MAUDE Adverse Event Report: PLAMERE PLASMA PEN; LIGHT BASED OVER THE COUNTER WRINKLE REDUCTION

Medical Device Problem Code	Inadequate or Insufficient Training (1643)
Health Effect - Clinical Code	Scar Tissue (2060)
Date of Event	05/28/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Severe facial scarring; i had a full face plasma pen treatment with plamere plasma pen that left me with hundreds of small atrophic scars on several areas of my face.The procedure is being done by non-medical technicians who have no skin care training.Fda safety report id# (b)(4).
Event or Problem Description
Additional information received for report number mw5109378 on 06/08/2022.

• Brand Name: PLAMERE PLASMA PEN
• Common Device Name: LIGHT BASED OVER THE COUNTER WRINKLE REDUCTION
• MDR Report Key: 14218771
• Report Number: MW5109378
• Device Sequence Number: 5838059
• Product Code: OHS
• 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,Followup
• Report Date (Section B): 04/24/2022

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
• Operator of Device: Other
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/26/2022
• Supplement Report FDA Received Date: 06/08/2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White