inforMED
InjuryLMH

REVANESSE LIPS+ 1.2 ML

Received Dec 12, 2024 · Event occurred Oct 26, 2024

Report 3004423487-2024-00027 · MDR key 20917905

Device

Generic name

Revanesse Lips+ 1.2 Ml

Model number

PN40149

Lot number

23K167

Product problems

  • Use of Device Problem
  • Use of Device Problem

Patient

37 YR · Female

  • Aspiration/Inhalation
  • Aspiration/Inhalation

Narrative

Description of Event or Problem

ON (B)(6) 2024 A PATIENT RECEIVED 0.4 CC OF REVANESSE LIPS + INTO HER LIPS. PRIOR TO THE TREATMENT THE PATIENT RECEIVED "IV VITAMINS" AND HAD "A TOPICAL NUMBING OINTMENT FROM EMPOWER PHARMACY " APPLIED TO THEIR LIPS, PRIOR TO INJECTION. THERE WERE NO DOCUMENTED CONCERNS OR ADVERSE EVENTS AT THE TIME OF INJECTION. THREE DAYS LATER THE PATIENT NOTICED A "SMALL OVAL SHAPED FORMATION ON THE LEFT UPPER LIP" AND WAS INSTRUCTED TO GENTLY MASSAGE THE AREA. THERE WAS NO ERYTHEMA, INFLAMMATION OR NODULES. THE PHOTOS PROVIDED ALL CLEARLY SHOWN AN AREA OF SUPERFICIAL PRODUCT DEPOSITION ON THE LEFT UPPER LIP. EVENTUALLY ON (B)(6) 2024 THE SUPERFICIALLY INJECTED PRODUCT WAS DISSOLVED WITH HYALURONIDASE.