BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-Q PAIN PUMP

    MDR report key: 642080 · Received October 4, 2005

    Report

    Report Number
    642080
    Event Type
    Malfunction
    Date Received
    October 4, 2005
    Date of Event
    September 27, 2005
    Report Date
    October 4, 2005
    Manufacturer
    VQ ORTHOCARE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A "PAIN BALL" WAS BEING USED FOR POST OP INCISIONAL PAIN FOLLOWING A CABG PROCEDURE FOUR DAYS PRIOR TO THIS EVENT. AS THE DOCTOR WAS REMOVING THE CATHETER, A PORTION BROKE OFF LEAVING A PORTION INSIDE THE PATIENT. THE PATIENT WAS TAKEN TO SURGERY THAT SAME DAY FOR EXPLORATION OF THE STERNAL INCISION AND REMOVAL OF THE CATHETER SEGMENT WHICH WAS FOUND IN THE SUBCUTANEOUS TISSUE OVERLYING THE STERNAL WIRES. NO DRAINS WERE NECESSARY. THE PATIENT HAS SINCE BEEN DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q PAIN PUMP PAIN MANAGEMENT CATHETER/PUMP MEB VQ ORTHOCARE UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR