BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-Q PUMP

    MDR report key: 2202144 · Received August 5, 2011

    Report

    Report Number
    2026095-2011-00205
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 8, 2011
    Report Date
    July 8, 2011
    Manufacturer
    I-FLOW CORPORATION
    Product Code
    MEB
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: NO SAMPLE REC'D FOR EVAL AND INVESTIGATION. THE DEVICE WAS DISCARDED BY THE PT. THE LOT NUMBER WAS NOT PROVIDED, THEREFORE, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. ADD'L INFO WAS REQUESTED BUT WAS NOT PROVIDED. 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: UNK. FILL VOLUME: 400ML AND FLOW RATE: UNK. PROCEDURE: LEFT SHOULDER BONE REMOVAL, CARPAL TUNNEL RELEASE. CATHPLACE: INTERSCALENE. PT CALLED HOTLINE TO REPORT RASH ALL OVER BODY. PT HAD SURGERY ON (B)(6), 2011 AND STATES THAT ON (B)(6), 2011, SHE BEGAN TO NOTICE ITCHING. ON (B)(6), 2011, HER ENTIRE BODY (EXCEPT PALMS AND SOLES OF FEET) WAS COVERED WITH A RED, ITCHY RASH. HOTLINE NURSE ADVISED THE PT TO CONTACT HER SURGEON AND ANESTHESIOLOGIST IN CASE OF AN ALLERGIC REACTION. 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