FDA Adverse Event Injury Summary report: N

AMERICA SLEEP DENTISTRY ORAL MOUTH PIECE FOR APNEA

MDR report key: 23962107 · Received January 5, 2026

Report

Report Number
MW5181759
Event Type
Injury
Date Received
January 5, 2026
Date of Event
October 20, 2025
Report Date
December 29, 2025
Manufacturer
AMERICA SLEEP DENTISTRY
Product Code
LRK
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
TN, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

I'VE HAD A HORRIBLE EXPERIENCE. IT TOOK FOREVER TO GET THE MOUTH PIECE IN THE MAIL, THEN WHEN I USED IT, IT MADE MY TEETH HURT SO BADLY I HAD TO QUIT USING IT. I THEN ASKED THEM TO PLEASE MAKE IT OVER SO IT WASN'T SO TIGHT ON MY TEETH. IT SQUEEZED MY TEETH AND SCRAPED REALLY BAD AND HURT THE LOWER PART OF MY MOUTH, THE FRENULUM. I COULDN'T GET THE THING OFF IN THE MORNING WITHOUT PRYING IT OFF WITH MY FINGERNAILS TO LOOSEN THE SUCTION EFFECT. WHEN I FINALLY GOT THE REMADE MOUTHPIECE BACK IT MADE MY JAW HURT SO BADLY THAT I HAD TO GO TO THE CHIROPRACTOR TWICE. FOR A JAW ADJUSTMENT. WHEN THEY TOLD ME TO SEND EVERYTHING BACK TO GET IT REMADE, I DID JUST THAT. I SENT THE MOUTHPIECE AND THE TOOL TO ADJUST IT ALONG WITH THE CASE. ALL IN THE EXACT BOX THEY SENT IT TO ME IN. WHEN THEY RESENT ME THE MOUTHPIECE AGAIN, THEY SENT IT IN A DIFFERENT CASE AND DIDN'T SEND ME ANOTHER ADJUSTING TOOL. THEY REFUSE TO SEND ME THE ADJUSTING TOOL STATING THAT IT'S AGAINST THEIR POLICY TO SEND OUT THE SCREWDRIVER. SINCE I CAN'T ADJUST IT CORRECTLY, I CAN'T WEAR IT. AT THIS TIME IT CAUSES TOOTH PAIN AND JAW PAIN AND I STILL GASP FOR AIR THROUGHOUT THE NIGHT. ALL OF THESE ARE POSSIBLE HEALTH CONCERNS. NOW I HAVE A USELESS APNEA MOUTHPIECE AND NO ONE IS REPLYING TO MY EMAILS. PT CODES: 1994, 2330, 1816. DEVICE CODES: 4012, 2183. REF REPORTS: MW5181757, MW5181758.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
15671 AMERICA SLEEP DENTISTRY ORAL MOUTH PIECE FOR APNEA DEVICE, ANTI-SNORING LRK AMERICA SLEEP DENTISTRY

Patients

Seq Age Sex Outcome Treatment
1 Female Required Intervention BIOTIN.| GARLIC.| GINGER. | MAGNESIUM.| TUMERIC.| VIT B COMPLEX.| VIT D.