BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-Q PAIN PUMP

    MDR report key: 2912720 · Received January 8, 2013

    Report

    Report Number
    2026095-2012-00370
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    August 22, 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 EVALUATION AND INVESTIGATION. RESULTS: 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: 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 (B)(4) 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 (B)(4) 2007, I-FLOW HAS ALSO PREPARED A TECHNICAL BULLETIN ENTITLED "WHAT WE KNOW ABOUT CHONDROLYSIS TODAY." (NUMBER 1303722, REV. E).

    Description of Event or Problem · 1

    DRUG/DILUENT: UNKNOWN. FILL VOLUME: 100ML. FLOW RATE: 2ML/HR. PROCEDURE: LEFT SHOULDER ARTHROSCOPY, WITH LABRAL DEBRIDEMENT, BICEPS TENODESIS, ROTATOR CUFF REPAIR AND DISTAL CLAVICLE EXCISION. CATHPLACE: ON-Q CATHETER WAS INSERTED WITHOUT DIFFICULTY UNDER DIRECT VISUALIZATION. LOCATION UNSPECIFIED. PATIENT ALLEGES CARTILAGE DAMAGE IN LEFT SHOULDER FOLLOWING PLACEMENT OF AN I-FLOW ON-Q PAINBUSTER, P100X2, AFTER SURGERY ON (B)(6) 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9895 ON-Q PAIN PUMP ELASTOMERIC PUMP MEB I-FLOW, LLC P100X2 832475

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other