BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-Q PAINBUSTER

    MDR report key: 1013944 · Received March 14, 2008

    Report

    Report Number
    2026095-2008-00024
    Event Type
    Injury
    Date Received
    March 14, 2008
    Date of Event
    January 1, 2008
    Report Date
    February 13, 2008
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE DEVICE INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. THE INFORMATION CONTAINED HEREIN IS BASED ON THE INFORMATION PROVIDED BY THE INITIAL REPORTER. THE INFORMATION PROVIDED INDICATED THAT THE PATIENT DEVELOPED AN INFECTION AFTER THE USE OF THE ON-Q PUMP. THE PHYSICIAN REPORTED THAT NO FURTHER INFORMATION WOULD BE PROVIDED. ALL I-FLOW PRODUCTS ARE STERILIZED AND SEALED IN APPROPRIATE PACKAGING, TO BE OPENED ONLY IN A STERILE ENVIRONMENT BY INDIVIDUALS TRAINED IN STERILE PROCEDURE. PRIOR TO RELEASE, ALL PRODUCTION LOTS ARE SUBJECTED TO STRINGENT LABORATORY TESTING TO ASSURE STERILITY. WITH THE ASSUMPTION THAT THE DEVICE WAS PROPERLY HANDLED BY THE CLINICAL PERSONNEL ASSOCIATED WITH THE SURGERY, THE DEVICE WAS INTRODUCED TO THE SURGICAL SITE IN A STERILE CONDITION. ANY INFECTION COMPLICATION FOLLOWING THEREAFTER IS MOST LIKELY DUE TO OTHER POSTOPERATIVE FACTORS. IF ADDITIONAL INFORMATION THAT IS PERTINENT TO THIS EVENT BECOMES AVAILABLE, I-FLOW WILL REOPEN THE COMPLAINT.

    Description of Event or Problem · 1

    PATIENT DEVELOPED INFECTION POST OPERATION. PHYSICIAN SAID, IT LOOKED LIKE PUS WAS COMING UP INTO THE CATHETER - NO PUS COMING FROM INCISION. PHYSICIAN DID NOT REOPEN OR CULTURE, INSTEAD PUT PATIENT ON AUGMENTIN FOR POSSIBLE CELLULITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q PAINBUSTER INFUSION PUMP MEB I-FLOW CORP. PM010-A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention