Breast/nipple bleeding since then [breast haemorrhage].Localized swelling [swelling].Pain to knee [arthralgia].Case narrative: this serious spontaneous case received from a consumer in united states.This report concerns a 70-year-old female who experienced breast/nipple bleeding, localized swelling, and pain to the knee during treatment with euflexxa (sodium hyaluronate) solution for injection, unknown route, concentration, and dose, for an unknown indication from(b)(6) 2022 to an unknown stop date.The consumer received her first euflexxa injection on (b)(6) 2022 and experienced breast/nipple bleeding since then (beginning on an unspecified date).Additionally, she experienced "all of the local side effects too", which was further explained as localized swelling and pain to the knee.No further information was provided.The breast/nipple bleeding since then was medically significant.Action taken with euflexxa was unknown.On an unknown date, the outcome of breast/nipple bleeding since then was not recovered, the outcome of localized swelling was unknown, the outcome of pain to knee was unknown.No concomitant medication was reported.The event breast/nipple bleeding since then was reported as serious.The events localized swelling, pain to knee were reported as non-serious.At the time of reporting the case outcome was unknown.Sender comment: very limited and important information has not been reported for this case including the patient's medical history, laboratory findings, concomitant medication, product indication, therapy dates, route of administration; furthermore, based on the known safety profile, when used according to label, it is considered highly unlikely that euflexxa caused the patient's breast bleeding.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: not related (breast bleeding).Other case numbers: internal # - others = (b)(4).Internal # - others = (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 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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