Description of Event or Problem · 1
PT WAS INJURED FROM THE USE OF VASER SHAPE FROM SOUND SURGICAL TECHNOLOGIES (SST), AFTER USE THE PT WAS UNABLE TO GET OUT OF BED AND WAS HOSPITALIZED AND IS STILL LIVING IN A NURSING HOME UNABLE TO PERFORM ADL'S. HE WAS PART OF A RESEARCH PROJECT MEASURING THE RELEASE OF STORED TOXINS FROM THE ADIPOSE TISSUE (FAT) USING ULTRASONIC DIATHERMY FROM THE DEVICE. HE HAD URANIUM LEVELS REPORTED TO BE IN THE 90TH PERCENTILE IN THE NATION AS WELL AS HIGH LEVELS OF OTHER TOXINS EMITTED WITH THE TREATMENT. I HAVE 3 OTHER INDIVIDUALS WITH URANIUM LEVELS ABOVE THE 80TH PERCENTILE BEING RELEASED AS WELL AS OTHER TOXINS. THE COMPANY SST HAS REFUSED TO PAY ME FOR THE DATA AND EVEN LOOK AT THE INFO OF THE TOXIC RELEASES FROM THEIR DEVICE. THIS POST FDA APPROVAL DATA SHOULD BE GIVEN TO THE DOCTORS AND THE PUBLIC BEING TREATED UNKNOWINGLY WITH THIS DEVICE. I WANT TO FILE A "CITIZEN'S COMPLAINT" AND A MORATORIUM AGAINST THE USE OF THIS DEVICE AS WELL AS THE USE OF THEIR OTHER ULTRASONIC DEVICE THE VASER USED FOR ULTRASONIC ASSISTED LIPOSUCTION. THEY HAVE USED THEIR LAWYER TO SCARE ME AWAY FROM GIVING THEM THE INFO WHICH IS NEEDED FOR PUBLIC SAFETY! PRODUCT: PT WAS USING STANDARD TREATMENT PROTOCOLS RECOMMENDED BY THE MANUFACTURER ON PRESET SETTINGS. TOXINS RELEASED WERE MEASURED BY LABORATORY METAMETRIX. TREATMENT WERE SPACED 2 WEEKS APART. MEASUREMENTS WERE REPEATED AFTER 6 TREATMENTS. ATTEMPTS WERE MADE TO MITIGATE SUSPECTED TOXIN RELEASED FROM STORED ADIPOSE SITES BY MYSELF, NOT W/MANUFACTURERS INSTRUCTIONS IN TRAINING OR ON THEIR WEBSITE. DOSE OR AMOUNT: 20 - 30 MINUTES OF TREATMENT, ROUTE: TRANSDERMAL. DATES OF USE: (B)(6) 2011 - (B)(6) 2013. DIAGNOSIS OR REASON FOR USE: APPROVED FOR EXTERNAL BODY SCULPTING OR THE TEMPORARY.