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

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Scar Tissue (2060)
Date of Event	05/21/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
I had the louise walsh international plasma pen procedure done on (b)(6) 2020.This left white scars all over the front of my neck where the procedure was performed.Fda safety report id# (b)(4).

• Brand Name: LOUISE WALSH INTERNATIONAL PLASMA PEN
• Common Device Name: POWERED MICRONEEDLE DEVICE
• Manufacturer (Section D): LOUISE WALSH INTERNATIONAL
• MDR Report Key: 14104768
• Report Number: MW5108944
• Device Sequence Number: 16120977
• Product Code: QAI
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• 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): 04/09/2022

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?: Yes
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/12/2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HERBS; VITAMIN A ; VITAMIN C; VITAMIN D ; VITAMIN D ; VITAMIN E
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White