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
Manufacturer
Prollenium Medical Technologies IncModel number
PN40149Lot 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.