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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MRI MACHINE

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Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Headache (1880); Pain (1994); Weakness (2145); Burning Sensation (2146); Toxicity (2333); Reaction (2414); No Code Available (3191)
Event Date 02/28/2018
Event Type  Injury  
Event Description
Mri and mra with contrast, doterem. Within an hour onset of severe leg weakness, pain, aches, burning in both legs. Two months problems have gotten worse. I have seen 4 drs who say they've never heard of this and contrast was safe! also stomach issues, burning esophagus and brain fog. I did a 24 hour unproved urine test at (b)(6) and gadolinium in my urine 34 days was level 29. I was told it would pass through me in one hour. I have no kidney issues or diabetes. I had bad headaches and after the injection and which i believe poisoned me, i have been hardly able to walk. I did a provoked challenge 6 hours urine test a week ago and waiting on results. This is not a safe contrast and i am suffering every day since. My legs are like lead. I was told this was safe if i had no kidney or diabetes and the symptoms keep getting worse. I have this poison in me and people should be alerted that this is a very toxic harmful drug! i am seeing dr number 5 today for a way to get it out of me. This product needs to be destroyed! it has destroyed my health! now my stomach burns and also i have trouble swallowing. All of this began within 2 hours after this contrast which west valley imaging put in my arm! they gave me the box they used! such a shame. I wake up in pain every day since (b)(6). When all i was getting tested safely for was headaches! each dr saying its safe, it is not!.
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Type of DeviceMRI MACHINE
MDR Report Key7464839
MDR Text Key106901555
Report NumberMW5076798
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 Patient
Type of Report Initial
Report Date 04/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/24/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? Yes
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: 04/24/2018 Patient Sequence Number: 1