InjuryEGD
PT RELIEF WAX
Received Jul 21, 2009
Report 1036212-2009-00084 · MDR key 1421195
Device
Product problems
- Insufficient Device Problem Information
Patient
UNK
- Swelling
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A PT EXPERIENCED SWELLING OF THE LIP WITHIN TEN MINUTES OF PLACING RELIEF WAX; THE COMPLAINANT INDICATED THAT MEDICAL TREATMENT WAS SOUGHT, THOUGH DID NOT SPECIFY THE TYPE OF TREATMENT.
Additional Manufacturer Narrative
WHILE IT IS UNK 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.