MAUDE Adverse Event Report: LOUISE WALSH INTERNATIONAL LOUISE WALSH PLASMA PEN; POWERED MICRONEEDLE DEVICE

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cyst(s) (1800); Erythema (1840); Skin Discoloration (2074); Impaired Healing (2378)
Date of Event	03/07/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
I went to an aesthetician to have a plasma pen (also known as fibroblast) treatment done on my periorbital wrinkles.The procedure was done on march 7th, and the aesthetician used a louise walsh plasma pen.The treatment left pock marks where each "carbon crust" was as well as a red mark at the site of each one.The healing process was supposed to only take a week, but mine took 3.I reached to the aesthetician who told me she's seen this happen often and i needed to come back in, so she can do another treatment but with a different technique once 3 months had passed.As the weeks went on, some of the indentations popped out and became bumps, 3 small cysts arose in the area, and the condition didn't improve.I went to a dermatology office after doing much research to inquire about my options involving lasers.At the advice of the rn working under a dermatologist, i had a fraxel dual laser treatment on may 29th and another on the 15th of this month (june) to correct the marks, discoloration, and small cysts.The first treatment helped a great deal, and i anticipate this will be the last fraxel treatment i need to correct the indentations.According to the rn, the redness is from broken capillaries caused by the pen and it requires a different type of laser called the v beam.I will need to undergo one treatment of v beam to correct the discoloration.The plasma pen cost me between $(b)(6); the two fraxel treatments and the v beam treatment to correct the damage from the plasma pen cost me a total of $(b)(6)not including the creams needed to aid in healing and the 2.5 hour round-trip drives i make each time i go.I can provide photos of the damage done to my eyes as well as the business information of where i got it done.Fda safety report id# (b)(4).

• Brand Name: LOUISE WALSH PLASMA PEN
• Common Device Name: POWERED MICRONEEDLE DEVICE
• Manufacturer (Section D): LOUISE WALSH INTERNATIONAL
• MDR Report Key: 10179046
• Report Number: MW5095108
• Device Sequence Number: 1009412
• Product Code: QAI
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 06/17/2020

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?: Yes
• Operator of Device: Other
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/19/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 33 YR