JET-FRESH PROPHY POWDER
Received Oct 24, 2012 · Event occurred Sep 24, 2012
Report 2424472-2012-00001 · MDR key 2818356
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Pain
- Swelling
Narrative
Description of Event or Problem
IN THIS EVENT IT WAS REPORTED BY A DOCTOR THAT WHEN HE USED MINT JET-FRESH POWDER ON A PT, SHE STARTED COMPLAINING ABOUT PAIN AND SWELLING. THE DOCTOR STATED THAT HE SENT THE PT TO EMERGENCY CARE WITHIN THE COMPANY WHERE SHE WAS GIVEN PREDNISONE.
Additional Manufacturer Narrative
WHILE 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, THIS EVENT IS MORE LIKELY THE RESULT OF THE MATERIAL INADVERTENTLY BEING DIRECTED INTO THE SOFT TISSUE, NOT AN ALLERGIC RESPONSE. AS SUCH, THE ADMINISTRATION OF PREDNISONE IS UNLIKELY TO HAVE BEEN REQUIRED TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE AND IS NOT LIKELY ATTRIBUTED TO RESOLUTION OF THE SYMPTOMS. HOWEVER, SINCE ADMINISTRATION OF PREDNISONE IS CONSIDERED MEDICAL INTERVENTION, REGARDLESS OF WHETHER IT WAS THE APPROPRIATE TREATMENT OR NOT, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. THE DEVICE IS AVAILABLE FOR EVAL, THOUGH HAS NOT BEEN RETURNED AS OF THIS REPORT. EVAL RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.