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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE 3T WIDE BORE MRI MRI - 3 TESLA WIDE BORE GE MAGNET WITH HIGH PERFORMANCE GRADIENTS

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GE 3T WIDE BORE MRI MRI - 3 TESLA WIDE BORE GE MAGNET WITH HIGH PERFORMANCE GRADIENTS Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Diarrhea (1811); Pyrosis/Heartburn (1883); Itching Sensation (1943); Nausea (1970); Pain (1994); Vomiting (2144); Burning Sensation (2146)
Event Date 01/22/2018
Event Type  Injury  
Event Description
On (b)(6) 2018, i had an mri at (b)(6). The mri was on my lower leg with and without contrast on a brand new mri machine - 3 tesla wide bore ge magnet with high performance gradients. They administered intravenous 15ml of multihance. I arrived at 10:45 am. I went in the room from 11:00 am - 1:20 pm. The procedure took 2 hours and 20 minutes. When they gave me the multihance, my mouth started itching. I told the male tech that my mouth started itching. He told me that it would go away. At home, two hours after having the mri, i became violently ill. I felt extremely nauseous and started throwing up profusely. My stomach became bloated. I also had diarrhea and sharp pains on top of my stomach. I tried drinking water, ginger ale or tea. There was burning at the end of my esophagus. The following day i had terrible heartburn, diarrhea and pain in stomach, and a lump in my throat at the bottom of my esophagus. That friday, (b)(6) 2018, i reported the incident to one of the techs ((b)(6)) that administered the test at (b)(6). She said, everything was normal that they were learning the new mri machine (3 tesla wide bore ge magnet with high performance gradients). I just wanted to alert you to the episode that i had after having an mri on this new machine with contrast.
 
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Brand Name3T WIDE BORE MRI
Type of DeviceMRI - 3 TESLA WIDE BORE GE MAGNET WITH HIGH PERFORMANCE GRADIENTS
Manufacturer (Section D)
GE
MDR Report Key7326974
MDR Text Key102107799
Report NumberMW5075758
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 01/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
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: 03/08/2018 Patient Sequence Number: 1
Treatment
ASPIRIN.; ATORVASTATIN; CHLORATHALIDONE; METFORMIN; OTC MEDS: VITAMIN C; RAMIPRIL; RX MEDS: INSULIN; VITAMIN D.
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