BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILED7

    MDR report key: 7142176 · Received December 21, 2017

    Report

    Report Number
    MW5074186
    Event Type
    Injury
    Date Received
    December 21, 2017
    Date of Event
    December 11, 2017
    Report Date
    December 20, 2017
    Manufacturer
    TRUMPF MEDICAL SYSTEMS
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NM, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT HAVING OPEN HEART SURGERY UNDER TRUMP FILED7 OPERATING ROOM LIGHT FOR A 4-5 HOUR CASE. PATIENT SUSTAINED A PARTIAL THICKNESS BURN TO THE CHEST WALL NEAR THE INCISION THAT WAS EVIDENT AFTER THE DRAPES WERE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920453 ILED7 LIGHT, SURGICAL FSY TRUMPF MEDICAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention