FDA Adverse Event
Injury
Summary report: N
9681707-2011-00002
MDR report key: 2142525
·
Received June 2, 2011
Report
- Report Number
- 9681707-2011-00002
- Event Type
- Injury
- Date Received
- June 2, 2011
- Product Code
- ELW
- PMA / PMN Number
- K991425
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS BEING SUBMITTED AS A RESULT OF CORRECTIVE MEASURE TO FDA FINDING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ELW |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |