inforMED
InjuryLMH

REVANESSE LIPS+

Received Nov 9, 2025 · Event occurred Sep 27, 2025

Report 3004423487-2025-00021 · MDR key 23507458

Device

Generic name

Implant, Dermal, For Aesthetic Use

Product problems

  • Use of Device Problem
  • Insufficient Device Problem Information
  • Use of Device Problem
  • Insufficient Device Problem Information

Patient

25 YR · Female

  • Pain
  • Nodule
  • Swelling/ Edema
  • Pain
  • Nodule
  • Swelling/ Edema

Narrative

Description of Event or Problem

AREA SALES MANAGER REPORTS: "A PATIENT WHO IS NEW TO LIP FILLER WAS INJECTED WITH 2.2 ML. AFTER TREATMENT THE PATIENT EXPERIENCED PAIN, SWELLING, LUMPS, BUMPS AND UNEVENNESS. AFTER BEING INSTRUCTED TO APPLY A HOT COMPRESS AND MASSAGE FOR TWO WEEKS, THE PATIENTS' LIPS ARE STILL LUMPY AND UNEVEN. SHE WANTED THE FILLER DISSOLVED." THE AREA SALES MANAGER SAYS THE FILLER HAS BEEN DISSOLVED. THE CLINIC HAS NOT PROVIDED LOT NUMBER AND OTHER INFORMATION REQUESTED TO DO THE INVESTIGATION.