InjuryEMA
TEMPBOND NE
Received Dec 3, 2015
Report 8020994-2015-00003 · MDR key 5264203
Device
Generic name
Temporary Dental Cement
Manufacturer
Kerr Italia S.r.l.Catalog number
60256
Lot number
5355539
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Patient Problem/Medical Problem
Narrative
Additional Manufacturer Narrative
THE DENTIST TREATED THE PATIENTS WITH DONTISOLON. THE DENTIST INDICATED THAT NO OTHER INFORMATION COULD BE PROVIDED. THE RETURNED PRODUCT WAS EVALUATED, YIELDING RESULTS WITHIN SPECIFICATIONS.
Description of Event or Problem
A DOCTOR'S OFFICE HAD ALLEGED THAT THREE (3) PATIENTS EXPERIENCED GINGIVITIS AFTER DENTAL PROCEDURES IN WHICH TEMP BOND NE WAS UTILIZED.THIS IS REPORT TWO (2) OF THREE (3).