FDA Adverse Event
Malfunction
Summary report: N
2020394-2007-00310
MDR report key: 1003687
·
Received November 26, 2007
Report
- Report Number
- 2020394-2007-00310
- Event Type
- Malfunction
- Date Received
- November 26, 2007
- Product Code
- DTK
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HISTORY RECORDS WERE NOT REVIEWED AS THE LOT NUMBER IS UNK. THE SAMPLE WAS NOT RETURNED FOR EVALUATION. BASED ON THE INFO SUBMITTED, THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE AND THE ROOT CAUSE IS UNK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DTK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |