FDA Adverse Event
Malfunction
Summary report: N
1717344-2010-00834
MDR report key: 2831983
·
Received November 12, 2010
Report
- Report Number
- 1717344-2010-00834
- Event Type
- Malfunction
- Date Received
- November 12, 2010
- Product Code
- GEI
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE SITE INDICATED THAT THE INCIDENT SAMPLE WILL NOT BE RETURNED FOR EVAL. IF ADD'L INFO PERTINENT TO THE INCIDENT IS OBTAINED, A F/U REPORT WILL BE SUBMITTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GEI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |