FDA Adverse Event
Other
Summary report: N
*
MDR report key: 1278623
·
Received December 29, 2008
Report
- Report Number
- 3003768277-2008-00054
- Event Type
- Other
- Date Received
- December 29, 2008
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Product Code
- LNH
- PMA / PMN Number
- K052013
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED, A F/U REPORT WILL BE SENT TO THE FDA. NOTE THE INDICATED IMPORTER HAS REC'D FDA EXEMPTION NUMBER, TO SUBMIT ONE FDA FORM 3500A TO SATISFY BOTH THE IMPORTER (803.42) AND MFR (803.52) FOR THE SAME EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | * | * | LNH | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |