FDA Adverse Event
Other
Summary report: N
9610617-2008-00016
MDR report key: 1083413
·
Received July 12, 2008
Report
- Report Number
- 9610617-2008-00016
- Event Type
- Other
- Date Received
- July 12, 2008
- Product Code
- FPK
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
UNIT WAS RELEASED 7/8/08 FOR EVAL, WHICH HAS NOT BEEN COMPLETED AT THIS TIME. WE WILL SEND A SUPPLEMENTAL REPORT CONTAINING EVAL WHEN AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FPK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |