MAUDE Adverse Event Report: HERO COSMETICS, INC. MIGHTY PATCH; DRESSING, WOUND, DRUG

Lot Number	AB20JB4S
Health Effect - Clinical Codes	Erythema (1840); Itching Sensation (1943); Skin Burning Sensation (4540); Skin Inflammation/ Irritation (4545)
Date of Event	01/27/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
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.

• Brand Name: MIGHTY PATCH
• Common Device Name: DRESSING, WOUND, DRUG
• Manufacturer (Section D): HERO COSMETICS, INC.; 407 broome street, 7th floor ; new york NY 10013
• MDR Report Key: 11301131
• Report Number: MW5099294
• Device Sequence Number: 15534604
• Product Code: FRO
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Expiration Date: 09/13/2023
• Device Lot Number: AB20JB4S
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/08/2021
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Weight: 33