inforMED
InjuryGFE

DERMINATOR 2

Received Mar 6, 2025 · Event occurred Feb 7, 2025

Report MW5167334 · MDR key 21539287

Device

Generic name

Brush, Dermabrasion, Powered

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.