HYPERBARIC OXYGEN THERAPY

Description of Event or Problem

I RECEIVED HYPERBARIC OXYGEN THERAPY AT A PRIVATE CLINIC IN (B)(6) (B)(6) FOR ABOUT SEVEN MONTHS, NEARLY 100 SESSIONS, USING A HARD-CHAMBER HYPERBARIC OXYGEN SYSTEM. I CAME WITH A PRESCRIPTION FROM A (B)(6)-LICENSED MEDICAL PROFESSIONAL AND TOLD THE OWNERS THAT THE PHYSICIAN-DIRECTED PRESSURE FOR MY CONDITION WAS 2.5 ATA. BEFORE I STARTED, THE OWNER TOLD ME BY PHONE THAT THEY TREATED AT 2.5 ATA, AND AFTER MY THIRD SESSION, HE LOOKED ME IN THE FACE WHEN I CAME OUT OF THE CHAMBER AND CONFIRMED THAT I WAS GETTING 2.5 ATA. ONLY MUCH LATER, AFTER ALMOST 100 SESSIONS AND ABOUT $20,000 IN PAYMENTS, HE ADMITTED THAT THEY HAD ACTUALLY BEEN RUNNING THE CHAMBER AT 2.0 ATA. IN MY VIEW, HE USED HIS OWN DISCRETION TO CHANGE A CORE TREATMENT PARAMETER ON AN FDA-REGULATED DEVICE INSTEAD OF FOLLOWING THE PHYSICIAN-DIRECTED PRESSURE I HAD PRESENTED. THROUGHOUT MY CARE I REPEATEDLY OBSERVED THE SAME PLASTIC BREATHING TUBING BEING REUSED ON MANY DIFFERENT CHRONICALLY ILL PATIENTS OVER LONG PERIODS. I WAS TOLD THAT THE INSIDE OF THE OXYGEN TUBING WAS NOT CLEANED BECAUSE "OXYGEN KILLS GERMS." I WAS ALSO TOLD THAT THE RETURN TUBING WAS RINSED IN A SMALL BATHROOM SINK NEXT TO A TOILET USING FRAGRANCED PURACY LAVENDER-AND-VANILLA HAND SOAP AND THEN HUNG TO DRY IN THE PATIENT AREA, AFTER WHICH IT WAS REUSED ON OTHER PATIENTS. I SAW TUBING HANGING OUT TO DRY IN THAT AREA MYSELF. I WAS ALSO TOLD THAT THE OWNER, DAN, USES HIS OWN DEDICATED PERSONAL TUBING, WHILE PATIENTS ARE EXPECTED TO USE THE SHARED REUSED TUBING. ON (B)(6) 2026, I HAD A SESSION USING THE CLINIC'S TUBING THAT HAD GONE THROUGH THIS HAND-SOAP BATHROOM-SINK PROCESS. ABOUT 10 MINUTES INTO THE TREATMENT I DEVELOPED A STRONG SOAP TASTE AND SMELL IN MY MOUTH AND THROAT WHILE BREATHING THROUGH THE TUBING. I REMAINED FOR THE FULL 60-MINUTE SESSION. OVER THE NEXT SEVERAL DAYS I EXPERIENCED SEVERE MUCOSAL IRRITATION INVOLVING MY EYES, NOSE, SINUSES, THROAT, TONGUE, AND MOUTH, CHEST DISCOMFORT AND LEFT ARM PAIN, AND I FELT ACUTELY UNWELL. MORE THAN A WEEK LATER I STILL FELT INFLAMED AND UNWELL. EARLIER IN MY CARE I HAD TRIED TO PROTECT MYSELF BY BUYING BRAND-NEW MEDICAL-SUPPLY HOSES AT MY OWN EXPENSE AND USING THEM FOR ABOUT A MONTH; DURING THAT PERIOD, I FELT NOTICEABLY BETTER, BUT THE CLINIC LATER REFUSED TO LET ME CONTINUE USING MY OWN CLEAN HOSES AND REQUIRED ME TO RETURN TO THEIR TUBING. AFTER MORE THAN A WEEK OF STILL FEELING HORRIBLE FOLLOWING THE (B)(6) 2026 SESSION, I SAW MY DOCTOR AND DESCRIBED WHAT I HAD SEEN AND EXPERIENCED. SHE TOLD ME THAT HER MEDICAL PRACTICE WOULD NEVER HANDLE BREATHING TUBING THAT WAY, THAT THIS WAS NOT NORMAL MEDICAL PROCESS OR PROCEDURE, AND THAT THIS TYPE OF TUBING IS INTENDED FOR SINGLE-PATIENT USE. SHE STATED THAT IT IS HIGHLY CONCERNING FOR A FACILITY TO REUSE BREATHING TUBES ON A CHRONICALLY ILL PATIENT POPULATION. SHE ALSO SAID THAT IN HER PRACTICE THEY DISPOSE OF THE TUBING AFTER USE AND THEN USE NEW TUBING FOR THAT PATIENT OR THE NEXT PATIENT. I ALSO HAVE PHOTOGRAPHS OF THE BATHROOM SINK, TOILET, HANGING REUSED TUBING, THE SOAP USED TO WASH THE TUBING, AND OTHER ASPECTS OF THE SETUP, AS WELL AS EMAILS, TEXTS, AND A VOICEMAIL FROM THE OWNERS ACKNOWLEDGING THAT WE HAD BEEN "GOING BACK AND FORTH WITH THE HOSES AND THE MASKS," AND I CAN PROVIDE THESE RECORDS TO FDA UPON REQUEST. PATIENT CODE: 1932, 1994, 2330, 2359, 4910. DEVICE CODE: 1091, 1126. REFERENCE REPORT: MW5189632, MW5189632-1. THIS REPORT CAPTURES HYPERBARIC DEVICE #2.