BEUDAMED
    FDA Adverse Event Other Summary report: N

    ON-Q PAINBUSTER

    MDR report key: 1017132 · Received March 20, 2008

    Report

    Report Number
    2026095-2008-00019
    Event Type
    Other
    Date Received
    March 20, 2008
    Date of Event
    November 1, 2007
    Report Date
    February 19, 2008
    Manufacturer
    I-FLOW CORPORATION
    Product Code
    MEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: INITIAL REPORTER INDICATED THAT NO SAMPLE WAS AVAILABLE FOR EVALUATION AND INVESTIGATION. THE INFO CONTAINED HEREIN IS BASED ON THE INFO PROVIDED BY THE INITIAL REPORTER. THE REPORTER WAS THE MOTHER OF A MALE THAT HAD SHOULDER SURGERY IN 2007 TO REPAIR A 180 DEGREE TEAR OF LABRUM. THE PUMP WAS INSERTED FOR PAIN RELIEF. IN SEVEN MONTHS LATER, THE PT WAS DIAGNOSED WITH CHONDROLYSIS. NO INFO WAS AVAILABLE ABOUT THE PUMP, INCLUDING MODEL, FILL VOLUME, FLOW RATE, OR MEDICATIONS USED. NO PROBLEMS WITH THE OPERATION OF THE PUMP WERE REPORTED AND THE CATHETER WAS REMOVED AT THE PATIENT'S HOME WITH NO PROBLEMS. PERMISSION TO CONTACT THE PHYSICIAN FOR THE REQUIRED INFORMATION WAS NOT GRANTED BY THE INITIAL REPORTER. ALTHOUGH, NO SPECIFIC INFORMATION WAS AVAILABLE FOR THIS REPORTED EVENT, IN LATE 2006, IN LIGHT OF THE POSSIBLE CONNECTION BETWEEN THE USE OF BUPIVACAINE IN THE INTRA-ARTICULAR SPACE AND THE ONSET OF CHONDROLYSIS AS SUGGESTED BY THE LITERATURE, AND IN AN ABUNDANCE OF CAUTION, I-FLOW MODIFIED THE ON-Q DIRECTIONS FOR USE (DFU) BY ADDING THIS WARNING: "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." IF ADDITIONAL INFORMATION THAT IS PERTINENT TO THIS EVENT BECOMES AVAILABLE, I-FLOW WILL SUBMIT A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MALE WAS REPORTED TO HAVE DEVELOPED CHONDROLYSIS FOLLOWING SHOULDER SURGERY IN 2007. DIAGNOSED IN SEVEN MONTHS LATER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Other