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

Device Problem Unintended Movement (3026)

Patient Problem Neck Pain (2433)

Event Type  Injury  

Event Description

Was getting a mri they put a helmet on me.Kind of like a football helmet.The helmet violently jerked my head and least ten times during the mri.Not just a little as hard as it could, i was in so much shock i couldn't brace my head so my head just got violently horribly jerked for so long.It left me with pain where my neck connects to my head and lower head and have been having medical problems since then.I do not have a past history or seizures and it hasn't happened since the mri.And it wasn't my head doing it.It was the helmet jerking my head.

• Brand Name: MRI WITH HELMET
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17186563
• MDR Text Key: 317877787
• Report Number: MW5118718
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White