Description of Event or Problem · 1
ON (B)(6) 2013, I WENT TO A DENTAL OFFICE IN (B)(6). THE DENTIST DETERMINED I HAD 5 CAVITIES TO FILL (TURNED OUT LATER THAT I HAD NONE) AND RECOMMENDED THE USE OF A WHISPERJET AIR ABRASION DEVICE. DURING THE USE OF THE WHISPERJET DEVICE, I NEARLY IMMEDIATELY FELT SOMETHING WRONG AND MOTIONED FOR THE DENTIST TO STOP THE PROCEDURE AS I EXPERIENCED NUMBNESS; A SWOLLEN LEFT EYE; SWOLLEN CHEEKS; MOUTH; HEAD, AND NECK; ACHES IN MY HEAD AND THORAX AS WELL AS SLOWED SPEECH AND AN INABILITY TO BREATHE PROPERLY. THE OFFICE MGR DROVE ME TO AN ORAL SURGEON WHO DIAGNOSED THE CONDITION AS EITHER AN ALLERGIC REACTION TO THE ALUMINUM OXIDE OR FACIAL EMPHYSEMA, PRESCRIBED BENADRYL AND AMOXICILLIN AND SENT ME HOME. MY CONDITION DETERIORATED AND ON (B)(6) 2013, I WAS TAKEN TO THE E.R. AND WAS ADMITTED TO THE CRITICAL CARE UNIT (CCU) TO MONITOR THE POTENTIAL FOR A FATAL EMBOLISM, AFTER A CT SCAN AND CHEST X-RAY CONFIRMED A DIAGNOSIS OF SUBCUTANEOUS EMPHYSEMA (ALSO KNOWN AS FACIAL EMPHYSEMA, DENTAL EMPHYSEMA, AIR EMPHYSEMA AND CERVICOFACIAL EMPHYSEMA) OPTICAL AND MEDIASTINAL EMPHYSEMA (ALSO KNOWN AS PNEUMOMEDIASTINUM) E.G. THE AIR TRAVELED FROM THE AIR ABRASION DEVICE THROUGH THE SOFT TISSUES AND INTO THE ESOPHAGUS AND CHEST CAVITY. I'M NOT SURE WHETHER THE DENTIST USED KCP100 OR KCP1000 OR FLEXIJET BUT THE DEVICE SPECS ARE HERE: HTTP://WWW.AFMS.AF.MIL/SHARED/MEDIA/DOCUMENT/AFD-130327-441.PDF AND HTTP://WWW.AMERICANDENTALAIRSONIC.COM/KCP_1000_FILES/KCP1000BRO.PDF WHISPERJET MEDICAL DEVICE MFR: AMERICAN DENTAL AIRSONIC TECHNOLOGIES, (B)(4). HTTP://AMERICANDENTALAIRSONIC.COM/AMERICAN_DENTAL_AIRSONIC.HTML SEC FILLING INFO RE: INCORPORATION OF COMPANY, PATENT RIGHTS, TECHNOLOGIES, NAME CHANGE ETC. HTTP://WWW.GETFILLINGS.COM/. OTHER NOTED MEDICAL DEVICE FDA ISSUES: ADT RECEIVES 510 (K) FDA CLEARANCE FOR PAC TECHNOLOGY USED IN WHISPERJET. LINK 11: LINK 11: HTTP://WWW.THEFREELIBRARY.COM/AMERICAN+DENTAL+TECNOLOGIES+CLEARED+TO+MARKET+NEW+CURING+SYSTEM+FOR...-A017190213 FDA INSPECTION OF AMERICAN DENTAL AIRSONIC TECHNOLOGIES FACILITY RESULTED IN FDA ISSUING A 483 FOR: "PROCEDURES FOR RECEIVING , REVIEWING AND EVALUATING COMPLAINTS BY A FORMALLY DESIGNATED UNIT HAVE NOT BEEN ADEQUATELY ESTABLISHED" . LINK 12: HTTP://WWW.FDANEWS.COM. DUE TO MY DISCUSSION WITH DR. (B)(6) - HE BELIEVES I NOW RUN A HIGHER RISK FOR LUNG CANCER AS THE ALUMINUM PARTICLES, UNLIKE THE AIR MOLECULES, ARE NOT ABLE TO BE RELEASED FROM MY BODY AND THEREFORE REMAIN IN MY LUNGS. (B)(4).