BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-Q PAIN PUMP

    MDR report key: 4109590 · Received September 16, 2014

    Report

    Report Number
    2026095-2014-00175
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    June 1, 2005
    Report Date
    August 19, 2014
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VI, 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 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 US 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. 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". ON (B)(4) 2007, I-FLOW HAS ALSO PREPARED A TECHNICAL BULLETIN ENTITLED: "WHAT WE KNOW ABOUT CHONDROLYSIS TODAY". (1303722,REV. E). INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEM.

    Description of Event or Problem · 1

    FILL VOLUME: NOT PROVIDED. FLOW RATE: NOT PROVIDED. PROCEDURE: UNKNOWN, NP. CATHPLACE: INTRA-ARTICULAR PLACEMENT. PATIENT ALLEGES CHONDROLYSIS FOLLOWING THE PLACEMENT OF A PAIN PUMP FOLLOWING SURGERIES ON OR ABOUT (B)(6) 2005. "NP: NOT PROVIDED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571743 ON-Q PAIN PUMP MEB I-FLOW CORP. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NP Other DRUG: UNKNOWN, NP