BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILED-7

    MDR report key: 7142183 · Received December 21, 2017

    Report

    Report Number
    MW5074187
    Event Type
    Injury
    Date Received
    December 21, 2017
    Date of Event
    December 13, 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 ILED7 SURGICAL LIGHTS FOR A 4-5 HOUR CASE. PATIENT SUSTAINED REDDENING TO THE SKIN OF THE CHEST SURROUNDING THE INCISIONAL SITE THAT REQUIRED DAYS TO RESOLVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920454 ILED-7 LIGHT, SURGICAL FSY TRUMPF MEDICAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention