BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PAINBUSTER CATHETER

    MDR report key: 4534438 · Received February 19, 2015

    Report

    Report Number
    2026095-2015-00071
    Event Type
    Injury
    Date Received
    February 19, 2015
    Date of Event
    July 2, 2004
    Report Date
    January 22, 2015
    Manufacturer
    HALYARD
    Product Code
    MEB
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE PROD WAS NOT RETURNED FOR AN EVAL AND INVESTIGATION. INFO REGARDING DEVICE MODEL AND LOT NUMBER WAS NOT PROVIDED; THEREFORE, THE DEVICE HISTORY RECORDS WOULD 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. CONCLUSIONS: AS THIS COMPLAINT WAS CREATED FROM A LAWSUIT REC'D BY I-FLOW, LLC OR THE THREAT OF LAWSUIT, NO CONSUMER CONTACT CAN BE MADE AT THIS TIME DUE TO PENDING OR THREATENED LITIGATION. AS OF (B)(4) 2006 I-FLOW HAS UPDATED ITS ON-Q PUMP DIRECTIONS FOR USE (DFU), TO INCLUDE THE FOLLOWING IN THE WARNINGS SECTIONS: "AVOID PLACING CATHETER IN JOINT SPACES. ALTHOUGH THERE IS NO DEFINITIVE ESTABLISHED CAUSAL RELATIONSHIP, SOME LITERATURE HAS SHOWN A POSSIBLE ASSOCIATION BETWEEN CONTINUOUS INTRAARTICULAR INFUSION (PARTICULARLY WITH BUPIVACAINE) AND THE SUBSEQUENT DEVELOPMENT OF CHONDROLYSIS." ((B)(4)). ON (B)(4) 2007, I-FLOW HAS ALSO PREPARED A TECHNICAL BULLETIN ENTITLED "WHAT WE KNOW ABOUT CHONDROLYSIS TODAY". ((B)(4)). INFO FROM THIS INCIDENT HAS BEEN INCLUDED IN OUT PRODUCT COMPLAINT AND MDR TREND REPORTING SYS. TREND INCO IS USED TO IDENTIFY THE NEED FOR ADD'L INVESTIGATIONS.

    Description of Event or Problem · 1

    FILL VOLUME: UNK- NOT PROVIDED. FLOW RATE: UNK- NOT PROVIDED. PROCEDURE: ARTHROSCOPIC BANKART REPAIR AND SLAP REPAIR. CATHPLACE: RIGHT GLENOHUMERAL JOINT. {PLEASE REFERENCE (B)(4)}. PT ALLEGES CHONDROLYSIS FOLLOWING THE PLACEMENT OF A PAINBUSTER PAIN PUMP CATHETER FOLLOWING SURGERY ON OR ABOUT (B)(4) 2004.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119728 PAINBUSTER CATHETER CATHETER MEB HALYARD UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other