DENTAURUM WAX
Received Oct 26, 2007 · Event occurred Sep 28, 2007
Report 1036212-2007-00190 · MDR key 933169
Device
Product problems
- Unknown (for use when the device problem is not known)
Patient
YR
- Allergic reaction
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT HAD AN ALLERGIC REACTION TO DENTAURUM WAX. FURTHER INFORMATION HAS BEEN REQUESTED, THOUGH NONE IS AVAILABLE AFTER SEVERAL UNSUCCESSFUL FOLLOW-UP ATTEMPTS.
Additional Manufacturer Narrative
WHILE IT IS UNK IF THE WAX 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 IS REPORTABLE PER 21 CFR PART 803. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER WAS NOT PROVIDED FOR RETAINED-PRODUCT TESTING AND/OR DHR REVIEW.