BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTLIPO LASER (SLT II)

    MDR report key: 6017844 · Received October 11, 2016

    Report

    Report Number
    1222993-2016-00046
    Event Type
    Injury
    Date Received
    October 11, 2016
    Report Date
    October 11, 2016
    Manufacturer
    EL. EN. ELECTRONIC ENGINEERING SPA
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DEVELOPED KELOID SCARRING AND HYPERPIGMENTATION ON THIGHS FROM A LASER PROCEDURE WITH THE SLT II DEVICE. IT WAS GIVEN 4% HYDROQUINONE AS INTERVENTION MEDICATION TO TREAT THE HYPERPIGMENTATION, WHILE KENALOG INJECTIONS/SILICONE SHEETING WERE GIVEN TO TREAT THE SCARRING (INTERVENTION MEDICATION). TREATMENT PARAMETERS AND PATIENT DETAILS WERE NOT PROVIDED BY THE CUSTOMER SITE DESPITE REQUESTS FOR ADDITIONAL INFORMATION. THE DEVICE WAS EVALUATED AND FOUND TO BE OPERATING AS INTENDED. THIS EVENT IS REPORTABLE BECAUSE THE PATIENT'S SCARRING MAY NOT IMPROVE AND IT HAD INTERVENTION MEDICATION.

    Description of Event or Problem · 1

    PATIENT DEVELOPED KELOID SCARRING ON THIGHS FROM A LASER PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669300 SMARTLIPO LASER (SLT II) ND: YAG LASER GEX EL. EN. ELECTRONIC ENGINEERING SPA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other