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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

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SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING Back to Search Results
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.
 
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Brand NameSYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
Type of DeviceSYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
MDR Report Key12421770
MDR Text Key270520569
Report NumberMW5103722
Device Sequence Number1
Product Code LNH
Reporter Country CodeUS
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received09/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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