LIMELIGHT

Description of Event or Problem

ON 12 JUNE 2024, CUTERA RECEIVED PHOTOGRAPHIC EVIDENCE OF A PARTIAL THICKNESS DERMAL BURN LOCATED ON THE PATIENT'S RIGHT LOWER ARM. THIS INJURY IS REPORTED TO HAVE OCCURRED SUBSEQUENT TO A LIMELIGHT PROCEDURE THAT WAS PERFORMED IN (B)(6) 2023. THE CLINIC HAS MULTIPLE LIMELIGHT HANDPIECES IN ITS INVENTORY AND IS CURRENTLY UNABLE TO PROVIDE THE SERIAL NUMBER OF THE HANDPIECE UTILIZED DURING THE PROCEDURE. THE CLINIC REPORTED THAT THE LIMELIGHT HANDPIECE WAS RETURNED TO CUTERA; HOWEVER, THERE IS NO RECORD OF A LIMELIGHT HANDPIECE BEING RETURNED TO CUTERA FROM THIS ACCOUNT AFTER DECEMBER 2023. AT THIS TIME, CUTERA IS AWAITING FURTHER DETAILS PERTAINING TO THE PATIENT, THE EXACT NATURE OF THE TREATMENT PERFORMED, AND THE RESOLUTION OF THE BURN INJURY. THIS INFORMATION IS PENDING AS CUTERA IS IN THE PROCESS OF OBTAINING THESE DETAILS FROM THE CLINIC.

Description of Event or Problem

THIS IS A FOLLOW-UP TO THE INITIAL EMDR FILED ON JULY 2, 2024. AS REPORTED INITIALLY, CUTERA RECEIVED PHOTOGRAPHIC EVIDENCE OF A PARTIAL THICKNESS DERMAL BURN LOCATED ON THE PATIENT'S RIGHT LOWER ARM ON (B)(6) 2024. THIS INJURY IS REPORTED TO HAVE OCCURRED SUBSEQUENT TO A LIMELIGHT PROCEDURE THAT WAS PERFORMED IN (B)(6) 2023. THE CLINIC HAS MULTIPLE LIMELIGHT HANDPIECES IN ITS INVENTORY AND WAS UNABLE TO PROVIDE THE SERIAL NUMBER OF THE HANDPIECE UTILIZED DURING THE PROCEDURE. THE CLINIC REPORTED THAT THE LIMELIGHT HANDPIECE WAS RETURNED TO CUTERA; HOWEVER, THERE IS NO RECORD OF A LIMELIGHT HANDPIECE BEING RETURNED TO CUTERA FROM THIS ACCOUNT AFTER (B)(6) 2023. AT THE TIME OF THE INITIAL EMDR, CUTERA WAS AWAITING FURTHER DETAILS PERTAINING TO THE PATIENT, THE EXACT NATURE OF THE TREATMENT PERFORMED, AND THE RESOLUTION OF THE BURN INJURY. HOWEVER, DESPITE MULTIPLE FOLLOW-UP ATTEMPTS, THE CLINIC HAS NOT PROVIDED ANY ADDITIONAL DETAILS.