SLEEP APNEA MOUTHPIECE
Received Jul 28, 2023 · Event occurred Aug 2, 2022
Report MW5120340 · MDR key 17424704
Device
Generic name
Sleep Appliances With Patient Monitoring
Manufacturer
Prosomnus Sleep TechnologiesPatient
82 YR · Male
- Sleep Dysfunction
- Weight Changes
- Sleep Dysfunction
- Weight Changes
Narrative
Description of Event or Problem
I TESTED POSITIVE FOR SLEEP APNEA. TO CORRECT THIS PROBLEM I WAS BREATHING OXYGEN WHILE SLEEPING. MY DENTIST, (B)(6), SOLD ME A DEVICE TO PREVENT THE SLEEP APNEA. I PURCHASED A PULSE OXIMETER FROM EBAY TO INDICATE WHEN I HAD SLEEP APNEA AND HOW MANY EPISODES I HAD. THE DEVICE WAS BY PR0SOMNUS SLEEP TECHNOLOGIES. WHEN USING THE DEVICE WITH THE OXYGEN, MY RESULTS WERE WONDERFUL. SUBSEQUENTLY, I LOST 20 POUNDS AND I WANT TO SEE IF I COULD ELIMINATE THE OXYGEN. WHEN I RETESTED THE MOUTHPIECE MY RESULTS WERE UNSATISFACTORY. I INITIALLY THOUGHT I HAD AN ISSUE WITH THE DENTIST, HOWEVER, I SEE A MUCH BIGGER ISSUE WITH PROSOMNUS. THE DENTIST RESOLD THE DEVICE, BUT THE DEVICE WAS NOT EFFECTIVE. I AM SURE THAT MANY PEOPLE BOUGHT THIS DEVICE AND OTHERS THAT WERE ALSO WORTHLESS. WHOEVER GOT A WORTHLESS DEVICE DID NOT CURE THEIR SLEEP APNEA AND SUBSEQUENTLY CREATED MORE CARDIAC DAMAGE. I HAVE NO IDEA AS TO THE NUMBER, BUT A LOT OF PEOPLE MUST HAVE DIED BECAUSE OF SOMETHING LIKE THIS. IT IS NECESSARY FOR YOU TO CLAMP DOWN ON PROVIDERS OF BOGUS MEDICAL PRODUCTS LIKE THIS.