FDA Adverse Event
Malfunction
Summary report: N
*
MDR report key: 1000066
·
Received October 25, 2004
Report
- Report Number
- 2950409-2004-00016
- Event Type
- Malfunction
- Date Received
- October 25, 2004
- Manufacturer
- TOSOH BIOSCIENCE, INC.
- Product Code
- GKL
- Report Source
- Manufacturer report
- Reporter Occupation
- INVALID DATA
Narratives
Additional Manufacturer Narrative · 1
THIS IS AN INITIAL REPORT. THE FINAL REPORT WILL BE SUBMITTED AT THE CONCLUSION OF THE INVESTIGATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | * | * | GKL | TOSOH BIOSCIENCE, INC. | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |