FDA.reportPublic FDA data

MAUDE MDR 5053496

MDR report key
5053496
Report number
MW5055890
Event key
0
Event type
3
Date of event
2015-08-20
Date received
2015-08-29
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
1VELASHAPEVELASHAPESYNERONNUV* *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-08-290

Event Narratives#

D

Patient 1

I HAD VELASHAPE BY SYNERON PERFORMED FOR 1/2 HOUR ON THE BACK SIDES OF MY UPPER LEGS. OPERATOR SAID, DRINK LOTS OF WATER AFTERWARDS, TO REMOVE TOXINS. DRIVING HOME, MY STOMACH GOT QUEASY, AND GOT WORSE AS THE DAY PROGRESSED. NEXT DAY, I GOT A HEMORRHOID (NEVER BEFORE HAD THEM). NEXT FEW DAYS, I GOT SEVERAL HEMORRHOIDS. I AM THIN, ATHLETIC, 5'5", (B)(6) CAUC FEMALE, BP AVG 112/69, ALWAYS SOFT, THIN STOOLS. I DO NOT EAT OUT, AND HAVE A VERY LIMITED DIET, THE ONLY CHANGE BEING THE SEALED WATER BOTTLE GIVEN BY PRACTITIONER. THE OPERATOR SAID SYNERON SAID THIS IS NOT A POSSIBLE SYMPTOM. WELL, I KNOW IT IS WHAT CAUSED MY EXCRUCIATINGLY PAINFUL SYMPTOMS. SO I AM NOW REPORTING IT.