MAUDE Adverse Event Report: MRI

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Dizziness (2194); Confusion/ Disorientation (2553); No Code Available (3191)

Event Date 02/03/2017

Event Type  Injury  

Event Description

Mri.Gadolinium.My ears won't stop ringing.Dizziness.Complete episodes of confusion.Entire back of scalp is tender.I can still taste the metal in my mouth.I feel like i'm dying.I need help.

• Brand Name: MRI
• Type of Device: MRI
• MDR Report Key: 7600635
• MDR Text Key: 111292544
• Report Number: MW5077855
• 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: 06/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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): Hospitalization
• Patient Age: 56 YR
• Patient Weight: 100