MERON APPLICATION CAPSULE

Additional Manufacturer Narrative

A PRODUCT DEFECT, AS THE CAUSE OF THE PROBLEMS DESCRIBED, IS NOT DETECTABLE.

Description of Event or Problem

DURING A VISIT BY OUR SALES REPRESENTATIVE, THE DENTIST CLAIMED THAT HE HAS HAD SEVERAL PROBLEMS AFTER THE DEFINITIVE INSERTION OF RESTORATIONS ON VITAL TEETH. SOME PATIENTS HAD COMPLAINED ABOUT PULP IRRITATIONS, HYPERSENSITIVITIES OR BITE SENSITIVITY (DESPITE GOOD OCCLUSION). THE RESTORATIONS WERE REMOVED AS A PRECAUTIONARY MEASURE AND INITIALLY PROVISIONALLY RESTORED. THE SYMPTOMS THEN IMMEDIATELY SUBSIDED. THE FURTHER TREATMENT WAS CARRIED OUT WITHOUT COMPLICATIONS.