LUMECCA

Additional Manufacturer Narrative

FEMALE PATIENT TREATED WITH LUMECCA ON HER NOSE BRIDGE AND DÉCOLLETÉ, PRESENTING WITH SCARRING DUE TO SECOND DEGREE BURNS. INVESTIGATION CONCLUDED THAT THE ADVERSE EVENT WAS CAUSED BY USER ERRORS: THE OPERATOR USED AN EXCESSIVE FLUENCE ON BONY AREAS, EXCEEDING THE RECOMMENDATIONS OF INMODE. THIS, COMBINED WITH THE SHORT WAVELENGTH CHOSEN BY THE OPERATOR, LED TO THE THERMAL DAMAGE. FURTHER, BAD HEALING, TYPICAL OF SUCH BONY AREAS, LED TO THE FORMATION OF THE SCAR TISSUE. THE CLINIC HAS BEEN RETRAINED.

Description of Event or Problem

SCARRING ON NOSE AND DÉCOLLETÉ FOLLOWING LUMECCA TREATMENT.