BEUDAMED
    FDA Adverse Event Injury Summary report: N

    I GROW HAIR GROWTH SYSTEM

    MDR report key: 6386916 · Received March 6, 2017

    Report

    Report Number
    MW5068341
    Event Type
    Injury
    Date Received
    March 6, 2017
    Date of Event
    January 15, 2017
    Report Date
    February 27, 2017
    Manufacturer
    APIRA SCIENCE
    Product Code
    OAP
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON BOTH OCCASIONS, I USED DEVICE. AFTER A COUPLE OF DAYS REDNESS APPEARS, THEN ITCHING, FLAKING. NOTE: I CONTACTED THE COMPANY AFTER FIRST INCIDENT. THEY TOLD ME THAT THE UNIT COULD NOT HAVE CAUSED IT, AS IT USES COLD LASERS. I THEN REPEATED USING WITH SAME RESULT ON (B)(6) 2017. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFO RECEIVED FROM REPORTER FOR REPORT MW5068341 ON (B)(6) 2017. THIS IS AN UPDATE TO A LETTER I SENT YOU DATED (B)(6). IT INCLUDED A FORM 3500 I SUBMITTING REGARDING AN ADVERSE EVENT WITH THE HAIR LASER PRODUCT IGROW AND PHOTOS OF MY FACE. AT THE TIME I WROTE YOU, I THOUGHT THAT THE UNIT HAD BURNED ME, TWICE. I AM WRITING TO REVISE MY STATEMENT OF FACTS ABOUT THE PROBLEM. I CONTINUE TO HAVE REDNESS AND FAKING IN THE AREAS THAT I WROTE ABOUT PREVIOUSLY. I AM NOW BEING TREATED FOR SEBORRHEIC KERATOSIS. IT APPEARS TO MY PHYSICIAN THAT THE UNIT MAY HAVE, IN SOME WAY, TRIGGERED THIS CONDITION. I HAD ACUTE OCCURRENCES EACH TIME I USE IT. THE FIRST TIME WAS ON (B)(6), BEFORE I HEADED BACK EAST. AFTER THE COMPANY ASSURED ME THAT THE UNIT COULD NOT CAUSE BURNS, I TRIED IT AGAIN ON (B)(6) OR SO. AGAIN, A FEW DAYS LATER, REDNESS APPEARED, THIS TIME ON MY LEFT ELBOW AND EYELID. I ASKED MY PHYSICIAN IF HE THOUGHT THESE WERE CONNECTED OR RANDOM EVENTS - USE OF THE UNIT AND DEVELOPMENT OF SKIN CONDITION. HE SAID HE REMAINS SUSPICIOUS THAT THERE MAY BE A CONNECTION BECAUSE I DEVELOPED IT AT THE TIMES OF USING THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163197 I GROW HAIR GROWTH SYSTEM I GROW HAIR GROWTH SYSTEM OAP APIRA SCIENCE

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other "OXYDINE" | AREDS| BIOTIN| C0Q10| CONJUGATED LINOLEIC ACID| DAILY VITAMINS| FENUGREEK | FISH OIL| FLUOXETINE| GLUCOSAMINE| LOSARTAN| MAGNESIUM| METFORMIN| MILK OF MAGNESIA| PRAVASTATIN| QUERCETIN| TRAZADONE| VIT D