REJUVAPEN NXT

Description of Event or Problem

I WAS DOING A MICRO-NEEDLING TREATMENT ON THE PATIENT, WHEN THE NEEDLES STABBED THE PATIENT IN THE FACE BEYOND THE INTENDED DEPTH. THERE WAS NO WARNING, THE CLIENT NEARLY JUMPED OFF THE TABLE AND BEGAN BLEEDING IN THE AREA WHERE THE INCIDENT HAPPENED. I REPLACED THE NEEDLE CARTRIDGE AND TESTED IT AND AGAIN THE NEEDLE WAS NOT TREATING PROPERLY. THIS IS A SERIOUS DANGER AS IT COULD CAUSE SEVER DAMAGE IN AREAS WITH BLOOD VESSELS. IN SPEAKING WITH OTHER PROVIDERS THIS IS A KNOWN ISSUE WITH THIS DEVICE AND SHOULD BE ADDRESSED IMMEDIATELY. FDA SAFETY REPORT ID# (B)(4).