Description of Event or Problem · 0
TO THE U.S. FOOD AND DRUG ADMINISTRATION, I AM FILING A FORMAL COMPLAINT REGARDING A DANGEROUS MEDICAL DEVICE CURRENTLY BEING SOLD IN THE UNITED STATES THROUGH AMAZON.COM. PRODUCT: WRIST BLOOD PRESSURE MONITOR BRAND: FOTOSY, AMAZON ASIN: (B)(4) THIS DEVICE HAS ALREADY CAUSED A SEVERE ADVERSE INCIDENT IN MY HOUSEHOLD. WHILE BEING USED BY A FAMILY MEMBER WHO REQUIRES DAILY MONITORING FOR HYPERTENSION, THE DEVICE CONSISTENTLY PROVIDED INACCURATE READINGS. IT FALSELY INDICATED NORMAL BLOOD PRESSURE VALUES EVEN DURING A HYPERTENSIVE CRISIS. AS A RESULT, URGENT MEDICAL TREATMENT WAS DELAYED. THE PATIENT COLLAPSED AT HOME, WAS TAKEN TO THE EMERGENCY ROOM, AND WAS LATER DIAGNOSED WITH CRITICALLY HIGH BLOOD PRESSURE THAT REQUIRED IMMEDIATE INTERVENTION. ACCORDING TO THE ATTENDING PHYSICIANS, IF WE HAD RELIED ON THIS DEVICE ANY LONGER, THE CONSEQUENCES COULD HAVE BEEN FATAL. THIS PRODUCT IS CLEARLY UNSAFE, MISLEADING, AND PRESENTS A DIRECT THREAT TO PUBLIC HEALTH. I STRONGLY QUESTION WHETHER IT MEETS THE SAFETY AND PERFORMANCE STANDARDS REQUIRED FOR MEDICAL DEVICES. I RESPECTFULLY REQUEST THAT THE FDA URGENTLY INVESTIGATE THIS MATTER, VERIFY THE REGULATORY STATUS OF THE FOTOSY WRIST BLOOD PRESSURE MONITOR, AND TAKE ENFORCEMENT ACTION TO PREVENT FURTHER HARM TO U.S. CONSUMERS. THANK YOU FOR YOUR IMMEDIATE ATTENTION TO THIS URGENT CASE. SINCERELY, (B)(6).