InjuryLRK
SOMNODENT HERBST ADVANCE FLEX
Received Nov 29, 2021 · Event occurred Oct 25, 2021
Report 3005598536-2021-00001 · MDR key 12883544
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Female
- Numbness
- Numbness
Narrative
Description of Event or Problem
ON (B)(6) 2021, THE PATIENT REPORTED TO THEIR PROVIDER THAT THEIR ORAL APPLIANCE CAUSED NUMBNESS TO THE POINT THE PATIENT WENT TO THE ER. THE ISSUE STARTED WITH NUMBNESS IN THE LIPS, THEN TO THE JAW ALL THE WAY TO THE EARS. PATIENT STOPPED WEARING THE DEVICE. ON 11/8/2021, AN UPDATE WAS RECEIVED STATING THAT THE PATIENT VISITED THEIR PRIMARY CARE DOCTOR AND IS SCHEDULED TO FOLLOW-UP WITH DR. (B)(6) DDS.