IRM CAPS ENCAPSULATED ZOE INTERNEDIATE RESTORATIVE MATERIAL
Received Jun 16, 2017 · Event occurred Oct 8, 2016
Report 2515379-2017-00009 · MDR key 6648889
Device
Product problems
- Patient-Device Incompatibility
Patient
Not reported
- Hypersensitivity/Allergic reaction
- Rash
- Hypersensitivity/Allergic reaction
- Rash
Narrative
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.
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT EXPERIENCED AN ALLERGIC REACTION AFTER UNDERGOING A RESTORATIVE PROCEDURE WITH IRM AS ONE OF THE MATERIALS. THE PATIENT DEVELOPED MODERATE RASH THAT EVENTUALLY SUBSIDED.
Additional Manufacturer Narrative
MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO OBTAIN THE DEVICE FOR EVALUATION. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER WAS NOT PROVIDED FOR RETAINED-PRODUCT TESTING AND/OR DHR REVIEW.