BEUDAMED
    FDA Adverse Event Injury Summary report: N

    I-FLOW

    MDR report key: 1431517 · Received July 24, 2009

    Report

    Report Number
    MW5012208
    Event Type
    Injury
    Date Received
    July 24, 2009
    Date of Event
    March 3, 2009
    Report Date
    July 24, 2009
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IN 2009, THE PT UNDERWENT VENTRAL HERNIA REPAIR WITH MESH PLACEMENT. ON-Q WAS PLACED IN SURGERY THE SAME DAY, AND REMOVED PRIOR TO DISCHARGE, PER OPERATIVE REPORT AND DISCHARGE SUMMARY. FIVE MONTHS LATER, RESPECTIVELY, THE PT RETURNED FOR SURGERY OF THE ABDOMEN AND TWO ON-Q CATHETER INTRODUCER SHEATHS WERE RETRIEVED DISCOVERED. RISK MANAGEMENT IS IN THE PROCESS OF INVESTIGATING THE INCIDENT. DATES OF USE:2009. DIAGNOSIS OR REASON FOR USE: PAIN MANAGEMENT POST VENTRAL HERNIA REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-FLOW ON-Q CATHETER INTRODUCER SHEATH MEB I-FLOW CORP. UNK
    2 I-FLOW ON-Q CATHETER INTRODUCER SHEATH MEB I-FLOW CORP. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Disability