BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILED 7 CEILING TRIO

    MDR report key: 20245465 · Received September 17, 2024

    Report

    Report Number
    MW5159657
    Event Type
    Injury
    Date Received
    September 17, 2024
    Date of Event
    August 30, 2024
    Report Date
    September 12, 2024
    Manufacturer
    BAXTER HEALTHCARE CORPORATION / BAXTER MEDICAL SYSTEMS GMBH + CO. KG.
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2024, THE PATIENT UNDERWENT A RIGHT TOTAL MASTECTOMY PROCEDURE AND RIGHT AXILLARY SENTINEL NODE MAPPING AND BIOPSY PROCEDURE AND RIGHT LATERAL AND RIGHT POSTEROLATERAL CHEST WALL CONE DEFORMITY EXCISION. DURING THE SECOND TO LAST SUTURE CLOSURE, THERE WAS EVIDENCE OF THERMAL INJURY TO THE EPIDERMIS OF THE SKIN OVERLYING THE DERMIS OF THE SKIN ALONG THE CENTRAL PORTION OF THE PATIENT'S RIGHT MASTECTOMY/RIGHT CHEST WALL SURGICAL RESECTION SITE, AND IT WAS DETERMINED IT WAS INTRAOPERATIVE THERMAL INJURY TO THE EPIDERMIS OF THE SKIN DUE TO EXCESSIVE HEAT GENERATED ON THE SURFACE OF THE SKIN BY THE 3 OVERHEAD OPERATIVE FIELD HILLROM SURGICAL LIGHTS (TRUMPF MEDICAL SYSTEMS). THE PATIENT HAS AN EXTENSIVE BURN THAT HAS LEFT SLUFF SKIN, SHE HAS REQUIRED MULTIPLE FOLLOW-UPS AND WILL NEED A DEBRIDEMENT OF THE SCAR/BURN. REF REPORTS: MW5159655, MW5159656.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2527898 ILED 7 CEILING TRIO LIGHT, SURGICAL, CEILING MOUNTED FSY BAXTER HEALTHCARE CORPORATION / BAXTER MEDICAL SYSTEMS GMBH + CO. KG.

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Hospitalization| O