D
Patient 1
THIS INCIDENT OCCURRED IN (B)(6). REPORTING TECHNICAL SERVICE: (B)(6). (B)(6) 2014: TELESCOPE PROSTHESIS PRODUCED WITH PALADUR (PATIENT FREE OF COMPLAINTS). END OF 2014: FIRST OF THREE REPAIRS WITH PALADUR WERE PERFORMED AND AFFLICTIONS OF THE PATIENT BEGAN (MUCOSA IRRITATION OF THE THROAT, BURNING SENSATION ON THE TONGUE). 2015: AN ALLERGY TEST WAS ACCOMPLISHED: WITH NO RESULT CONCERNING PALADUR BUT WITH AN ADVERSE REACTION TO A SO CALLED ALLERGY-FREE COMPOUND SINOMER (USED DUE TO A GOOD EXPERIENCE OF THE DENTAL LAB WITH THIS PRODUCT). FURTHER PLANNED MEASURE IS TO REMOVE PALADUR AS FAR AS POSSIBLE AND TO REPLACE THE BASE MATERIAL BY PALADON. PATIENT HAS NEVER SEEN AN ALLERGIST. OBVIOUSLY, A DENTAL TECHNICIAN DID THIS "ALLERGY TESTING" ON ITS OWN; HE DID THIS TEST TO COMPARE PALADUR WITH SINOMER (NOVODENT - METHYL METHACRYLATE FREE PRODUCT). BY NOW THE PATIENT'S AFFLICTIONS AND THE CAUSATION FOR THEM ARE STILL UNCLEAR AND FURTHER INFORMATION HAS TO BE REQUIRED FROM THE LAB AND A REGULAR ALLERGY TEST IS RECOMMENDED. WE RECOMMENDED TO WORK TOGETHER WITH AN ALLERGIST AND WILL SEND THE COMPOUND INFORMATION IF A CONTACT IS GIVEN. ADDITIONALLY, AN ALLOY ALLERGY SHOULD BE CONSIDERED AS IT IS A TELESCOPIC WORK WITH METAL PARTS WHICH COULD BE THE CAUSE FOR THE SYMPTOMS, TOO (SEE NEGATIVE RESULT OF THE UNQUALIFIED ALLERGY TESTING). THIS IS REPORTABLE ACCORDING TO 21 CFR 803. THERE IS AN ALLEGATION OF SERIOUS INJURY AS DEFINED IN PART 803.3. THE PATIENT INVOLVED IS INVESTIGATING A POTENTIAL ALLERGIC REACTION. NO ACCUSATION OR PROOF HAS BEEN GIVEN THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE PATIENTS SYMPTOMS. OUT OF AN ABUNDANCE OF CAUTION WE WILL REPORT THIS INCIDENT. ALTHOUGH THIS EXACT PRODUCT IS NOT AVAILABLE IN NORTH AMERICA, IT IS SUBSTANTIALLY EQUIVALENT TO PALAPRESS AND PALAXPRESS WHICH ARE AVAILABLE IN NORTH AMERICA.