Patient passed away [death].Case (b)(4) is a serious spontaneous case received from a consumer via regulatory authority in united states.This report concerns a patient (no patient identifiers reported) who passed away during treatment with euflexxa (sodium hyaluronate) solution for injection unknown concentration and dose, for an unknown indication from an unknown start date to an unknown stop date.The patient's mother reported the patient passed away.The treatment dates and onset of the event are unknown.The patient died on an unknown date due to an unknown reason.Action taken with euflexxa was not applicable.At the time of this report, the outcome was fatal.No concomitant medication and medical history are reported.All events in the case were reported as serious.At the time of reporting the case outcome was fatal.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: related.Other case numbers: internal # - others = mw5089071.This ae occurred in united states and concerns the medical device euflexxa.Please report to your local health authority if required by local law.This ae is not reportable in eu because it does not meet the definition of a medical device incident according to the requirements of the medical device directive/ because it did not occur in a eu + efta country and did not result in a corrective action by the manufacturer.No corrective action was done by the manufacturer or requested by regulators.
|