VELASHAPE
Received Aug 29, 2015 · Event occurred Aug 20, 2015
Report MW5055890 · MDR key 5053496
Device
Generic name
Velashape
Manufacturer
SyneronProduct problems
- Device Operates Differently Than Expected
Patient
61 YR
- No Code Available
Narrative
Description of Event or Problem
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.