IRM ZOE INTERMEDIATE RESTORATIVE MATERIAL
Received Feb 11, 2015
Report 2515379-2015-00004 · MDR key 4516752
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Extreme Exhaustion
- Dizziness
- Complaint, Ill-Defined
- Reaction
Narrative
Additional Manufacturer Narrative
WHILE IT IS UNK IF THE DEVICE USED IN THIS CASE CAUSED OR CONTRIBUTED TO THE PT'S SYMPTOMS, IT IS POSSIBLE AS ALLERGIC REACTIONS TO DENTAL MATERIALS ARE KNOWN AND REPORTED, WITH MEDICAL CONSEQUENCES BEING DEPENDENT UPON THE SEVERITY OF THE INDIVIDUAL ALLERGIC RESPONSE AND SUBSEQUENT EXPOSURE TO THE SAME MATERIAL. THEREFORE, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. THE DEVICE IS AVAILABLE FOR EVAL, THOUGH HAS NOT BEEN RETURNED AS OF THIS REPORT. EVAL RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.
Description of Event or Problem
IN THIS EVENT IT WAS REPORTED THAT A PT EXPERIENCED AN ALLERGIC REACTION AFTER THE USE OF IRM DURING A DENTAL PROCEDURE. THE CUSTOMER REPORTED THAT THIS WAS THE SECOND TIME DURING THE PROCEDURE THAT INCORPORATED THE USE OF IRM, WHERE THIS PT EXPERIENCED A REACTION. THE SYMPTOMS REPORTED WERE TIGHTNESS OF THE THROAT, DIZZINESS AND EXTREME EXHAUSTION. THE PT TOOK BENADRYL TO COMBAT THE SYMPTOMS AND IS REPORTEDLY "FINE".