This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No product sample was received; therefore, visual and functional testing could not be performed.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 issues were find when reviewing the device history record.D4: catalog number is unknown.D4: udi information is unknown.G5: premarket (510k) number is unknown.
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