GLASS IONOMER LUTING CEMENT
Received Jan 11, 2019 · Event occurred Dec 14, 2018
Report 1410097-2019-00001 · MDR key 8241882
Device
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
Not reported
- Hypersensitivity/Allergic reaction
- Hypersensitivity/Allergic reaction
Narrative
Additional Manufacturer Narrative
WE WILL REVIEW IFU OF THE DEVICE TO DETERMINE IMPROVEMENT OF THE INFORMATION ON POTENTIAL ALLERGENS.
Description of Event or Problem
THE PATIENT RECENTLY HAD ALLERGY TESTING DONE AND DETERMINED TO HAVE ALLERGIES TO SOME OF THE INGREDIENTS IN DENTAL MATERIAL IE 2 HYDROXYETHYL METHACRYLATE , POLYMETHYLMETHACRYLATE AND AMIODARONE. DR. REPORTED ON (B)(6) 2019 THAT THE PATIENT HAD A STRONG REACTION TO HEMA ( HYDROXYETHYL METHACRYLATE). HER SYMPTOMS HAVE BEEN A REOCCURRING FACIAL RASH. THE PATIENT IS BEING TREATED WITH FACIAL CREAM. DR. IS EVALUATING IF CREAM WILL RESOLVE THE PROBLEM. IF NOT, WILL THEN CONSIDER TO REMOVE THE RESTORATION WITH 3 UNIT BRIDGE. THE MOST RECENT ONE WAS PLACED WITH FUJICEM 2 IN 2016. THEY DO NOT KNOW WHAT OTHER CEMENTS WERE USED ON HER OTHER RESTORATIONS.