BEUDAMED
    FDA Adverse Event Other Summary report: N

    ON-Q PAINBUSTER SOAKER

    MDR report key: 752311 · Received August 11, 2006

    Report

    Report Number
    2026095-2006-00051
    Event Type
    Other
    Date Received
    August 11, 2006
    Date of Event
    July 11, 2006
    Report Date
    August 7, 2006
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE DEVICE INVOLVED IN THIS INCIDENT WAS NOT AVAILABLE FOR EVALUATION. WITHOUT THE ACTUAL PRODUCT, A COMPLETE ANALYSIS CANNOT BE CONDUCTED. THEREFORE, THE INFORMATION CONTAINED HEREIN WAS BASED ON THE INFORMATION PROVIDED BY THE INITIAL REPORTER (SURGEON). IF ADD'L INFO THAT IS PERTINENT TO THIS EVENT BECOMES AVAILABLE, I-FLOW WILL SUBMIT A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    EIGHT (8) DAYS STATUS POST METATARSAL FRACTURE REPAIR (RIGHT FOOT) PERFORMED IN 2006, THE PATIENT PRESENTED WITH A NECROTIC AREA ON THE FOOT. BUPIVACAINE 0.5% WAS INFUSED DIRECTLY INTO THE INCISION. THE PUMP (MODEL # PM036 ON-Q PAINBUSTER SOAKER, 100 FILL VOLUME) USED IN THIS INCIDENT DELIVERS 1 ML OF A DRUG PER HOUR WHEN FILLED TO THE NOMINAL FILL VOLUME (100 ML). INTERVENTION SURGERY WAS REQIRED THREE WEEKS LATER, WITH ONE WEEK OF CONCOMITANT ANTIBIOTIC TREATMENT, AND A WOUND VAC WAS PLACED THE FOLLOWING MONTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q PAINBUSTER SOAKER INFUSION PUMP MEB I-FLOW CORP. PM036 652566

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other| R