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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC MRI SCANNER SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

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GE MEDICAL SYSTEMS, LLC MRI SCANNER SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING Back to Search Results
Device Problem Patient Device Interaction Problem (4001)
Patient Problem Burning Sensation (2146)
Event Date 10/04/2021
Event Type  Injury  
Event Description
Patient completed lumbar mri study and began experiencing internal burning under his right rib approximately 30 minutes after study was completed. Patient had no contact with coil or machine. Patient had been medically cleared to proceed with mri with all implants on the safe list, patient has no implants where burning was indicated. Fda safety report id # (b)(4).
 
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Brand NameMRI SCANNER
Type of DeviceSYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
Manufacturer (Section D)
GE MEDICAL SYSTEMS, LLC
MDR Report Key12589930
MDR Text Key275429278
Report NumberMW5104443
Device Sequence Number1
Product Code LNH
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 10/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/06/2021
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? Yes
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? No
Type of Device Usage

Patient Treatment Data
Date Received: 10/06/2021 Patient Sequence Number: 1
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