BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMOS

    MDR report key: 21337654 · Received February 7, 2025

    Report

    Report Number
    3006437518-2025-00001
    Event Type
    Injury
    Date Received
    February 7, 2025
    Date of Event
    January 3, 2025
    Report Date
    February 6, 2025
    Manufacturer
    DKK DAI-ICHI SHOMEI
    Product Code
    FSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON THE (B)(6), DKK WAS INFORMED THAT THE STAFF AT THE HOSPITAL USED TWO OF THE THREE LUMOS LIGHTS AT AN INTENSITY LEVEL OF 3. POST SURGERY, THERE WAS A VISIBLE PIGMENTATION CHANGE TO THE PATIENT SKIN AROUND SURGICAL SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    881504 LUMOS SURGICAL LIGHT, CEILING MOUNTED FSY DKK DAI-ICHI SHOMEI LUMOS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other