No product sample was received; therefore, visual and functional testing could not be performed.If the product is returned, will reopen this complaint for further investigation.No root cause could be determine since the complaint could not be confirmed since no samples or pictures were received for evaluation.No lot number was provided; therefore, device history record review could not be completed.Model# was unknown.No product information has been received to date.Initial reporter 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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