Description of Event or Problem · 1
WE HAVE EXPERIENCED BOTH BURNING AND BLEEDING WHEN USING THIS DEVICE ON THE FACE. WHEN USING THIS DEVICE ON A CLIENT AROUND HER NOSE, THE PROBE END BEGAN TO SPARK AND THEN ACTUALLY BURNED THE CLIENT'S SKIN. I IMMEDIATELY DISCONTINUED THE SERVICE, BUT THE DEVICE WAS SMOKING AND GAVE OFF AN ELECTRICAL SMELL. I UNPLUGGED THE DEVICE AND CALLED THE MANUFACTURER. HE TOOK THE DEVICE BACK, "MADE AN ADJUSTMENT" AND SENT IT BACK TO US. ADDITIONALLY, THE DEVICE CAUSES BLEEDING ON THE SKIN. NO WHERE IN THE MANUAL IS IT INDICATED THAT THIS IS SUPPOSED TO HAPPEN. THE PROCEDURE IS NOT INVASIVE, WE APPLY PRESSURE WITH THE PROBE SIGNIFICANT ENOUGH TO CLOSE DOWN THE SUPERFICIAL VESSELS IN THE SKIN, BUT THE PROBE IS NOT SHARP AND DOES NOT PENETRATE THE SKIN. IN THE MANUFACTURER'S CONSENT; COUMADIN, ASPIRIN OR OTHER BLOOD THINNERS ARE LISTED AS A CONTRAINDICATION, SO WE DO NOT PERFORM THIS ON THEM, BUT BLEEDING OCCURS IN MOST ELIGIBLE CLIENTS DURING CARE. WE HAD A DEMONSTRATION WITH A SIMILAR DEVICE, NOT A TC3000, BUT A MORE ADVANCED DEVICE BY THE SAME INVENTOR, AND WERE TOLD BY THE REPRESENTATIVE THAT BLEEDING IS NOT SUPPOSED TO OCCUR. TO CONFIRM THAT IS WAS NOT TECHNIQUE, WE USED OUR DEVICE ON THE COMPANY REPRESENTATIVE, AND HE BLED. BLEEDING INTERFERES WITH THE TREATMENT, AS SUCCESS DEPENDS ON A COMPLETELY DRY FIELD. IT IS ALSO A UNIVERSAL PRECAUTION. TC3000 DEVICE TO TREAT SPIDER VEINS. THIS DEVICE IS FDA APPROVED UNDER THE 510K NUMBER K083352.