MAUDE Adverse Event Report: GC CORPORATION -FUJI OYAMA FACTORY GLASS IONOMER LUTING CEMENT; GC FUJICEM 2

Catalog Number	441000
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	12/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
We will review ifu of the device to determine improvement of the information on potential allergens.
Event or Problem Description
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.

• Brand Name: GLASS IONOMER LUTING CEMENT
• Common Device Name: GC FUJICEM 2
• Manufacturer (Section D): GC CORPORATION -FUJI OYAMA FACTORY; 584-1 nakahinata; oyama-cho, sunto-gun; shizuoka-ken, 410-1 307; JA 410-1307
• MDR Report Key: 8241882
• Report Number: 1410097-2019-00001
• Device Sequence Number: 16546053
• Product Code: EMA
• UDI-Device Identifier: D6584410001
• UDI-Public: D6584410001
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K001730
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 01/11/2019

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: Health Professional
• Device Catalogue Number: 441000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/14/2018
• Event Location: Outpatient Treatment Facility
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2018
• Initial Report FDA Received Date: 01/11/2019
• 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: Other