BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENTLEMAX PRO

    MDR report key: 4143419 · Received September 3, 2014

    Report

    Report Number
    1218402-2014-00018
    Event Type
    Injury
    Date Received
    September 3, 2014
    Date of Event
    June 20, 2014
    Report Date
    August 18, 2014
    Manufacturer
    CANDELA CORP.
    Product Code
    GEX
    PMA / PMN Number
    K133283
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS INSTALLED AT THE USER SITE (B)(4) 2012. THERE HAS BEEN NO PREVIOUS CLINICAL COMPLAINTS FROM THE USER SITE REGARDING THIS SPECIFIC SERIAL NUMBER SINCE THAT TIME. THE PRODUCT DEVICE HISTORY RECORD AND SERVICE HISTORY WAS REVIEWED 08/27/2014 WITH NO ISSUES FOUND. THE TREATMENT PARAMETERS REPORTEDLY USED BY THE OPERATOR WERE WITHIN THE TREATMENT PARAMETERS AS RECOMMENDED BY CANDELA'S TREATMENT GUIDELINES. CANDELA QA FOLLOWED-UP WITH THE INITIAL REPORTER TO OBTAIN ADDITIONAL INFORMATION ON THE INJURY AND ON THE CLINIC WHERE THE TREATMENT WAS PERFORMED. INVESTIGATION IS CURRENTLY ONGOING.

    Description of Event or Problem · 1

    A PATIENT SUBMITTED A VOLUNTARY REPORT TO THE FDA MEDWATCH PROGRAM (REPORT NO. MW5036939). THE PATIENT REPORTED AN INJURY AFTER RECEIVING LASER HAIR REMOVAL TREATMENT ON THE LEGS. THE PATIENT REPORTEDLY HAD 3 LASER HAIR REMOVAL TREATMENTS PRIOR TO THIS INJURY. THE PATIENT ALSO REPORTED THAT THEY HAD SUN EXPOSURE 3 WEEKS PRIOR TO THE TREATMENT AND EXPLAINED IT TO THE PRACTITIONER, WHO REPORTEDLY STATED THAT TREATMENT WOULD STILL BE FINE. THE PRACTITIONER PROCEEDED WITH THE LASER TREATMENT AND THE PATIENT REPORTED THAT TREATMENT WAS PAINFUL. AFTER THE TREATMENT, THE PATIENT REPORTED THAT THEY WENT TO URGENT CARE AFTER NOTING BURNS ON THE TREATED AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536070 GENTLEMAX PRO DERMATOLOGY LASER GEX CANDELA CORP. 9914-00-9035 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention