REVANESSE LIPS+ 1.2 ML
Received Jan 3, 2025 · Event occurred May 23, 2024
Report 3004423487-2024-00028 · MDR key 21072717
Device
Generic name
Revanesse Lips+
Manufacturer
Prollenium Medical Technologies Inc.Model number
40149Lot number
23I030
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
60 YR · Unknown
- Swelling/ Edema
- Swelling/ Edema
Narrative
Description of Event or Problem
ON AN UNSPECIFIED DATE A NP PROVIDER INJECTED REVANESSE LIPS+ INTO A PATIENTS LIPS. THERE IS NO ASSOCIATED PATIENT DATA, HISTORY OR PHOTOS PROVIDED. THERE WERE NO REPORTED ADVERSE EVENTS. THE ONLY INFORMATION THE INJECTING NP PROVIDED CAME IN THE FORM OF A QUESTION. " I JUST WANTED TO ASK, HAVE YOU HEARD OF A PATIENT GETTING TRANSIENT LIP SWELLING, LASTING ONLY A COUPLE OF HOURS, AFTER DRINKING THE NIGHT BEFORE?" MY CLINICAL OPINION IS THAT THERE IS NO INFORMATION PROVIDED IN THIS CASE TO INDICATE AN ADVERSE EVENT TO HA FILLER. TRANSIENT LIP SWELLING THE MORNING AFTER DRINKING (ALCOHOL OR FLUIDS) IS A USUAL CONSEQUENCE OF EXCESS DRINKING THE NIGHT BEFORE. INTERNAL REPORT NUMBER: (B)(4).