BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-Q SILVER SOAKER 5IN, 400 ML/5ML/HR

    MDR report key: 2680331 · Received July 31, 2012

    Report

    Report Number
    2026095-2012-00203
    Event Type
    Injury
    Date Received
    July 31, 2012
    Date of Event
    June 20, 2007
    Report Date
    December 11, 2009
    Manufacturer
    I-FLOW, LLC
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: NO PRODUCT WAS RETURNED FOR EVAL AND INVESTIGATION. RESULT: 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 U.S. 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". (1303722, REV E).

    Description of Event or Problem · 1

    DRUG/DILUENT: UNK, FILL VOLUME: 400 ML, FLOW RATE: 5.0 ML/HR, PROCEDURE: ARTHROSCOPY OF LEFT SHOULDER WITH SUBACROMIAL DECOMPRESSION. ARTHROSCOPY OF LEFT SHOULDER WITH DISTAL CLAVICLE EXCISION. CATHPLACE: LEFT SHOULDER. PT ALLEGES CHONDROLYSIS IN LEFT SHOULDER FOLLOWING PLACEMENT OF AN ON-Q PAINBUSTER AFTER SURGERY ON (B)(6) 2007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q SILVER SOAKER 5IN, 400 ML/5ML/HR ELASTOMERIC PUMP MEB I-FLOW, LLC PM026-A 722232

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other