PROFLUORID L SD
Received May 21, 2026 · Event occurred May 6, 2026
Report 8010908-2026-00002 · MDR key 25241515
Device
Product problems
- Use of Device Problem
- Patient Device Interaction Problem
Patient
NA · Female
- Headache
- Nausea
- Vomiting
Narrative
Description of Event or Problem
A PATIENT WAS TREATED WITH PROFLUORID L FOR SENSITIVE TOOTH NECKS IN THE UPPER AND LOWER JAWS AND WAS DISCHARGED WITHOUT ANY SIDE EFFECTS. THE PATIENT REPORTS HAVING SUFFERED FROM NAUSEA, VOMITING, AND HEADACHES IMMEDIATELY AFTER TREATMENT WITH PROFLUORID L. SHE FELT UNABLE TO DRIVE AND CONSULTED A DOCTOR. THE ATTENDING PHYSICIAN SUGGESTED THAT AN OVERDOSE OF FLUORIDE MIGHT BE THE CAUSE OF HER SYMPTOMS.
Additional Manufacturer Narrative
THE INSTRUCTIONS FOR USE STATE THAT THE SYMPTOMS DESCRIBED MAY OCCUR IF THE PRODUCT IS USED INCORRECTLY OR IN EXCESSIVE AMOUNTS. "...INCORRECT APPLICATION (SEE SECTION ENTITLED "METHOD OF USE") CAN RESULT IN LARGER AMOUNTS OF FLUORIDE BEING INTRODUCED INTO THE ORAL CAVITY THAN INTENDED. SWALLOWING SUCH AN AMOUNT CAN LEAD TO NAUSEA, VOMITING AND/OR DIARRHOEA..." PROFLUORID L CONTAINS ETHYL ACETATE, SODIUM FLUORIDE, CALCIUM FLUORIDE, CELLULOSE ESTER AND EUGENOL. DO NOT USE IN CASE OF KNOWN ALLERGIES TO INGREDIENTS. THERE ARE NO KNOWN SIMILAR INCIDENTS ASSOCIATED WITH PROFLUORID L.