Other text: this mdr was generated under protocol b10010116, 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.D5: operator of device is patient/consumer.D4: udi information is unknown.G5: premarket (510k) number is unknown.
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