inforMED
InjuryLMH

REVANESSE LIPS+ 1.2 ML

Received Aug 8, 2025 · Event occurred Jun 18, 2025

Report 3004423487-2025-00019 · MDR key 22761041

Device

Generic name

Revanesse Lips+ 1.2 Ml

Model number

PN40149

Lot number

24J105

Product problems

  • Adverse Event Without Identified Device or Use Problem
  • Adverse Event Without Identified Device or Use Problem

Patient

NA · Female

  • Swelling/ Edema
  • Swelling/ Edema

Narrative

Description of Event or Problem

THEY DID A HALF SYRINGE OF JUVEDERM VOLBELLA ON LIPS ON (B)(6) 2024. ALSO HAD DONE A HALF SYRINGE OF VOLBELLA PRIOR TO THAT IN (B)(6) 2023. NO CONCERNS OR MIGRATION WITH EITHER OF THOSE SYRINGES. THEN ON (B)(6) THEY DID 1 ML OF LIPS. ON THE WAY HOME THE PATIENT TEXTED ABOUT "SWELLING" ABOVE THE LIP. SHE CAME BACK 2 WEEKS LATER AND THE MIGRATION WAS STILL PRESENT. 1 CC OF HYLENEX WAS DISSOLVED AND IT INSTANTLY STARTED CHANGING.3 DAYS LATER SHE CAME BACK AND THEY DID ANOTHER 1 CC OF HYLENEX ALONG THE BORDER."