BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDLITE C6 SYSTEM

    MDR report key: 2757056 · Received September 24, 2012

    Report

    Report Number
    3009132703-2012-00001
    Event Type
    Injury
    Date Received
    September 24, 2012
    Report Date
    July 30, 2012
    Manufacturer
    CONBIO A CYNOSURE COMPANY
    Product Code
    GEX
    PMA / PMN Number
    K014234
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LASER EQUIPMENT WORKED PROPERLY DURING THE PROCEDURE. IT CAN NOT BE DETERMINED WHAT CAUSED THE INFECTION OR IF IT OCCURRED DURING OR AFTER TREATMENT.

    Description of Event or Problem · 1

    PT DEVELOPED CELLULITIS AT TATTOO REMOVAL REGION AFTER FIRST PROCEDURE. PT WAS PRESCRIBED ANTIBIOTICS. PT REPORTED THAT HE IS HEALED, BUT MAY HAVE SOME SCARRING IN THE AREA OF CELLULITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDLITE C6 SYSTEM DERMATOLOGY LASER SYSTEM GEX CONBIO A CYNOSURE COMPANY NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention