MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-04 for VARIOLINK VENEER 591425AN manufactured by Ivoclar Vivadent Ag.
[71907279]
Patient Sequence No: 1, Text Type: N, H10
[71907280]
Customer complained that the material did not polymerize properly when used with the bluephase style curing light. Due to a darkening under the crowns (microleakage), the health care professional had to cut off all of the restorations.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612352-2017-00002 |
| MDR Report Key | 6456204 |
| Date Received | 2017-04-04 |
| Date of Report | 2017-03-27 |
| Date Mfgr Received | 2017-02-14 |
| Date Added to Maude | 2017-04-04 |
| 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 |
| Manufacturer G1 | IVOCLAR VIVADENT AG |
| Manufacturer Street | BENDERERSTRASSE 2 |
| Manufacturer City | SCHAAN, LI 9494 |
| Manufacturer Country | LS |
| Manufacturer Postal Code | 9494 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VARIOLINK VENEER |
| Generic Name | MATERIAL, TOOTH SHADE, RESIN |
| Product Code | EBF |
| Date Received | 2017-04-04 |
| Returned To Mfg | 2017-02-14 |
| Catalog Number | 591425AN |
| Lot Number | U33189 |
| Operator | DENTIST |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IVOCLAR VIVADENT AG |
| Manufacturer Address | BENDERERSTRASSE 2 SCHAAN, LS 9494 LS 9494 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-04-04 |