BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYLATOPIC PLUS CREAM

    MDR report key: 10060886 · Received May 14, 2020

    Report

    Report Number
    MW5094495
    Event Type
    Injury
    Date Received
    May 14, 2020
    Date of Event
    August 1, 2018
    Report Date
    May 12, 2020
    Manufacturer
    ENCORE DERMATOLOGY INC.
    Product Code
    FRO
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    TO WHOM IT MAY CONCERN: I HOPE THIS NOTE FINDS YOU WELL. I PREVIOUSLY (WITHIN THE LAST COUPLE OF WEEKS) SUBMITTED AN ADVERSE DRUG REACTION REPORT THROUGH YOUR MEDWATCH WEBSITE. IN IT, I DETAILED HOW AFTER DOING A FULL PROGRAM OF A GENERIC OF ACCUTANE (ENDING IN (B)(6) 2018), I DEVELOPED PSORIASIS SYMPTOMS WHICH I HAVE TO THIS DAY AND AM CURRENTLY TREATING WITH OTEZLA AND TOPICALS. WHAT I WANT TO ADD, AND WHAT I LEFT OUT OF MY ORIGINAL MEDWATCH REPORT ON ACCUTANE, IS THAT WHILE USING ACCUTANE, I WAS ALSO USING THE TOPICAL HYLATOPIC PLUS CREAM. THANK YOU FOR YOUR TIME. HAVE A GREAT DAY. (B)(6), PS: THE PREVIOUSLY REFERENCED SUBMISSION AGAINST ACCUTANE STATED: "AFTER BEING ON (A GENERIC OF) ACCUTANE FOR THE FULL DURATION OF THE PROGRAM, I DEVELOPED AND NOW HAVE PSORIASIS SYMPTOMS. THOUGH THIS IS ANECDOTAL, I WANT THE FDA TO BEGIN BEING AWARE OF THIS ASSOCIATION. MY PSORIASIS IS ON MY NAILS, SCALP, AND HAIRLINE, AND I AM USING TOPICALS (FLUOCINONIDE, CALCIPOTRIENE + BETAMETHASONE), ECZEMA LASER PHOTOTHERAPY, AND OTEZLA TO TREAT THE PSORIASIS. PSORIASIS AND OTEZLA ARE PARTICULARLY DANGEROUS NOW AS PART OF MY IMMUNE SYSTEM IS NOW COMPROMISED AGAINST COVID-19."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518374 HYLATOPIC PLUS CREAM DRESSING, WOUND, DRUG FRO ENCORE DERMATOLOGY INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Disability