ELMEX WAX
Received Oct 11, 2007 · Event occurred Sep 11, 2007
Report 1036212-2007-00165 · MDR key 925632
Device
Product problems
- Unknown (for use when the device problem is not known)
Patient
12 YR
- Erythema
- Hives
- Irritation
- Burning Sensation
- Therapy/non-surgical treatment, aborted/stopped
- Treatment with medication(s)
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT DEVELOPED REDDENING, BURNING, IRRITATION, AND LARGE HIVES ON THE GINGIVAL TISSUE AND BACK, EYES, AND STOMACH WITHIN A FEW HRS OF USING ELMEX WAX. THE PT DISCONTINUED USE AND CONSULTED A PHYSICIAN WHO ADMINISTERED SOLUPRED (CORTISONE) AND VIZAL (AN ANTIHISTAMINE). ALSO, THE PHYSICIAN TESTED THE PT FOR FOOD ALLERGIES WITH NEGATIVE RESULTS; FURTHER ALLERGY TESTS ARE PLANNED, THOUGH RESULTS ARE NOT AVAILABLE AS OF THIS REPORT.
Additional Manufacturer Narrative
WHILE IT IS UNKNOWN, IF THE WAX 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. FURTHER, A STEROID AND AN ANTIHISTAMINE WERE ADMINISTERED AS A RESULT. THEREFORE, THIS EVENT IS REPORTABLE PER 21 CFR PART 803. A DHR REVIEW CONDUCTED INDICATES THAT THE PRODUCT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. ALSO, THE SUPPLIER NOTED THAT THE WAX IS DERIVED ENTIRELY FROM PETROLEUM HYDROCARBONS AND DOES NOT CONTAIN ANY ALLERGENS.