PROTECTOR, HEEL, HEEL RAISER, OSFM

Additional Manufacturer Narrative

IT WAS REPORTED THAT THE END-USER WAS DISCHARGED HOME WITH TWO (2) HEEL SORES AND THE HEEL PROTECTORS WERE PURCHASE FOR HOME USE. REPORTEDLY, AFTER SEVERAL DAYS OF USE THE END-USER'S FAMILY MEMBER IDENTIFIED "ADDITIONAL SORES AT THE OUTSIDE JOINT OF THE BIG TOE ON BOTH FEET AND SEVERAL SMALL SORES ALONG THE OUTSIDE OF BOOTH FEET." IT WAS ALSO NOTED THAT "THE ORIGINAL TWO SORES ON THE HEELS LOOKED IMPROVED." THE END-USER'S FAMILY MEMBER REPORTED THAT THE END-USER EXPERIENCES "TWITCHING AND NERVOUSLY SHAKING" OF HIS FEET. THE END-USER IS RECEIVING FOLLOW-UP AT-HOME NURSING CARE AND THE FAMILY MEMBER WAS PROVIDED WITH 3M CAVILON NO STING BARRIER FILM FOR USE ON THE SORES. USE OF THE HEEL PROTECTORS WERE DISCONTINUED AND THE FAMILY MEMBER IS, INSTEAD, USING PILLOWS UNDER THE END-USER'S ANKLES AND CALVES. A SAMPLE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE HEEL PROTECTORS WERE FOUND TO HAVE ALL SEAMS INTACT WITH ALL COMPONENTS PRESENT AND WITHIN SPECIFICATION. BOTH HEEL PROTECTORS WERE FOUND TO BE ABLE TO OFFLOAD PRESSURE ON THE HEEL AND FIX THE FOOT IN PLACE. ALTHOUGH A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED, IT IS POSSIBLE FOR THE HEEL PROTECTORS TO APPLY FRICTION TO THE SIDES OF THE FOOT DEPENDING ON AN END-USER'S FOOT SIZE. DUE TO THE REPORTED NEED FOR FOLLOW-UP CARE AND THE ADDITIONAL SORES, THIS MEDWATCH IS BEING FILED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT THE END-USER EXPERIENCED ADDITIONAL SORES TO HIS FEET.