BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICON

    MDR report key: 6109498 · Received November 17, 2016

    Report

    Report Number
    1222993-2016-00056
    Event Type
    Injury
    Date Received
    November 17, 2016
    Date of Event
    October 18, 2016
    Report Date
    November 17, 2016
    Manufacturer
    CYNOSURE INC
    Product Code
    GEX
    PMA / PMN Number
    K110907
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WAS GIVEN CORTISONE AS INTERVENTION MEDICATION FOR POST CARE TREATMENT. TREATMENT TECHNIQUE WAS NOT FOLLOWED PER CLINICAL GUIDELINES, SO USER ERROR CONTRIBUTED TO THIS INCIDENT. CUSTOMER SITE HAS BEEN UNRESPONSIVE TO CYNOSURE'S MULTIPLE REQUESTS TO SCHEDULE A DEVICE EVALUATION. BURNS ARE AN EXPECTED SIDE EFFECT FROM LASER TREATMENTS, HOWEVER THIS IS REPORTABLE BECAUSE THE PATIENT RECEIVED INTERVENTION MEDICATION FOR THIS EVENT. CUSTOMER UNRESPONSIVE AND USER ERROR.

    Description of Event or Problem · 1

    PATIENT RECEIVED A BURN ON ITS LEGS FROM A LASER HAIR REMOVAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759132 ICON ICON GEX CYNOSURE INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other