InjuryLRK
SOMNOMED
Received Apr 21, 2021 · Event occurred Feb 10, 2020
Report MW5100932 · MDR key 11706198
Device
Generic name
Device, Anti-snoring
Manufacturer
Dental Prosthetic Services, Inc./ Somnomed Inc.Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
34 YR
- Pain
- Pain
Narrative
Description of Event or Problem
I HAD A TRIAL OF SOMNOMED ORAL APPLIANCE FOR SLEEP APNEA. I DEVELOPED JAW PAIN. THE DENTIST SUGGESTED I HAVE TMJ. I WAS RECOMMENDED BY BOTH DENTIST AND SLEEP DOCTOR TO STOP USING THE DEVICE. FDA SAFETY REPORT ID # (B)(4).