BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILED 7 SURGICAL LIGHTS

    MDR report key: 21595778 · Received March 13, 2025

    Report

    Report Number
    MW5167645
    Event Type
    Injury
    Date Received
    March 13, 2025
    Date of Event
    February 6, 2025
    Report Date
    March 11, 2025
    Manufacturer
    BAXTER MEDICAL SYSTEMS GMBH + CO. KG
    Product Code
    FSQ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SECOND TO 3RD DEGREE SKIN BURN OF LEFT LOWER EXTREMITY RESULTING FROM HEAT EMITTED FROM OVERHEAD SURGICAL LIGHTS DURING SURGICAL VASCULAR PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1482090 ILED 7 SURGICAL LIGHTS LIGHT, SURGICAL, INSTRUMENT FSQ BAXTER MEDICAL SYSTEMS GMBH + CO. KG 4068310

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Male Required Intervention| O