FOOT ELEVATOR

Additional Manufacturer Narrative

DEVICE EVALUATED BY MFR: THE CUSTOMER COULD NOT BE REACHED TO FACILITATE RETURN OF THE DEVICE. THIS EVENT IS REPORTED SOLELY ON THE INFORMATION PROVIDED BY THE CUSTOMER. A HISTORICAL REVIEW OF THE COMPLAINT DATABASE FOUND TWO (2) OTHER COMPLAINTS OF THIS PRODUCT CAUSING OR CONTRIBUTING TO BED SORES. OF THE TWO, THERE WAS ONLY ONE FOR WHICH THE UNIT WAS RETURNED FOR EVALUATION. IT WAS DETERMINED THAT THE UNIT MET SPECIFICATIONS. THE INSTRUCTION FOR USE INDICATES TO REDUCE PRESSURE ON THE ANKLE AND HYPERTENSION OF THE KNEE, A PILLOW MAY BE PLACED UNDER THE PATIENT¿S KNEE AND LEG. ADDITIONALLY, THE INSTRUCTION FOR USE STATES THAT THIS PRODUCT RECOMMENDS TO BE REMOVED AT LEAST EVERY TWO (2) HOURS TO CHECK FOR SKIN INTEGRITY, PROPER CIRCULATION, AND RANGE OF MOTION. AT THIS TIME THERE IS NO EVIDENCE THAT A MANUFACTURING NON-CONFORMITY CONTRIBUTED TO THE REPORTED COMPLAINT, AND THE INSTRUCTIONS FOR USE WERE REVIEWED AND DETERMINED TO PROVIDE ADEQUATE INSTRUCTIONS AND WARNINGS FOR THE SAFE AND EFFECTIVE USE OF THE DEVICE. THEREFORE, NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE NECESSARY. ALL COMPLAINTS ARE TRENDED AND REVIEWED BY MANAGEMENT ON A MONTHLY BASIS. AS PART OF THIS MONTHLY REVIEW, ANY EXCURSION ABOVE THE CONTROL LIMITS FOR THIS FAILURE MODE WILL BE ASSESSED, DOCUMENTED AND ACTED UPON AS WARRANTED. MANUFACTURER REFERENCE FILE # (B)(4).

Description of Event or Problem

CUSTOMER REPORTED PER (B)(6) THAT THE PRODUCT IS NOT MEDICALLY SAFE FOR SOMEONE WITH HEEL PRESSURE SORES, ALTHOUGH ADJUSTED TIGHTLY AROUND THE ANKLE WITH THE VELCRO STRAP, THE DEVICE ROLLS AROUND IN THE NIGHT SO THAT THE FOOT IS NO LONGER ELEVATED AND THE SORE HEEL IS SUBJECT TO RUBBING THEREFORE COMPROMISED. THE DATE THE ISSUE WAS DISCOVERED IS UNKNOWN.