MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-07 for FUJI II LC CORE 000181 manufactured by Gc Corporation.
[61696497]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1410097-2016-00004 |
| MDR Report Key | 6152490 |
| Date Received | 2016-12-07 |
| Date of Report | 2016-12-07 |
| Date of Event | 2011-01-01 |
| Date Facility Aware | 2016-11-22 |
| Report Date | 2016-12-07 |
| Date Reported to FDA | 2016-12-07 |
| Date Reported to Mfgr | 2016-12-07 |
| Date Added to Maude | 2016-12-07 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FUJI II LC CORE |
| Generic Name | DENTAL CEMENT |
| Product Code | EMA |
| Date Received | 2016-12-07 |
| Catalog Number | 000181 |
| Operator | DENTIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GC CORPORATION |
| Manufacturer Address | 76-1 HASUNUMA-CHO, ITABASHI-KU TOKYO, 174-8585 JA 174-8585 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 3 | 1. Other | 2016-12-07 |