No product sample was received; therefore, visual, and functional testing could not be performed.A device history record (dhr) review was performed and found no discrepancies or abnormalities.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.No information has been provided to date.No product information has been provided to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# 617147.
|