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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENERAL ELECTRIC 3T DISCOVERY 750 MRI GE SYSTEM, NUCLEAR MAGNETIC RESONNENCE IMAGING

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GENERAL ELECTRIC 3T DISCOVERY 750 MRI GE SYSTEM, NUCLEAR MAGNETIC RESONNENCE IMAGING Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Radiation Burn (1755); Erythema (1840); Burning Sensation (2146)
Event Date 02/15/2018
Event Type  No Answer Provided  
Event Description
Pt had mri of prostate on 3t scanner (ge discovery 750) for about 30 min. During the exam he felt burning sensation on his right lower leg above the knee cap outer side. Later that night he noticed redness, like sun burn in three areas about one inch in size. No blisters or break skin noted, but there is darkened area per pt. Pt was advised to seek medical attention for the burned skin. He is treating burn with aloe vera, per his dr's instruction.
 
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Brand Name3T DISCOVERY 750 MRI GE
Type of DeviceSYSTEM, NUCLEAR MAGNETIC RESONNENCE IMAGING
Manufacturer (Section D)
GENERAL ELECTRIC
MDR Report Key7302343
MDR Text Key101279085
Report NumberMW5075559
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 Other Health Care Professional
Type of Report Initial
Report Date 02/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/27/2018
Device Operator
Was Device Available for Evaluation? Yes
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?
Type of Device Usage

Patient Treatment Data
Date Received: 02/27/2018 Patient Sequence Number: 1
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