inforMED
MalfunctionPLC

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

Patient

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.