MAUDE Adverse Event Report: UNKNOWN MRI; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Pain (1994); Burning Sensation (2146); Discomfort (2330); Burn, Thermal (2530)

Event Date 05/15/2020

Event Type  Injury  

Event Description

I am diabetic and have ms.Went to (b)(6) for a doctor visit and brain mri.For the mri, i was told i could leave street clothes on except remove my belt, which i did.The shorts i was wearing had a metal zipper and had a metal button.There were buttons on the shirt of unknown content.I was not padded in any way.Just a sheet over me.I questioned the technician about wearing the shorts and was told that it was okay to leave on.I always feel warm in an mri, but i was not aware of any burning during the mri.The day after the mri i began to feel heat, pain, and obvious redness to my face, back of shoulders, across the upper back and inner part of both lower legs, ankles, and feet.On monday, (b)(6) 2020, i visited my primary care physician who observed the burns and treated me with a medication.I sent a letter to (b)(6) ceo and also the doctor who saw me on (b)(6).The letter i received back from (b)(6) indicated that i was no longer a patient with them and that i could request all my medical records be sent to another doctor.These burns continue to be uncomfortable.This is the second time i have been burned in a mri.The first time i reported to the fda which was done at a different facility and with a different doctor was due to burns on (b)(6) 2019.Something must be done to ensure the safety of mris for all clients and especially those of us that have mris to access effect of medications.Fda safety report id #: (b)(4).

• Brand Name: MRI
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 10189661
• MDR Text Key: 196589420
• Report Number: MW5095192
• 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: 06/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2020
• 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: 51 YR
• Patient Weight: 100