\manufacturing device history record review was not performed because the results of the complaint investigation do not indicate a problem with the manufacture of the device.No product sample has been provided and the investigation could not confirm whether a quality related issue has resulted in the customer reported problem.The reported problem could not be verified and/or confirmed with confidence, therefore no further action will be conducted at this time.Complaint information will continue to be monitored for any new information or adverse trends and take further actions accordingly.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
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