MAUDE Adverse Event Report: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Device Problem Overheating of Device (1437)

Patient Problems Burning Sensation (2146); Superficial (First Degree) Burn (2685)

Event Date 08/18/2021

Event Type  Injury  

Event Description

A reporter called to submit a report regarding his face burn after an he had an mri.He said he was having an mri for the first time after an accident.He said a coil was put in around his forehead and was placed in the chamber for the mri test.He told the person who was performing the mri test that he felt very warm in the chamber.He said after he finished the test and got in his car, he looked in his car mirror and saw that his forehead was pure red and also he felt a burning sensation.The following day his face broke out with sever burn and the red marks got brighter.He said he went to the emergency room to get checked out and was given ibuprofen and other medication for pain.The burn was diagnosed as 1st degree burn.He said the hospital where he had the mri, contacted him and asked him to sign a paper.He said they were going to measure the burn but did not end up doing it when he declined to sign the paper.He said the coil that goes on his forehead was touching his face and caused him the burn but the coil was not supposed make contact to his face.He said he contacted (b)(6) health department and reported the adverse event to them and they are the one who advised him to report it to fda.

• Brand Name: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• MDR Report Key: 12421770
• MDR Text Key: 270520569
• Report Number: MW5103722
• Device Sequence Number: 1
• Product Code: LNH
• 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: 09/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 91