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U.S. Department of Health and Human Services

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

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GE GE SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING Back to Search Results
Model Number SIGNA EXCITE HDXT 3T
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Burning Sensation (2146); Partial thickness (Second Degree) Burn (2694)
Event Date 09/11/2017
Event Type  Injury  
Event Description
Pt was scanned for a wrist mri post arthrogram. Pt was positioned in the superman position with contralateral arm not touching the arm that was being scanned. Pt had a pad between head and arm. During the exam the pt moved the contralateral hand under the elbow region of the affected side. This caused contact and a loop. Scanning technologist was not aware of this. Pt stated that he felt heat/burning sensation during the last sequence of exam and had a reddened area on knuckles and elbow. Pt left and about 20 min later called and reported blistering where it was red. Pt came back to the clinic and was evaluated by a radiologist and also sent to an urgent care for treatment.
 
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Brand NameGE
Type of DeviceSYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
Manufacturer (Section D)
GE
WI
MDR Report Key6868395
MDR Text Key86468762
Report NumberMW5072156
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 09/13/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/14/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberSIGNA EXCITE HDXT 3T
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? No
Type of Device Usage

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