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

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Skin Inflammation (2443)

Event Date 04/03/2019

Event Type  Injury  

Event Description

I had an mri at (b)(6) in (b)(6) on (b)(6) 2019.3 hours after returning home, i noticed my face and neck were red, like sunburn.It's been 3 days now and my face and neck are still a light pink and i have intermittent feelings of feeling warm.I called (b)(6) and they refused to let me speak to an mri tech or radiologist.I believe i received a thermal or radio frequency burn from their mri machine.I was in the mri machine for 17 minutes.I was not told to change into a gown because i didn't have anything that contained metal.The tech also said i could keep my tennis shoes on.At the time of the test i did not feel warm or look red.That showed up 3 hours later.(b)(4).

• Brand Name: MRI
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 8501129
• MDR Text Key: 141666318
• Report Number: MW5085756
• 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: 04/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/09/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR
• Patient Weight: 69