BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENTLEMAX PRO

    MDR report key: 5003094 · Received August 11, 2015

    Report

    Report Number
    1218402-2015-00012
    Event Type
    Injury
    Date Received
    August 11, 2015
    Date of Event
    July 23, 2015
    Report Date
    August 11, 2015
    Manufacturer
    CANDELA CORP.
    Product Code
    GEX
    PMA / PMN Number
    K133283
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A CANDELA FIELD SERVICE ENGINEER (FSE) INSPECTED THE UNIT AND REPORTED THAT THE UNIT WAS OPERATING WITHIN SPEC. THE CANDELA FSE INSPECTED THE HANDPIECE AND FOUND THE WINDOW INSIDE WAS BURNED AND SHATTERED. THE BURNT WINDOW MAY BE DUE TO DEBRIS BUILDING UP ON THE WINDOW CAUSING IT TO SHATTER. CANDELA INSTRUCTS USERS THROUGH TRAINING AND PROVIDES LABELING TO EMPHASIZE THE IMPORTANCE OF INSPECTING AND CLEANING THE WINDOW FREQUENTLY SO DEBRIS DOES NOT GET BURNED ONTO THE WINDOW SURFACE.

    Description of Event or Problem · 1

    A SITE REPORTED A PATIENT REC'D LASER HAIR REMOVAL TREATMENT AND REPORTED THAT DURING A PULSE, A LOUD "POP" OCCURRED, SENDING A SMALL FRAGMENT OF HOT MATERIAL ON THE PATIENT'S NECK FROM THE HANDPIECE, WHICH RESULTED IN A 2ND DEGREE BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523695 GENTLEMAX PRO DERMATOLOGY LASER GEX CANDELA CORP. 9914-00-9035

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability