BEUDAMED
    FDA Adverse Event Other Summary report: N

    ON-Q PAINBUSTER

    MDR report key: 610748 · Received June 2, 2005

    Report

    Report Number
    2026095-2005-00035
    Event Type
    Other
    Date Received
    June 2, 2005
    Date of Event
    April 12, 2005
    Report Date
    May 21, 2005
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PT UNDERWENT AN ARTHROSCOPIC SHOULDER PROCEDURE IN 2005. POST OPERATION DURING THE REMOVAL OF THE CATHETER BY THE PT'S SPOUSE THE CATHETER STRETCHED AND THEN BROKE. THE LENGTH OF THE REMAINING SEGMENT IN THE PT WAS UNK. A PROCEDURE WAS SCHEDULED FOR 5/2005 TO RETRIEVE THE REMAINING SEGMENT. A FOLLOW-UP BY I-FLOW WAS MADE ON THE 5TH DAY WITH THE DOCTOR. THE CATHETER SEGMENT HAD BEEN REMOVED AND THE PT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q PAINBUSTER INFUSION PUMP MEB I-FLOW CORP. PM012 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other