MAUDE Adverse Event Report: GC CORP.; FUJICEM2

Catalog Number 44100

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); Irritation (1941); Itching Sensation (1943); Swelling (2091)

Event Date 12/04/2017

Event Type  Injury  

Event 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.

• Type of Device: 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
• MDR Text Key: 95180397
• Report Number: 1410097-2017-00005
• Device Sequence Number: 1
• Product Code: EBG
• UDI-Device Identifier: D6584410001
• UDI-Public: D6584410001
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 12/04/2017,12/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Catalogue Number: 44100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/04/2017
• Event Location: Other
• Date Report to Manufacturer: 12/04/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention