PREMIER NEXTEMP

Additional Manufacturer Narrative

THE ADVERSE EVENT OCCURED TO THE DENTIST. NO PATIENTS WERE IMPACTED. NEXTEMP CEMENT CREATES AN EXOTHERMIC REACTION. THE MORE CEMENT USED, THE MORE HEAT WOULD BE GENERATED. THE AMOUNT THE DENTIST APPLIED TO HIS FINGER IS A SUBSTANTIALLY AND SIGNIFICANTLY MORE THAN WHAT WOULD BE APPLIED TO A TOOTH PREPARATION. THEREFORE, THE RISK OF PULP DAMAGE OR INCREASE SENSITIVITY TO NEXTEMP CEMENT IS A NOMINAL RISK TO THE PATIENT.

Description of Event or Problem

DENTIST APPLIED NEXTEMP CEMENT TO HIS GLOVED HAND SINCE PATIENTS HAVE BEEN MORE SENSITIVE TO TEMPERATURES RECENTLY. HE REPORTED THAT NEXTEMP GOT EXTREMELY HOT AND HAD TO RIP HIS GLOVE OFF DUE TO PAIN FROM THE HEAT. DENTIST ASSUMES THAT NEXTEMP MAY BE TOO HOT ON PATIENTS TOOTH PREPARATION BASED ON THE ADVERSE EVENT WHICH OCCURED ON HIS GLOVED HAND.