Evaluation results: it has been confirmed that the product will not be returned as it has been discarded.Without the return of the product for evaluation, and without clarification of the reported issue the root cause cannot be determined.Historical data was reviewed; however, it did not reveal any similar instances of moisture causing "slippage" issues for this particular device.The instructions for use warn the user that, "this device is designed for use in normal indoor environments.This device may be stored in ambient warehouse temperatures at normal humidity levels.Avoid excess moisture or high humidity that may damage product materials." 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.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.(b)(4).
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