BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VECTUS

    MDR report key: 4998245 · Received August 12, 2015

    Report

    Report Number
    1222993-2015-00037
    Event Type
    Injury
    Date Received
    August 12, 2015
    Date of Event
    July 6, 2015
    Report Date
    August 12, 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

    PATIENT EXPERIENCED OPEN SORES ON ITS NECK AREA AFTER A LASER PROCEDURE. TREATMENT PARAMETERS WERE FOLLOWED WITHIN CLINICAL GUIDELINES. VASELINE WAS PRESCRIBED TO THE PATIENT AS MEDICAL INTERVENTION, WHICH IS REPORTABLE. THERE WAS NO PROBLEM FOUND WITH THE LASER DURING THE SERVICE EVALUATION.

    Description of Event or Problem · 1

    PATIENT EXPERIENCED OPEN SORES FROM LASER TREATMENT AND WAS PRESCRIBED VASELINE AS MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528603 VECTUS VECTUS GEX CYNOSURE INC

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other