MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2019-11-27 for PROCLEIX WEST NILE VIRUS ASSAY 9051166 manufactured by Grifols Diagnostics Solutions Inc..
| Report Number | 2032600-2019-00011 |
| MDR Report Key | 9381278 |
| Report Source | LITERATURE |
| Date Received | 2019-11-27 |
| Date of Report | 2019-11-26 |
| Date of Event | 2017-01-01 |
| Date Mfgr Received | 2019-10-30 |
| Date Added to Maude | 2019-11-27 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS AMANDA DOE |
| Manufacturer Street | 10808 WILLOW COURT |
| Manufacturer City | SAN DIEGO CA 92127 |
| Manufacturer Country | US |
| Manufacturer Postal | 92127 |
| Manufacturer Phone | 8582020852 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROCLEIX WEST NILE VIRUS ASSAY |
| Generic Name | WNV ASSAY |
| Product Code | NOP |
| Date Received | 2019-11-27 |
| Catalog Number | 9051166 |
| Lot Number | UNKNOWN |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GRIFOLS DIAGNOSTICS SOLUTIONS INC. |
| Manufacturer Address | 4560 HORTON STREET EMERYVILLE CA 94608 US 94608 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2019-11-27 |