BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-Q PAIN PUMP

    MDR report key: 3909529 · Received June 11, 2014

    Report

    Report Number
    2026095-2014-00078
    Event Type
    Injury
    Date Received
    June 11, 2014
    Date of Event
    July 12, 2007
    Report Date
    May 13, 2014
    Manufacturer
    I-FLOW LLC.
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD - THE PRODUCT WAS NOT RETURNED FOR AN EVALUATION AND INVESTIGATION. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. RESULTS - THE INFO CONTAINED IS FROM LEGAL DOCUMENTS SERVED ON I-FLOW, LLC. THE COMPLAINT WAS OPENED SO THAT A MEDICAL DEVICE REPORT (MDR) CAN BE FILED WITH THE USFDA. NO FURTHER INVESTIGATION WILL BE CONDUCTED. CONCLUSIONS - AS THIS COMPLAINT WAS CREATED FROM A LAWSUIT RECEIVED BY I-FLOW, LLC, NO CUSTOMER CONTACT CAN BE MADE AT THIS TIME DUE TO PENDING OR THREATENED LITIGATION. INFO FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEM.

    Description of Event or Problem · 1

    FILL VOLUME: 300ML. FLOW RATE: UNK. PROCEDURE: INDEX SURGERY. CATHPLACE: GLENOHUMERAL JOINT. PT ALLEGES PAGCL FOLLOWING PLACEMENT OF AN ON-Q PAIN PUMP AFTER SURGERY ON (B)(6) 2007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344562 ON-Q PAIN PUMP ELASTOMERIC PUMP MEB I-FLOW LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other MARCAINE/BUPIVACAINE