N
Patient 1
EVALUATION CODES: CUSTOMER CONFIRMED THE PRODUCT WAS MISPLACED AND WILL NOT RETURNING. THIS EVENT IS REPORTED SOLELY ON THE INFORMATION PROVIDED BY THE CUSTOMER. THE CUSTOMER REPORTED THE PATIENT CAUSED THE DAMAGE TO THE DEVICE AND CAUSED THE BEADS TO LEAK OUT. A HISTORICAL REVIEW OF THE COMPLAINT DATABASE SHOWED 2 OTHER COMPLAINTS WHERE BEADS WERE LEAKING OUT OF THE APRON DUE TO LOOSE STITCHING. ROOT CAUSE FOR THE LOOSE STITCHING COULD NOT BE DETERMINED AND NO PATIENT INJURY WAS REPORTED FOR EITHER EVENTS. 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. THE IFU STATES AS A WARNING "PATIENTS MAY ATTEMPT TO REMOVE BUTTONS AND PUT THEM IN THEIR MOUTH." IT WAS ALSO RECOMMENDED TO "INSPECT BEFORE EACH USE: CHECK FOR BROKEN STITCHES; OR TORN, CUT OR FRAYED MATERIAL. DO NOT USE SOILED OR DAMAGED PRODUCTS." THEREFORE, NO CORRECTIVE OR PREVENTIVE 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). PRODUCT HAD BEEN DISCARDED.