BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-Q PAINBUSTER POST-OP PAIN RELIEF SYSTEM

    MDR report key: 604014 · Received May 9, 2005

    Report

    Report Number
    604014
    Event Type
    Malfunction
    Date Received
    May 9, 2005
    Date of Event
    April 28, 2005
    Report Date
    May 9, 2005
    Manufacturer
    I-FLOW CORPORATION
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    UPON CHANGING DRESSING, NURSE NOTICED THAT THE ON-Q BALL HAD YET TO DECREASE IN SIZE. UPON EXAMINING THE DEVICE, THERE WAS NO MEDICATION THAT WAS DELIVERED TO THE INCISION AREA AS WAS INTENDED. THE ON-Q WAS DISCONTINUED, PHYSICIAN NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q PAINBUSTER POST-OP PAIN RELIEF SYSTEM ELASTOMERIC PUMP PAIN RELIEF SYSTEM MEB I-FLOW CORPORATION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR