FDA Adverse Event
Malfunction
Summary report: N
2250051-2008-00286
MDR report key: 1140303
·
Received June 12, 2008
Report
- Report Number
- 2250051-2008-00286
- Event Type
- Malfunction
- Date Received
- June 12, 2008
- Product Code
- KSZ
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
OTHO CLINICAL DIAGNOSTICS (OCD) QA PERFORMED RETAINED TESTING TO CONFIRM THE REACTIVITY OF THE E AND JKA ANTIGENS. RESULTS WERE SATISFACTORY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KSZ |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |