BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC

    MDR report key: 2971513 · Received May 2, 2007

    Report

    Report Number
    2971513
    Event Type
    Injury
    Date Received
    May 2, 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
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

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

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other