MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-01 for MINIGOLD 576628 manufactured by Ivoclar Vivadent, Inc..
[59224670]
Patient Sequence No: 1, Text Type: N, H10
[59224671]
Doctor inserted crown made of minigold on (b)(6) 2016. After four days the patient came back to see the dentist because of discoloration of the minigold crown. The doctor polished the crown with a rubber cup, and the stain went away. After two days the crown become discolored again.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1316092-2016-00005 |
| MDR Report Key | 6070882 |
| Date Received | 2016-11-01 |
| Date of Report | 2016-11-01 |
| Date of Event | 2016-09-13 |
| Date Added to Maude | 2016-11-01 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | MS. DONNA HARTNETT |
| Manufacturer Street | 175 PINEVIEW DRIVE |
| Manufacturer City | AMHERST NY 14228 |
| Manufacturer Country | US |
| Manufacturer Postal | 14228 |
| Manufacturer Phone | 7166912260 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MINIGOLD |
| Generic Name | ALLOY, GOLD-BASED NOBEL METAL |
| Product Code | EJT |
| Date Received | 2016-11-01 |
| Model Number | 576628 |
| Lot Number | V19831 |
| Operator | DENTIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IVOCLAR VIVADENT, INC. |
| Manufacturer Address | 175 PINEVIEW DRIVE AMHERST NY 14228 US 14228 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-11-01 |