MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2020-01-08 for PROCLEIX ULTRIO PLUS ASSAY manufactured by Grifols Diagnostics Solutions Inc..
| Report Number | 2032600-2019-00014 |
| MDR Report Key | 9564074 |
| Report Source | FOREIGN |
| Date Received | 2020-01-08 |
| Date of Report | 2020-03-20 |
| Date of Event | 2019-12-08 |
| Date Mfgr Received | 2019-12-08 |
| Date Added to Maude | 2020-01-08 |
| 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 | MS AMANDA DOE |
| Manufacturer Street | 10808 WILLOW COURT |
| Manufacturer City | SAN DIEGO, CA 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 ULTRIO PLUS ASSAY |
| Generic Name | HIV-1/HCV/HBV DEVICE |
| Product Code | MZF |
| Date Received | 2020-01-08 |
| Lot Number | 701857 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GRIFOLS DIAGNOSTICS SOLUTIONS INC. |
| Manufacturer Address | 4560 HORTON STREET EMERYVILLE, CA CA 94608 US 94608 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-08 |