FDA.reportPublic FDA data

MAUDE MDR 8191726

MDR report key
8191726
Report number
MW5082525
Event key
0
Event type
3
Date of event
2018-12-19
Date received
2018-12-20
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
1ULTRASOUNDULTRASOUNDUNKMUII N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-12-2001. S

Event Narratives#

D

Patient 1

I HAD AN EXTENSIVE ULTRASOUND CHECK OF THE ABDOMEN WITH MY GENERAL PRACTITIONER (IN (B)(6)) YESTERDAY MORNING AND THAT EVENING I HAD SUDDEN, UNUSUAL PAIN IN THE EXACT AREAS HE CONCENTRATED ON. IT WAS A DIFFERENT KIND OF PAIN THAN ANY OTHER ABDOMINAL PAIN I'VE HAD BEFORE AND DIFFERENTLY DISTRIBUTED. MY ABDOMEN FEELS BLOATED AND SOMEHOW WOUNDED. I DON'T THINK IT'S BECAUSE OF WHAT I ATE. I'VE NEVER EXPERIENCED PAIN AFTER ULTRASOUND BEFORE BUT THIS EXAMINATION WAS PROLONGED AND INVOLVED TWO DIFFERENT HEADS ON THE DEVICE.