BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-Q PAINPUMP

    MDR report key: 3480846 · Received November 14, 2013

    Report

    Report Number
    2026095-2013-00163
    Event Type
    Injury
    Date Received
    November 14, 2013
    Date of Event
    May 5, 2006
    Report Date
    October 9, 2013
    Manufacturer
    I-FLOW, LLC
    Product Code
    MEB
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE PRODUCT WAS NOT RETURNED FOR AN EVALUATION AND INVESTIGATION. THE LOT NUMBER NOT PROVIDED; THEREFORE THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. RESULTS: RESULTS ARE NOT AVAILABLE SINCE THERE WERE NO METHODS PERFORMED. THE INFORMATION CONTAINED IS FROM LEGAL DOCUMENTS SERVED ON I-FLOW, LLC. THE COMPLAINT WAS OPENED SO THAT A MEDICAL DEVICE REPORT (MDR) CAN BE FILED WITH THE US FOOD AND DRUG ADMINISTRATION. NO FURTHER INVESTIGATION WILL BE CONDUCTED. CONCLUSION: THE DEVICE WAS NOT RETURNED AND DEVICE INFORMATION WAS NOT PROVIDED. AS THIS COMPLAINT WAS CREATED FROM A LAWSUIT SERVED ON I-FLOW, NO CUSTOMER CONTACT CAN BE MADE AT THIS TIME DUE TO THE PENDING OR THREATENED LITIGATION. ON 8/8/2007, I-FLOW HAS ALSO PREPARED A TECHNICAL BULLETIN ENTITLED "WHAT WE KNOW ABOUT CHONDROLYSIS TODAY"; (1303722, REV.E).

    Description of Event or Problem · 1

    DRUG/DILUENT: NOT PROVIDED; FILL VOLUME: NOT PROVIDED; FLOW RATE: NOT PROVIDED; PROCEDURE: NOT PROVIDED; CATHPLACE: SHOULDER JOINT. PATIENT ALLEGED CHONDROLYSIS IN SHOULDER FOLLOWING PLACEMENT OF AN ON-Q PAINPUMP AFTER SURGERY ON OR ABOUT (B)(6) 2006. PATIENT HAS FILED THIS COMPLAINT AGAINST BOTH I-FLOW, LLC AND KIMBERLY-CLARK WORLDWIDE, INC. IS NOT, HOWEVER, THE SUCCESSOR IN INTEREST TO I-FLOW, LLC, NOR DOES IT MANUFACTURER THE ON-Q PAINBUSTER. ONLY I-FLOW, LLC IS THE MANUFACTURER OF THE ON-Q PAINBUSTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590536 ON-Q PAINPUMP ELASTOMERIC PUMP MEB I-FLOW, LLC UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other