BEUDAMED
    FDA Adverse Event Other Summary report: N

    ON-Q PAINBUSTER PUMP

    MDR report key: 1943700 · Received December 15, 2010

    Report

    Report Number
    2026095-2010-00308
    Event Type
    Other
    Date Received
    December 15, 2010
    Date of Event
    November 16, 2010
    Report Date
    November 16, 2010
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS RECEIVED FOR EVALUATION AND INVESTIGATION, AND TESTING IS CURRENTLY BEING PERFORMED. A FOLLOW-UP REPORT WILL BE FILED WHEN INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    ON DAY OF SURGERY, (B)(6) 2010, THE EVENING NURSE NOTICED ARRHYTHMIAS. IN THE MORNING, (B)(6) 2010, THE SURGEON HAD THE CATHETERS REMOVED AT 11:25 AM. IT WAS A MARCAINE REACTION, NOT A PRODUCT ISSUE. DATE OF EVENT: (B)(6) 2010. ASKED BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q PAINBUSTER PUMP ELASTOMERIC PUMP MEB I-FLOW CORP. P270X4D 082355

    Patients

    Seq Age Sex Outcome Treatment
    1 Other