BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SKYTRON

    MDR report key: 7734558 · Received July 31, 2018

    Report

    Report Number
    3006437518-2015-00002
    Event Type
    Injury
    Date Received
    July 31, 2018
    Report Date
    May 23, 2020
    Manufacturer
    DAI-ICHI SHOMEI CO., LTD
    Product Code
    FSY
    PMA / PMN Number
    K002463
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON APRIL 28, 2015, DAI-ICHI SHOMEI RECEIVED INFORMATION THAT DURING A LEG PROCEDURE, THE SURGICAL LIGHT WAS 24" AWAY FROM A WRAPPED PATIENT'S LEG WHEN THE PHYSICIAN CONFIRMED THAT THE WRAP WAS HOT. THE WRAP WAS STUCK TO THE LEG SKIN AND CAUSED A BURN OR BLISTER UPON REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579522 SKYTRON SURGICAL LIGHT FSY DAI-ICHI SHOMEI CO., LTD ST23LH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other