| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NUPRO PROPHY PASTE | DENTSPLY PROFESSIONAL | EJR | 801313-5 | UNK | R | N |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2013-08-23 | 0 | 1. O |
Patient 1
IN THIS EVENT A DOCTOR CALLED ASKING IF "BALSAM OF (B)(4)" WAS AN INGREDIENT IN NUPRO BECAUSE ONE OF HIS FORMER EMPLOYEES HAS INDICATED THE DEVELOPMENT OF AN ALLERGY WHILE WORKING AT HIS PRACTICE AND HE BELIEVES HE MAY BE SUED. NO SYMPTOMS WERE REPORTED AND THE DOCTOR REFUSED TO COMPLETE AN ALLERGIC REACTION CHECKLIST BECAUSE THEY DO NOT HAVE ANY FURTHER INFO.
Patient 1
DENTSPLY DOES NOT ADD BALSAM OF (B)(4) AS AN INGREDIENT IN NUPRO. HOWEVER, IT MAY BE PRESENT IN SOME OF THE FLAVORS. THE FLAVOR SUPPLIER DOES NOT DISCLOSE THE COMPOSITION SO IT COULD NOT BE DETERMINED IF ANY OF THE FLAVORS HAVE BALSAM OF (B)(4) AS AN INGREDIENT. WHILE IT IS UNKNOWN IF THE DEVICE USED IN THIS CASE CAUSED OR CONTRIBUTED TO THE USER'S ALLEGED ALLERGIC RESPONSE, 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. THIS COMPLAINT IS NOT REGARDING A SPECIFIC INSTANCE OF AN ALLERGIC REACTION DUE TO USE OF THE MATERIAL. IT IS BELIEVED THAT AN ALLERGY DEVELOPED OVER TIME WITH A DENTAL STAFF ASSOCIATE WHO REGULARLY APPLIED NUPRO TO PT DURING PROPHYLAXIS TREATMENTS. THEREFORE, A DEVICE EVALUATION IS NOT POSSIBLE DUE TO THE NATURE OF THIS COMPLAINT.