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

Health Effect - Clinical Codes	Erythema (1840); Pain (1994); Tingling (2171); Chest Tightness/Pressure (2463); Heart rate, increased (2557); Superficial (First Degree) Burn (2685)
Date of Event	05/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Reporter called with complaint of abdominal burns she received during a magnetic resonance imaging (mri) test she underwent in (b)(6) 2023.She stated that all preliminary safety procedures were okay but during testing, the safety-assistant bulb on the machine did not work.During testing, she started to feel a burning sensation in her sacral area and tried to gain attention for the technologist by pressing the assistant bulb.She pressed it about 30 times and was not able to get any assistance.She was in the mri for about 20 minutes where, the burning sensation went up her back and was causing extreme pain.Reporter described that it was like being in a "crematorium." along with the burning sensation and heat, her heart rate dramatically increased and she felt pressure in her chest.Upon completion of the test, the technologist did not ask if she was okay or check to see if she had any burn marks on her body.The following day, reporter found superficial burns on her abdominal and private areas.She also noticed reddish-wrinkled blotches (erythema) on her lower body area.As of today she has imprints on the burned areas and can feel electrical sensations in those areas as well as soreness under her breasts and "heart area." reporter states that she does have a cardiac implant that was switched to mri mode before the test and passed all safety checks prior to testing.

• Brand Name: MRI
• Common Device Name: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• MDR Report Key: 17436565
• Report Number: MW5120416
• Device Sequence Number: 2437479
• Product Code: LNH
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 07/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/31/2023
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Female