BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILED-7

    MDR report key: 7142143 · Received December 21, 2017

    Report

    Report Number
    MW5074185
    Event Type
    Injury
    Date Received
    December 21, 2017
    Date of Event
    December 15, 2017
    Report Date
    December 20, 2017
    Manufacturer
    TRUMPF MEDICAL SYSTEMS
    Product Code
    FSQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NM, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERGOING OPEN HEART SURGERY, NOTED THAT EXPOSED SKIN APPEARED VERY RED UNDER LIGHTS AFTER CLOSE OF 4-5 HOUR CASE. DRAPES REMOVED, REDNESS RESOLVED SEVERAL HOURS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920452 ILED-7 LIGHT, SURGICAL FSQ TRUMPF MEDICAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Required Intervention