BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BBLS

    MDR report key: 3827751 · Received May 8, 2014

    Report

    Report Number
    2953696-2014-00015
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    April 28, 2014
    Report Date
    May 7, 2014
    Manufacturer
    SCITON, INC.
    Product Code
    GEX
    PMA / PMN Number
    070388
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS SUGGESTED TO THE COMPLAINANT THAT THE FLUENCE SETTING WAS TOO HIGH, AND ALSO THAT THE PATIENT MAY HAVE HAD A SENSITIVITY TO WHATEVER HAD BEEN TOPICALLY APPLIED TO HER LEGS. PHOTOS HAVE BEEN SENT TO TWO LUMINARIES FOR THEIR REVIEW AT THE REQUEST OF THE COMPLAINANT. INPUT FROM THE TWO LUMINARIES CONFIRM THAT THE TREATMENT SETTING WAS TOO HIGH FOR THE PATIENT.

    Description of Event or Problem · 1

    CLINICIAN REPORTS A VIGOROUS REACTION ON THE LEGS FROM A HAIR REDUCTION TREATMENT. (B)(6) PATIENT WAS TREATED FOR PHOTO-FACIAL, AND AXILLA HAIR REDUCTION, AND LEG HAIR REDUCTION ON (B)(6) 2014. SETTINGS WERE: BBL 640 FILTER; 16 JOULES/CM2; 25 AND 20MS PULSE WIDTH; CLINICIAN STATES THAT THE IMMEDIATE CLINICAL END-POINTS WERE "NORMAL". PATIENT HAD PREVIOUS TREATMENT 6 WEEKS AGO WITH THE SAME SETTINGS, AND REPORTED "EXTREME REDNESS" FOLLOWING THE TREATMENT. CLINICIAN REPORTED THAT THE PATIENT HAD BEEN "TAKING A WATER PILL WHICH MADE HER LIGHT SENSITIVE". THEREFORE, THE PATIENT WAS INSTRUCTED TO BE OFF OF THE MEDICATION 5 WEEKS PRIOR TO THIS SECOND TREATMENT. THE AXILLA WAS TREATED WITH THE SAME PARAMETERS, WITH NO ADVERSE REACTION. THE PATIENT SENT THE FIRST PHOTO ON (B)(6) WITH SIGNIFICANT REDNESS AND SWELLING, AND WAS INSTRUCTED BY THE CLINICIAN TO "TAKE BENADRYL AND USE ALOE-VERA-STRAIGHT-FROM-THE-PLANT ON HER LEGS". SHE SENT ANOTHER PHOTO ON (B)(6), AND THE THIRD PHOTO WHICH SHOWS THE BLISTERS ON MA(B)(6). THE PATIENT WENT TO HER OWN PHYSICIAN, AND REC'D A PRESCRIPTION "FOR AN ANTIBIOTIC AND SPECIAL CREAM TO PUT ON MY LEGS WHEN THE BLISTERS POP".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278133 BBLS IPL DEVICE GEX SCITON, INC. BBLS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA