MAUDE MDR 9392041
- MDR report key
- 9392041
- Report number
- 1020279-2019-04205
- Event key
- 0
- Event type
- 3
- Date of event
- 2019-11-05
- Date received
- 2019-11-29
- 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 | GII PS HI FLEX ISRT TR S3-4 9 | TRAY, SURGICAL, INSTRUMENT | SMITH & NEPHEW, INC. | FSM | | 71430408 | 11KM03355 | | | | R
| R |
Patients#
Sequence, Received, Treatment table| Sequence | Received | Treatment | Outcome |
|---|
| 1 | 2019-11-29 | 0 |
|
Event Narratives#
No narrative records found.