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

Device Problem Insufficient Information (3190)

Patient Problems Dry Eye(s) (1814); Emotional Changes (1831); Hair Loss (1877); Headache (1880); Pain (1994); Tinnitus (2103); Arthralgia (2355); Depression (2361)

Event Date 05/12/2017

Event Type  Injury  

Event Description

On (b)(6) 2017 i had a brain mri with contrast done at (b)(6).Shortly thereafter i started to experience the following symptoms; tinnitus, head pains, headaches, very dry eyes, knee pain in both knees, pain in left hpi, loss of eyelashes, and loss of hair.The hair loss is the most distressing as i am a female and half is gone already.This precipitated severe depression.The contrast agent used was gadavist.

• Brand Name: MRI MACHINE
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• MDR Report Key: 6689106
• MDR Text Key: 79248385
• Report Number: MW5070814
• 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: 07/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 68 YR