inforMED
InjuryQAI

ELLACOR

Received Nov 29, 2023 · Event occurred Sep 19, 2023

Report MW5148582 · MDR key 18239059

Device

Generic name

Powered Microneedle Device

Patient

60 YR · Female

  • Hemorrhage/Blood Loss/Bleeding
  • Pain
  • Scar Tissue
  • Deformity/ Disfigurement
  • Swelling/ Edema
  • Hyperpigmentation
  • Hemorrhage/Blood Loss/Bleeding
  • Pain
  • Scar Tissue
  • Deformity/ Disfigurement
  • Swelling/ Edema
  • Hyperpigmentation

Narrative

Description of Event or Problem

ELLACOR MICROCORE TREATMENT AT LASER DOCTOR OFFICE SEVERE FACIAL SCARS AND HYPERPIGMENTATION AT SITES OF DEVICE. HAD IMMEDIATE SWELLING AND PAIN AFTER TREATMENT. I HAVE PHOTOS I AM A PHYSICIAN. I TRULY UNDERSTAND WHAT OCCURRED. THIS DEVICE IS A PROTOTYPE NO MATTER WHAT CYTRELLIS OR THE DR DENY. DEVICE VIOLENTLY PUNCHES ONE IN THE FACE WITH NEEDLES. LASER AND SKIN SURGERY CENTER OF NEW YORK DERMATOLOGIST PERFORMED. IMMEDIATE PAIN, SEVERE DISFIGURING SWELLING AND BLEEDING DOWN NECK AND INTO EARS. I AM NOW 9 WEEKS POST TREATMENT AND HAVE SCARS ALL OVER MY FACE OF THE DEVICE' IMPRINT AS WELL AS POST, INFLAMMATORY HYPERPIGMENTATION, ESPECIALLY ABOVE MY LIP, WHERE THE LINES ARE PARTICULARLY EGREGIOUS FROM THE ELLACOR. THIS DEVICE NOT READY FOR THE PUBLIC. I WILL RETAIN AN ATTORNEY. I HAVE BEFORE AND AFTER PHOTOS AND UPLOADED THESE PHOTOS TO REAL SELF. THIS SHOULD NOT HAVE HAPPENED. CYTRELLIS IS RESPONSIBLE.