D
Patient 1
HERAEUS KULZER (B)(4) REPORTS POTENTIAL ALLERGIC REACTION TWO YEARS AFTER DENTURES WERE MANUFACTURED USING (B)(4). LABORATORY OF SOLTA-DENT DENTAL LABORATORY HAS OBTAINED THE EXACT COMPOSITION OF OUR PRODUCT OF PALAXPRESS. AFTER SENDING (B)(4) HAS ASKED FOR RECALL WITH THE ZAP (B)(4). IN THE PHONE CALL WITH (B)(4) TURNED OUT, THAT PATIENT HAS A REACTION TO THEIR UK AND OK - PROSTHESIS. IT HIGHLIGHTS MUCOSAL CHANGES - WHITE ICH, RED SORES. THE DENTURES WERE MADE IN THE YEARS 2012 - SINCE THEN THE POSITIONS ARE AVAILABLE. AFTER A LINING OF THE UK - PROSTHESIS IN MAY OF THIS YEAR WITH PALAXPRESS CLEAR THESE PLACES HAVE DISAPPEARED. THE OK - GRAFT NEXT YEAR SHOULD ALSO BE COLORLESS RELINED. I TOLD THE CUSTOMER TO REFER THE PATIENT TO AN ALLERGIST BEFORE THEY RELINED THE OK OR TO KEEP ME ON THIS CASE ON THE CURRENT. IF IT'S ALLERGY ONLY COLOR PIGMENTS CAN BE THE TRIGGER. THIS INCIDENT OCCURRED IN (B)(6). 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. REPORT TO FDA DUE TO PRODUCT BEING SUBSTANTIALLY EQUIVALENT TO PRODUCT AVAILABLE FOR PURCHASE IN NORTH AMERICA.