MAUDE Adverse Event Report: MRI; SYSTEM, NEUCLEAR MAGNETIC RESONANCE

Device Problem Unintended Movement (3026)

Patient Problems Radiation Burn (1755); Pain (1994); Peeling (1999); Skin Irritation (2076); No Code Available (3191)

Event Date 04/10/2019

Event Type  Injury  

Event Description

Mri machine seemed to malfunction in that it vigorously shook, tossing me side to side and banging my right elbow painfully on the inside of the machine.Buzzer sounded.Mri machine stopped briefly and then continued and finished the procedure.In a few hours my face became very red and painful.Called the facility twice the next morning and never received a return call.Visited my family physician on the day following the mri and like me, thought i may have had a reaction to the contrast dye.Was put on medication and again seen by my family dr on (b)(6).Dr and i both had done research on risks with mri's.My family dr stated that i indeed had received a burned face and i was put on further medication and a return in two weeks.My face was painful, red and with an open draining spot on my chin and some peeling skin.I have sent a letter to the mri facility and the affiliated hosp and my neurologist who had ordered the mri.I am a ms and diabetic pt.(b)(6) is the affiliated hosp, university medical (b)(6) is the location where the mri was done, and my neurologist is dr (b)(6), dept of neurology, (b)(6).Burn to face from mri.Fda safety report id# (b)(4).

• Brand Name: MRI
• Type of Device: SYSTEM, NEUCLEAR MAGNETIC RESONANCE
• MDR Report Key: 8569411
• MDR Text Key: 143891016
• Report Number: MW5086312
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR
• Patient Weight: 91