STRAWBERRY AND CREAM LASER LIPO

Description of Event or Problem

AFTER USING THE STRAWBERRY LASER LIPO MACHINE FOR FAT REDUCTION FOR SEVERAL MONTHS. I NOTICED THAT IT LEFT BURN MARKS ON THE PTS. THE BURN MARKS PROGRESSIVELY BECAME MORE PROFOUND WITH EACH USE. LESS THAN A YEAR AFTER PURCHASING THE UNIT, I ATTEMPTED TO REACH THEIR U.S. DISTRIBUTOR REGARDING THE PROBLEM BUT GOT TO RESPONSE. I LATER LEARNED THAT THE DISTRIBUTOR, (B)(4), HAD GONE OUT OF BUSINESS EVEN THOUGH I HAD PAID HER OVER (B)(6) FOR EDUCATION AND TECHNICAL SUPPORT. MY ACCOUNT WAS ABANDONED. I THEN CONTACTED THE CEO OF THE COMPANY, (B)(6), BY EMAIL TO MAKE HIM AWARE OF THE ADVERSE EVENTS BUT HE DID NOTHING. HE REFUSED TO TAKE THE UNIT BACK OR HAVE IT EXAMINED TO DETERMINE THE NATURE OF DEFECT. I EVENTUALLY AFTER HAVING NO LUCK WITH THE DISTRIBUTOR OR MFR, LASER LIPO LTD, I WAS ABLE TO FIND THE NAME OF THEIR TECHNICAL COMPANY, BIOCORE, LISTED ON A PAST INVOICE. I SHIPPED THE UNIT TO THEM IN (B)(6) 2019 AND THEY SUPPOSEDLY REPAIRED IT. BUT WHEN I GOT IT BACK, IT CONTINUED TO BURN MY PTS. BIOCORE APPEARS TO LACK THE KNOWLEDGE TO REPAIR OR MAINTAIN THE UNITS. I HAVE HAD AT LEAST 5 PTS WHO EXPERIENCE BURNS FROM THE UNIT. LASER LIPO LTD IS BASED OUT OF (B)(4), AND THEIR CONTACT INFO IS AS FOLLOWS: (B)(4). I HAVE REPEATEDLY CONTACTED LASER LIPO, AND THEIR CURRENT U. S. DISTRIBUTOR, 321 FATLOSS, BUT THEY HAVE CHOSEN TO IGNORE MY COMPLAINTS. THE COMPANY HAS DENIED FOR OVER TWO YEARS KNOWING ABOUT THE BURNS EVEN THOUGH I HAVE EMAILS SHOWING THAT I REPORTED THE ADVERSE EFFECTS TO THEM. LASER LIPO HAS SHOWN NO REGARD FOR THE SAFETY OF THE PUBLIC AND HAS FAILED TO INVESTIGATE OR REPORT THESE ADVERSE EVENTS. AS A FORMAL MEDICAL TRAINER FOR STRAWBERRY LIPO, IT WAS MY EXPERIENCE THAT ONCE A UNIT WAS SOLD TO A DR, LITTLE OR NO TECHNICAL OR EDUCATIONAL SUPPORT WAS PROVIDED. THEY ALSO PROVIDE LITTLE OPERATIONAL INFO ON HOW TO USE THE UNITS AND AVOID ADVERSE EFFECTS. THEIR MAINTENANCE AND REPAIR SERVICES ARE GREATLY LACKING AND INADEQUATE AT BEST. BIOCORE IS UNABLE TO GET PARTS TO SERVICE THE UNITS AND NEITHER CAN DR PURCHASE REPLACEMENT PARTS IF NEEDED. THERE ARE NO INSTRUCTIONS ON HOW TO GET YOUR UNIT SERVICED OR FROM WHOM. LASER LIPO AND THEIR U.S. DISTRIBUTOR ARE PLACING THE PUBLIC AND DRS ARE RISK BY NOT PROVIDING ADEQUATE TRAINING AND SUPPORT MATERIALS ON THE OPERATION OF THE UNIT. THERE IS NO PROCESS TO REPORT AN ADVERSE EVENT OR RECALL A UNIT. MY MEDICAL PRACTICE HAS SUFFERED A GREAT FINANCIAL LOSS BECAUSE I PAID (B)(6) FOR THE UNIT THAT BEGAN TO MALFUNCTION LESS THAN A YEAR AFTER PURCHASING IT. THESE ADVERSE EFFECTS HAVE ALSO PLACED MY PRACTICE AT RISK FOR A MALPRACTICE SUIT DUE TO THE ADVERSE EFFECTS. THESE UNITS ARE SOLD TO SPA AND BEAUTY SALON BUT CAN CAUSE HARM TO UNSUSPECTING CONSUMERS. THERE IS NO MENTION IN STRAWBERRY LASER LIPO OF POTENTIAL BURNS FROM A TREATMENT AND NEITHER WAS THIS POTENTIAL ADVERSE EFFECT DISCLOSED TO ME AS A DR. MY MEDICAL PRACTICE HAS BEEN PLACED AT RISK FOR MALPRACTICE SUITS AND THESE UNITS SHOULD NOT BE SOLD TO BEAUTY SALON OR OTHER NON-PHYSICIAN BUSINESS. I HAVE NO OTHER RECOURSE BUT TO FILE A COMPLAINT DIRECTLY WITH THE FDA REGARDING THE ADVERSE EVENTS. FDA SAFETY REPORT ID# (B)(4).