inforMED
InjuryHPH

VELASMOOTH

Received Jun 12, 2007 · Event occurred Jul 26, 2006

Report MW5002653 · MDR key 865517

Device

Generic name

Velasmooth Treatment

Product problems

  • False claim

Patient

37 YR

  • Depression

Narrative

Description of Event or Problem

I HEARD ABOUT THE VELASMOOTH TREATMENT THROUGH LOCAL ADVERTISING. I WAS OPTIMISTIC ABOUT THE PROCEDURE AND I FELT MORE CONFIDENCE IN THE PROCEDURE BECAUSE OF THE FDA APPROVAL AS WELL AS THE POSITIVE OUTLOOK ON THE PROCEDURE. I BEGAN THE TREATMENT OF LAST YEAR AND I COMPLETED MY 16TH TREATMENT. I WENT THROUGH THIS TREATMENT TWICE, A TOTAL OF 32 TREATMENTS. I AM VERY DEPRESSED OVER THE PROCEDURE AS I LOOK EXACTLY THE SAME AFTER AS I DID BEFORE. IT DID NOTHING FOR ME. THE OWNER HAS BEEN VERY NICE AND PROFESSIONAL AND ASSURED ME THAT SHE HAS DONE THE PROCEDURE AS INDICATED BY THE CO. THE CO PROMISED POSITIVE RESULTS AND THERE HAS BEEN NO RESULTS AT ALL. I FEEL LIKE I WAS FOOLED BY THE PROMISE OF LOOSING MY CELLULITE AND NOW ALL I HAVE LOST IS MONEY. I AM AT A LOSS AS TO WHAT TO DO. SHOULD I JUST EXPECT THAT I HAVE LOST MONEY, IN EXCHANGE FOR NO RESULTS AND ADDITIONAL GRIEF AND STRESS? I AM NOT IN A POSITION TO WASTE THIS AMOUNT OF MONEY. I AM A SCHOOL TEACHER AND I HAVE TWO CHILDREN. I WAS REALISTIC ABOUT MY RESULTS. I WAS NOT EXPECTING TOTAL PERFECTION; I WAS JUST EXPECTING SOME IMPROVEMENT AND GOT NOTHING. I AM NOT OVERWEIGHT EITHER. I WORK OUT 4-5 DAYS PER WEEK AND TAKE GREAT CARE OF MY BODY. I RECENTLY CONTACTED THE CO, SYNERON. THEY REVIEWED MY SITUATION AND SAID THAT THEY WILL NOT REFUND ANY OF MY MONEY, AND THAT THERE IS NOTHING ELSE THAT THEY CAN DO. I FEEL THAT THIS PROCEDURE IS FRAUDULENT AND I WOULD LIKE TO KNOW WHAT OTHER OPTIONS ARE AVAILABLE TO ME. CAN YOU PLEASE HELP ME? P.S. PLEASE LET ME KNOW IF YOU NEED FURTHER INFO. DIAGNOSIS OR REASON FOR USE: REDUCE CELLULITE APPEARANCE.