Description of Event or Problem · 0
CUTERA, INC., RECEIVED A REPORT FROM A PHYSICIAN STATING THAT A PATIENT EXPERIENCED TWO LOCALIZED BURNS FOLLOWING A TRUSCULPT TREATMENT TO THE ABDOMINAL AREA. THE PHYSICIAN SUBMITTED A PHOTO SHOWING TWO SMALL DEEP DERMAL THICKNESS BURNS--ONE ON THE UPPER ABDOMEN AND ONE ON THE LOWER ABDOMEN. ALTHOUGH THE EXACT DATE OF THE PROCEDURE WAS NOT PROVIDED, THE PHYSICIAN INDICATED THAT THE TREATMENT OCCURRED DURING THE FIRST WEEK OF (B)(6) 2025. APPROXIMATELY ONE WEEK AFTER THE TRUSCULPT PROCEDURE, THE PATIENT RECEIVED AN EMSCULPT NEO TREATMENT TO THE ABDOMEN. ACCORDING TO THE PHYSICIAN, THE SUBSEQUENT EMSCULPT NEO TREATMENT DID NOT INVOLVE THE AREAS AFFECTED BY THE BURNS. NO DEVICE MALFUNCTION OR FAILURE WAS REPORTED, AND THE PHYSICIAN HAS NOT PROVIDED FURTHER CLINICAL DETAILS OR TREATMENT PARAMETERS RELATED TO THE BURNS. BURNS ARE LISTED AS A POSSIBLE ADVERSE EFFECT IN THE TRUSCULPT INSTRUCTIONS FOR USE. THIS REPORT IS BEING SUBMITTED IN ACCORDANCE WITH FDA REPORTING REQUIREMENTS. FURTHER INFORMATION WILL BE SUBMITTED IF/WHEN IT BECOMES AVAILABLE.