IRM ZOE INTERMEDIATE RESTORATIVE MATERIAL
Received Jun 18, 2015 · Event occurred May 11, 2015
Report 8010638-2015-00007 · MDR key 4860127
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Reaction
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS EVALUATED AND FOUND TO BE WITHIN SPEC.
Description of Event or Problem
IN THIS EVENT IT WAS REPORTED THAT A PATIENT EXPERIENCED AN ALLERGIC REACTION AFTER THE USE OF IRM CEMENT. THE PATIENT DEVELOPED A COUGH, WHICH WORSENED AND THEN HAD DIFFICULTY BREATHING. THE PATIENT SAW HER DOCTOR WHO PRESCRIBED AN ANTIHISTAMINIC DRUG. THE PATIENT HAS SINCE RECOVERED.
Additional Manufacturer Narrative
WHILE IT IS UNKNOWN IF THE DEVICE USED IN THIS CASE CAUSED OR CONTRIBUTED TO THE PATIENT'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 EVALUATION, THOUGH HAS NOT BEEN RETURNED AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.