MAUDE MDR 9147857
- MDR report key
- 9147857
- Report number
- 1221359-2019-00066
- Event key
- 0
- Event type
- 3
- Date of event
- 2019-09-08
- Date received
- 2019-10-02
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 100
- 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 | ALERE DETERMINE HIV-1/2 AG/AB COMBO | IVD FOR HIV 1/2 AG/AB | ABBOTT DIAGNOSTICS SCARBOROUGH | MZF | | 7D2648 | 110834 | | | | N
| N |
Patients#
Sequence, Received, Treatment table| Sequence | Received | Treatment | Outcome |
|---|
| 1 | 2019-10-02 | 0 |
|
Event Narratives#
No narrative records found.