|
Nose bleed [epistaxis].Pressure was 205/123 [hypertension].Patient received in arm (inappropriate site) [product use issue].Patient received an injection (arm and knee each) [due to euflexxa injection into arm] [off label use of device].Case narrative: (b)(6) is a serious spontaneous case received from a consumer in the united states.This report concerns a female patient of unknown age, who experienced a nose bleed, was hospitalized with high blood pressure, and received an injection in her arm (product use at inappropriate site/off label use) during treatment with euflexxa (sodium hyaluronate) solution for injection, two injections, unknown route and concentration, for unknown indication from an unknown start date to an unknown stop date.The patient reported that she had a problem with her right arm and left knee which prompted her to visit "oaa".The patient reported that her doctor suggested a series of three euflexxa injections given at one week intervals.She received an injection (arm and knee each), then a week later another.Several days later, the patient stated she woke up with a nose bleed she could not control.She called an ambulance to take her to the hospital.She was shocked to learn her blood pressure was 205/123.She stated they treated her bleeding with balloons in her nose.The patient remained in the hospital for six days.The patient stated she had no way of being sure the euflexxa caused this, but she had never had this kind of pressure problem before and wanted to inform us of her experience.The patient was hospitalized on an unknown date due to a nose bleed and blood pressure was 205/123.Action taken with euflexxa was unknown.At the time of this report, the outcome of events was unknown.No concomitant medication or medical history were reported.The events blood pressure was 205/123 and nose bleed were reported as 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, concomitant medication, product indication and administration dates preventing a proper medical assessment.Blood pressure increase is a known event for euflexxa which has most likely contributed to the patient's epistaxis, hence epistaxis is considered not related to euflexxa but to the hypertension per se.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: related for 'hypertension', 'product use issue, and 'off label use of device' and not related to 'epistaxis'.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.
|
