BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SKYTRON

    MDR report key: 4694114 · Received April 8, 2015

    Report

    Report Number
    1825014-2015-00008
    Event Type
    Injury
    Date Received
    April 8, 2015
    Report Date
    April 8, 2015
    Manufacturer
    DAI-ICHI SHOMEI CO
    Product Code
    FSY
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE SURGICAL CASE WAS KNEE SURGERY AND A PORTION OF THE PT'S LEG WAS WRAPPED (WRAP NOT IDENTIFIED). DOCTOR REPORTED THAT DURING THE CASE THE STELLAR ST23LH WAS 24" FROM THE WRAPPED PORTION OF THE LEG AND THE WRAP WAS WARM TO THE TOUCH. FOLLOWING THE CASE WHEN THE WRAP WAS REMOVED, A SKIN WOUND WAS DISCOVERED AND/OR PRODUCED, SKIN STICKING TO THE WRAP AND PEELING OFF AS THE WRAP WAS REMOVED. THE WOUND WAS DESCRIBED AS A BURN OR BURST BLISTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230307 SKYTRON SURGICAL LIGHT FSY DAI-ICHI SHOMEI CO ST23LH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other