Patient has passed away [death].Case (b)(4) is a serious spontaneous case received from a non-health professional via regulatory authority in united states.This report concerns a patient (no identifiers reported) who passed away during treatment with intra-articular euflexxa (sodium hyaluronate) solution for injection 10 mg, weekly for 3 weeks, for unilateral primary osteoarthritis right knee from 2019 to 2019.Lot no.:p14514a.Exp.Date.: 03-may-2020.The non-health professional reported the patient had passed away.The patient died in (b)(6) 2019 due to unknown reason.Action taken with euflexxa was not applicable.In 2019, the outcome of patient had passed away was fatal.The following concomitant medications were reported: sulfasalazin, prednisone, multivitamin, synvisc, saw palmetto, b complex (from an unknown start date to an unknown stop date).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: unassessable other case numbers: internal # - others = mw5089158.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.
|