MOUTH GUARD NEOMEN

Description of Event or Problem

I USED A MOUTH GUARD WHICH WAS SUPPOSEDLY FDA APPROVED. I SHOULD HAVE DONE MY RESEARCH. THIS MOUTH GUARD IS NOT FDA APPROVED, AS PER YOUR SEARCH FUNCTION, DESPITE CLAIMING THAT IT IS. THIS DEVICE DOES NOT LIST WHAT SORT OF MATERIAL IT IS. I FOLLOWED THE PROVIDED INSTRUCTIONS TO MOLD THE MOUTH GUARD TO MY TEETH, BUT UNFORTUNATELY IT NOT ONLY BURNED MY GUMS A BIT, IT LEFT A STRANGE FILM ON MY TEETH AND AFTER USING IT I HAVE HAD A STRANGE STOMACH PAIN. I REMOVED THE DEVICE AND WILL NOT USE IT AGAIN. I AM UNCOMFORTABLE WITH NOT KNOWING WHAT MATERIAL I HAD IN MY MOUTH, AND I'M UPSET THAT I STUPIDLY JUST THOUGHT THAT THE FDA APPROVAL WAS THERE BECAUSE THEY LABELED THE SIDE OF THE PRODUCT WITH THAT. I WANT TO MAKE SURE NO ONE ELSE HAS ANY STRANGE SIDE EFFECTS. IT'S IMPOSSIBLE TO KNOW IF SOMEONE IS ALLERGIC TO THIS THING IF IT DOESN'T EVEN LIST WHAT IT'S MADE OF. THIS IS THE LINK TO THE ITEM I PURCHASED. I SHOULD NOTE THAT THE ITEM I RECEIVED HAS A DIFFERENT BRAND LISTED ON IT - PROTECH DENTAL. (B)(6). FDA SAFETY REPORT ID# (B)(4).