FDA Adverse Event Death Summary report: N

3ON-Q PAIN MANAGEMENT SYSTEM

MDR report key: 457690 · Received April 30, 2003

Report

Report Number
2026095-2003-00009
Event Type
Death
Date Received
April 30, 2003
Date of Event
April 24, 2003
Report Date
April 29, 2003
Manufacturer
I-FLOW CORPORATION
Product Code
MEB
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
GA, US
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

PATIENT USING ON-Q EXPIRED. SURGERY WAS 3 DAYS PRIOR TO DEATH FOR TAH DUE TO EARLY CERVICAL CANCER. PATIENT DISCHARGED AND WENT HOME 2 DAYS AFTER SURGERY. PUMP WAS SCHEDULED TO BE REMOVED ON THE DAY THEY DECEASED. FULL AUTOPSY WAS DONE AND IT IS UNKNOWN AT THIS TIME WHAT WAS THE CAUSE OF DEATH.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 3ON-Q PAIN MANAGEMENT SYSTEM INFUSION PUMP MEB I-FLOW CORPORATION PM024 322922

Patients

Seq Age Sex Outcome Treatment
1 UNKNOWN Death