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

Catalog Number 441000

Device Problem Insufficient Information (3190)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 12/14/2018

Event Type  Injury  

Manufacturer Narrative

We will review ifu of the device to determine improvement of the information on potential allergens.

Event 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
• Type of Device: 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
• MDR Text Key: 132911743
• Report Number: 1410097-2019-00001
• Device Sequence Number: 1
• Product Code: EMA
• UDI-Device Identifier: D6584410001
• UDI-Public: D6584410001
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K001730
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 441000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/14/2018
• Event Location: Outpatient Treatment Facility
• Initial Date Manufacturer Received: 12/14/2018
• Initial Date FDA Received: 01/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other