FUJI II LC CORE
Received Dec 7, 2016 · Event occurred Jan 1, 2011
Report 1410097-2016-00004 · MDR key 6152490
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Skin Irritation
- Skin Irritation
Narrative
Description of Event or Problem
THE INITIAL REPORTER CALLED (B)(4) ON (B)(6) 2016 REGARDING A RASH ON A PATIENT ON THE RIGHT SIDE OF THEIR FACE, ON THE CHEEK FOR 5 YEARS. THE REPORTER STATED THE PATIENT WAS TESTED AND MAY HAVE SENSITIVITY TO METALS. THE REPORTER PROVIDED THE PATIENT'S DENTAL PROVIDER'S INFORMATION. THE REPORTER DID NOT PROVIDE TEST RESULTS. (B)(4) CALLED THE DENTAL PROVIDER ON (B)(4) 2016. THE DENTAL PROFESSIONAL CONFIRMED FUJI II LC CORE, A 3M MANUFACTURED CEMENT, AND A METAL FREE CROWN WAS USED IN 2011 ON THE PATIENT. THE DENTAL PROFESSIONAL STATED THEY SPOKE WITH THE PATIENT ABOUT THEIR CONCERNS AND DID NOT THINK THEY HAD SIGNS OF AN ALLERGY, BUT WOULD CONTINUE TO WORK WITH THE PATIENT AND THEIR ALLERGIST.