BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SLT II

    MDR report key: 4965517 · Received August 4, 2015

    Report

    Report Number
    1222993-2015-00035
    Event Type
    Injury
    Date Received
    August 4, 2015
    Date of Event
    April 9, 2015
    Report Date
    August 4, 2015
    Manufacturer
    CYNOSURE INC
    Product Code
    OYW
    PMA / PMN Number
    K102541
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WAS PRESCRIBED POLYSPORIN MEDICATION AND A COMPRESSION GARMENT FOR PREVENTATIVE CARE. TREATMENT PARAMETERS WERE WITHIN CLINICAL GUIDELINES. THERE WAS NO PROBLEM FOUND WITH THE DEVICE AND OPERATED WITHIN SPECIFICATION. HOWEVER THIS IS A REPORTABLE EVENT BECAUSE A FULL THICKNESS BURN IS A SERIOUS INJURY.

    Description of Event or Problem · 1

    PATIENT EXPERIENCED A FULL THICKNESS BURN ON ITS LEFT INNER THIGH FROM A LASER PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507593 SLT II SLT II OYW CYNOSURE INC

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Disability