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U.S. Department of Health and Human Services

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

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MRI SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Pain (1994); Burning Sensation (2146); Burn, Thermal (2530)
Event Date 12/26/2018
Event Type  Injury  
Event Description
I was in the emergency room (er) at (b)(6) for severe back pain. They were having trouble identifying the cause of the pain so they did an mri. During the procedure, i had a severe burning pain and had to yell at the person administering the test to stop. He did not remove the lead, but did rearrange some of the wiring. Upon removing the lead the next day, discovered a burn and also had a red burn across my chest.
 
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Brand NameMRI
Type of DeviceSYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
MDR Report Key8228517
MDR Text Key132604012
Report NumberMW5082946
Device Sequence Number1
Product Code LNH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 01/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/07/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
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

Patient Treatment Data
Date Received: 01/07/2019 Patient Sequence Number: 1
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