COOLTONE

Description of Event or Problem

HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT RECEIVED A COOLTONE TREATMENT ON (B)(6) 2026 USING THE COOLTONE APPLICATOR ON THE ABDOMEN AREA. DURING THE 22-MINUTE TREATMENT, THE PADDLE LEAKED ALL OVER PATIENT, INCLUDING INTO THEIR GENITALIA AND BILATERAL UPPER LEG. THE PATIENT EXPERIENCED REDNESS ON THE ABDOMEN POST TREATMENT THAT WORSENED AFTER A FEW MINUTES. HEALTHCARE PROFESSIONAL IS CONSIDERING SENDING THE PATIENT TO THE EMERGENCY ROOM. HEALTHCARE PROFESSIONAL LATER REPORTED "THE CUSTOMER'S SKIN BECAME RED AFTER THE LEAK WAS NOTICED, POISON CONTROL NOTIFIED, SENT TO THE EMERGENCY DEPARTMENT AS RECOMMENDED BY POISON CONTROL".