BEUDAMED
    FDA Adverse Event Injury Summary report: N

    METRX MD INSTRUMENT

    MDR report key: 517676 · Received March 17, 2004

    Report

    Report Number
    1030489-2004-00014
    Event Type
    Injury
    Date Received
    March 17, 2004
    Date of Event
    February 17, 2004
    Report Date
    February 17, 2004
    Manufacturer
    SOFAMOR DANEK - WARSAW
    Product Code
    HRX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    EVENT DATE: IN 2004. DURING SURGERY, PT RECEIVED 2ND DEGREE BURNS BY THE METAL CONNECTOR, WHERE THE METRIX CABLE AND THE POWER CABLE ARE CONNECTED TOGETHER. PT WAS TREATED FOR BURN WITH TOPICAL OINTMENT AND REPORTED TO BE DOING FINE. NOTE: CUSTOMER WAS NOT USING COMPANY'S LIGHT SOURCE OR POWER CABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 METRX MD INSTRUMENT RADIANCE ILLUMINATION SYSTEM HRX SOFAMOR DANEK - WARSAW NA 480530

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN