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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GC CORPORATION FUJI II LC CORE; DENTAL CEMENT
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GC CORPORATION FUJI II LC CORE; DENTAL CEMENT Back to Search Results
Catalog Number 000181
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Skin Irritation (2076)
Event Date 01/01/2011
Event Type  Injury  
Event Description
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.
 
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Brand Name
FUJI II LC CORE
Type of Device
DENTAL CEMENT
Manufacturer (Section D)
GC CORPORATION
76-1 hasunuma-cho, itabashi-ku
tokyo, 174-8 585
JA  174-8585
MDR Report Key6152490
MDR Text Key61696497
Report Number1410097-2016-00004
Device Sequence Number1
Product Code EMA
UDI-Device IdentifierD0470001811
UDI-PublicD0470001811
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 12/07/2016
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 Dentist
Device Catalogue Number000181
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/07/2016
Distributor Facility Aware Date11/22/2016
Date Report to Manufacturer12/07/2016
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/07/2016
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
3M MANUFACTURED CEMENT; METAL FREE CROWN
Patient Outcome(s) Other;
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