EECP FLOW THERAPY TABLE AND EQUIPMENT

Description of Event or Problem

MY CARDIOLOGIST REFERRED ME TO (B)(6). I STARTED THERAPY SESSIONS (B)(6) 2024. I ASKED DURING MY INTAKE INTERVIEW ABOUT THE SIDE EFFECTS OF THIS THERAPY AND REALLY WASN'T GIVEN THE CLEAR PICTURE THAT THE EECP EQUIPMENT CAN CAUSE SKIN DAMAGE, BRUISING ETC. THE TOPIC WAS REALLY JUST GLOSSED OVER. I REPORTED IMMEDIATE DISCOMFORT (B)(6) 2024 WHEN THEY HOOKED ME UP TO THIS MACHINE. I FELT LIKE I WAS BEING SUFFOCATED, I COULDN'T BREATHE. THEY ACCOMMODATED THE SUFFOCATION WITH ALLOWING ME TO SIT UP BUT IT REQUIRED OXYGEN ALONG WITH SITTING UP FOR ME TO EVEN HAVE MY FIRST SESSION. I REPORTED THAT I HAD BRUISING TO THE ATTENDANT AROUND (B)(6) 2024. I REPORTED TO THEIR EECP ATTENDANT THAT I HAD BLISTERING ON MY RIGHT UNDER THIGH ON (B)(6) 2024 AFTER THE LABOR DAY HOLIDAY. I HAD OBSERVED THE DAMAGE THE MORNING OF (B)(6) 2024 AFTER COMPLETING 6 THERAPY SESSIONS. SINCE FDA APPROVED THE EECP EQUIPMENT WAS FDA ALSO SHOWN CORRECT SIDE EFFECT DATA REGARDING FEELINGS OF SUFFOCATION, SKIN DAMAGE, BLISTERING, BRUISING, MUSCLE PAIN ETC. THE (B)(6) BROCHURE IS FILLED WITH ALL KINDS OF CLAIMS AND POTENTIAL CURES THAT THIS THERAPY IS SUPPOSED TO PROVIDE. IT IS ONE OF THE MOST UNCOMFORTABLE THERAPIES I HAVE EVER EXPERIENCED AND CONSUMERS NEED TO BE MADE AWARE OF THIS ALONG WITH WHAT ACTUAL SIDE EFFECTS TO EXPECT. I THINK THE FDA NEEDS TO REVIEW THE LITERATURE THAT IS BEING DISTRIBUTED AND SCALE IT BACK TO ACTUAL PROVABLE SUBMITTED TO THE FDA FACTS ON WHAT RESULTS HAVE ACTUALLY BEEN PROVIDED TO THE FDA. THIS THERAPY WASN'T TEST RELATED. I AM ENCLOSING PICTURES OF ACTUAL SKIN DAMAGE FROM THE EECP EQUIPMENT.