REVANESSE VERSA+ 1.2 ML
Received Sep 22, 2023
Report 3004423487-2023-00035 · MDR key 17801413
Device
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
Female
- Skin Inflammation/ Irritation
- Skin Inflammation/ Irritation
Narrative
Description of Event or Problem
ON AN UNREPORTED DATE IN (B)(6) 2023 A PATIENT RECEIVED REVANESSE VERSA + INJECTED INTO THEIR TEMPLE REGION. AFTER GOING TO THE GYM POST TREATMENT, THE PATIENT REPORTED AN ERYTHEMATOUS RASH ON ONE TEMPLE. THE INJECTOR REPORTED IT AS LOOKING LIKE "CONTACT DERMATITIS". NO FURTHER HISTORY WAS REPORTED. THERE IS NO HISTORY OF DISINFECTANT OR TOPICAL ANESTHETICS USED. THERE WAS NO PAST MEDICAL HISTORY OR HISTORY OF THE RASH TREATMENT OR OUTCOME. HISTORY OF LUPUS. HASN'T HAD ANY ASSOCIATED SYMPTOMS OF LUPUS FOR OVER 20 YEARS. IN SHORT 22/30 OF THE DIRECT QUESTIONS ON THE INTAKE FORM WERE LEFT UNANSWERED. RASHES POST PROCEDURE ALWAYS HAVE A MULTI FACTORIAL DIFFERENTIAL DIAGNOSIS. UNFORTUNATELY, IN THIS CASE THERE IS NOT ENOUGH INFORMATION TO PROVIDE AN INFORMED CLINICAL OPINION. INTERNAL REPORT NUMBER: (B)(4).