DELTON LIGHT CURE PIT AND FISSURE SEALANT
Received Mar 21, 2013 · Event occurred Feb 16, 2013
Report 2515379-2013-00006 · MDR key 3030606
Device
Product problems
- Patient-Device Incompatibility
Patient
Not reported
- Hypersensitivity/Allergic reaction
- Swelling
Narrative
Description of Event or Problem
IN THIS EVENT IT WAS REPORTED THAT A PATIENT EXPERIENCED AN ALLERGIC REACTION TO THE USE OF DELTON, A PRODUCT USED AS A SEALANT. THE SYMPTOMS REPORTED WERE SWELLING OF THE GINGIVA WHICH LASTED FOR TWO WEEKS. NO MEDICAL INTERVENTION WAS NECESSARY.
Additional Manufacturer Narrative
WHILE IT IS UNKNOWN IF THE DEVICE 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 WAS NOT RETURNED FOR EVALUATION. HOWEVER, THE LOT NUMBER WAS PROVIDED AND RETAINED-PRODUCT TESTING AND/OR DHR REVIEW ARE PLANNED. THE RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.