BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-Q PAINBUSTER KIT 270ML, X (DUAL)2ML/HR

    MDR report key: 3780675 · Received April 18, 2014

    Report

    Report Number
    2026095-2014-00039
    Event Type
    Injury
    Date Received
    April 18, 2014
    Date of Event
    December 21, 2014
    Report Date
    March 28, 2014
    Manufacturer
    I-FLOW, LLC.
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE PRODUCT WAS NOT RETURNED FOR AN EVALUATION AND INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) WAS CONDUCTED FOR THE LOT NUMBER PROVIDED AND THE DEVICE PASSED ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. 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 FILLED WITH THE US FOOD AND DRUG ADMINISTRATION. 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 THE PENDING LITIGATION. INFO FROM THIS INCIDENT WILL BE INCLUDED IN OUT PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEM.

    Description of Event or Problem · 1

    DRUG/DILUENT:UNK. FILL VOLUME: UNK. FLOW RATE: 4ML/HR. PROCEDURE: LEFT SHOULDER SURGERY. CATHPLACE: GLENOHUMERAL SUBACROMIAL SPACES OF LEFT SHOULDER. DATE OF SURGERY: (B)(6) 2004. PATIENT ALLEGES CHONDROLYSIS IN SHOULD FOLLOWING PLACEMENT OF AN ON-Q PAINBUSTER PAIN PUMP AFTER SURGERY ON (B)(6) 2004.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238811 ON-Q PAINBUSTER KIT 270ML, X (DUAL)2ML/HR ELASTOMERIC PUMP MEB I-FLOW, LLC. PM005 462832

    Patients

    Seq Age Sex Outcome Treatment
    1 Other UNK.