MAUDE Adverse Event Report: MRI TESLA 3; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hair Loss (1877); Pain (1994); Peeling (1999); Hot Flashes/Flushes (2153); Pallor (2468); Abdominal Cramps (2543); Weight Changes (2607); Unspecified Mental, Emotional or Behavioural Problem (4430); Decreased Appetite (4569)

Event Date 10/11/2021

Event Type  Injury  

Event Description

My (b)(6) son receives mris every 3 months for his brain tumor.This was the first time he was in a tesla 3.All other times he was in a 1.5 tesla.No contrast was given.He suffered from stomach cramps, loss of appetite, pale skin, severe weight loss (was 1lb away from being failure to thrive) psychotic episodes, bone and nerve pain, hot and freezing sensations, peeling skin on palms of hands and feet and hair loss.These symptoms lasted around 6-8 weeks although he is still losing hair to this day.I want to say i do not know the manufacturer of the mri but his test was done at (b)(6) hospital in (b)(6).Fda safety report id # (b)(4).

Event Description

Additional information received for report mw5107673 on 03/31/2022; mfr unknown.Procode: lnh.

• Brand Name: MRI TESLA 3
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• MDR Report Key: 13592247
• MDR Text Key: 286163688
• Report Number: MW5107673
• 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 Family Member or Friend
• Type of Report: Initial,Followup
• Report Date: 02/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2022
• 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
• Patient Outcome(s): Other
• Patient Age: 5 YR
• Patient Sex: Male
• Patient Weight: 21 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White