BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-Q PUMP

    MDR report key: 2091645 · Received April 28, 2011

    Report

    Report Number
    2026095-2011-00126
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    January 1, 2011
    Report Date
    March 30, 2011
    Manufacturer
    I-FLOW CORPORATION
    Product Code
    MEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: NO SAMPLE REC'D FOR EVAL AND INVESTIGATION. AS NO LOT NUMBER WAS PROVIDED, THE DEVICE HISTORY RECORD CANNOT BE REVIEWED. RESULTS: W/O THE ACTUAL PRODUCT, AN ANALYSIS CANNOT BE CONDUCTED. IF ADD'L INFO PERTINENT TO THIS COMPLAINT, A F/U REPORT WILL BE FILED.

    Description of Event or Problem · 1

    (DRUG/DILUENT: MARCAINE), (FILL VOLUME: 400ML AND FLOW RATE: 4ML/HR), (PROCEDURE: SPINE AND CATHPLACE: UNK). SINCE (B)(6) 2011, THIS FACILITY HAS IDENTIFIED 4 INFECTIONS (2 CULTURED AS E-COLI AND 2 WERE NOT CULTURED). THERE WERE ALSO 7 WOUNDS THAT DID NOT HEAL. ALL PTS HAD SPINE SURGERY IN A NEW OPERATING ROOM AT THE FACILITY. THEY NOTED THAT THE 7 WOUNDS NOT HEALING HAD CLEAR LIQUID COMING FROM THEM UP TO 3 WEEKS AFTER THE PUMP WAS REMOVED. THEY USED A "PACKIN" BANDAGE. THEY USE A 5 DAY PUMP. DATE OF EVENT: (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q PUMP ELASTOMERIC PUMP MEB I-FLOW CORPORATION UNK ANP

    Patients

    Seq Age Sex Outcome Treatment
    1 Other