BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-Q PAIN PUMP

    MDR report key: 2912698 · Received January 8, 2013

    Report

    Report Number
    2026095-2012-00336
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    November 21, 2008
    Report Date
    December 11, 2012
    Manufacturer
    I-FLOW, LLC
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: NO PRODUCT WAS RETURNED FOR EVAL 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 US FOOD AND DRUG ADMINISTRATION. NO FURTHER INVESTIGATION WILL BE CONDUCTED. CONCLUSION: AS THIS COMPLAINT WAS CREATED FROM A LAWSUIT SERVICE ON I-FLOW OR THE THREAT OF A LAWSUIT, NO CUSTOMER CONTACT CAN BE MADE AT THIS TIME DUE TO THE PENDING OR THREATENED LITIGATION." AS OF 11/09/2006 I -FLOW UPDATED THE ON-Q PUMP DIRECTIONS FOR USE (DHR), TO INCLUDE THE FOLLOWING IN THE WARNINGS SECTION: "AVOID PLACING THE CATHETER IN JOINT SPACES. ALTHOUGH THERE IS NO DEFINITIVE ESTABLISHED CAUSAL RELATIONSHIP, SOME LITERATURE HAS SHOWN A POSSIBLE ASSOCIATION BETWEEN CONTINUOUS INTRA-ARTICULAR INFUSIONS (PARTICULARLY WITH BUPIVACAINE) AND THE SUBSEQUENT DEVELOPMENT OF CHONDROLYSIS". (DFU 1307011). ON 08/08/2007, 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: UNK. FILL VOLUME: 100ML. FLOW RATE: 2ML/HR. PROCEDURE: REPAIR OF HIGH GRADE PARTIAL-THICKNESS SUPRASPINATUS TEAR, REPAIR OF SUBSCAPULARIS TEAR, DISTAL CLAVICLE EXCISION, SUBACROMIAL DECOMPRESSION, AND INSERTION OF PAIN PUMP. CATHPLACE:UNK. (REFERENCE: 2026095-2012-00390 (B)(6). PT ALLEGES CARTILAGE DAMAGE IN LEFT SHOULDER FOLLOWING PLACEMENT OF AN I-FLOW PAIN PUMP, PM012A, AFTER SURGERY ON (B)(6) 2009. SURGERY WAS PERFORMED ON THE RIGHT SHOULDER ON (B)(6) 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10135 ON-Q PAIN PUMP ELASTOMERIC PUMP MEB I-FLOW, LLC PM012-A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other