Passed away [death].Case narrative: this is a serious spontaneous case received from a health professional 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, dose, and route, both knees weekly for three weeks, for unknown indication from an unknown start date to an unknown stop date.On (b)(6) 2022, the healthcare professional reported that the nephew of the patient stated the patient passed away.The cause of death was not reported, and it was unknown if an autopsy was performed.Action taken with euflexxa was not applicable.No concomitant medication was reported.The event was reported as serious.At the time of reporting the case outcome was fatal.Sender comments: important information has not been reported for this case including the patient's medical history, laboratory findings, concomitant medication, product indication, as well as the details relating to the death of the patient preventing a proper medical assessment.Based on the known safety profile, when used according to label, it is considered highly unlikely that euflexxa caused the patient's death.Overall listed (core label) is unlisted.Reporter causality: related.Company causality: not related.Other case numbers: internal # - others = mw5113429.(b)(4).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 an 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.Correction: (b)(6) 2022: updated reporter causality to related.
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