Description of Event or Problem · 0
I'M WRITING TO ASK THAT YOU PLEASE CONDUCT AN INVESTIGATION INTO POSSIBLE FRAUD COMMITTED BY SONENDO, INC. IN THE FDA REGISTRATION OF THEIR DENTAL DEVICE CALLED THE GENTLEWAVE SYSTEM WITH YOUR OFFICE. I'M A PATIENT IN LOS ANGELES AND I WAS SEVERELY INJURED BY THIS MEDICAL DEVICE THAT YOUR OFFICE REGULATES, NAMELY, AN ENDODONTIC CLEANSING DEVICE CALLED GENTLEWAVE SYSTEM MANUFACTURED BY SONENDO, INC. THIS IS A DEVICE THAT IN ADDITION TO UTILIZING A SONOGRAPHIC DESCALER ALSO UTILIZES A HYDRAULIC PRESSURIZED CHAMBER TO DELIVER A VERY HIGHLY PRESSURIZED SODIUM HYPOCHLORITE (BLEACH) SOLUTION WITHIN A TOOTH BEING ENDODONTICALLY TREATED. THIS HYDRAULICALLY PRESSURIZED SYSTEM THAT DELIVERS A SPECIFIC PRESSURE OF LIQUID WITHIN EACH TOOTH DEPENDING ON THE TOOTH BEING TREATED ALONG WITH A BUBBLE CHAMBER SEAL AROUND THE TOOTH ARE ENTIRELY NEW TECHNOLOGIES WITHIN THE FIELD OF DENTISTRY AND ENDODONTICS THAT CLEARLY DO NOT QUALIFY FOR A PRE-MARKET FDA EXEMPTION PURSUANT TO 21 CFR 872.4850. NEVERTHELESS, IT APPEARS THAT THIS COMPANY CLAIMED THIS EXEMPTION PRIOR TO THE MARKET LAUNCH OF THIS PRODUCT IN THE US BACK IN 2016 AND WAS GRANTED THIS EXEMPTION BY YOUR OFFICE. AS A RESULT, THIS HYDRAULIC CHAMBER DELIVERING HIGHLY PRESSURIZED SODIUM HYPOCHLORITE INTO A PATIENT'S TOOTH HAS NEVER BEFORE BEEN PROFESSIONALLY EVALUATED BY THE FDA TO ASSURE ITS SAFETY AND EFFICACY. THIS SODIUM HYPOCHLORITE PRESSURIZED SYSTEM IS WHAT CAUSED A SEVERE INJURY TO ME. IT CAUSED A SEVERE CHEMICAL BURN ABOVE MY TOOTH 15 BEING TREATED WITH A SEVERE CHEMICAL BURN WITHIN MY LEFT MAXILLARY SINUS LEAVING ME WITH PERMANENT AND DEBILITATING CHRONIC NERVE PAIN IN THAT AREA AND CHRONIC SINUSITIS STEMMING FROM THE DAMAGE TO THE SINUS MEMBRANE ABOVE MY TOOTH 15. I HAD BLOOD AND BLEACH SPILLING OUT OF MY LEFT NOSTRIL AS A RESULT OF THIS MACHINE WHICH IS NOT WHAT PATIENTS EXPECT WHEN THEY GO IN FOR A ROOT CANAL PROCEDURE. TISSUES FROM MY LEFT MAXILLARY SINUS THROUGH MY LEFT NASAL CAVITY WERE CHEMICALLY BURNED BY THIS MACHINE DUE TO THE HIGHLY PRESSURIZED BLEACH THAT IT EMITS WITHIN THE TOOTH THAT THE DEVICE IS TREATING. MY ENDODONTIST IN WHOSE OFFICE I WAS SEVERELY INJURED INFORMED ME THAT HE WAS GOING TO FILE AN FDA ADVERSE INCIDENT REPORT REGARDING MY INJURIES AND INCIDENT WITH THIS MACHINE, AND YET, NO SUCH INCIDENT REPORT APPEARS IN YOUR DATABASE. PRIOR TO MY INJURY AND MY TREATMENT WITH THIS MACHINE, HE HAD STATED THAT HE HAD BEEN INSTRUMENTAL IN HELPING THE COMPANY RECEIVE FDA APPROVAL FOR THEIR DEVICE AS A PROFESSIONAL ADVISOR TO THE COMPANY. PERHAPS HE THOUGHT IT WOULD BE FINANCIALLY INCONVENIENT TO BRING MY INJURIES AND INCIDENT TO THE ATTENTION OF THE FDA GIVEN THE FINANCIAL TIES HE HAS WITH THE COMPANY? WHILE I CANNOT SPEAK FOR HIS BEHAVIOR, I'M HEREBY BRINGING THIS MATTER TO YOUR ATTENTION AS A PATIENT WHO WAS SEVERELY INJURED BY THIS DEVICE. WAS YOUR OFFICE AWARE THAT THIS COMPANY'S DEVICE HAS A LOT OF NOVEL TECHNOLOGICAL MODULES WITHIN IT THAT ARE ENTIRELY NEW TO THE FIELD OF DENTISTRY WITH EACH NOVEL MODULE DIRECTLY AFFECTING THE SAFETY AND EFFICACY OF THIS DEVICE? EACH NOVELTY LAUNCHED AS A MODULE WITHIN A MEDICAL DEVICE THAT AFFECTS THE DEVICE'S SAFETY AND EFFICACY FOR PATIENTS SHOULD REQUIRE CAREFUL FDA PRE-MARKET EVALUATION AND APPROVAL WHICH THIS DEVICE HAS NEVER RECEIVED. WERE YOU AWARE THAT THIS DEVICE HAS A HYDRAULIC PRESSURE CHAMBER THAT DELIVERS BLEACH INTO TEETH WITH SUCH FORCE THAT THE ROOT TIPS CAN TURN INTO HIGH PRESSURE SPRINKLERS OF BLEACH INTO ONE'S BODY ABOVE THE ROOT TIP WITH SEVERE POSSIBLE DAMAGE TO THE PATIENT'S MAXILLARY SINUS AND SURROUNDING TISSUES? WAS THE BUBBLE CHAMBER SEAL OF THIS MACHINE EVER DISCLOSED TO YOU BY THE APPLICANT THAT RECEIVED A SUMMARY EXEMPTION OF PRE-MARKET REVIEW AND EVALUATION BY YOUR OFFICE CLAIMING THEIR MACHINE WAS SUBSTANTIALLY SIMILAR TO ENDODONTIC DESCALING SYSTEMS DATING BACK TO THE 70'S? A CAREFUL EXAMINATION OF ENDODONTIC SYSTEMS DATING BACK TO THE 1970'S HAS REVEALED THAT WE HAVE NEVER HAD A SYSTEM SIMILAR TO THE GENTLEWAVE SYSTEM IN THE 1970'S. YES, THERE WERE SOME ENDODONTIC DESCALER'S, BUT NOTHING LEVERAGING THE TECHNOLOGICAL MODULES THAT THIS SYSTEM HAS. THERE WERE NO SYSTEMS WITH COMPLICATED HYDRAULICS NOR BUBBLE CHAMBER SEALS DATING BACK TO THIS TIME WITH INDIVIDUALIZED COMPUTER CONTROLLED PRESSURE SETTINGS PER TOOTH FOR THE BLEACH BEING EMITTED AT HIGH VELOCITY AND PRESSURE INTO A PATIENT'S TOOTH THAT THEIR EXEMPTION FROM PRE-MARKET EVALUATION CITES. IF THE MACHINE IS AUTOMATICALLY ADJUSTING PRESSURE SETTINGS BASED ON THE TOOTH BEING TREATED, SHOULD NOT THOSE PRESSURE SETTINGS HAVE BEEN REVIEWED BY AN EXPERT PANEL AT THE FDA TO ASSURE THEIR SAFETY PRIOR TO THE LAUNCH AND MARKETING OF THIS DEVICE IN THE US? WHAT ABOUT PATIENTS GOING THROUGH ENDODONTIC RE-TREATMENT? THIS HAPPENED TO BE MY CASE. WE HAVE VERY LITTLE PULP LEFT IN OUR TOOTH FROM A PRIOR ENDODONTIC TREATMENT. IS THIS MACHINE'S ONE-SIZE-FITS-ALL PRESSURE SETTINGS BASED ON THE TOOTH BEING TREATED A SMART WAY TO DELIVER SODIUM HYPOCHLORITE INTO A PATIENT'S TOOTH, OR DOES THAT ONE-SIZEFITS- ALL MODEL PUT THE PATIENT AT RISK OF THE DEVASTATING INJURY I SUSTAINED BECAUSE RETREATMENT PATIENTS DO NOT HAVE AS MUCH PULP IN THEIR TOOTH AS THE COMPUTER MODULE OF THIS SYSTEM PRESUMES? PRESSURE SETTINGS SHOULD OBVIOUSLY BE ADJUSTED FOR PATIENTS THAT ARE GOING THROUGH RETREATMENT VS. FIRST TIME ENDODONTIC TREATMENT AS THEY DON'T HAVE VERY MUCH PULP WITHIN THEIR TOOTH TO SERVE AS A BUFFER AGAINST THE TOXICITY OF THE PRESSURIZED BLEACH BEING EMITTED BY THIS MACHINE. SODIUM HYPOCHLORITE SOLUBILIZES ALL BIOLOGICAL TISSUES AND NERVES. WITHIN THE CONTEXT OF A ROOT CANAL PROCEDURE AND WHILE CONFINED WITHIN A TOOTH, IT CAN SERVE AN IMPORTANT CLEANSING FUNCTION. HOWEVER, WHEN EMITTED WITH HIGH PRESSURE ABOVE THE ROOT TIP OF A TOOTH, THE TOXICITY CONSEQUENCES CAN BE EXTREMELY DANGEROUS. THIS MACHINE AND ALL OF THE NOVEL TECHNOLOGIES EMBEDDED WITHIN IT HAS VERY LITTLE IN COMMON WITH ENDODONTIC SYSTEMS DATING BACK TO THE 1970'S, AND AS SUCH, IT SHOULD NOT HAVE RECEIVED AN EXEMPTION FROM PREMARKET REVIEW PURSUANT TO 21 CFR 872.4850 AT THE FDA. I WOULD LIKE YOUR OFFICE TO PLEASE TAKE IMMEDIATE ACTION TO INVESTIGATE, AND IF WARRANTED, REMOVE THIS PRODUCT FROM THE US MARKET UNTIL THIS MACHINE AND ALL OF ITS NOVEL "BELLS AND WHISTLES" HAVE BEEN THOROUGHLY VETTED BY FDA. IT IS ABSOLUTELY FRAUDULENT FOR THIS COMPANY TO CLAIM A 21 CFR 872.4850 EXEMPTION FROM PREMARKET REVIEW BY YOUR OFFICE AND YET HAVE ALL OF THESE NEW TECHNOLOGIES INCORPORATED WITHIN THEIR DEVICE THAT CAN PUT PATIENT SAFETY AT RISK. I'M ATTACHING THE DEVICE'S USER MANUAL FOR YOUR REFERENCE AND REVIEW. BELOW IS A LINK WITH SOME INFORMATION THAT THEY USE TO MARKET THEIR DEVICE TO DENTISTS: YOU WILL NOTE THAT IN THE VIDEO ON THIS PAGE THE COMPANY CLAIMS THAT THEIR DEVICE EXERTS A NEGATIVE VORTEX THAT ASSURES THAT NO SODIUM HYPOCHLORITE IS EMITTED FROM THE ROOT TIPS OF TEETH BEING TREATED BY THIS SYSTEM. THIS IS ABSOLUTELY A FALSE CLAIM AS PRECISELY THE EMISSION OF THIS CHEMICAL IS WHAT CAUSED THE SEVERE BURN IN MY LEFT MAXILLARY SINUS. SO THEIR SYSTEM CLEARLY DOES NOT WORK AS ADVERTISED AND NO SYSTEM SIMILAR TO THIS EVER EXISTED IN THE 1970'S. I WOULD LIKE YOU TO PLEASE IMMEDIATELY INVESTIGATE ANY POSSIBLE MISCONDUCT AND OR FRAUD COMMITTED BY THIS COMPANY IN THE REGISTRATION OF THEIR DEVICE WITH YOUR OFFICE AND TO IMMEDIATELY CONSIDER RESCINDING THEIR EXEMPTION FROM FDA PRE-MARKET REVIEW AND APPROVAL. WHEN SUCH DESTRUCTIVE LIQUIDS SUCH AS SODIUM HYPOCHLORITE (BLEACH) THAT CAN SOLUBILIZE AND CHEMICALLY BURN ALL TISSUES AND NERVES WITHIN ONE'S BODY ARE BEING DELIVERED WITH SUCH FORCE INTO A PATIENT'S TEETH, AND DONE SO WITH INDIVIDUALIZED PRESSURES ASSIGNED PER TOOTH, SHOULD NOT SUCH A DEVICE RECEIVE AN APPROPRIATE FDA REVIEW AND APPROVAL PROCESS BEFORE PATIENTS ARE EXPOSED TO SUCH TECHNOLOGY? I FIRMLY BELIEVE THAT HAD THIS DEVICE BEEN CAREFULLY EVALUATED BY YOUR OFFICE BEFORE ITS MARKET LAUNCH MY INJURIES COULD HAVE BEEN AVOIDED AS THE EXPERTS ON YOUR REVIEW PANEL COULD HAVE PROVIDED VALUABLE INPUT REGARDING HOW THIS DEVICE COULD HAVE BEEN CONSTRUED WITH BETTER SAFETY FEATURES EMBEDDED WITHIN IT. A MORE SAFETY-FOCUSED GUI FOR EXAMPLE THAT CAN REMIND PRACTITIONERS REGARDING THE SPACE BETWEEN ROOT TIPS AND A PATIENT'S SINUS (WHICH CAN VARY FROM PATIENT TO PATIENT) COULD BE HELPFUL IN ENHANCING THE SAFETY OF THIS PRODUCT. SUCH A SAFETY GUI WARNING SYSTEM CAN WARN PRACTITIONERS REGARDING THE USE OF THIS MACHINE IF THEIR PATIENT DOES NOT HAVE ENOUGH SPACE BETWEEN THEIR ROOT TIPS AND THEIR MAXILLARY SINUS FOR THIS MACHINE TO BE USED SAFELY. THE ABILITY FOR A PRACTITIONER TO UPLOAD DENTAL CT SCANS AND X-RAYS OF THE TOOTH BEING TREATED TO THEIR TECH SUPPORT DEPARTMENT TO FINE TUNE THE PRESSURE SETTINGS OF THEIR HYDRAULIC SYSTEM COULD HAVE ALSO HELPED TO MITIGATE MY INJURIES. THE MACHINE'S PRESSURE SETTINGS WERE SIMPLY TOO HIGH FOR A PATIENT GOING THROUGH RE-TREATMENT WITH VERY LITTLE PULP IN THEIR TOOTH WHICH LED TO MY DEVASTATING INJURIES. THIS DEVICE HAS VERY LITTLE IN COMMON WITH DEVICES THAT WERE IN THE MARKET IN THE 1970'S WITHIN THE ENDODONTICS INDUSTRY. WE NEVER HAD SODIUM HYPOCHLORITE HYDRAULIC SYSTEMS THAT DELIVERED BLEACH IN AN ENCLOSED AND SEALED TOOTH WITH A BUBBLE CHAMBER SEAL DELIVERING BLEACH WITH SUCH FORCE WITHIN A PATIENT'S TOOTH SUCH THAT THE BLEACH COULD SHOOT OUT OF THEIR ROOT TIPS LIKE A FIRE HOSE AND BURN THEIR SINUS AND CAUSE PERMANENT AND CHRONIC NEURALGIA AND SINUS PAIN RESULTING FROM SUCH A DEVICE. THEIR ONE-SIZE-FITS-ALL PRESSURE SYSTEM CLEARLY DOES NOT FIT ALL. PRESSURE DESIGNED FOR A FIRST TIME TREATMENT WITH A TOOTH FULL OF PULP WITHIN IT SHOULD NOT BE USED IN A PATIENT GOING THROUGH RE-TREATMENT WITH MOST OF THEIR TOOTH'S PULP HAVING BEEN REMOVED IN A PRIOR TREATMENT. THAT PRESSURE IS CLEARLY TOO MUCH AND CAN CAUSE HORRIFIC TOXICITIES SUCH AS WHAT I EXPERIENCED.