BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-Q PAINBUSTER

    MDR report key: 2043273 · Received February 25, 2011

    Report

    Report Number
    2026095-2011-00054
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    October 29, 2008
    Report Date
    October 29, 2008
    Manufacturer
    I-FLOW CORP
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: CUSTOMER REPORTED THAT NO SAMPLE WAS AVAILABLE FOR EVALUATION AND INVESTIGATION. AS NO LOT NUMBER WAS PROVIDED, THE DEVICE HISTORY RECORD AND LOT HISTORY CANNOT BE REVIEWED. RESULTS: WITHOUT THE ACTUAL PRODUCT, A COMPLETE ANALYSIS CANNOT BE CONDUCTED. AT THIS TIME, THIS COMPLAINT IS BEING CLOSED WITH NO FURTHER INVESTIGATION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IN THE FUTURE, WE WILL REOPEN THIS COMPLAINT.

    Description of Event or Problem · 1

    (DRUG/DILUENT: MARCAINE 0.25%). (PROCEDURE: MASTECTOMY). THE PUMP IS REPORTED TO HAVE A FAST FLOW. FILL VOLUME 400ML AND UNK FLOW RATE. NO ADVERSE EVENT OCCURRED. DATE OF EVENT: (B)(6) 2008. PER DFU: NORMAL FILL VOLUME: 400ML AND NOMINAL FLOW RATE: 4ML/HR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q PAINBUSTER ELASTOMERIC PUMP MEB I-FLOW CORP PM028-A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK