TELIO CS LINK
Received Oct 5, 2016 · Event occurred Mar 4, 2015
Report 9612352-2016-00005 · MDR key 6001542
Device
Product problems
- Appropriate Device Problem Term/Code Not Available
Patient
Not reported
- Pain
- Reaction
- Sensitivity of Teeth
- Pain
- Reaction
- Sensitivity of Teeth
Narrative
Description of Event or Problem
THE DENTIST REPORTS THAT 6-7 PATIENTS AS WELL AS 2 STAFF MEMBERS COMPLAIN OF SEVERE SENSITIVITY AFTER USING THE CEMENT. THERE WERE SEVERAL PATIENTS IN WHICH THE CEMENT WAS USED AS WELL HOWEVER WITH NO REACTION. EACH PATIENT SHOWED A PULPAL REACTION TO THE CEMENT. IN EACH COMPLAINT CASE, THE PATIENT COMPLAINED OF A LOT OF PAIN. A TOTAL OF 3 COMPLAINTS WERE RECEIVED: (B)(4) FROM THE SAME DENTIST. ONLY ONE PATIENT RESULTED IN A ROOT CANAL THERAPY RECOMMENDED BY A DIFFERENT/NEW DENTIST. IN THE OTHER PATIENTS THE PAIN CEASED ONCE THE PROVISIONAL RESTORATION AND CEMENT WAS REPLACED.