MAUDE Adverse Event Report: RAEL, INC. ACNE HEALING PATCH, MICRONEEDLE TECHNOLOGY; DRESSING, WOUND, HYDROPHILIC

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/12/2019

Event Type  malfunction  

Event Description

The product was purchased through (b)(6).The product shows a health claim on the front package "acne healing patch".It includes salicylic acid, but doesn't have any dosage or warning or any type of direction.The patch was for acne and the patch had a microneedle.It also says "heal" on the backside of the package which makes us assume this is some type of drug product.However, it doesn't properly show active ingredient or any other information.I am worried if the teenagers purchase the product might have the side effects depends on their condition.Also, i was worried if that might cause second had an infection or introducing bacteria through the skin.I would like the company to properly register or update their package by the fda regulation.Acne.

• Brand Name: ACNE HEALING PATCH, MICRONEEDLE TECHNOLOGY
• Type of Device: DRESSING, WOUND, HYDROPHILIC
• Manufacturer (Section D): RAEL, INC.
• MDR Report Key: 8912703
• MDR Text Key: 155697572
• Report Number: MW5089203
• Device Sequence Number: 1
• Product Code: NAC
• 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
• Type of Report: Initial
• Report Date: 08/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/27/2022
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 35 YR
• Patient Weight: 54