FDA Adverse Event
Other
Summary report: N
8010456-2007-00001
MDR report key: 1008886
·
Received March 13, 2007
Report
- Report Number
- 8010456-2007-00001
- Event Type
- Other
- Date Received
- March 13, 2007
- Product Code
- GEI
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
AS WE HAVE BEEN INFORMED BY THE DISTRIBUTOR VIA PHONE THE INSTRUMENT IN QUESTION IS SAID TO HAVE FAILED DURING PROCEDURE. NEITHER THE INSTRUMENT WAS RETURNED NOR THE PRODUCTION LOT NUMBER COULD BE PROVIDED, WHAT MADE FURTHER INVESTIGATIONS IMPOSSIBLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GEI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |