MAUDE Adverse Event Report: GCS CO., LTD PLAMERE PLASMA PEN; MASSAGER, THERAPEUTIC, ELECTRIC

Device Problem Use of Device Problem (1670)

Patient Problems Pain (1994); Scar Tissue (2060); Anxiety (2328)

Event Date 01/07/2022

Event Type  Injury  

Event Description

I need corrective procedures; my esthetician recently talked me into a new procedure she was just certified in, called plasma fibroblast.She wanted to do it for free for advertising.I did research, and really couldn't find anything other than a bunch of competitive advertising.I went ahead and did it.First of all, it was very painful, despite the numbing agent she used.Afterwards, she told me she had used a much higher intensity for "more lift." i followed all her aftercare instructions and i am still left with deep scars.She has offered to "make it right" with even more cosmetic procedures.She wants to do 2 chemical peels and then microneedling to try to correct it.I was never told this could be a possibility.After all this, i found out that she got her certification in 48 hours online and practiced on fruit!! this device that she is using-the plamere plasma pen, has already been banned in (b)(6), and i believe for good reason! this device needs more testing and should require better hands on training.She's completely deleted my procedure from her business page and did not show the updates.She is very busy, doing this to a good amount of women in the last 2 months! i'm sure there are more to come.This device needs banned! i am left with scars, and anxiety.I'm afraid to get another treatment from her and cannot afford to go to someone else for a second opinion.Fda safety report id# (b)(4).

• Brand Name: PLAMERE PLASMA PEN
• Type of Device: MASSAGER, THERAPEUTIC, ELECTRIC
• Manufacturer (Section D): GCS CO., LTD
• MDR Report Key: 13548992
• MDR Text Key: 285828110
• Report Number: MW5107528
• Device Sequence Number: 1
• Product Code: ISA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 36 YR
• Patient Sex: Female
• Patient Weight: 50 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White