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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Emotional Changes (1831); Erythema (1840); Itching Sensation (1943); Blister (4537); Skin Inflammation/ Irritation (4545); Contact Dermatitis (4546)

Event Date 10/03/2022

Event Type  Injury  

Event Description

This patient got a severe allergic contact dermatitis and subsequent post inflammatory hyperpigmentation for using the product "mighty patch" to self treat her acne vulgaris of her face.She used multiple patches on her numerous acne nodules, pustules, papules and comedones of her face.She then developed severe itching and redness and blistering, followed by the hyperpigmentation on the skin areas where the patches were placed on the face.This required a prescription bleaching cream and in office chemical peels to treat.The patient was emotionally distressed from the effects of the patches.These patches are mis-branded because they claim to treat acne.They are not safe for patients and should be pulled from the market immediately.I'm a board certified dermatologist in practice for 11 years.

• Brand Name: MIGHTY PATCH
• Type of Device: DRESSING, WOUND, OCCLUSIVE
• Manufacturer (Section D): HERO COSMETICS, INC.
• MDR Report Key: 15616151
• MDR Text Key: 301951520
• Report Number: MW5112658
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/12/2022

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/14/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 26 YR
• Patient Sex: Female
• Patient Weight: 57 KG
• Patient Ethnicity: Hispanic