VASERLIPO SYSTEM AND ACCESSORIES

Additional Manufacturer Narrative

NO OTHER INFORMATION WAS PROVIDED BY THE CUSTOMER. THE CUSTOMER DECLINED TO RETURN THE EQUIPMENT FOR EVALUATION. IT IS THE RESPONSIBILITY OF THE CUSTOMER TO PROVIDE ACCESS TO THE EQUIPMENT. THE CANNULA AND/OR PROBE IS A PIECE OF METAL USED DURING THE PATIENT PROCEDURE. THIS PIECE OF METAL DOES NOT STORE ANY TREATMENT DATA AND THUS THERE IS NO INFORMATION TO GATHER FROM ITS RETURN. THE EXCEPTION TO THIS WOULD BE IF THE CANNULA AND/OR PROBE HAD BROKEN INTO PIECES OR WAS REPORTED TO HAVE A BURR THAT WAS INVOLVED IN THE PATIENT INJURY. FOR OTHER REPORTED EVENTS, THESE ITEMS ARE NOT A VIABLE SOURCE OF EVALUATION DATA. THE SYSTEM HAS NO SYSTEM/DATA LOGS THAT CAN BE REVIEWED. ACCORDING TO THE VASERLIPO SYSTEM RISK ASSESSMENT, BURNS ARE A KNOWN POTENTIAL RISK DURING TREATMENT. THE TREND ANALYSIS, RISK ANALYSIS AND DIRECTIONS FOR USE REVIEW WERE CONSIDERED ACCEPTABLE, WITH THE PRODUCT PERFORMING WITHIN ANTICIPATED RATES. DUE TO LACK OF INFORMATION, NO CAUSAL FACTORS CAN BE DETERMINED, AND NO CONCLUSIONS CAN BE DRAWN. NO CORRECTIVE ACTION IS NECESSARY AT THIS TIME.

Description of Event or Problem

AVAILABLE PICTURES OF PRE AND POST PROCEDURE WERE SENT IN AND REVIEWED BY THE MEDICAL REVIEWER. POST INFLAMMATORY HYPERPIGMENTED AREAS ARE VISIBLE ON THE CHEST AND ABDOMEN MOSTLY ON BOTH LATERAL SIDES OF THE ABDOMEN.

Additional Manufacturer Narrative

ATTEMPTS ARE BEING MADE TO CONTACT THE CUSTOMER AND GATHER INFORMATION. AT THIS TIME, NO OTHER INFORMATION IS AVAILABLE. A SUPPLEMENTAL REPORT WILL BE FILED WHEN INFORMATION IS RECEIVED.

Description of Event or Problem

SOLTA MEDICAL INC. WAS CONTACTED BY A PATIENT WHO REPORTED SURFACE BURNING ON THE FLANKS AND STOMACH REGION, WITH PAIN AND A HARDENED BELLY POST VASERLIPO TREATMENT. THE PATIENT REPORTS INTENSE PERSISTING PAIN. NO OTHER TREATMENTS HAD BEEN PERFORMED IN THE SAME SYMPTOM AREA WITHIN THE PREVIOUS 90 DAYS. THE PATIENT HAD NO HISTORY OF AESTHETIC TREATMENTS. THE PATIENT STATED THAT A FORENSIC INVESTIGATION IS IN PROGRESS. THE USER FACILITY REPORTED THAT THE PATIENT WAS BEING TREATED BY LIPOSUCTION OF THE ABDOMEN, FLANKS, PUBIS, NECK, AND SUPRACLAVICULAR LIPOMAS BY THE VASER TECHNIQUE. THE PATIENT EXPERIENCED 2ND DEGREE BURN TO THE SIDE OF THE ABDOMEN POST VASERLIPO TREATMENT. THE AFTERMATH OF THE OPERATION WAS DIFFICULT (INTENSE PAIN, BURNING IN THE STOMACH AND FLANKS). THE PATIENT HAD TO TAKE MORPHINE FOR SEVERAL MONTHS POST PROCEDURE. TREATMENT DESCRIBED AS FAT PANSEMENT WAS PERFORMED. THE SYSTEM WAS TESTED BEFORE THE PROCEDURE IN THE SSI WHILE THE PATIENT WAS UNDER ANESTHESIA. IN THE AREA WHERE THE INJURY OCCURRED, THE SYSTEM WAS IN VASER (V) MODE AND THE HIGHEST AMPLITUDE LEVEL USED WAS 70. NO SYSTEM ERRORS OCCURRED, NOR WAS ANYTHING OUT OF THE ORDINARY NOTICED DURING TREATMENT. THE TOTAL TIME OF THE VASER DELIVERY WAS 25 MINUTES. 4L OF TUMESCENT FLUID WAS USED. A SKIN PORT WAS USED AND WAS NOT DAMAGED OR MISALIGNED. A WET TOWEL BARRIER WAS UTILIZED TO PROTECT THE SKIN FROM THE PROBE CONTACT. 3,7 2 GROOVES PROBES WERE USED FOR TREATMENT. THIS IS NOT THE FIRST TIME THE PROBE/CANNULA WERE USED. THE CANNULAS WERE INTACT AND WITHOUT ISSUE DURING USE. THE DOCTOR REPORTS THE CURRENT PATIENT STATUS AS SLIGHT ABDOMINAL FIBROSIS, SLIGHT DYSCHROMIA RIGHT FLANK 1CM X 2. THE REPORTED OUTCOME IS NOTED AS LIGHT DYSCHROMIA. THE PATIENT¿S BELLY IS STILL INDURATED TO THIS DAY.