MAUDE Adverse Event Report: GC CORP.; FUJICEM2

Catalog Number	44100
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Irritation (1941); Itching Sensation (1943); Swelling (2091)
Date of Event	12/04/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
After placing a crown the patient experienced itching,swelling, and sores in the mouth.Dr removed the crown & cement and patient was placed on steroid and the symptoms dissipated.Patient saw an allergist who determined that the patient is allergic to the fujicem2.

• Common Device Name: FUJICEM2
• Manufacturer (Section D): GC CORP.; 584-1 nakahinata; oyama-cho, sunto-gun; sizouka, shizouka-ken 410-1 307; JA 410-1307
• MDR Report Key: 7126964
• Report Number: 1410097-2017-00005
• Device Sequence Number: 19168750
• Product Code: EBG
• UDI-Device Identifier: D6584410001
• UDI-Public: D6584410001
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 12/18/2017
• Report Date (Section F): 12/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Dentist
• Device Catalogue Number: 44100
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/04/2017
• Event Location: Other
• Date Report to Manufacturer: 12/04/2017
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention