SUREFIL ONE ECO A2

Additional Manufacturer Narrative

INVESTIGATION RESULTS: COMPLAINT MATERIAL WAS DISCARDED AND LOT IS NOT KNOWN - SO NO INVESTIGATIONS CAN BE CONDUCTED! UPON REQUEST, A BATCH WAS COMMUNICATED AND TWO ACTIVATED CAPSULES WERE SENT IN. CUSTOMER SENT TWO ACTIVATED CAPSULE, THEREFORE RETAIN WAS TESTED. THE RETAIN PRODUCT CAN BE MIXED AND PROCESSED AS USUAL. WORKING TIME IS IN SPECIFICATION. COMPLAINT CANNOT BE CONFIRMED.

Description of Event or Problem

IN THIS EVENT IT IS REPORTED THAT SUREFIL ONE ECO A2, WHEN ACTIVATING OR SHAKING THE CAPSULE, THE TWO COMPONENTS POWDER AND LIQUID DID NOT MIX. ONLY LIQUID CAME OUT OF THE CAPSULE. IN THE PROCESS, SOME OF IT ENTERED THE PATIENT'S MOUTH. THE ORAL MUCOSA IS AFFECTED. THE DENTIST APPLIED A WOUND OINTMENT FOLLOWING THE INCIDENT. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION IS BEING REQUESTED.

Additional Manufacturer Narrative

WHILE IT IS UNKNOWN IF THE DEVICE USED IN THIS CASE CAUSED OR CONTRIBUTED TO THE PATIENT¿S SYMPTOMS, IT IS POSSIBLE AS ALLERGIC REACTIONS TO DENTAL MATERIALS ARE KNOWN AND REPORTED, WITH MEDICAL CONSEQUENCES BEING DEPENDENT UPON THE SEVERITY OF THE INDIVIDUAL ALLERGIC RESPONSE AND SUBSEQUENT EXPOSURE TO THE SAME MATERIAL. THEREFORE, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER WAS NOT PROVIDED FOR RETAINED-PRODUCT TESTING AND/OR DHR REVIEW.