BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PAIN PUMP

    MDR report key: 3412311 · Received October 4, 2013

    Report

    Report Number
    2026095-2013-00151
    Event Type
    Injury
    Date Received
    October 4, 2013
    Date of Event
    June 28, 2004
    Report Date
    September 5, 2013
    Manufacturer
    I-FLOW, LLC
    Product Code
    MEB
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 SERVICED ON I-FLOW, NO CUSTOMER CONTACT CAN BE MADE AT THIS TIME DUE TO THE PENDING LITIGATION. ON 8/8/2007, I-FLOW 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: UNK. FLOW RATE: UNK. PROCEDURE: LEFT SHOULDER LABRAL REPAIR. CATHPLACE: SHOULDER. PT ALLEGES CHONDROLYSIS IN LEFT SHOULDER FOLLOWING PLACEMENT OF AN PAIN PUMP AFTER LABRAL REPAIR SURGERY ON OR ABOUT (B)(6) 2004. ADD'L INFO REC'D FROM LEGAL (B)(6) 2013): I-FLOW UNDERSTANDS UPON INFO AND BELIEF, THAT THIS IS A MCKINLEY PUMP, BUT IN AN ABUNDANCE OF CAUTION, I-FLOW IS FILING THIS MDR TO MEET ANY REGULATORY OBLIGATIONS THAT IT MAY HAVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502733 PAIN PUMP ELASTOMERIC PUMP MEB I-FLOW, LLC UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NP Other