TELEPATCH MONITORING SYSTEM

Description of Event or Problem

MEDICOMP TELEPATCH HEART MONITOR BURNED MY SKIN. DIAGNOSIS WAS ULCERATION CONSISTENT WITH SECOND DEGREE BURN. CONTACTED DR OFFICE AND MEDICOMP IMMEDIATELY. DR. OFFICE ADDRESSED MY CONCERNS. MEDICOMP IGNORED MY COMPLAINT FOR FIVE MONTHS. THEIR CONCERN WAS FOR THEIR EQUIPMENT. THIS CONTINUES TO BE THEIR CONCERN. PATIENT WELL BEING APPEARS TO BE OF NO CONCERN TO THIS COMPANY AS NOTED BY THEIR LACK OF COMMUNICATION AND TRANSPARENCY. FDA SAFETY REPORT ID # (B)(4).