inforMED
InjuryLMH

REVANESSE VERSA+ 1.2 ML

Received Jan 13, 2025 · Event occurred Aug 15, 2024

Report 3004423487-2024-00029 · MDR key 21143557

Device

Generic name

Revanesse Versa+

Model number

40083

Lot number

24C127

Product problems

  • Adverse Event Without Identified Device or Use Problem
  • Adverse Event Without Identified Device or Use Problem

Patient

68 YR · Female

  • Swelling/ Edema
  • Swelling/ Edema

Narrative

Description of Event or Problem

PATIENT RECEIVED THE INJECTION ON (B)(6)2024. ONE SYRINGE WAS SPREAD OUT IN THE NASOLABIAL FOLDS AND MARIONETTE LINES. PUFFINESS/REDNESS LASTED LONGER AND GOT WORSE, THEN ITCHY FROM DATE OF INJECTION. LASTED FOR ONE WEEK. INTERNAL REPORT NUMBER: (B)(4).