FDA Adverse Event
Other
Summary report: N
*
MDR report key: 979580
·
Received September 24, 2007
Report
- Report Number
- 8010099-2007-00003
- Event Type
- Other
- Date Received
- September 24, 2007
- Manufacturer
- MEDICON, E.G.
- Product Code
- GAD
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
AS TO THE MFR DATE, PLEASE NOTE THIS REFERS TO A MFR PERIOD: STARTING 07/2007 UNTIL 09/2007. 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 | * | * | GAD | MEDICON, E.G. | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |