameLARGE BORE MRI
Generic NameMAGNETIC RESONANCE DIAGNOSTIC DEVICE
Product CodeMOS
Date Received2018-08-02
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerUNK
Manufacturer AddressUNK UNK


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-08-02

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