PROPHY-JET POWDER
Received Mar 23, 2011
Report 2424472-2011-00001 · MDR key 2032263
Device
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Erythema
- Swelling
Narrative
Additional Manufacturer Narrative
WHILE IT IS UNKNOWN IF THE PROPHY-JET POWDER 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 MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH RESULTS ARE NOT AVAILABLE AS OF THIS REPORT.
Description of Event or Problem
IN THIS EVENT, IT WAS REPORTED THAT A PATIENT EXPERIENCED LIP SWELLING AND REDNESS DURING A PROCEDURE THAT WAS PERFORMED USING PROPHY-JET POWDER. NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT. LATEX GLOVES WERE USED BY THE CLINICIAN DURING THIS EVENT.