MAUDE Adverse Event Report: DERMAVEL DERMAVEL FIBROBLAST PLASMA PEN; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Patient Problems Scar Tissue (2060); Impaired Healing (2378)

Event Type  Injury  

Event Description

Company is selling a "plasma pen" intended to improve the appearance of skin by stimulating the production of collagen and other proteins and aid in the removal of skim "imperfections." "effectively combat aging signs with a non-invasive plasma pen treatment proven to tackle a wide range of skin conditions" - (ex.Tummy tightening) "this advanced device produces small plasma flashes (also known as ionized carbonation), creating tiny dots on your skin.Each dot is a trigger point for rejuvenation, marking the path to a more radiant, youthful-looking you." "the fibroblast plasma pen is a groundbreaking technology that has revolutionized the way we rejuvenate skin.It's the world's most advanced, non-invasive device to lift, tighten, and revitalize dull, lifeless skin.It's no wonder why more and more people are starting to make the switch to plasma pen." fine print at bottom of page - "services, information, and products written or mentioned on this site are only for informational and educational purposes.Words, statements or claims on this site are not intended to diagnose, treat, cure, or prevent any disease or health condition, and have not been verified by local authorities, a health department or a government body.Always talk to a health professional to determine your condition and recommendations.Information about product can be found at dermavel.Com/mustknows.Must be read before use.By using this site, or any of our services & products, you agree to our terms & privacy policy" reviews included the following - "the device left severe scars on my face that hasn't healed in over a month.Left me with hyperpigmentation as well that will require many months to treat." https://dermavel.Com/products/fibroblast-plasma-pen.

• Brand Name: DERMAVEL FIBROBLAST PLASMA PEN
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): DERMAVEL; magasinsgatan 1; gothenburg 411 1 8; SW 411 18
• MDR Report Key: 18921417
• MDR Text Key: 337905325
• Report Number: MW5152911
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1