BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENTLEMAX

    MDR report key: 2516804 · Received March 30, 2012

    Report

    Report Number
    1218402-2012-00005
    Event Type
    Injury
    Date Received
    March 30, 2012
    Date of Event
    January 13, 2012
    Report Date
    March 30, 2012
    Manufacturer
    CANDELA CORP.
    Product Code
    GEX
    PMA / PMN Number
    K063074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS INSTALLED AT THE USER SITE (B)(6), 2010. THERE HAVE BEEN NO CLINICAL COMPLAINTS FROM THE USER SITE OR REGARDING THIS SPECIFIC SERIAL NUMBER SINCE THAT TIME. THE PRODUCT DEVICE HISTORY RECORD AND SERVICE HISTORY WERE REVIEWED (B)(6), 2012 WITH NO CONCLUSIONS MADE. THE TREATMENT PARAMETERS REPORTEDLY USED BY THE OPERATOR WERE: 3MM SPOT SIZE, 60MS PULSE DURATION, 220J/CM2, AND 15/20/0 DCD SETTING, WHICH ARE WITHIN THE PARAMETERS AS RECOMMENDED BY CANDELA'S TREATMENT GUIDELINES. A CANDELA FIELD SERVICE ENGINEER INSPECTED THAT THE UNIT INVOLVED IN THE EVENT AND REPORTED THAT THE UNIT WAS OPERATING WITHIN SPECIFICATION. THE SITE HAD ALSO REPORTED THAT THE PATIENT HAD A PREVIOUS TREATMENT FOR A LARGER VEIN, WHICH HAD RESULTED IN A BURN, BUT THE PATIENT INSISTED ON CONTINUING TREATMENTS.

    Description of Event or Problem · 1

    A SITE REPORTED THAT A PATIENT RECEIVED TREATMENT FOR SPIDER VEINS AND RESPONDED WITH A BURN ON THE LOWER PART OF THE LEFT LEG. THE SITE REPORTED THAT THE BURN WAS AN ULCERATION THAT TURNED BLACK. IT WAS ALSO REPORTED THAT THE PATIENT WAS TAKING THE FOLLOWING MEDICATIONS: ALLEGRA D, LEVOXYL, AND PREMPRO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENTLEMAX DERMATOLOGY LASER GEX CANDELA CORP. 9914-00-0400 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability