BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PAINCARE 3000

    MDR report key: 1916928 · Received November 29, 2010

    Report

    Report Number
    1916928
    Event Type
    Malfunction
    Date Received
    November 29, 2010
    Date of Event
    October 20, 2010
    Report Date
    November 29, 2010
    Manufacturer
    LMA NORTH AMERICA, INC.
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING SHOULDER ARTHROSCOPY, THE LIDOCAINE PUMP DID NOT WORK, AND SUBSEQUENTLY WAS REPLACED. IN THIS CASE THE SURGEON DID NOT PLACE THE TUBING IN THE PATIENT'S JOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PAINCARE 3000 PUMP, INFUSION, ELASTOMERIC MEB LMA NORTH AMERICA, INC. 3000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR NO OTHER THERAPIES