MAUDE MDR 8935068
- MDR report key
- 8935068
- Report number
- 3010141591-2019-00185
- Event key
- 0
- Event type
- 3
- Date of event
- 2019-06-07
- Date received
- 2019-08-27
- 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 | BD KIESTRA? INOQULA+? TLA | MICROBIAL SPECIMEN INOCULATION/STREAKING INSTRUMENT | BD KIESTRA LAB AUTOMATION | JTC | | 447213 | | | | | Y
| N |
Patients#
Sequence, Received, Treatment table| Sequence | Received | Treatment | Outcome |
|---|
| 1 | 2019-08-27 | 0 | 1. O
|
Event Narratives#
No narrative records found.