MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-18 for 44100 manufactured by Gc Corp..
[95180397]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1410097-2017-00005 |
| MDR Report Key | 7126964 |
| Date Received | 2017-12-18 |
| Date of Report | 2017-12-18 |
| Date of Event | 2017-12-04 |
| Date Facility Aware | 2017-12-04 |
| Report Date | 2017-12-04 |
| Date Reported to Mfgr | 2017-12-04 |
| Date Added to Maude | 2017-12-18 |
| 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 |
| Reporter Occupation | DENTIST |
| 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 |
| Generic Name | FUJICEM2 |
| Product Code | EBG |
| Date Received | 2017-12-18 |
| Catalog Number | 44100 |
| Operator | DENTIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GC CORP. |
| Manufacturer Address | 584-1 NAKAHINATA OYAMA-CHO, SUNTO-GUN SIZOUKA, SHIZOUKA-KEN 410-1307 JA 410-1307 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-12-18 |