No product sample was received; therefore, visual, and functional testing could not be performed.A device history record (dhr) review could not be performed as the catalog number and lot number were unknown.No root cause could be determined as the complaint could not be confirmed.Device information was unknown.No product information has been received to date.If initial reporter also sent report to fda was unknown.No information has been received to date this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
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