inforMED
InjuryLMH

REVANEESE VERSA

Received Dec 3, 2019 · Event occurred Nov 27, 2019

Report MW5091426 · MDR key 9411744

Device

Generic name

Implant, Dermal, For Aesthetic Use

Product problems

  • Adverse Event Without Identified Device or Use Problem

Patient

36 YR

  • Bruise/Contusion
  • Pain
  • Swelling
  • Bruise/Contusion
  • Pain
  • Swelling

Narrative

Description of Event or Problem

I HAD LIP FILLER WITH REVANESSE VERSA ON (B)(6). AFTER 2 WEEKS ALL BRUISING AND SWELLING HAD RESOLVED. EVENT # 1: ON (B)(6) I WOKE UP WITH LOWER LIP VERY SWOLLEN ON THE RIGHT SIDE, LIP PAIN AND NODULE ON LIP. I WAS PRESCRIBED ORAL STEROIDS WITH IMPROVEMENT. EVENT #2: (B)(6) I WOKE UP WITH LOWER LIP SWOLLEN AGAIN NOW ON THE LEFT SIDE AND FLUCTUANT PAINFUL NODULE. THE FILLER WAS DISSOLVED WITH HYALURONIDASE SAME DAY (B)(6) WITH RESOLUTION SYMPTOMS SO FAR. NEEDED REVERSAL AGENT.