BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILIGHT IPL6500

    MDR report key: 8737821 · Received June 26, 2019

    Report

    Report Number
    3005855240-2019-00001
    Event Type
    Injury
    Date Received
    June 26, 2019
    Date of Event
    April 15, 2019
    Report Date
    June 26, 2019
    Manufacturer
    SHASER INC
    Product Code
    ONF
    PMA / PMN Number
    K120080
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IN QUESTION WAS NOT RETURNED SO WE WERE UNABLE TO CONDUCT AN INVESTIGATION OF IT. HOWEVER, THE DHR OF THE DEVICE FROM THE SUPPLIER SHOWED THAT ALL ITEMS MET THE DESIGN SPECIFICATIONS WHEN SHIPPED FROM THE MANUFACTURER. MOREOVER: THE IPL6500 DEVICE IS DESIGNED AND MANUFACTURED WITH A SPECIFIC CAP MEANT TO BE USED ON THE FEMALE FACE BELOW THE CHEEKBONE. THIS FACIAL ATTACHMENT WAS DESIGNED WITH NO VENT HOLES TO MINIMIZE THE LIGHT LEAKAGE WHEN OPERATING BELOW THE CHEEKBONE. IN ADDITION, THE DEVICE HAS SKIN CONTACT SENSORS THAT PREVENT ACCIDENTAL FLASHING. THE DEVICE WILL NOT FLASH UNLESS BOTH OF THE SKIN CONTACT SENSORS ARE IN FULL CONTACT WITH THE SKIN. THE INSTRUCTIONS FOR USE OF THE DEVICE SHOW AND WARN THE USER MULTIPLE TIMES HOW TO PROPERLY USE THE FACIAL ATTACHMENT. THIS IS COVERED IN THE SKIN CHART SECTION, THE WARNINGS AND SAFETY SECTION, THE TREATMENT SECTION, AND THE FAQ SECTION. THE INSTRUCTIONS FOR USE SPECIFICALLY WARN THAT USING THE DEVICE ON OR AROUND THE EYES, EYEBROWS, OR EYELASHES CAN CAUSE SERIOUS AND PERMANENT EYE INJURY. THIS IS THE ONLY COMPLAINT OF THIS NATURE THAT SPECTRUM BRANDS, INC. OWNER OF SHASER,INC HAS RECEIVED IN THE 5 YEARS WE HAVE SOLD THE DEVICE. SPECTRUM BRANDS, INC. OWNER OF SHASER, INC. RECEIVED THIS COMPLAINT FROM A PREVIOUSLY UNKNOWN END-USER LOCATED IN (B)(6). NEITHER SPECTRUM NOR SHASER SELL THIS DEVICE IN (B)(6) AND CURRENTLY SUSPECT THAT THIS ACTIVITY MAY HAVE OCCURRED THROUGH AN UNAUTHORIZED THIRD-PARTY DISTRIBUTION CHANNEL OR A COUNTERFEITER. SPECTRUM FILED INITIAL VOLUNTARY SELF-DISCLOSURE NOTICES REGARDING THIS ISSUE WITH THE U.S. TREASURY DEPARTMENT¿S OFFICE OF FOREIGN ASSETS CONTROL (OFAC) AND U.S. COMMERCE DEPARTMENT¿S BUREAU OF INDUSTRY & SECURITY (BIS) ON JUNE 20, 2019 AND WILL PROVIDE COMPLETE REPORTS TO THOSE AGENCIES REGARDING POTENTIAL ECONOMIC SANCTIONS OR EXPORT CONTROL CONCERNS WITHIN 60 DAYS.

    Description of Event or Problem · 1

    THE END USER REPORTED USING THE IPL6500 AND THE DEVICE CAUSED AN INJURY TO HER EYES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527411 ILIGHT IPL6500 IPL6500 ONF SHASER INC IPL6500

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Other