Hospitalized [hospitalisation].Administered via subcutaneous route [incorrect route of drug administration].Dose of 10 mg [incorrect dose administered by device].This serious, regulatory authority, spontaneous report was received from a pharmacist in united states.This report concerns a patient of unknown age and gender who was hospitalized, administered euflexxa via subcutaneous route, and received a dose of 10 mg during treatment with subcutaneous euflexxa (sodium hyaluronate) solution for injection unknown concentration 10 mg, weekly, for osteoarthritis from 2015 and ongoing.It was reported that the patient was hospitalized for an unknown reason.Dates of hospitalization and treatment received were not reported.The patient received euflexxa subcutaneously (the approved route is intra-articular) and the dose was 10 mg (the approved dose is 2 ml).The event of hospitalization was deemed serious due to hospitalisation.Action taken with euflexxa was dose not changed.At the time of this report, the outcome was unknown.Concomitant medication use and medical history were not reported.At the time of reporting the case outcome was unknown.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: related.Other case numbers: case number, others = mw5070755.This ae occurred in the us 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 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.(b)(4).
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