HYPERBYTE VIBRATION DEVICE

Additional Manufacturer Narrative

WHILE IT IS UNKNOWN IF THE DEVICE USED IN THIS CASE CAUSED OR CONTRIBUTED TO THE PATIENT¿S SYMPTOMS, IT IS POSSIBLE AS ALLERGIC REACTIONS TO DENTAL MATERIALS ARE KNOWN AND REPORTED, WITH MEDICAL CONSEQUENCES BEING DEPENDENT UPON THE SEVERITY OF THE INDIVIDUAL ALLERGIC RESPONSE AND SUBSEQUENT EXPOSURE TO THE SAME MATERIAL. THEREFORE, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER WAS NOT PROVIDED FOR RETAINED-PRODUCT TESTING AND/OR DHR REVIEW.

Description of Event or Problem

IN THIS EVENT IT IS ALLEGED THAT THE PATIENT HAD AN ALLERGIC REACTION- FACIAL SWELLING (ANGIOEDEMA) - TO THE USE OF THE HYPERBYTE VIBRATION DEVICE. THE MOTHER OF THE PATIENT REPORTED THEIR DAUGHTER HAD TO GO TO THE ER FOR FACIAL SWELLING WHICH IS ALLEGED TO BE TRIGGED BY THE DEVICE. THE PATIENT IS AN ALIGNER WEARER. FURTHER INFORMATION IS REQUESTED. NO INJURY WAS REPORTED FROM THE ALLEGED EVENT. SINCE THE FACIAL SWELLING (ANGIOEDEMA), COULD NECESSITATE MEDICAL/SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR PERMANENT IMPAIRMENT OF A BODY FUNCTION, THIS MALFUNCTION WOULD BE LIKELY TO CAUSE/CONTRIBUTE TO A SERIOUS INJURY SHOULD IT RECUR. AS SUCH, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803.

Additional Manufacturer Narrative

INVESTIGATION: DURING THE INVESTIGATION, THE DEVICE HAD NOT BEEN RECEIVED, AND THE LOT NUMBER INFORMATION REQUIRED FOR A DEVICE HISTORY RECORD (DHR) REVIEW WAS NOT PROVIDED. THE USER WAS INSTRUCTED TO IMMEDIATELY DISCONTINUE USE OF THE DEVICE. FOLLOWING THE REVIEW, IT APPEARS THAT THE PATIENT'S FACIAL SWELLING IS LIKELY CAUSED BY AN UNDERLYING CONDITION. PLEASE SEE THE ATTACHED EMAIL AND COMMENTS FROM THE CLINICAL TEAM FOR FURTHER DETAILS. TAKEN FROM EMAIL FROM DOCTOR THAT THIS EVENT WAS DISCUSSED ABOUT. I WOULD AGREE THAT THIS IS A REPORTABLE EVENT BUT IT CAN BE DIFFICULT TO ESTABLISH IF THE HYPERBYTE WAS THE ROOT AND SOLE CAUSE OF THE INCIDENT. IT¿S IMPORTANT TO NOTE THAT SHE STARTED TREATMENT IN (B)(6) 2022 AND I HAVE INCLUDED A SCREENSHOT BELOW FROM A CHECK-IN ON (B)(6) 2022 WHERE SHE STATES THAT SHE WAS USING HYPERBYTE EVERY DAY FOR 5 MIN A DAY. IN MY OPINION THERE MAY HAVE BEEN SOMETHING ELSE UNDERLYING OR HAPPENING THAT SIMULTANEOUSLY WAS TRIGGERED AND CAUSED THE REACTION.