inforMED
InjuryLMH

REVANESSE VERSA+ (WITH LIDOCAINE) 1.2ML

Received Aug 6, 2024

Report 3004423487-2024-00017 · MDR key 19924214

Device

Generic name

Revanesse Versa+ (with Lidocaine) 1.2ml

Model number

PN40083

Lot number

21E014

Product problems

  • Insufficient Device Problem Information
  • Insufficient Device Problem Information

Patient

NA · Female

  • Nodule
  • Nodule

Narrative

Description of Event or Problem

ADVERSE EVENT INFORMATION: THE INJECTOR REPORTS TO THAT THE PATIENT WAS INJECTED WITH REVANESSE VERSA+ (WITH LIDOCAINE) 1.2ML,21E014 ON (B)(6) 2022 ON THE VERSA, 0.3ML OF PRODUCT WAS INJECTED. THE PATIENT REPORTS TO THE INJECTOR THAT SHE HAS DEVELOPED BUMPS ON HER LIPS A YEAR LATER. PROLLENIUM MEDICAL TECHNOLOGIES INC. WAS NOT ABLE TO CONSULT ITS MEDICAL DIRECTOR OWING TO THE LACK OF INFORMATION PROVIDED. PROLLENIUM MEDICAL TECHNOLOGIES INC. WAS NOT ABLE TO CONSULT ITS MEDICAL DIRECTOR OWING TO THE LACK OF INFORMATION PROVIDED.

Remedial action

  • Patient Monitoring