FDA Adverse Event
Malfunction
Summary report: N
2250051-2008-00350
MDR report key: 1211256
·
Received July 30, 2008
Report
- Report Number
- 2250051-2008-00350
- Event Type
- Malfunction
- Date Received
- July 30, 2008
- Product Code
- KSZ
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
ORTHO-CLINICAL DIAGNOSTICS (OCD) QUALITY ASSURANCE PERFORMED LOT HISTORY AND BATCH RECORD REVIEW. THE RESULTS WERE SATISFACTORY. NO ADDITIONAL TESTING OF THE PRODUCT CAN BE PERFORMED AS THE PRODUCT IS PASSED THE EXPIRY DATING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KSZ |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |