Product is scheduled to be returned, but has not been received by manufacturer at the time of this report.Therefore, this report is based solely on the information provided by the customer.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 provided adequate instructions and warning for the safe and effective use of the device.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 expected, but not yet received.
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Customer is reporting an issue regarding item 2790q (wrist restraint).Patient was able to unlock himself, staff physician was punched in the process.They suspect the restraints may have been applied incorrectly, requested sales rep for further training and evaluations.The date the event occurred is unknown.
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