BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SKYTRON

    MDR report key: 4749809 · Received April 30, 2015

    Report

    Report Number
    1825014-2015-00015
    Event Type
    Injury
    Date Received
    April 30, 2015
    Report Date
    April 17, 2015
    Manufacturer
    DAI-ICHI SHOMI
    Product Code
    FSY
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FACILITY REPORTED DIFFUSER LENS OF SURGICAL LIGHT FELL DURING A CASE INTO THE PT'S SURGICAL SITE. THIS REQUIRED INTERVENTION FROM SURGICAL STAFF TO REMOVE THE GLASS PARTICULATE FROM THE WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286069 SKYTRON SURGICAL LIGHT FSY DAI-ICHI SHOMI ST23

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention