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

Device Problem Unexpected Therapeutic Results (1631)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 09/19/2021

Event Type  Injury  

Event Description

Both of my feet were burned during an mri at (b)(6) hospital in (b)(6).I am still suffering from these injuries.Fda safety report id# (b)(4).

• Brand Name: MRI MACHINE
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• MDR Report Key: 13207847
• MDR Text Key: 283615927
• Report Number: MW5106559
• 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: 01/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Patient Sequence Number: 1
• Treatment: TIROSINT 75MCG/PER DAY
• Patient Outcome(s): Disability
• Patient Age: 43 YR
• Patient Sex: Female
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White