It was reported via a survey that a dialysis patient had fistula surgery.There were no recorded allegations, nor any objective evidence of any adverse event being caused by a fresenius device or product malfunction, deficiency, or otherwise product related issue.The fistula used by the patient is not a fresenius device.The manufacturer of the fistula, and further product information, is unknown.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).
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