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

Device Problem Inadequate or Insufficient Training (1643)

Patient Problem Scar Tissue (2060)

Event Date 05/28/2021

Event Type  Injury  

Event 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 Description

Additional information received for report number mw5109378 on 06/08/2022.

• Brand Name: PLAMERE PLASMA PEN
• Type of Device: LIGHT BASED OVER THE COUNTER WRINKLE REDUCTION
• MDR Report Key: 14218771
• MDR Text Key: 290302104
• Report Number: MW5109378
• Device Sequence Number: 1
• Product Code: OHS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 04/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White