MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2019-08-08 for VIPI FLASH LIQUID V458 manufactured by Dentsply Brazil.
| Report Number | 8040288-2019-00003 |
| MDR Report Key | 8874857 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-08-08 |
| Date of Report | 2019-08-08 |
| Date Mfgr Received | 2019-07-11 |
| Date Added to Maude | 2019-08-08 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. KARL NITTINGER |
| Manufacturer Street | 221 W. PHILADELPHIA ST. SUITE 60W |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178494424 |
| Manufacturer G1 | DENTSPLY BRAZIL |
| Manufacturer Street | RUA ALICE HERVE 86, BINGEN |
| Manufacturer City | PETROPOLIS, 25665-010 |
| Manufacturer Country | BR |
| Manufacturer Postal Code | 25665-010 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VIPI FLASH LIQUID |
| Generic Name | RESIN, DENTURE, RELINING, REPAIRING, REBASING |
| Product Code | EBI |
| Date Received | 2019-08-08 |
| Model Number | NA |
| Catalog Number | V458 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DENTSPLY BRAZIL |
| Manufacturer Address | RUA ALICE HERVE 86, BINGEN PETROPOLIS, 25665-010 BR 25665-010 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-08-08 |