BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STELLAR SERIES

    MDR report key: 9498069 · Received December 19, 2019

    Report

    Report Number
    3006437518-2019-00002
    Event Type
    Injury
    Date Received
    December 19, 2019
    Report Date
    December 19, 2019
    Manufacturer
    DKK DAI-ICHI SHOMEI CO., LTD.
    Product Code
    FSY
    PMA / PMN Number
    K002463
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE SERVICE TECHNICIAN'S INSPECTION RECORDS, DETERGENTS REMAINED ON THE DIFFUSER. SUGGESTED WAS A REVIEW OF CLEANING DETERGENTS AND CLEANING METHODS.

    Description of Event or Problem · 1

    THIS MDR IS BEING REPORTED AT THIS TIME AS PART OF AN INTERNAL REVIEW OF PAST COMPLAINTS. DUE TO THE INCIDENT BEING IN THE PAST, THE INFORMATION THAT CAN BE OBTAINED FROM THE INITIAL REPORTER IS LIMITED. 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
    1293015 STELLAR SERIES LIGHT, SURGICAL, CEILING MOUNTED FSY DKK DAI-ICHI SHOMEI CO., LTD. ST23LH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other