BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIGHTY PATCH

    MDR report key: 11301131 · Received February 8, 2021

    Report

    Report Number
    MW5099294
    Event Type
    Injury
    Date Received
    February 8, 2021
    Date of Event
    January 27, 2021
    Report Date
    February 1, 2021
    Manufacturer
    HERO COSMETICS, INC.
    Product Code
    FRO
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    MY PATIENT USED AN "ACNE PATCH" FROM THE BRAND "(B)(6)". IT PRODUCED SEVERE REDNESS, ITCHING AND BURNING AND EVENTUAL POST INFLAMMATORY HYPERPIGMENTATION (PIH). THE PIH REQUIRED IN OFFICE CHEMICAL PEELING TO TREAT. I AM APPALLED AND CONCERNED THAT "ACNE PATCHES" ARE ALLOWED TO LABEL THEIR PRODUCTS AS A TREATMENT FOR ACNE, WHEN IN FACT IT IS A COSMETIC PRODUCT. TO LABEL THE PRODUCT AS A TREATMENT OF ACNE IS A DRUG CLAIM. THEREFORE, I WOULD LIKE THIS PRODUCT AND SIMILAR "ACNE PATCH" PRODUCTS PULLED FROM THE MARKET BECAUSE THEY ARE MISLEADING PATIENTS AND THE PUBLIC WITH DRUG CLAIMS OF "REDUCING" AND "ELIMINATING" ACNE. AS A DERMATOLOGIST, I KNOW THESE ACNE PATCHES HAVE NOT BEEN THOROUGHLY STUDIED FOR SAFETY AND EFFICACY, YET I SEE PATIENTS COMING INTO MY OFFICE WITH REACTIONS (AS DESCRIBED IN THIS CASE). TO ME, THESE PRODUCTS ARE NOT SAFE AND ARE MISLABELED, MASQUERADING AS A COSMETIC WHILE PROMOTING DRUG CLAIMS. "PLEASE PULL THESE FROM"; THIS PATIENT HAS MODERATE ACNE VULGARIS OF THE FACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193344 MIGHTY PATCH DRESSING, WOUND, DRUG FRO HERO COSMETICS, INC. AB20JB4S

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR