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Patient 1
CUSTOMER CONFIRMED THE PRODUCT WAS DISCARDED AND THEY WILL NOT BE RETURNING. THEREFORE, THIS COMPLAINT IS BASED SOLELY ON THE CUSTOMER REPORTED ISSUE. ADDITIONAL CUSTOMER FEEDBACK IS CURRENTLY PENDING. 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. INSTRUCTIONS FOR USE INDICATE; NOT TO USE THIS DEVICE ON A PATIENT WHO IS OR BECOMES; HIGHLY AGGRESSIVE OR COMBATIVE; SELF-DESTRUCTIVE; OR DEEMED TO BE AN IMMEDIATE RISK TO OTHERS, UNLESS THE PATIENT IS UNDER CONSTANT SUPERVISION. INSTRUCTIONS FOR USE ALSO INDICATE; SEVERE PSYCHOLOGICAL, OR PHYSICAL PROBLEMS MAY OCCUR: IF THE APPLIED DEVICE IS UNCOMFORTABLE; OR IF IT SEVERELY LIMITS MOVEMENT. IF THE PATIENT IS LIKELY TO CAUSE INJURY TO HIM/HERSELF OR OTHERS, GET HELP FROM A QUALIFIED MEDICAL AUTHORITY TO FIND ALTERNATE INTERVENTION OR METHOD OF RESTRAINT. 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). PRODUCT WAS DISCARDED.