THERMALMAX HEAT PACK

Additional Manufacturer Narrative

WHILE DETAILS TO DETERMINE THE MOST APPROPRIATE INVESTIGATIONS IS SOUGHT. LIFE WEAR TECHNOLOGIES HAS OPEN A CAPA TO DETERMINE THE ROOT CAUSE OF THE EVENT AND WILL CAPTURE ANY PREVENTATIVE AND/OR CORRECTIVE ACTIONS NEEDED AS A RESULT OF ITS INVESTIGATION IN ACCORANCE WITH ITS QUALITY MANAGMENT SYSTEM.

Description of Event or Problem

THE PATIENT'S ATTORNEY REPORTS THAT A THERMAL PACK PLACED ON THE PATIENTS SKIN CAUSED 3RD DEGREE BURNS TO THE PATIENTS LEG RESULTING IN THE NEED FOR TWO SKIN GRAFTS