DEROYAL HEEL WARMER

Additional Manufacturer Narrative

NEITHER THE INCIDENT DEVICE OR ITS LOT NUMBER WAS PROVIDED TO DEROYAL INDUSTRIES, INC, FOR INVESTIGATION OF THE REPORTED DEVICE FAILURE. A NON-ACTIVATED HEEL WARMER WAS INSTEAD RETURNED. UPON ACTIVATION OF THE RETURNED HEEL WARMER, THE SEALS WERE FOUND TO BE WITHIN DEVICE SPECS. THERE WAS NO LEAKING AND NO WEAK SEALS WERE SEEN UPON EXAMINATION. IN PROCESS MFG QUALITY RECORDS WERE REVIEWED AND INDICATE THAT THE HEEL WARMERS ARE TESTED BY SAMPLING TO MAKE SURE THE SOLUTION HEAT DOES NOT EXCEED AN ACCEPTABLE RANGE WITH A MAXIMUM OF 104 DEGREES. DOCUMENTED TESTING SUBSTANTIATES THAT MAXIMUM. THE MATERIAL SAFETY DATA SHEET PROVIDED WITH THE DEVICE INDICATES THE HEEL WARMER SOLUTION TO BE NON-TOXIC.

Description of Event or Problem

WHEN A PHLEBOTOMIST ACTIVATED A HEEL WARMER, IT RUPTURED, SPLASHING HER IN THE FACE AND FOREARM. SHE EXPERIENCED A BURNING SENSATION AND WENT TO THE EMERGENCY ROOM FOR CARE. THE EMPLOYEE WAS NOTED TO HAVE ERYTHEMA TO HER LEFT CHEEK AND MINIMAL ERYTHEMA TO HER FOREARM. SHE WAS SENT HOME TO SHOWER WITH UNSCENTED SOAP AND INSTRUCTED TO TREAT THE AREAS WITH ALOE VERA OR ANTIBIOTIC OINTMENT.