VOCO PROFLUORID VARNISH
Received Feb 23, 2023 · Event occurred Jan 31, 2023
Report 8010908-2023-00001 · MDR key 16425510
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Patient Device Interaction Problem
- Adverse Event Without Identified Device or Use Problem
- Patient Device Interaction Problem
Patient
56 YR · Female
- Erosion
- Erosion
Narrative
Additional Manufacturer Narrative
VOCO PROFLUORID VARNISH HAS NO POTENTIAL TO CAUSE THE DESCRIBED DAMAGE TO THE GINGIVA DUE TO ITS COMPOSITION AND CONCENTRATION OF INGREDIENTS. NO SIMILAR CASES ARE KNOWN. THE PRODUCT SENT IN AND THE PRODUCTION RECORDS WERE CHECKED. THERE IS NO PRODUCT DEFECT. THE CASE IS EVALUATED AS AN INDIVIDUAL CASE THAT WAS MOST LIKELY NOT CAUSED BY VOCO PROFLUORIDE VARNISH.
Description of Event or Problem
ACCORDING TO THE DENTIST, A PARODONTOSIS PATIENT UNDERWENT PROPHYLAXIS WITH ULTRASOUND, POLISHING WITH POLISHING PASTE FROM KERR HAWE AND SUBSEQUENT APPLICATION OF VOCO PROFLUORID VARNISH IN (B)(6) FRONT 41/31. THE PATIENT HAD NO ACUTE INFLAMMATION OR SYMPTOMS. AFTER TREATMENT, THE PATIENT HAD EXPERIENCED BURNING AND STINGING OF THE TOOTH AND GUMS. AFTER TWO DAYS, THE PATIENT TELEPHONED TO INQUIRE WHETHER THE PAIN WAS USUAL AND RETURNED TO THE PRACTICE TWO DAYS LATER. THE GUMS AND TEETH WERE DISCOLORED BROWN AND THE GINGIVA HAD RECEDED.