PATIENT RELIEF WAX

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT DEVELOPED AN ITCHY RASH ON THE HANDS AND FEET 3 - 4 HOURS AFTER APPLICATION OF PATIENT RELIEF WAX TO BANDS THAT HAD BEEN PLACED EARLIER. THE WAX WAS REMOVED IMMEDIATELY. THE RASH REPORTEDLY SPREAD OVER THE ENTIRE BODY AND DEVELOPED INTO RED PATCHES RESEMBLING BLISTERS. TWO DAYS LATER, THE PATIENT CONSULTED A GENERAL PRACTITIONER AND WAS PRESCRIBED PIRITON ANTIHISTAMINE. THE PATIENT ALSO RETURNED TO THE DENTAL PRACTICE WHERE IT WAS NOTED THAT THE ENTIRE ORAL MUCOSA WAS RED AND THAT THE PATIENT HAD RED SPOTS AROUND THE EYES. THE PATIENT REPORTED THAT IT TOOK 3 - 4 DAYS AFTER REMOVAL OF THE BANDS BEFORE THE REACTION WAS 95% CLEAR.

Additional Manufacturer Narrative

WHILE IT IS UNKNOWN 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 REPORTED.