MAUDE MDR 9599299
- MDR report key
- 9599299
- Report number
- 2032600-2020-00001
- Event key
- 0
- Event type
- 3
- Date of event
- 2019-12-11
- Date received
- 2020-01-16
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Devices#
Seq, Brand, Generic table| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|
| 1 | PROCLEIX ULTRIO ELITE ASSAY | HIV-1/HIV-2/HCV/HBV DEVICE | GRIFOLS DIAGNOSTICS SOLUTIONS INC. | MZF | | | 701444 | | | | *
| N |
Patients#
Sequence, Received, Treatment table| Sequence | Received | Treatment | Outcome |
|---|
| 1 | 2020-01-16 | 0 | 1. O
|
Event Narratives#
No narrative records found.