BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-Q PAINBUSTER

    MDR report key: 2000656 · Received February 16, 2011

    Report

    Report Number
    2026095-2011-00030
    Event Type
    Injury
    Date Received
    February 16, 2011
    Date of Event
    June 24, 2004
    Report Date
    February 4, 2011
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: NO PRODUCT WAS RETURNED FOR EVAL AND INVESTIGATION. HOWEVER, A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) WAS CONDUCTED FOR THE LOT NUMBER AND INCIDENT REPORTED. THE DEVICE PASSED ALL MFG SPECIFICATIONS PRIOR TO RELEASE. RESULTS: THE INFO CONTAINED HEREIN IS BASED ON THE INFO PROVIDED BY THE INITIAL REPORTER. THE REPORT DID NOT PROVIDE ANY SPECIFIC INFO CONCERNING THE PROCEDURE, OR OTHER PARTICULARS OF THE ALLEGED INCIDENT. WITHOUT THE ACTUAL PRODUCT OR DETAILS OF THE INCIDENT, AN ANALYSIS COULD NOT BE CONDUCTED. THE ON-Q PUMP DIRECTIONS FOR USE (DFU) CONTAIN A WARNING THAT STATES: "AVOID PLACING THE CATHETER IN JOINT SPACES. ALTHOUGH THERE IS NO DEFINITIVE ESTABLISHED CAUSAL RELATIONSHIP, SOME LITERATURE HAS SHOWN A POSSIBLE ASSOCIATION BETWEEN CONTINUOUS INTRA-ARTICULAR INFUSIONS (PARTICULARLY WITH BUPIVACAINE) AND THE SUBSEQUENT DEVELOPMENT OF CHONDROLYSIS." (DFU 1304265, REV. L). I-FLOW HAS ALSO PREPARED A TECHNICAL BULLETIN ENTITLED "WHAT WE KNOW ABOUT CHONDROLYSIS TODAY". (1303722, REV. E). IF ADDITIONAL INFO THAT IS PERTINENT TO THIS EVENT BECOMES AVAILABLE, I-FLOW WILL SUBMIT A F/U REPORT.

    Description of Event or Problem · 1

    PT ALLEGEDLY DEVELOPED CHONDROLYSIS FOLLOWING PLACEMENT OF A PAIN PUMP WITH CONTINUOUSLY INJECTED ANESTHETIC DRUGS DIRECTLY INTO HER SHOULDER JOINT FOLLOWING SURGERY ON (B)(6) 2004.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q PAINBUSTER INFUSION PUMP MEB I-FLOW CORP. 5001363 472104

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other