TELIO CS DESENSITIZER
Received Oct 24, 2014 · Event occurred Aug 17, 2014
Report 9612352-2014-00002 · MDR key 4237297
Device
Generic name
Dental Material, Desensitizing Resin
Manufacturer
Ivoclar Vivadent AgCatalog number
627911AN
Lot number
T10346
Product problems
- Device Operates Differently Than Expected
Patient
Not reported
- Numbness
Narrative
Description of Event or Problem
ACCORDING TO THE REPORT FROM THE DENTIST THE PT COMPLAINED OF UNPLEASANT NUMBNESS DIRECTLY AFTER THE PROPHYLAXIS TREATMENT. AFTER TWO DAYS THE PT CONTACTED THE DENTISTS AGAIN AND REQUESTED AN APPOINTMENT BECAUSE THE GINGIVA WAS DISCOLORED.
Additional Manufacturer Narrative
TELIO CS DESENSITIZER IS USED TO CLOSE DENTINE TUBULI AND FOR EXAMPLE TO TREAT SENSITIVE TOOTH NECKS. IN THIS PARTICULAR CASE THE PT WAS AWARE OF NUMBNESS DURING THE TREATMENT. THE SYMPTOMS WERE DESCRIBED BY THE PT. THEY COULD INDICATE AN ALLERGIC REACTION. PRODUCTION RECORDS FOR THIS BATCH WERE NORMAL.
Remedial action
- Notification