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Patient 1
(B)(6) USER COMMENT ON VIDEO "EXPLAINING GLUMA DESENSITIZER (EN)." (B)(6) I JUST HAD SOME APPLIED A FEW HOURS AGO. NOT ONLY DID IT NOT HELP THE PAIN, IT BURNED MY LIP AND GAVE ME HORRIBLE DRY MOUTH. THE DENTIST CLAIMS THEY'VE NEVER SEEN THESE SIDE EFFECTS BEFORE. I FELT A DROP FALL ON MY TONGUE AND I FELT A BURNING SENSATION. THEY WIPED IT OFF BUT I'VE BEEN HAVING PROBLEMS SINCE. BEWARE! (B)(4) STATEMENT ON (B)(6) COMMENT: WE ARE VERY SORRY FOR THE INJURY YOU SUFFERED. IT IS A CHEMICAL BURN THAT MAY COME ABOUT IF THE PRODUCT COMES IN CONTACT WITH UNPROTECTED SOFT TISSUES IN THE MOUTH. IT COULD HAVE BEEN PREVENTED WITH THE USE OF A RUBBER DAM TO PROTECT THE SOFT TISSUE AND USING A MINIMAL AMOUNT OF DESENSITIZING AGENT ON THE BRUSH. THESE RECOMMENDATIONS ARE STATED IN THE DENTIST'S INSTRUCTIONS FOR USE. THE BURN IS SELF-HEALING AND THE SOFT TISSUE WILL REGENERATE NORMALLY WITHIN 5 TO 10 DAYS. FOR MORE INFORMATION PLEASE DO NOT HESITATE TO CONTACT OUR SAFETY MANAGEMENT AT (B)(4) SCREEN SHOT (B)(6). THIS INCIDENT IS REPORTABLE ACCORDING TO 21 CFR 803. THE FDA DEFINES THIS AS A SERIOUS INJURY(21 CFR SEC. 803.3) THIS INCIDENT CAME TO OUR ATTENTION VIA (B)(6) COMMENT. A PATIENT COMMENTED THAT AFTER GLUMA WAS APPLIED IT BURNED HIS LIP AND GAVE HIM DRY MOUTH, HE ALSO FELT A DROP CONTACT HIS TONGUE AND FELT A BURNING SENSATION. THE INCIDENT WILL BE REPORTED TO MAINTAIN COMPLIANCE WITH 21 CFR 803. DUE TO THE FACT THAT (B)(4) DOES NOT HAVE THE PATIENT'S CONTACT INFORMATION, THE PATIENT'S INJURIES AND HEALING STATUS CANNOT BE VERIFIED. IT ALSO CANNOT BE DETERMINED IF THERE WAS MEDICAL INTERVENTION. (B)(4) IS REPORTING OUT OF AN ABUNDANCE OF CAUTION.