BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENTLELASE

    MDR report key: 4276451 · Received November 7, 2014

    Report

    Report Number
    1218402-2014-00019
    Event Type
    Injury
    Date Received
    November 7, 2014
    Date of Event
    October 2, 2014
    Report Date
    November 7, 2014
    Manufacturer
    CANDELA CORP.
    Product Code
    GEX
    PMA / PMN Number
    K111144
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CANDELA DOES NOT PROVIDE TREATMENT PARAMETERS FOR MELASMA TREATMENT WITH THIS LASER SYSTEM, SINCE THE DEVICE IS NOT CLEARED FOR THIS INDICATION. INVESTIGATION IS CURRENTLY ON-GOING.

    Description of Event or Problem · 1

    A SITE IN (B)(6) REPORTED THAT A PATIENT RECEIVED LASER TREATMENT FOR MELASMA. THE DOCTOR PERFORMED 3 PULSES ON THE PATIENT'S FACE AND NOTED THAT THE EPIDERMIS WAS REMOVED ON THE TREATMENT AREA AFTER THOSE 3 PULSES. IT WAS REPORTED THAT THE DOCTOR SAW THE PATIENT AFTERWARDS AND THAT THE PATIENT EXPERIENCED HYPERPIGMENTATION ON THE TREATED AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718627 GENTLELASE DERMATOLOGY LASER GEX CANDELA CORP. 9914-00-0880

    Patients

    Seq Age Sex Outcome Treatment
    1 Other