BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA SERIES

    MDR report key: 2852424 · Received November 16, 2012

    Report

    Report Number
    2852424
    Event Type
    Malfunction
    Date Received
    November 16, 2012
    Date of Event
    November 12, 2012
    Report Date
    November 16, 2012
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE SURGICAL BLADE WAS PLUGGING UP AND COULD NOT BE UNPLUGGED FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRA SERIES ARTHROSCOPE HRX SMITH & NEPHEW, INC. * 50672144

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR