MAUDE Adverse Event Report: MRI

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Fever (1858); Headache (1880); Cognitive Changes (2551)

Event Date 04/10/2018

Event Type  Injury  

Event Description

Feeling extremely hot during a chest mri.Informed the staff, they took my shirt off, but the exam continued.Two hours have passed since the exam ended and i'm feeling headache, cognitive issues and extremely hot in the head.

• Brand Name: MRI
• Type of Device: MRI
• MDR Report Key: 7424986
• MDR Text Key: 105379842
• Report Number: MW5076453
• 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: 04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 30 YR