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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNKNOWN MRI MACHINE SYSTEM, NUCLEAR , MAGNETIC RESONANCE IMAGING

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UNKNOWN MRI MACHINE SYSTEM, NUCLEAR , MAGNETIC RESONANCE IMAGING Back to Search Results
Event Date 02/17/2019
Event Type  No Answer Provided  
Event Description

Water intake 1300 16 oz. Mri at about (b)(6) 2019 at 14:00-15:00 mst. Given contrast dye for mri. Water intake about 16 oz and light dinner at 1900. Sushi, which i often have, first time at this restaurant. Shopping until 2130. Water intake 16oz plus 16oz juice. Drive home arrive home 2300. At 2315 snack: water and cheese, mashed potatoes, salami and olives. Woke on (b)(6) 2019 0530 feeling ill. Mouth filling up with spit of the sort which i have personally experienced right before vomiting when i was a kid. Got up spat out spit, did not vomit. Nauseated for a few minutes. Chief complaint: nausea. On (b)(6) 2019: fatigue.

 
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Brand NameMRI MACHINE
Type of DeviceSYSTEM, NUCLEAR , MAGNETIC RESONANCE IMAGING
Manufacturer (Section D)
UNKNOWN
MDR Report Key8367269
Report NumberMW5084344
Device Sequence Number1
Product CodeLNH
Report Source Voluntary
Reporter Occupation PATIENT
Report Date 02/18/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/21/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Was Device Available For Evaluation? No
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

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