EMBODYPLUS (TITE) APPLICATOR

Additional Manufacturer Narrative

NO TECHNICAL ISSUES WERE IDENTIFIED UPON DEVICE INSPECTION. THE OPERATOR USED TREATMENT SETTINGS CONGRUENT WITH OUR RECOMMENDED PROTOCOL. THE ROOT CAUSE WAS ATTRIBUTED TO FOCAL LACK OF COUPLING GEL OR INCOMPLETE CONTACT DUE TO PATIENT MOVING. ADDITIONALLY, THE FIBROTIC TISSUE OF THE SCAR ON WHICH THE ELECTRODES WERE PLACED ALSO CONTRIBUTED TO THE THERMAL DAMAGE DUE TO INEFFICIENT DISSIPATION OF THE HEAT IN THE FIBROTIC TISSUE COMPARED TO HEALTHY SKIN. THE CLINIC WAS REITERATED ON THE IMPORTANCE OF SUFFICIENT AMOUNTS OF COUPLING GEL AND MAINTAINING FULL CONTACT THROUGHOUT THE TREATMENT.

Description of Event or Problem

A FEMALE PATIENT PRESENTING WITH A ROUNDISH FULL THICKNESS BURN OF APPROXIMATELY 1.5CM IN DIAMETER ON HER LOWER ABDOMEN FOLLOWING TREATMENT WITH TITE APPLICATOR. THE BURN IS SITUATED IN THE CENTER OF A PRE-EXISTING SCAR THAT VERTICALLY CROSSES THE LOWER ABDOMEN, GOING FROM THE NAVEL DOWNWARDS.