FDA Adverse Event
Other
Summary report: N
*
MDR report key: 979641
·
Received October 5, 2007
Report
- Report Number
- 8010099-2007-00005
- Event Type
- Other
- Date Received
- October 5, 2007
- Manufacturer
- MEDICON, E.G.
- Product Code
- GES
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
AS TO THE MANUFACTURE DATE, PLEASE NOTE THIS REFERS TO A MANUFACTURE PERIOD: STARTING 07/2006 UNTIL 09/2006. EVAL/INVESTIGATION OF DEVICE IS STILL PENDING. WE AUTHORIZED THREE EXTERNAL SITES (RESEARCH LAB, UNIV OF TECHNOLOGY, EDUCATION CENTER FOR INSTRUMENT MAKERS) TO PERFORM FURTHER INVESTIGATION. AS SOON AS THE RESULTS ARE ON HAND WE WILL SUBMIT A RESPECTIVE F/U MDR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | * | * | GES | MEDICON, E.G. | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |