FDA Adverse Event
Injury
Summary report: N
AUTO LOGIC
MDR report key: 3689681
·
Received February 28, 2014
Report
- Report Number
- 3005619970-2014-00004
- Event Type
- Injury
- Date Received
- February 28, 2014
- Manufacturer
- GETINGE (SUZHOU) CO., LTD.
- Product Code
- FNM
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS BEING FILED UNDER EXEMPTION (E2012066) BY ARJOHUNTLEIGH, INC (1419652) ON BEHALF OF THE MANUFACTURER (GETINGE (SUZHOU) CO., LTD.). MANUFACTURER COMPLAINT REFERENCE NO: (B)(4). ADDITIONAL INFORMATION WILL BE PROVIDED UPON CONCLUSION OF THE MANUFACTURERS INVESTIGATION.
Description of Event or Problem · 1
REF IMP# (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 124089 | AUTO LOGIC | FNM | GETINGE (SUZHOU) CO., LTD. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |