FDA Adverse Event
Injury
Summary report: N
2243656-2001-00001
MDR report key: 821101
·
Received February 9, 2007
Report
- Report Number
- 2243656-2001-00001
- Event Type
- Injury
- Date Received
- February 9, 2007
- Product Code
- KGX
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
DEVICE RECORDS EVALUATED, NO TRENDS IDENTIFIED. THIS MDR IS BEING SUBMITTED BASED ON AN INTERNAL AUDIT OF OUR MDR PROCESS. THE CASE WAS REEVALUATED AND DETERMINED TO HAVE BEEN REPORTABLE. THIS REPORT IS CONSIDERED CLOSED UNLESS ADDITIONAL RELEVANT INFO IS RECEIVED.DEVICE RECORDS EVALUATED, NO TRENDS IDENTIFIED. THIS MDR IS BEING SUBMITTED BASED ON AN INTERNAL AUDIT OF OUR MDR PROCESS. THE CASE WAS REEVALUATED AND DETERMINED TO HAVE BEEN REPORTABLE. THIS REPORT IS CONSIDERED CLOSED UNLESS ADD'L RELEVANT INFO IS RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KGX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |