BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC SOFAMORE DANEK

    MDR report key: 2624744 · Received May 1, 2007

    Report

    Report Number
    2624744
    Event Type
    Injury
    Date Received
    May 1, 2007
    Date of Event
    February 14, 2007
    Report Date
    April 23, 2007
    Product Code
    HRX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT BURNED BY METRX RADIANCE ILLUMINATION SYSTEM. VENDOR UNAWARE OF WARNING ON BOX. USED 400 W LIGHT SOURCE INSTEAD OF 100W. VENDOR NO LONGER SELLS 100W LIGHT SOURCE. HOSP HAD TO RESEARCH AND PURCHASE 100W LIGHT SOURCE FROM ANOTHER VENDOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC SOFAMORE DANEK METRX RADIANCE ILLUMINATION SYSTEM HRX 9560702 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other