InjuryGFE
DERMINATOR 2
Received Mar 6, 2025 · Event occurred Feb 7, 2025
Report MW5167334 · MDR key 21539287
Device
Generic name
Brush, Dermabrasion, Powered
Manufacturer
Vaughter Wellness (owndoc.com)Patient
NA · Unknown
- Needle Stick/Puncture
- Needle Stick/Puncture
Narrative
Description of Event or Problem
PERSONAL PRODUCT USE OF THE DERMINATOR 2 RESULTED IN IRREVERSIBLE SCARRING ON SKIN. THE PRODUCT REACHES A NEEDLE DEPTH THAT EXCEEDS COSMETIC APPLICATION, MAKES CLAIMS ABOUT ITS ABILITY TO TREAT SKIN CONDITIONS AND DOES NOT APPEAR TO HAVE PROPER FDA CLEARANCE REQUIRED FOR MEDICAL DEVICES. SEE HTTPS://DERMINATOR.COM/ & HTTPS://DERMINATOR.COM/DERMINATOR2-INSTRUCTIONS.PDF FOR SPECIFICATIONS OF NEEDLE DEPTH AND NO LISTED FDA CLEARANCE.