SOMNODENT CLASSIC

Additional Manufacturer Narrative

FROM THE FDA FORWARDED, VOLUNTARY REPORT FROM THE PATIENT, SOMNOMED INITIALLY SUSPECTED A HYPERSENSITIVITY REACTION. HOWEVER, AFTER DISCUSSIONS WITH THE PATIENT AND RESEARCH, THE PATIENT APPEARS TO BE HAVING SYMPTOMS RELATED TO CURRENT HEALTH ISSUES (OSA/HYPOTHYROIDISM) AND NOT THE DEVICE. THE PRIMARY AND GASTROENTEROLOGIST DOCTORS, AS WELL AS THE PRESCRIBING DDS, COULD NOT DETERMINE THE CAUSE AND ACCORDING TO THE PATIENT "DON'T SEEMED CONCERNED" ABOUT THE SYMPTOMS. HE SEES SEVERAL DOCTORS QUARTERLY. THE PATIENT AND THE DDS DO NOT WANT TO DISCONTINUE USE OF THE SOMNODENT DEVICE; HOWEVER, THE PATIENT WAS ADVISED TO IMMEDIATELY DISCONTINUE USING THE DEVICE IF A HYPERSENSITIVITY IS SUSPECTED OR CONFIRMED. THE PATIENT ALSO REPORTED NOT CLEANING HIS DEVICE ACCORDING TO THE IFU. THIS REPORT APPEARS TO BE RELATED TO THE PATIENT'S CONCERNS AND QUESTIONS. ONCE RA/QA CALLED AND EMAILED THE PATIENT TO DISCUSS THE DEVELOPMENT PROCESS, WHICH INCLUDED BIOCOMPATIBILITY TESTING/MATERIAL CHARACTERISTICS/DESIGN VALIDATION/510K PROCESS, AND POST-MARKET SURVEILLANCE ACTIVITIES, THE PATIENT WAS MORE CONFIDENT IN THE DEVICE. THIS REPORT DOES NOT MEET THE DEFINITION OF A SERIOUS INJURY, AND THE PATIENT INDICATED THAT HE WAS "LESS CONCERNED ABOUT THIS" PROBLEM. THE PATIENT HAS CHOSEN TO CONTINUE TO RECEIVE OSA TREATMENT BY WEARING HIS SOMNODENT DEVICE NIGHTLY.

Description of Event or Problem

A DEVICE USER REPORTED A VOLUNTARY, SERIOUS INJURY EVENT REPORT WITH THE FDA (MW5060797). SOMNOMED RECEIVED THE REPORT FROM FDA AND IS POSTING THIS RESPONSE. THE PATIENT REPORTED THAT HE DEVELOPED AN UNUSUAL COATING AND CRACKS ON HIS TONGUE. HE ALSO COULD NOT TOLERATE SPICY FOODS ON THE FRONT PART OF HIS TONGUE AND DEVELOPED AN IRRITATION IN HIS STOMACH AND THROAT. AFTER VISITS WITH THREE DOCTORS, THE DOCTORS COULD NOT FIND THE CAUSE OF THE SYMPTOMS. THE PATIENT DID NOT CONTACT SOMNOMED WITH THE PRODUCT COMPLAINT.