BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENTLEMAX

    MDR report key: 3093635 · Received May 1, 2013

    Report

    Report Number
    1218402-2013-00007
    Event Type
    Injury
    Date Received
    May 1, 2013
    Date of Event
    March 20, 2013
    Report Date
    May 1, 2013
    Manufacturer
    CANDELA CORP.
    Product Code
    GEX
    PMA / PMN Number
    K112715
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS INSTALLED AT THE USER SITE (B)(6) 2011. THERE HAVE BEEN NO CLINICAL COMPLAINTS FROM THE USER SITE REGARDING THIS SPECIFIC SERIAL NUMBER SINCE THAT TIME. THE PRODUCT DEVICE HISTORY RECORD AND SERVICE HISTORY WAS REVIEWED (B)(6) 2013 WITH NO ISSUES FOUND. THE SITE REPORTED THEY INITIALLY TREATED THE PATIENT USING THE 755NM TREATMENT PARAMETERS FOR A SKIN TYPE III. THEY REPORTED THE UNIT THEN "MADE A PUFF NOISE" AND PROMPTED THE USER "TO RECALIBRATE THE MACHINE OR CALL FOR SERVICE." IT WAS REPORTED THAT THE TREATMENT PROCEEDED USING THE 1064NM TREATMENT PARAMETERS FOR A SKIN TYPE IV.

    Description of Event or Problem · 1

    A SITE REPORTED THAT A PATIENT RECEIVED TREATMENT FOR HAIR REMOVAL AND REPORTED A BLISTER AND ULCERATION ON THE INNER AND OUTER RIGHT THIGH. EMLA WAS REPORTED TO BE USED AS A TOPICAL ANESTHETIC. IT WAS REPORTED THAT BIAFINE AND TNS RECOVERY COMPLEX WAS USED ON THE TREATED AREA POST TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189358 GENTLEMAX DERMATOLOGY LASER GEX CANDELA CORP. 9914-00-0400 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability