DEROYAL

Additional Manufacturer Narrative

DEROYAL: THE BILL OF MATERIAL FOR THE COMPONENTS OF THE PRODUCT WAS REVIEWED AND NO MATERIAL CHANGES TO THE COMPONENTS WERE IDENTIFIED. THE APPROPRIATE LEVEL OF SKIN CONTACT BIOCOMPATIBILITY ON THE MATERIALS WAS CONFIRMED. SENSITIZATION, IRRITATION, CYTOTOXICITY, AND LATEX PROTEIN CONCENTRATION TESTING WERE SUCCESSFULLY COMPLETED AND PASSED. FURTHERMORE, THE PRODUCT DOES NOT CONTAIN NATURAL RUBBER LATEX.

Description of Event or Problem

THE HOSPITAL REPORTED THAT A PATIENT BROKE OUT IN A RASH WHILE THEY WERE WEARING THE BINDER.