BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENTLEMAX PRO

    MDR report key: 3934853 · Received June 20, 2014

    Report

    Report Number
    1218402-2014-00013
    Event Type
    Injury
    Date Received
    June 20, 2014
    Date of Event
    May 27, 2014
    Report Date
    June 4, 2014
    Manufacturer
    CANDELA CORP.
    Product Code
    GEX
    PMA / PMN Number
    K133283
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS INSTALLED AT THE USER SITE ON 12/23/2013. THERE HAS BEEN ONE PREVIOUS CLINICAL COMPLAINT FROM THE USER SITE REGARDING THIS SPECIFIC SERIAL NUMBER SINCE THAT TIME. THE PRODUCT DEVICE HISTORY RECORD AND SERVICE HISTORY WAS REVIEWED (B)(4) 2014 WITH NO ISSUE FOUND. A CANDELA FIELD SERVICE ENGINEER INSPECTED THE UNIT AND REPORTED THAT THE UNIT WAS OPERATING WITHIN SPECIFICATION. THE TREATMENT PARAMETERS REPORTEDLY USED BY THE OPERATOR WERE WITHIN THE TREATMENT PARAMETERS AS RECOMMENDED BY CANDELA'S TREATMENT GUIDELINES. IT IS RECOMMENDED BY CANDELA'S TREATMENT GUIDELINES TO NOT TREAT RECENTLY TANNED SKIN. BASED ON WHAT WAS REPORTED BY THE SITE, PRIOR TANNING BY THE PATIENT BEFORE THE TREATMENT MAY HAVE BEEN A CONTRIBUTING FACTOR TO THE INJURY.

    Description of Event or Problem · 1

    A SITE REPORTED THAT A PATIENT RECEIVED LASER HAIR REMOVAL TREATMENT AND THAT THE PATIENT RESPONDED WITH 2ND DEGREE BURNS AND BLISTERS ON THE TREATED AREA. IT WAS ALSO REPORTED THAT THE PATIENT SUSTAINED 1ST DEGREE BURNS ON THE FRONT PORTION OF HER LEGS. THE SITE REPORTED THAT IT BELIEVED THE PATIENT HAD SUN EXPOSURE PRIOR TO TREATMENT, DESPITE DENIAL FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364227 GENTLEMAX PRO DERMATOLOGY LASER GEX CANDELA CORP. 9914-00-9035 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability