BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICON

    MDR report key: 6043966 · Received October 20, 2016

    Report

    Report Number
    1222993-2016-00049
    Event Type
    Injury
    Date Received
    October 20, 2016
    Date of Event
    September 22, 2016
    Report Date
    October 20, 2016
    Manufacturer
    CYNOSURE INC
    Product Code
    GEX
    PMA / PMN Number
    K110907
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WAS GIVEN TOPICAL VITAMIN C AND SKIN-LIGHTENING PRODUCTS AS INTERVENTION MEDICATION FOR POST CARE TREATMENT. TREATMENT PARAMETERS WERE NOT FOLLOWED PER CLINICAL GUIDELINES, SO USER ERROR CONTRIBUTED TO THIS INCIDENT. HYPERPIGMENTATION IS AN EXPECTED SIDE EFFECT FROM LASER TREATMENTS, HOWEVER THIS IS REPORTABLE BECAUSE THE PATIENT RECEIVED INTERVENTION MEDICATION FOR THIS EVENT. PATIENT IS NOW HEALING WELL. CUSTOMER SITE DECLINED A DEVICE EVALUATION FROM CYNOSURE, BUT INFORMED THAT THE DEVICE WAS OPERATING WITHOUT ANY PROBLEMS. CUSTOMER DECLINED AND USER ERROR.

    Description of Event or Problem · 1

    PATIENT HAD INTERVENTION MEDICATION FOR THE HYPERPIGMENTATION THAT DEVELOPED ON ITS FACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696025 ICON ICON GEX CYNOSURE INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other