BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VECTUS LASER SYSTEM

    MDR report key: 4935975 · Received July 23, 2015

    Report

    Report Number
    1222993-2015-00029
    Event Type
    Injury
    Date Received
    July 23, 2015
    Date of Event
    June 20, 2015
    Report Date
    July 23, 2015
    Manufacturer
    CYNOSURE INC
    Product Code
    GEX
    PMA / PMN Number
    K120622
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT INVOLVED USER ERROR BECAUSE THE SCABBING WAS A RESULT OF THE OPERATOR NOT CLEANING THE DEBRIS OFF THE OPTICS DURING LASER TREATMENT. TREATMENT WAS NOT WITHIN GUIDELINES. THERE WAS NO MEDICATION PRESCRIBED AND NO PROBLEM WAS FOUND WITH THE LASER. SCABBING IS AN EXPECTED REACTION FROM LASER TREATMENTS, BUT IS REPORTABLE IN THIS INCIDENT BECAUSE OF USER ERROR.

    Description of Event or Problem · 1

    PATIENT EXPERIENCED SCABBING (EXPECTED REACTION FROM HAIR REMOVAL LASER TREATMENT), BUT IS REPORTABLE BECAUSE IT WAS CAUSED BY USER ERROR AND HAS NOT YET HEALED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480635 VECTUS LASER SYSTEM VECTUS GEX CYNOSURE INC

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other