MRI WITH GADOLINIUM CONTRAST AGENT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-14 for MRI WITH GADOLINIUM CONTRAST AGENT manufactured by Unk.

Event Text Entries

[121638866] I had a contrast mri (magnevist contrast agent) of my prostate and had immediate adverse reactions. This was my first mri with a contrast agent. The contrast agent was injected into me by iv about 30 mins into the mri procedure. I immediately had an incredible pins and needles feeling all over my body that intensified for about 5 secs. Not painful but very scary. The pins and needles feeling slowly subsided and the mri continued for about another 5 mins. The tech had to help me off the mri machine and had to help me sit down in a nearby chair. I had a bad headache, spaced out feeling that hindered my walking, and a brain fog feeling that kept me from thinking clearly. He helped me into the waiting area and said the reactions should clear up soon. The reactions diminished during the next 20 mins so that i felt able to go home. My reactions continued for a few days when i "googled contrast mri side effects" and realized that i had gadolinium poisoning. I took a toxic metals test which tested for 20 toxic metals and the only metal outside the reference interval was gadolinium. The ref interval was 1 and my gadolinium level was 12. I will gladly send this report to you if requested. Since the mri, my headaches have doubled in intensity, and brain fog is still the same. It is very clear to me after doing research that the gadolinium contrast agents break down in the body and gadolinium metal finds areas to go in the body. This is a toxic situation. I was lucky that my side effects showed up immediately and i knew the cause. It is my opinion that there are tens of thousands or more in the usa that have gadolinium poisoning but do not know this because their side effects appear months or even years after their last contrast mri.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5079842
MDR Report Key7880757
Date Received2018-09-14
Date of Report2018-09-13
Date of Event2018-07-21
Date Added to Maude2018-09-17
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameMRI WITH GADOLINIUM CONTRAST AGENT
Generic NameCONTRAST AGENT
Product CodeKTA
Date Received2018-09-14
Model NumberNA
Catalog NumberNA
Lot NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerUNK
Manufacturer AddressUNK UNK


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Deathisabilit 2018-09-14

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