BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONQ PAIN RELIEF SYSTEM

    MDR report key: 3040172 · Received April 1, 2013

    Report

    Report Number
    MW5029635
    Event Type
    Malfunction
    Date Received
    April 1, 2013
    Date of Event
    March 29, 2013
    Report Date
    April 1, 2013
    Manufacturer
    I-FLOW
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AN ONQ PAIN RELIEF PUMP WAS PLACED IN THE OPERATING ROOM DURING BILATERAL TOTAL MASTECTOMIES, BILATERAL SENTINEL NODE MAPPING AND RECONSTRUCTION SURGERY UTILIZING AN UPPER ABDOMINAL SKIN FLAP ON (B)(6) 2013. THE ONQ PUMP WAS REMOVED ON POD NUMBER 3 ((B)(6) 2013) WHEN IT WAS NOTED TO STILL BE FULL OF MEDICATION. THE CATHETER WAS REMOVED WITHOUT ISSUE AND THE PATIENT WAS DISCHARGED AS PLANNED THE NEXT DAY ((B)(6) 2013). POSSIBLY DEFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131965 ONQ PAIN RELIEF SYSTEM ONQ PUMP MEB I-FLOW 270 ML, 4 ML/HR 0200765819

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR