H3 product was not returned for evaluation.Therefore, this report is based solely on the information provided by the customer.A device history review could not be performed due to lot information not provided.A recreation of the reported issue was performed and the customer's experience could not be recreated.A review of the complaint database did not reveal any similar events against this issue in the past two years.Therefore, it appears this complaint was an isolated event.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 make sure that both filler cushions are securely in place and cannot be removed by the patient and that the patient cannot crawl under or around the posey filler cushions.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 warning 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).
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