Device serial number/lot number is unknown.Device manufacturing date device expiration date could not be determined.Event problem and evaluation codes: updated.A valid lot number was not provided; therefore, device history record review could not be performed.No product sample nor photos were received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.If the product is returned, the manufacturer will reopen this complaint for further investigation.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
|