BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHREX

    MDR report key: 2941011 · Received October 17, 2006

    Report

    Report Number
    2941011
    Event Type
    Malfunction
    Date Received
    October 17, 2006
    Date of Event
    October 12, 2006
    Report Date
    October 12, 2006
    Manufacturer
    ARTHREX
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A KNEE ARTHROSCOPY, THE DOCTOR NOTED THE KNEE SWELLING WITH FLUID ABNORMALITY. THE ARTHREX PUMP IMMEDIATELY TURNED OFF AND REPLACED WITH DIFFERENT TUBING. NO PROBLEMS NOTED AFTER THE CHANGE OF TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTHREX ORTHO LXH ARTHREX MACHINE

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR ARTHREX PUMP TUBING: (B)(4), LOT # 002211