FDA.reportPublic FDA data

MAUDE MDR 7317014

MDR report key
7317014
Report number
MW5075702
Event key
0
Event type
3
Date of event
2018-03-01
Date received
2018-03-05
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
1AQUASONIC CLEAR ULTRASOUND GELAQUASONIC CLEAR ULTRASOUND GELPARKERMUII N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-03-0501. O

Event Narratives#

D

Patient 1

I HAD A TRANSVAGINAL ULTRASOUND AND THE RADIOLOGY TECH USED THE CLEAR AQUASONIC ULTRASOUND GEL. I HAD A SEVERE REACTION TO THE BLUE ONE BEFORE AND I HAD A MUCH LESSER BUT STILL EVIDENT REACTION TO THIS CLEAR ONE. THE SKIN IRRITATION IS AN INTENSE BURNING AND ITCHING THE LONGER IT'S THERE AND DOESN'T GO AWAY AFTER WASHING IT OFF. THIS REACTION IS VERY SIMILAR TO MY LATEX ALLERGY. I'M NOT SURE IF THIS GEL HAS ANYTHING IN COMMON WITH LATEX. "DID THE PROBLEM RETURN IF THE PERSON REDUCED THE DOSE OR STOPPED TAKING OR USING THE PRODUCT: NO, DID THE PROBLEM RETURN IF THE PERSON STARTED TAKING OR USING THE PRODUCT AGAIN: YES, DO YOU STILL HAVE THE PRODUCT IN CASE WE NEED TO EVALUATE IT: NO." REASON FOR USE: TRANSVAGINAL ULTRASOUND GEL OR TUBE.