FDA.reportPublic FDA data

MAUDE MDR 7960647

MDR report key
7960647
Report number
MW5080533
Event key
0
Event type
3
Date of event
2018-05-28
Date received
2018-10-11
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1MEDIUM, CONTRAST, RADIOLOGICMEDIUM, CONTRAST, RADIOLOGICUNKKTAI N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-10-1101. S

Event Narratives#

D

Patient 1

I WOKE UP WITH VERTIGO ALTHOUGH I DID NOT KNOW THAT AT THE TIME. CALLED 911 AND WAS TAKEN TO LOCAL HOSPITAL WHERE THEY SAID THEY WANTED TO GIVE ME A CT BRAIN SCAN. I TOLD THEM I HAD PREVIOUSLY HAD GRAVES' DISEASE AND BELIEVED A PREVIOUS CT SCAN WITH CONTRAST SEVERAL YEARS BEFORE HAD BEEN THE CAUSE. THE DOCTOR SAID HE HAD NEVER HEARD OF THAT AND I SHOULD GET THE SCAN WHICH I DID WITH THE IODINE CONTRAST. I ALSO HAD BLOOD TAKEN WHICH WERE ALL NORMAL. I WAS DISCHARGED WITH DIAGNOSIS OF VERTIGO AND TOLD THE SCAN WAS CLEAR. I CONTINUED TO HAVE VERTIGO EPISODES AND FURTHER HOSPITAL AND DOCTOR VISITS. AFTER ABOUT SIX WEEKS A BLOOD TEST SHOWED MY THYROID NUMBERS WERE ALL INDICATING HYPERTHYROIDISM AND I AM NOW TAKING MEDICATION TO RETURN MY THYROID TO NORMAL. I BELIEVE MORE NOTICE SHOULD BE TAKEN OF THIS POSSIBILITY WITH CT SCANS.