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); Gastritis (1874); Itching Sensation (1943); Skin Discoloration (2074)

Event Date 10/03/2022

Event Type  Injury  

Event Description

This spontaneous report (b)(4) from the united states of america was reported by a physician (dermatologist) via food and drug administration (fda) medwatch program, concerning a female consumer (age unspecified) who experienced emotional changes, erythema, itching sensation, blister, skin inflammation/ irritation, contact dermatitis, hyperpigmentation, and patient-device incompatibility coincident with the mighty patch.The consumer's medical history and concomitant medications were not reported.On an unspecified date, the consumer initiated mighty patch, a multiple patches via the topical route, to self-treat her acne vulgaris (numerous acne nodules, pustules, papules, and comedones) of the face.On (b)(6) 2022, she developed a severe allergic contact dermatitis and subsequent post inflammatory hyperpigmentation.She developed severe itching, redness, and blistering, followed by hyperpigmentation on the skin areas where the patches were placed on the face.She was emotionally distressed by the effects of the patches.She sought medical attention with the dermatologist, who provided treatment that required a prescription bleaching cream and in office chemical peels to treat.No additional information was available.The action taken with the mighty patch was not applicable.The outcome of the events was unknown.Company comment: although investigation was unable to confirm any of the alleged facts, it is understood the user of the device applied multiple patches to her face and developed contact dermatitis and post inflammatory hyperpigmentation.The user sought medical \attention from a dermatologist who treated the hyperpigmentation with bleaching cream and in-office chemical peels.The conditions described in the voluntary medwatch report would not normally be expected to meet fda's definition of a "serious injury" as they are not considered life threatening, do not result in permanent impairment of a body unction, or permanent damage (i.E., trivial, transitory, and non-cosmetic) damage to a body structure.However, as our investigation has not been able to identify any additional information outside of that contained in the medwatch report to support a better reasoned decision from the regulatory perspective, we are reporting this event out of an abundance of caution.

• Brand Name: MIGHTY PATCH
• Type of Device: DRESSING, WOUND, OCCLUSIVE
• Manufacturer (Section D): HERO COSMETICS, INC; t and l co., ltd. 70-17; wonam-ro, wongok-myeon; anseong-si, gyeonggi-do ; KS
• Manufacturer (Section G): HERO COSMETICS, INC; t and l co., ltd. 70-17; wonam-ro, wongok-myeon; anseong-si, gyeonggi-do ; KS
• Manufacturer Contact: 407 broom street, 7th floor; new york, NY 10013
• MDR Report Key: 15823859
• MDR Text Key: 303900805
• Report Number: 3013752208-2022-01622
• 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: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female