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

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

Patient Problems Headache (1880); Superficial (First Degree) Burn (2685)

Event Date 02/04/2022

Event Type  Injury  

Event Description

Received a burn on my neck after brain mri.Received burn on neck from brain mri at (b)(6) in (b)(6).Their response was that they have never seen this before and examined.The mri in question and found nothing wrong with it.Also had headache, pressure on top of skull, base of skull and both temples for about 6 weeks.Mayo clinic.Fda safety report id # (b)(4).

• Brand Name: MRI
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• MDR Report Key: 13929518
• MDR Text Key: 288169431
• Report Number: MW5108549
• 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: 03/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Patient Sequence Number: 1
• Treatment: ALBUTEROL; ASHWAGANDHA; B-COMPLEX ; BEBERINE; BIOTIN ; BOSWELLIA EXTRACT ; D3; EPI PEN; GINKGO BILOBA ; K2; LUTEIN; MAG GLYCINATE ; METAXALONE; MULTI VITAMIN; NAC; OMEGA 3; QUERCETIN; RESVERATROL ; SELENIUM; ZINC
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 67 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White