BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-Q PAINBUSTER POST-OP PAIN RELIEF SYSTEM

    MDR report key: 604012 · Received May 9, 2005

    Report

    Report Number
    604012
    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 ON INCISION, NOTICED THAT Q BALL HAD NOT DECREASED IN SIZE. UPON FURTHER INVESTIGATION, ON-Q BALL NOTED TO BE SAME SIZE AS WHEN APPLIED TO INCISION IN SURGERY. DISCONTINUED ON-Q, AND NOTIFIED PHYSICIAN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR