FDA Adverse Event
Malfunction
Summary report: N
9617604-2008-00064
MDR report key: 1113863
·
Received May 23, 2008
Report
- Report Number
- 9617604-2008-00064
- Event Type
- Malfunction
- Date Received
- May 23, 2008
- Product Code
- FPA
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT IS STILL UNDER INVESTIGATION. UPON RECEIPT OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED. WE HAVE BEEN INFORMED THAT UNOPENED SAMPLES WERE BEING RETURNED FOR INVESTIGATION. WE CAN REPORT THAT WE HAVE NOT RECEIVED ANY OTHER REPORTS ON THIS DEVICE LOT NUMBER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FPA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |