DETREY CONDITIONER 36
Received Aug 19, 2011
Report 8010638-2011-00011 · MDR key 2227005
Device
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Pain
- Skin Discoloration
- Burning Sensation
Narrative
Description of Event or Problem
IN THIS EVENT IT WAS REPORTED THAT TWO PTS EXPERIENCED BURNING, WHITE DISCOLORATION AND ABLATION OF THE GINGIVAL IMMEDIATELY AFTER CONTACT WITH DETREY CONDITIONER 36. BOTH PTS WERE TREATED WITH KAMISTAD GEL. ONE PT STATED THE PAIN OCCURRED FOR SEVERAL MINUTES. THE OTHER PT RETURNED TO THE DENTIST'S OFFICE TWO DAYS LATER AND HE WAS TREATED WITH VOLON-A AT THAT TIME.
Additional Manufacturer Narrative
IT IS POSSIBLE THAT PROLONGED SKIN / ORAL MUCOSA CONTACT WITH PHOSPHORIC ACID COULD RESULT IN BURNING, IRRITATION, SENSITIZATION, AND OTHER SYMPTOMS. THE DIRECTIONS FOR USE CLEARLY ADDRESS THE POSSIBLE EFFECTS OF ORAL MUCOSA AND SKIN CONTACT AND PROVIDE PREVENTIVE AND CORRECTIVE MEASURES. FURTHERMORE, THIS EVENT IS RELATED TO USE-ERROR AND IS NOT THE RESULT OF A MALFUNCTION OF THE SYRINGE. PLEASE NOTE THAT THE DEVICE INVOLVED IS NOT SOLD IN THE US. HOWEVER, IT IS CONSIDERED SIMILAR TO DEVICES THAT ARE BASED ON ITS COMPOSITION AND SYRINGE DELIVERY MECHANISM. THEREFORE, BECAUSE A SERIOUS HISTORY INJURY OCCURRED, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803.