inforMED
InjuryEGD

PT RELIEF WAX

Received Jul 21, 2009

Report 1036212-2009-00084 · MDR key 1421195

Device

Model number

NA

Catalog number

WB-HS

Lot number

150432

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.