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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENERAL ELECTRIC / GE MEDICAL SYSTEMS, LLC GE TWINSPEED 1.5 TESLA MRI; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
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GENERAL ELECTRIC / GE MEDICAL SYSTEMS, LLC GE TWINSPEED 1.5 TESLA MRI; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING Back to Search Results
Model Number TWIN SPEED
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Swelling (2091); Burning Sensation (2146)
Event Date 05/26/2020
Event Type  Injury  
Event Description
An mri of the lumbar spine with and without contrast was performed on the patient at approximately 8:00 am.The patient did not complain of any adverse signs or symptoms throughout the performance of the examination.The patient called back to the facility approximately 6 hours later, complaining of a blister on her leg.The patient stated that she felt a burning in her leg during the mri but thought it may have been related to her lower back pain.Therefore, she did not mention anything at the time of the exam.The patient returned to the facility at approximately 3:00 pm where she was seen by a physician and received treatment for her blister.The occurrence was documented and the quality department was notified to follow up with the patient later in the week to document her progress.Fda safety report id# (b)(4).
 
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Brand Name
GE TWINSPEED 1.5 TESLA MRI
Type of Device
SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
Manufacturer (Section D)
GENERAL ELECTRIC / GE MEDICAL SYSTEMS, LLC
MDR Report Key10108741
MDR Text Key193636222
Report NumberMW5094776
Device Sequence Number1
Product Code LNH
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 05/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/01/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Model NumberTWIN SPEED
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age52 YR
Patient Weight127
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