REVANESSE LIPS+ 1.2 ML
Received Dec 11, 2023 · Event occurred Nov 14, 2023
Report 3004423487-2023-00042 · MDR key 18306132
Device
Generic name
Revanesse Lips+
Manufacturer
Prollenium Medical Technologies Inc.Model number
40149Lot number
23E222
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Female
- Swelling/ Edema
- Swelling/ Edema
Narrative
Description of Event or Problem
ON (B)(6) 2023 A PATIENT RECEIVED 1.2 CC OF REVANESSE LIPS+ INTO THEIR LIPS. IMMEDIATELY PRIOR TO THE INJECTION THE LIPS WERE CLEANSED WITH HIBICLENS AND A COMPOUNDED TOPICAL ANESTHETIC CONTAINING LIDOCAINE, TETRACAINE AND PHENYLEPHRINE WAS APPLIED. THERE WERE NO ADVERSE EVENTS OR SYMPTOMATIC CONCERNS AT THE TIME OF INJECTION. THE FOLLOWING MORNING THE PATIENT REPORTED SWELLING OF THE LIPS. NO PHOTOS OR CLINIC ASSESSMENT WERE PROVIDED. THE PATIENT WAS INSTRUCTED TO USE COLD COMPRESSES AND ANTI-INFLAMMATORY MEDS. MY CLINICAL OPINION IS THAT THIS CASE REPRESENTS EXPECTED POST FILLER LIP SWELLING WHICH USUALLY RESOLVES IN 48 HOURS. THIS CAN BE IMPACTED BY ORAL FLUID INTAKE POST PROCEDURE. THERE WAS NO HISTORY OF LUMPS, NODULES, ANGIOEDEMA, VASCULAR OCCLUSION OR INFLAMMATION. INTERNAL REPORT NUMBER: (B)(4).