BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-Q PAIN PUMP

    MDR report key: 2912754 · Received January 8, 2013

    Report

    Report Number
    2026095-2012-00398
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    June 11, 2009
    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 SERVED 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 11/9/2006 I-FLOW UPDATED THE ON-Q PUMP DIRECTIONS FOR USE (DFU), 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 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: UNK, FLOW RATE: 270ML, FLOW RATE: UNK, PROCEDURE: EXTENSIVE DEBRIDEMENT OF GLENOHUMERAL JOINT, INCLUDING THE ROTATOR INTERVAL, THE SUPERIOR LABRAL ANTERIOR POSTERIOR TEAR, THE FOOTPRINT OF THE ROTATOR CUFF TENDON TEAR, THE BICEPS TENDON AND ANTERIOR LABRUM. ARTHROSCOPIC ROTATOR CUFF REPAIR 1CM FULL THICKNESS X 1.5CM TEAR AT THE LEADING EDGE OF THE SUPRASPINATUS TENDON. SUBACROMIAL DECOMPRESSION. DISTAL CLAVICLE EXCISION. INSERTION OF PAIN PUMP UNDER ANESTHESIA. CATHPLACE: SUBACROMIAL SPACE. PT ALLEGES CARTILAGE DAMAGE IN RIGHT SHOULDER FOLLOWING PLACEMENT OF AN I-FLOW ON-Q PAIN PUMP, AFTER SURGERY ON (B)(6) 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10026 ON-Q PAIN PUMP ELASTOMERIC PUMP MEB I-FLOW, LLC UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other