VIORA INC.

Additional Manufacturer Narrative

THE DEVICE INVESTIGATION IS ONGOING.

Description of Event or Problem

ON THURSDAY, (B)(6), A CLIENT UNDERWENT A COMBINED TREATMENT FOR FAT REDUCTION AND SKIN TIGHTENING IN THE SUBMENTAL (CHIN) AREA USING V-FORM AND V-ST TECHNOLOGIES. THE V-FORM PROCEDURE WAS PERFORMED FIRST, UTILIZING THE RF1 SETTING DUE TO THE SMALL SIZE OF THE TREATMENT AREA. FOLLOWING THIS, THE V-ST TREATMENT WAS ADMINISTERED. A THICK LAYER OF CONDUCTIVE GEL WAS APPLIED TO THE SKIN, AND THE ENERGY SETTINGS WERE ADJUSTED BASED ON THE CLIENT'S REPORTED SENSATION. THE TREATMENT BEGAN AT A LOW SETTING AND WAS GRADUALLY INCREASED TO A MAXIMUM OF 118 J/CM². THROUGHOUT THE PROCEDURE, THE CLIENT REPORTED FEELING COMFORTABLE AND DID NOT EXPRESS ANY DISCOMFORT OR SENSATION OF EXCESSIVE HEAT. HOWEVER, DURING THE SECOND PASS OF THE V-ST TREATMENT, A VISIBLE CHANGE IN SKIN COLOR TO WHITE WAS OBSERVED, INDICATING A POTENTIAL BURN. THE TREATMENT WAS IMMEDIATELY STOPPED, AND POST-CARE WAS INITIATED, INCLUDING THE APPLICATION OF ALOE VERA, PCA SKIN CLINIC CALM 1% HYDROCORTISONE, AND SPF. THE CLIENT WAS ADVISED TO KEEP THE AREA COOL AND TO APPLY COLD COMPRESSES IF NECESSARY. DESPITE THESE MEASURES, THE CLIENT RETURNED TO THE SPA FOUR DAYS LATER WITH A SERIOUS BURN. SHE REPORTED THAT BLISTERS HAD DEVELOPED ON THE SAME DAY AS THE TREATMENT AND THAT SHE HAD APPLIED A MEDICATED BANDAGE AT HOME IN AN ATTEMPT TO SOOTHE THE AREA. IMAGES OF THE BURNS WERE RECEIVED AND REVIEWED BY A MEDICAL EXPERT, WHO CLASSIFIED THESE AS: SECOND DEGREE BURNS IN THE NECK REGION. THIS IS INITIAL REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A FOLLOW UP REPORT WILL BE FILED UPON RECEIPT OF NEW OR ADDITIONAL INFORMATION