BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHTMAT

    MDR report key: 3202300 · Received June 26, 2013

    Report

    Report Number
    MW5030716
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 20, 2013
    Manufacturer
    LUMITEX
    Product Code
    HJM
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT IN THE OPERATING ROOM FOR BILATERAL MASTECTOMY AND RECONSTRUCTION. THE LIGHTMAT, SURGICAL ILLUMINATOR, WAS USED THROUGH OUT THE PROCEDURE. DURING THE PROCEDURE, THE LIGHT CORD SAME IN CONTACT WITH PT CAUSING 3 DIFFERENT BURNS. THE LIGHTMAT AS USES WITH THE RECOMMENDED LIGHT CORD FROM LUMITEX AND A STRYKER X8000 LIGHT SOURCE AT 100%. IT WAS NOTED THAT THE METAL CONNECTION PIECE BETWEEN THE LIGHTMAT AND THE LIGHT CORD BECAME VERY HOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290277 LIGHTMAT SURGICAL ILLUMINATOR HJM LUMITEX UA2550 I02386

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other