MAUDE MDR 9166299
- MDR report key
- 9166299
- Report number
- 2247413-2019-00002
- Event key
- 0
- Event type
- 3
- Date received
- 2019-10-08
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 0
- Initial report to FDA
- 0
- Event location
- 3
Devices#
Seq, Brand, Generic table| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|
| 1 | PIFA HEPARIN/PF4 RAPID ASSAY | PIFA HEPARIN/PF4 RAPID ASSAY | AKERS BIOSCIENCES, INC. | LCO | | 4036025 | 24298 | | | | R
| N |
Patients#
Sequence, Received, Treatment table| Sequence | Received | Treatment | Outcome |
|---|
| 1 | 2019-10-08 | 0 | 1. L; 2. S
|
Event Narratives#
No narrative records found.