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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MRI IMAGING SYSTEM, NEUCLEAR MAGNETIC RESONANCE IMAGING

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MRI IMAGING SYSTEM, NEUCLEAR MAGNETIC RESONANCE IMAGING Back to Search Results
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problems Dehydration (1807); Memory Loss/Impairment (1958); Necrosis (1971); Pain (1994); Burning Sensation (2146)
Event Date 04/08/2018
Event Type  Injury  
Event Description
My (b)(6) y/o had a closed mri for leg without contrast, they left her sports underwear on which i read contains metal, afterwards asked to cross her arms which i read shouldn't cross arms. She had deodorant and possible mascara have metal and braces, frequency was on 3 which i read a person with brain trauma she has fetal alcohol syndrome should be lower, frequent stops on the way home felt nauseous, extreme dehydration, hot and cold, burning internally from legs to head for weeks. Had to miss school 3 weeks, has gastro pain, short term memory loss. This occurred at (b)(6). Drs haven't heard of this, conveniently, but i see it all over the internet. Internal burns when i looked up her symptoms, also water was burning, going down her throat. Please look into this, i was told none of those things she had would do that, they are lying and covering up for mri and you are putting peoples' lives in danger. They should seriously look into this and report to fda like i just did.
 
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Brand NameMRI IMAGING
Type of DeviceSYSTEM, NEUCLEAR MAGNETIC RESONANCE IMAGING
MDR Report Key7518305
MDR Text Key108600202
Report NumberMW5077260
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 Family Member or Friend
Type of Report Initial
Report Date 05/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/15/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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

Patient Treatment Data
Date Received: 05/15/2018 Patient Sequence Number: 1
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