FDA Adverse Event Other Summary report: N

2026095-2007-00054

MDR report key: 933256 · Received October 16, 2007

Report

Report Number
2026095-2007-00054
Event Type
Other
Date Received
October 16, 2007
Product Code
MEB
Report Source
Manufacturer report

Narratives

Additional Manufacturer Narrative · 1

EVAL SUMMARY: THE DEVICE INVOLVED IN THIS INCIDENT WAS REPORTED AVAILABLE, BUT HAS NOT BEEN RETURNED TO I-FLOW CORP FOR EVAL. WITHOUT THE ACTUAL PRODUCT, A COMPLETE ANALYSIS CANNOT BE CONDUCTED. THE INFO CONTAINED HEREIN IS BASED ON THE INFO PROVIDED BY THE INITIAL REPORTER. IF ADD'L INFO THAT IS PERTINENT TO THIS EVENT BECOMES AVAILABLE, I-FLOW WILL SUBMIT A FOLLOW-UP REPORT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 MEB

Patients

Seq Age Sex Outcome Treatment
1