VIORA INC.

Additional Manufacturer Narrative

INVESTIGATION ONGOING.

Description of Event or Problem

A HEALTH CARE PROFESSIONAL (HCP) REPORTED A BURN WAS NOTED ON THE ARMS OF THE PATIENT DURING TREATMENT WITH THE V-FORM HANDPIECE. IT WAS CONFIRMED THAT BLISTERS FORMED IN THE AREA AT THE FOLLOW UP VISIT. IMAGES OF THE BURN WERE PROVIDED BY THE HCP. THE BURN AREA "APPEARED" TO BE APPROXIMATELY ONE SQUARE INCH. THE IMAGES WERE REVIEWED BY THE COMPANY'S MEDICAL EXPERT WHO ASSESSED THE BURN AS "VERY SUPERFICIAL SECOND-DEGREE BURN ". THE HCP PRESCRIBED BIAFINE 3-4 TIMES A DAY ON THE AFFECTED SKIN AREA. THE HCP REPORTED THAT DURING TREATMENT SHE KEPT THE DEVICE SETTINGS AT THE THERAPEUTIC RANGE: STARTED WITH PREHEATING AND MOVED TO MODE ONE. ONCE SHE "SWITCHED" TO MODE TWO, SHE NOTICED THAT SMALL BLISTERS WERE DEVELOPING ON THE "TESTED" AREA AND STOPPED THE TREATMENT. THE HCP ALSO STATED THAT AN ADEQUATE AMOUNT OF GLIDE WAS USED AND THE THAT THE FILTERS WERE CHANGE EVERY TWO WEEKS. A COMPANY REPRESENTATIVE RESPONDED AND PROVIDED REFERENCE MATERIALS TO THE HCP REGARDING FILTER MAINTENANCE FOR THE V-FORM HANDPIECE. ADDITIONAL INFORMATION RELATED TO TH EVENT, THE PATIENT, AND THE DEVICE USED WAS ALSO REQUESTED BY THE COMPANY REPRESENTATIVE FROM THE REPORTER. SHOULD ANY FURTHER INFORMATION BE RECEIVED, IT WILL BE PROVIDED IN A FOLLOW UP REPORT.