PROTECTOR, HEEL RAISER

Additional Manufacturer Narrative

THE PT DEVELOPED A DEEP TISSUE INJURY TO BOTH HEELS AFTER WEARING THE BOOTS FOR 90 DAYS. THE LEFT MEASURED 1.5 CM X 2 CM AND THE RIGHT MEASURED 2 CM X 3 CM. THE FACILITY REPORTED THAT SKIN ASSESSMENTS WERE PERFORMED EVERY SHIFT. DRESSINGS WERE APPLIED AND OFF LOADING BOOTS WERE INITIATED. NO SAMPLE WAS RETURNED FOR EVAL. NO LOT NUMBER WAS PROVIDED. A ROOT CAUSE HAS NOT BEEN DETERMINED. WE HAVE NOT CONFIRMED THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED TISSUE INJURY.

Description of Event or Problem

WHILE WEARING THE DEVICE, THE PT DEVELOPED DEEP TISSUE INJURIES OF THE HEEL.