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.D4 was unknown.No product information has been received to date.E4 was unknown.No information has been received to date.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# 617147.
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