BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-Q PUMP

    MDR report key: 3893504 · Received June 9, 2014

    Report

    Report Number
    3893504
    Event Type
    Malfunction
    Date Received
    June 9, 2014
    Date of Event
    January 17, 2014
    Report Date
    June 9, 2014
    Manufacturer
    I-FLOW CORPORATION
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    PATIENT ADMITTED FOR OUTPATIENT SURGERY FOR HERNIA REPAIR AND WAS DISCHARGED WITH ON-Q PUMP KIT AND HE WOULD RECEIVE PAIN MEDICATION VIA PUMP. PATIENT INDICATES NO RELIEF AND TO BE IN PAIN DURING THIS TIME AND DURING TAPE REMOVAL OF PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336585 ON-Q PUMP PUMP, INFUSION, ELASTOMERIC MEB I-FLOW CORPORATION 400 ML *

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR