Pericarditis [pericarditis].Case (b)(4) is a serious spontaneous case received from a consumer via a regulatory authority in the united states.This report concerns a female of unknown age who developed pericarditis during treatment with intra-articular euflexxa (sodium hyaluronate) solution for injection 10 mg/ml, 2 ml, weekly for 3 weeks, for osteoarthritis from 2016 to an unknown stop date.The patient reported she was hospitalized and treated for pericarditis.No additional information was reported.The patient was hospitalized on (b)(6) 2018 due to pericarditis.The pericarditis was medically significant.Action taken with euflexxa was unknown.At the time of this report, the outcome of pericarditis was unknown.The following concomitant medications were reported: aspirin, climara, colchicine, indocin, nasacort, women's daily formula and xyzal.All events in the case were reported as serious.At the time of reporting the case outcome was unknown.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: unassessable.Other case numbers: case number, others = mw5078345.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.
|