MAUDE Adverse Event Report: MAGNETIC RESONANCE IMAGING WITH CONTRAST (GADOLINIUM); SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Device Problem Radiation Output Problem (4026)

Patient Problem Ambulation Difficulties (2544)

Event Date 02/28/2021

Event Type  Injury  

Event Description

After returning home from the hospital i was unable to walk on my own.I must use a walker to get around.The neurologist thought i needed yet another mri with contrast of my brain.I believe this last one ruined me.I already had at least 10 and i had a mouthful of amalgums.Too much heavy metals in my body.My brain could not handle it.I have taken a urine test to measure the gad(gadolinium) in my urine, which is still excreting.Help me.Gadolinium-based contrast.Fda safety report id# (b)(4).

• Brand Name: MAGNETIC RESONANCE IMAGING WITH CONTRAST (GADOLINIUM)
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• MDR Report Key: 15925474
• MDR Text Key: 304986701
• Report Number: MW5113655
• 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: 12/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: MAGNESIUM; VITAMIN C; WALKER
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 82 KG
• Patient Ethnicity: Hispanic
• Patient Race: White