MAUDE MDR 9314728
- MDR report key
- 9314728
- Report number
- 1220984-2019-00126
- Event key
- 0
- Event type
- 3
- Date of event
- 2019-10-24
- Date received
- 2019-11-13
- 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 | SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM | FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM | HOLOGIC, INC | MUE | SDM-SYS-9000-2D | SDM-SYS-9000-2D | | | | | Y
| N |
Patients#
Sequence, Received, Treatment table| Sequence | Received | Treatment | Outcome |
|---|
| 1 | 2019-11-13 | 0 |
|
Event Narratives#
No narrative records found.