PULSETTO

Description of Event or Problem

I AM REPORTING AN ADVERSE EVENT RELATED TO USE OF A WELLNESS/NEUROMODULATION DEVICE CALLED PULSETTO. WHILE USING THE DEVICE AS DIRECTED, I SUSTAINED THREE BURNS TO MY NECK. TWO BURNS (ONE ON THE LEFT SIDE OF THE NECK AND ONE ON THE RIGHT SUPERIOR NECK) APPEARED CONSISTENT WITH HEAT-RELATED INJURY. A THIRD BURN ON THE RIGHT INFERIOR PORTION OF MY NECK WAS MORE SEVERE AND DEMONSTRATED A CHANGE IN COLOR, INCREASED INFLAMMATION, AND SIGNIFICANTLY GREATER PAIN COMPARED TO THE OTHER TWO BURNS. DUE TO THESE FEATURES, THERE WAS MEDICAL CONCERN THAT THIS INJURY COULD HAVE AN ELECTRICAL COMPONENT. I SOUGHT MEDICAL EVALUATION AT A (B)(6) CLINIC. THE PROVIDER EXPRESSED CONCERN REGARDING THE THIRD BURN AND RECOMMENDED FOLLOW-UP WITH A BURN UNIT. THE INJURY THEREFORE REQUIRED MEDICAL CARE BEYOND ROUTINE SELF-TREATMENT. IN ADDITION TO PHYSICAL INJURY, THE EVENT CAUSED SIGNIFICANT PAIN, INCREASED ANXIETY, AND EMOTIONAL DISTRESS. THE DEVICE WAS MARKETED AND UNDERSTOOD TO BE THERAPEUTIC AND BENEFICIAL; INSTEAD, IT RESULTED IN INJURY, INCREASED PAIN, STRESS, AND THE NEED FOR ADDITIONAL MEDICAL EVALUATION. THE SITUATION ALSO CREATED LOGISTICAL AND EMOTIONAL STRAIN RELATED TO TRANSPORTATION, CHILDCARE, AND PROLONGED MEDICAL VISITS. I HAVE RAYNAUD'S PHENOMENON, WHICH CAN AFFECT TEMPERATURE REGULATION, BUT I DO PERCEIVE HEAT SENSATION. WHILE THE INTENSITY OF HEAT MAY AT TIMES BE MORE DIFFICULT TO DISTINGUISH FROM EXPECTED DEVICE STIMULATION, I AM ABLE TO FEEL HEAT, AND THE INJURY WAS UNEXPECTED. I AM SUBMITTING THIS REPORT TO DOCUMENT THIS ADVERSE EVENT AND TO SUPPORT POST-MARKET SAFETY MONITORING IN CASE SIMILAR INJURIES ARE OCCURRING IN OTHER USERS. PHOTOS OF BURNS AVAILABLE IF REQUESTED. MEDICAL VISIT DOCUMENTED.