BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-Q PAIN BUSTER

    MDR report key: 1105903 · Received August 8, 2008

    Report

    Report Number
    MW5007944
    Event Type
    Malfunction
    Date Received
    August 8, 2008
    Date of Event
    July 31, 2008
    Report Date
    August 8, 2008
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IN 2008, TOTAL KNEE ARTHROPLASTY PERFORMED. ON-Q PAIN BUSTER WITH DUAL LUMEN INSERTED FOR PAIN MANAGEMENT. AT ABOUT 2 DAYS LATER, THE ON-Q WAS REMOVED, IT WAS NOTED THE END OF THE CATHETER WAS MISSING ON ONE LUMEN. DATES OF USE: 2008. DIAGNOSIS OR REASONS FOR USE: PAIN MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q PAIN BUSTER ON-Q PAIN BUSTER MEB I-FLOW CORP. PM025-A 832493

    Patients

    Seq Age Sex Outcome Treatment
    1