BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-Q PAIN PUMP

    MDR report key: 4189072 · Received October 17, 2014

    Report

    Report Number
    2026095-2014-00201
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    October 15, 2013
    Report Date
    September 18, 2014
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    PMA / PMN Number
    K063530
    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 WAS NOT PROVIDED; THEREFORE, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. 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 FILED WITH THE UNITED STATES FOOD AND DRUG ADMINISTRATION. NO FURTHER INVESTIGATION WILL BE CONDUCTED. CONCLUSIONS: AS THIS COMPLAINT WAS CREATED FROM A LAWSUIT RECEIVED BY I-FLOW, LLC OR THE THREAT OF A LAWSUIT, NO CUSTOMER CONTACT CAN BE MADE AT THIS TIME DUE TO THE PENDING OR THREATENED LITIGATION. INFO FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEM.

    Description of Event or Problem · 1

    DRUG/DILUENT: NP. FILL VOLUME: NP. FLOW RATE: NP. PROCEDURE: LEFT SHOULDER SURGERY. CATHPLACE: LEFT SHOULDER. DATE OF SURGERY: (B)(6) 1999. PT ALLEGES CHONDROLYSIS IN HIS LEFT SHOULDER FOLLOWING PLACEMENT OF AN ON-Q PAINBUSTER AFTER SURGERY ON OR ABOUT (B)(6) 1999.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661780 ON-Q PAIN PUMP ELASTOMERIC PUMP MEB I-FLOW CORP. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NP