MERON APPLICATION CAPSULE
Received Feb 12, 2019 · Event occurred Jan 28, 2019
Report 8010908-2019-00001 · MDR key 8331504
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Pain
- Pain
Narrative
Additional Manufacturer Narrative
THE TESTING OF THE MANUFACTURING AND RELEASE DOCUMENTATION DID NOT REVEAL ANY DEVIATIONS. CONTACT WAS MADE WITH THE DENTIST IN CHARGE IN ORDER TO CLARIFY POSSIBLE CAUSES OF THE PROBLEMS. A CLEAR CAUSE COULD NOT BE IDENTIFIED. A PRODUCT DEFECT, AS THE CAUSE OF THE PROBLEMS DESCRIBED, IS NOT IDENTIFIED.
Description of Event or Problem
A DENTIST COMPLAINED THAT HE HAD BEEN HAVING PROBLEMS USING MERON APPLICATION CAPSULES SINCE ABOUT 4 WEEKS. IN AT LEAST 15 CASES, PATIENTS COMPLAINED OF PAIN ONE DAY AFTER THE RESTORATION WAS INSERTED. IN AT LEAST 10 CASES AN ENDODONTIC TREATMENT HAD BEEN CARRIED OUT. DETAILS ON THE PATIENTS AND THE INDIVIDUAL TREATMENT PROCEDURES ARE NOT AVAILABLE. VARIOUS CROWNS AND BRIDGES WERE ATTACHED.