SCULPSURE

Additional Manufacturer Narrative

THE DEVICE HISTORY RECORD CONFIRMS THAT THE PRODUCT PASSED AND MET ALL REQUIREMENTS BEFORE RELEASING. THE DEVICE WAS EVALUATED AND FOUND TO BE OPERATING AS INTENDED WITHIN SPECIFICATION. CYNOSURE CLINICAL INVESTIGATED THE INCIDENT AND DETERMINED THE EVENT TO BE INCONCLUSIVE. PATIENT WAS GIVEN TRANSFORM BODY AND TRIHEX AS PREVENTATIVE MEDICATION. PATIENT WAS ALSO GIVEN PRP AS MEDICAL INTERVENTION. AT THIS POINT, THE ROOT CAUSE OF THE ISSUE IS UNKNOWN BECAUSE THE DEVICE IS IDENTIFIED TO BE MEETING ALL THE REQUIREMENTS. AS PART OF THE PRODUCT RISK MANAGEMENT REVIEW, BURNS HAS BEEN IDENTIFIED AS A POTENTIAL RISK ASSOCIATED WITH THE DEVICE WITH APPROPRIATE MITIGATIONS IN PLACE WHERE APPLICABLE. THIS EVENT IS REPORTABLE BECAUSE THE PATIENT RECEIVED MEDICAL INTERVENTION.

Description of Event or Problem

IT WAS REPORTED THAT PATIENT EXPERIENCED A BURN ON THE RIGHT FLANK FOLLOWING A NONINVASIVE LASER LIPOLYSIS TREATMENT USING SCULPSURE.