Patient passed away [death].Case (b)(4) 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 intra-articular euflexxa (sodium hyaluronate) solution for injection 10 mg/ml, unknown frequency and dose, for unknown indication from an unknown start date to an unknown stop date.The health professional reported that the patient passed away on (b)(6) 2019.Action taken with euflexxa was not applicable.At the time of this report, the outcome of patient passed away was fatal.The following concomitant medications were reported: amaryl (from an unknown start date to an unknown stop date), atorvastatin (from an unknown start date to an unknown stop date), citalopram (from an unknown start date to an unknown stop date), docusate (from an unknown start date to an unknown stop date), gabapentin (from an unknown start date to an unknown stop date), hydrocodone (from an unknown start date to an unknown stop date), klonopin (from an unknown start date to an unknown stop date), lactulose (from an unknown start date to an unknown stop date), midodrine (from an unknown start date to an unknown stop date), omeprazole (from an unknown start date to an unknown stop date), renvela (from an unknown start date to an unknown stop date), sevelamer (from an unknown start date to an unknown stop date), tresiba (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.Sender comment: death assessed as not related due to limited information available in the case without any details that could indicate a specified nor implied attribution of the death to euflexxa.Furthermore, the lack of information in the report precludes the assessment for a medical device incident.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: not related.Other case numbers: internal # - others = mw51046907.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.
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