FDA Adverse Event
Other
Summary report: N
3003768277-2008-00025
MDR report key: 1150363
·
Received August 21, 2008
Report
- Report Number
- 3003768277-2008-00025
- Event Type
- Other
- Date Received
- August 21, 2008
- Product Code
- IZI
- PMA / PMN Number
- K031333
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
(EVAL METHOD, RESULTS, CONCLUSIONS) CODE (OTHER) - THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED A FOLLOW-UP REPORT WILL BE SENT TO THE FDA. NOTE THE INDICATED IMPORTER HAS RECEIVED FDA EXEMPTION NUMBER, TO SUBMIT ONE FDA FORM 3500A TO SATISFY BOTH THE IMPORTER AND MFR FOR THE SAME EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IZI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |