THE COMFORT COMPANIES

Description of Event or Problem

THE USER REPORTS PRESSURE-RELATED WOUNDS ON BOTH FEET AND HEELS, ALLEGEDLY CAUSED BY THE COMFORT FOOT BOX.

Additional Manufacturer Narrative

A REPORT WAS RECEIVED WHERE IT WAS CLAIMED OVER PROLONGED USE OF THE COMFORT FOOT BOX, THE END-USER HAD DEVELOPED PRESSURE INJURIES TO THE HEELS OF THEIR FEET WHICH REQUIRED MEDICAL INTERVENTION TO ADDRESS. INFORMATION WAS NOT PROVIDED AS TO THE EXTENT OF THE INJURIES, ONLY THAT THEY HAD DEVELOPED PRESSURE WOUNDS. PERMOBIL REPRESENTATIVE VISITED THE END-USER TO EVALUATE THE REPORTED CONCERNS. INSPECTION OF THE HEEL PRESSURE INJURY ASSOCIATED WITH THE COMFORT FOOTBOX WAS ASSESSED AND DETERMINED TO BE THE RESULT OF INCORRECT INSTALLATION. THE PADDED POTION OF THE CALF REST WAS INSTALLED DIRECTLY AGAINST THE PAD OF FOOT SECTION. THIS CLOSE PROXIMITY CAUSING THE SEAM OF THE HEEL OPENING TO CONTACT THE USER'S HEEL. THE CALF SECTION WAS REPOSITIONED UPWARD, ELIMINATING THE PRESSURE POINT AND ALLOWING HIS HEEL TO FLOAT FREELY. FURTHER INSPECTION DID NOT NOTE ANY MANUFACTURING DEFECTS OR PRODUCT FAILURES HAVING OCCURRED. NO PRODUCT REPLACEMENT WAS REQUIRED, AND PROPER POSITIONING OF THE PRODUCT WAS REPORTED TO HAVE ADDRESSED THE ISSUE.