Evaluation results: visual findings observed the box stitch for the bed connecting strap is broken causing the product to come apart.Evaluation confirmed the reported issue.The box stitch on the top and the bottom are intact, but the threads in-between have loosened or broken resulting in failure.The root cause could not be determined only suggested possible causes such as product applied to a combative patient who exerted enough force beyond the threshold of the stitching to cause failure, or incorrect sewing machine settings causing a loose or tight box stitch.All complaints are trended and reviewed by management on a monthly basis.As a part of the monthly review, any excursion above the control limits for this failure mode will be assessed, documented and acted upon as warranted.The instructions for use (ifu) were reviewed and found to provide adequate instructions and warnings for safe and effective use of the device.No corrective or preventative actions are necessary at this time.Manufacturer reference file # (b)(4).
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