VELASHAPE AND ULTRASHAPE

Description of Event or Problem

ON (B)(6) 2015 SYNERON QA WAS MADE AWARE OF A POSSIBLE ADVERSE EVENT THAT OCCURRED TO A PT OF LASER MD MEDSPA. PT REPORTEDLY SUSTAINED BURNS POST TREATMENT WITH ULTRASHAPE TREATMENT FOLLOWED BY VELASHAPE II TREATMENT ON THE ABDOMEN ON THE SAME DAY. PT (B)(6) IS A FEMALE CAUCASIAN PT TREATED ON THE ABDOMEN FOR CIRCUMFERENCE REDUCTION. ULTRASHAPE PROCEDURE HAD THE FOLLOWING SETTINGS: HORIZONTAL TREATMENT WAS USED WITH 8 ACTUAL FOCAL ZONES. PARKER ULTRASOUND GEL WAS USED ALONG WITH STRAPS, AND TRANSDUCER SURFACE APPEARED SMOOTH. VELASHAPE II TREATMENT PARAMETERS ARE UNK AT THIS TIME. POST TREATMENT, PT WAS GIVEN AQUAPHOR WITH NON-STICK GAUZES. PT EXPERIENCED MINOR REDNESS WITHOUT DISCOMFORT AROUND THE BELLY BUTTON AREA DURING ULTRASHAPE PROCEDURE. VELASHAPE II PROCEDURE WAS PERFORMED AFTER, AVOIDING THE BELL BUTTON AREA. FROM PHOTOS TAKEN 1 DAY POST TREATMENT, THE BURNS APPEAR TO BE LOW IN SEVERITY. THE CLINIC STATED THAT THE BURNS WERE FIRST DEGREE BURNS. HOWEVER THE SUBSEQUENT PHOTOS (RECEIVED ON 04/27/2015) SHOW BLISTERS MODERATE IN SEVERITY DURING WHAT SHOULD HAVE BEEN RECOVERY PERIOD.

Additional Manufacturer Narrative

UPON REVIEWING ALL AVAILABLE DATA AND INFORMATION AT THIS MOMENT IN TIME, THE MOST PROBABLE ROOT CAUSE IS UNK DUE TO LACK OF TREATMENT INFORMATION AND EQUIPMENT INFORMATION. UPON ARRIVAL TESTING OF THE SYSTEM INVOLVED IS PENDING.