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Patient 1
THE RETURNED DEVICE WAS EVALUATED FOLLOWING THE INSTRUCTIONS FOR USE AND ALL FUNCTIONAL SPECIFICATIONS WERE MET. THE CAM BUCKLE HAS NO SHARP EDGES THAT COULD CONTRIBUTE TO THE REPORTED ISSUE AS THE EDGES ARE ROUNDED, AND THE BACK SURFACE IS SMOOTH. THE LITERATURE OR INTENDED FOR USE FOR THIS PRODUCT INDICATES TO ADJUST THE BELT SO IT IS SNUG, BUT NOT UNCOMFORTABLE FOR THE PATIENT. IN ADDITION, THE CAREGIVER HAS TO MAKE SURE THAT HE/SHE CAN SLIDE HIS/HER OPEN HAND (FLAT) BETWEEN THE BELT AND PATIENT. SKIN TEAR ARE WIDELY SEEN IN ELDERLY INDIVIDUALS WHO'S SKIN IS ALREADY COMPROMISED DUE TO AGE AND/OR ILLNESS (CLINICAL MANAGEMENT (B)(6) 2013). ADDITIONALLY, THE IFU STATES "ALWAYS CHECK FOR SKIN INTEGRITY, PROPER CIRCULATION AND RANGE OF MOTION WHEN THE BELT IS IN USE. ENSURE THAT THE BELT IS SECURE AND DOES NOT COMPROMISE THE PATIENT?S MEDICAL CONDITION AND DOES NOT INTERFERE WITH TUBES, LINES OR OTHER EQUIPMENT." 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. A REVIEW OF THE COMPLAINT DATABASE DID NOT REVEAL ANY SIMILAR ALLEGATIONS. 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. (B)(4).