BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYNOSURE

    MDR report key: 1410867 · Received June 27, 2009

    Report

    Report Number
    MW5011771
    Event Type
    Malfunction
    Date Received
    June 27, 2009
    Date of Event
    February 4, 2009
    Report Date
    June 27, 2009
    Manufacturer
    CYNOSURE, INC.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT DEVELOPED KELOID SCARRING ON NECK FOLLOWING HER 2ND LASER TREATMENT WITH THE CYNOSURE VSTAR. SHE WAS TREATED WITH THE CYNOSURE VSTAR. SHE WAS TREATED ONCE PREVIOUSLY IN 2008, WITH NO COMPLICATIONS. THE SAME SETTINGS -6.1 J/CM2 IN 2009, AND 6.0 J/CM2 IN 2008-, COOLING, TECHNIQUE AND POST-TREATMENT SKIN CARE USED FOR THE 2008 TREATMENT WERE USED FOR THE 2009 TREATMENT. HAVE BEEN UNABLE TO DETERMINE A CLINICAL OR PROCEDURAL EXPLANATION FOR THE DIFFERENT OUTCOME OF THE 2ND TREATMENT. OTHER PTS WERE TREATED THE SAME DAY, WITH THE SAME LASER WITH GOOD OUTCOME. CONCERNED THAT THERE MAY BE AN INTERMITTENT PROBLEM WITH THE LASER CAUSING IT TO RANDOMLY FIRE MORE INTENSELY DESPITE NO CHANGE IN SETTINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYNOSURE VSTAR GEX CYNOSURE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Other