Description of Event or Problem · 0
I AM WRITING TO REPORT A SERIOUS ADVERSE EVENT AND TO BRING TO YOUR ATTENTION A DISCREPANCY BETWEEN THE PRODUCT DESCRIPTION ON AMAZON AND THE FDA APPROVAL DOCUMENTATION (510(K): K200727) FOR A TENS & EMS DEVICE. THE PRODUCT WAS PURCHASED ON AMAZON, AND I EXPERIENCED SIGNIFICANT NEGATIVE EFFECTS DESPITE FOLLOWING ALL RECOMMENDED SAFETY GUIDELINES. PRODUCT INFORMATION: AUVON DUAL CHANNEL TENS EMS UNIT 24 MODES MUSCLE STIMULATOR, MODEL NUMBER: AS8012, ORDER ID: (B)(4), ASIN: B085TL8TPJ. THE PRODUCT IS LISTED ON AMAZON WITH A DESCRIPTION STATING IT HAS 24 MODES. HOWEVER, ACCORDING TO THE FDA APPROVAL DOCUMENTATION FOR 510(K) K200727, THE AS8012 MODEL HAS ONLY 20 OPERATION PROGRAMS, WHICH INDICATES A DISCREPANCY BETWEEN THE PRODUCT LISTING AND THE APPROVED SPECIFICATIONS. ON SEVERAL OCCASIONS, AFTER USING THE TENS & EMS DEVICE AS PER THE INSTRUCTIONS PROVIDED, I EXPERIENCED ELECTRICAL SHOCKS THAT WERE UNEXPECTED AND INTENSE. ADDITIONALLY, I DEVELOPED SKIN IRRITATION AND SEVERE BLISTERING IN THE AREAS WHERE THE ELECTRODE ADHESIVE PADS WERE PLACED. THE SKIN DAMAGE OCCURRED AFTER REPEATED USE, AND THE BLISTERS WERE PAINFUL AND REQUIRED MEDICAL ATTENTION. THE PRODUCT CAUSED PHYSICAL HARM, INCLUDING SKIN INJURIES, NECESSITATING A COMPLAINT TO THE FDA. THE ELECTRICAL SHOCKS AND SUBSEQUENT SKIN REACTIONS WERE ALARMING. THE PRODUCT CAUSED ME CONSIDERABLE PHYSICAL DISCOMFORT AND LED TO VISIBLE SKIN INJURIES THAT REQUIRED CLEANING, BANDAGING, AND FURTHER MEDICAL EVALUATION. I HAVE NOT RETURNED TO USING THE DEVICE SINCE THE LAST INCIDENT DUE TO SAFETY CONCERNS. DUE TO THE SERIOUS ADVERSE EVENT AND THE DISCREPANCY IN THE PRODUCT DESCRIPTION, I RESPECTFULLY REQUEST THAT THE FDA INVESTIGATES THIS MATTER. I WOULD BE MORE THAN WILLING TO PROVIDE FURTHER DOCUMENTATION OR TO BE INTERVIEWED IF NEEDED. I AM CONCERNED ABOUT THE SAFETY OF THIS DEVICE AND THE POTENTIAL HARM IT MAY CAUSE TO OTHER USERS. THANK YOU FOR YOUR ATTENTION TO THIS IMPORTANT MATTER. I LOOK FORWARD TO YOUR RESPONSE. THE PRODUCT IS LISTED ON (B)(6) WITH A DESCRIPTION STATING IT HAS 24 MODES. HOWEVER, ACCORDING TO THE FDA APPROVAL DOCUMENTATION FOR 510(K) K200727, THE AS8012 MODEL HAS ONLY 20 OPERATION PROGRAMS, WHICH INDICATES A DISCREPANCY BETWEEN THE PRODUCT LISTING AND THE APPROVED SPECIFICATIONS.