| Catalog Number 6301182010 |
| Device Problems
Therapeutic or Diagnostic Output Failure (3023); Patient Device Interaction Problem (4001)
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| Patient Problems
Cyst(s) (1800); Headache (1880); Hypersensitivity/Allergic reaction (1907); High Blood Pressure/ Hypertension (1908); Burning Sensation (2146); Myalgia (2238); Unspecified Heart Problem (4454); Wheezing (4463); Unspecified Gastrointestinal Problem (4491); Renal Impairment (4499)
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Event Type
Injury
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Event Description
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Hypothyroidism [hypothyroidism].Cardiac disorder [cardiac disorder].Asthma [asthma].Blood test abnormal [blood test abnormal].Burning sensation [burning sensation].Carpal tunnel syndrome [carpal tunnel syndrome].Ejection fraction [ejection fraction].Fibromyalgia [fibromyalgia].Gastroesophageal reflux disease [gastrooesophageal reflux disease].Loss of personal independence in daily activities [loss of personal independence in daily activities].Nephrectomy [nephrectomy].Polycystic ovaries [polycystic ovaries].Sensitization [sensitisation].Sleep apnea syndrome [sleep apnoea syndrome].Sleep disorder due to a general medical condition [sleep disorder due to a general medical condition].Rhinitis allergic [rhinitis allergic].Hypertension [hypertension].Dyspnea [dyspnoea].Full blood count abnormal [full blood count abnormal].Renal disorder [renal disorder].Wheezing [wheezing].Headache [headache].Therapeutic product effect incomplete [therapeutic product effect incomplete].Case narrative: this serious spontaneous case from a physician via a regulatory authority in canada.This report concerns a 54-year-old female who experienced asthma, blood test abnormal, burning sensation, cardiac disorder, carpal tunnel syndrome, ejection fraction, fibromyalgia, full blood count abnormal, gastroesophageal reflux disease, hypothyroidism, loss of personal independence in daily activities, nephrectomy, polycystic ovaries, renal disorder, rhinitis allergic, sensitization, sleep apnea syndrome, sleep disorder due to a general medical condition, hypertension, headache, dyspnea, wheezing, and therapeutic product effect incomplete during treatment with euflexxa (sodium hyaluronate) solution for injection unknown route, concentration, dose and frequency, from an unknown start date to an unknown stop date and co-suspect drugs: budesonide, unknown route, formulation, dose and frequency, for an unknown indication, acyclovir, unknown route, formulation, dose, and frequency, for an unknown indication, apixaban, unknown route, formulation, dose, and frequency, for an unknown indication, apo-tramadol, tablets, unknown route, dose, and frequency, for an unknown indication, budesonide/formoterol fumerate, unknown route, formulation, dose, and frequency, for an unknown indication, buproprion, tablets, unknown route, dose, and frequency, for an unknown indication, clonazepam, tablets, unknown route, dose, and frequency, for an unknown indication, cyanocobalamin, unknown route, dose, formulation and frequency, for an unknown indication, ergocalciferol, unknown route, formulation, dose, and frequency, for an unknown indication, esomeprozole, unknown route, formulation, dose, and frequency, for an unknown indication, esomeprazole magnesium trihydrate, unknown route, formulation, dose and frequency, for an unknown indication, formoterol fumarate, unknown route, formulation, dose, and frequency, for an unknown indication, hyaluronate sodium, unknown route, formulation, dose and frequency, for an unknown indication, levothyroxine, unknown route, formulation, dose, and frequency, for an unknown indication, levothyroixine sodium, unknown route, formulation, dose and frequency, for an unknown indication, liothyronine sodium, tablets, unknown route, dose, and frequency, for an unknown indication, metoprolol, unknown route, formulation, dose, and frequency, for an unknown indication, mometasone, intra-nasal, 50.0 mcg 2 every 1 days, for unknown indication, mometasone, intra-nasal, 50.0 mcg 1 every 1 day, for unknown indication, mometasone, intra-nasal, 50.0 mcg 1 every 5 days, for unknown indication, montelukast sodium, unknown route, formulation, dose, and frequency, for an unknown indication, nasonex, spray, metered dose, unknown route, formulation, dose, and frequency, for an unknown indication, perindopril, unknown route, formulation, dose, and frequency, for an unknown indication, prednisone, unknown route, formulation, dose, and frequency, for an unknown indication, salbutamol, unknown route, formulation, dose, and frequency, for an unknown indication, seawater, unknown route, dose, formulation and frequency, for an unknown indication, sodium bicarbonate, unknown route, dose, formulation and frequency, for unknown indication, sodium bicarbonate/sodium chloride, unknown route, formulation, dose, and frequency, for an unknown indication, sprironolactone, tablets, unknown route, dose, and frequency, for an unknown indication, sympbicort turbuhaler, unknown route, powder, dose, frequency, for an unknown indication, tramadol, unknown route, dose, formulation, and frequency, for an unknown indication, tramadol hydrochloride, tablet, unknown dose, route, and frequency, for an unknown indication, tramadol hydrochloride, unknown formulation, dose, route, and frequency, for an unknown indication, trazodone, tablet, unknown route, dose, and frequency, for an unknown indication, vitamin b12, unknown route, formulation, dose, and frequency, for an unknown indication, vitamin c, unknown route, formulation, dose, and frequency, for an unknown indication, vitamin d, unknown route, dose, frequency, for an unknown indication.A physician reported that on an unknown date, the patient experienced asthma, blood test abnormal, burning sensation, cardiac disorder, carpal tunnel syndrome, ejection fraction, fibromyalgia, gastroesophageal reflux disease, hypothyroidism, loss of personal independence in daily activities, nephrectomy, polycystic ovaries, rhinitis allergic, sensitization, sleep apnea syndrome, sleep disorder due to a general medical condition, hypertension, headache, and therapeutic product effect incomplete.No further information was reported.On (b)(6) 2022, a physician reported the patient experienced asthma, blood test abnormal, burning sensation, cardiac disorder, carpal tunnel syndrome, ejection fraction, fibromyalgia, full blood count abnormal, gastroesophageal reflux disease, hypothyroidism, loss of personal independence in daily activities, nephrectomy, polycystic ovaries, renal disorder, rhinitis allergic, sensitization, sleep apnea syndrome, sleep disorder due to a general medical condition, hypertension, headache, wheezing and therapeutic product effect incomplete.The patient was hospitalized on an unknown date due to an unknown reason.Action taken with euflexxa, acyclovir [aciclovir sodium], apixaban, apo-tramadol, budesonide, budesonide/formoterol fumarate, bupropion, clonazepam, ergocalciferol, esomeprazole, esomeprazole magnesium trihydrate, formoterol fumarate, hyaluronate sodium, levothyroxine, levothyroxine sodium, liothyronine sodium, metoprolol, mometasone, montelukast sodium, nasonex, perindopril, prednisone, salbutamol, seawater, sodium bicarbonate/sodium chloride, spironolactone, sodium bicarbonate, symbicort turbuhaler, tramadol, tramadol hydrochloride, trazodone, ventolin [salbutamol], vitamin c [ascorbic acid], vitamin b12 [cyanocobalamine], and vitamin d, was unknown.On an unknown date, the outcome of asthma, blood test abnormal, burning sensation, cardiac disorder, carpal tunnel syndrome, dyspnea, ejection fraction, fibromyalgia, full blood count abnormal, gastroesophageal reflux disease, hypothyroidism, loss of personal independence in daily activities, nephrectomy, polycystic ovaries, renal disorder, rhinitis allergic, sensitization, sleep apnea syndrome, sleep disorder due to a general medical condition, hypertension, headache, wheezing, and therapeutic product effect incomplete, was recovered.Concomitant medications included ventolin (from unknown start date to unknown stop date), salbutamol (from unknown start date to unknown stop date), and salbutamol sulfate (from unknown start date to unknown stop date).All events in the case were reported as serious.At the time of reporting the case outcome was recovered.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality (euflexxa): related: therapeutic product effect incomplete.Not related: asthma, blood test abnormal, burning sensation, cardiac disorder, carpal tunnel syndrome, dyspnea, ejection fraction, fibromyalgia, full blood count abnormal, gastroesophageal reflux disease, hypothyroidism, loss of personal independence in daily activities, nephrectomy, polycystic ovaries, renal disorder, rhinitis allergic, sensitization, sleep apnea syndrome, sleep disorder due to a general medical condition, hypertension, headache, wheezing.Company causality (budesonide): not related.Unassessable: blood test abnormal, full blood count abnormal.Related: headache, therapeutic product effect incomplete.Ferring sender comment: this case contains very limited information.The case lists several events and several suspect products, however does not specify causal relationship between each product and event.Based on the known safety profile of euflexxa all events (except hospitalization and therapeutic product effect incomplete) are considered not related.Concerning budesonide, the indication for use is unknown, as is the administration, dosage etc.The patient has asthma, so it might as well be the indication, as there is no information on gastrointestinal disease.Based on biological plausibility and the known safety profile of budesonide, causality is considered not related for all events except from blood test abnormal, and full blood count abnormal, headache and therapeutic product effect incomplete.Blood test abnormal, and full blood count abnormal is assessed as unassessable due to limited information provided, while headache and therapeutic product effect incomplete is assessed as related to budesonide taking a conservative approach.Updated sender comments upon follow-up 01: no information reported on medical history, therapy dates and event onset dates making difficult to perform a thorough medical evaluation.Due to clinical interpretation in alignment with known safety profile, company causality is considered not related to euflexxa for the reported events as there is no clinical evidence, but might most likely related to confounding diseases as per the numerous concomitant medication reported.Other case numbers: (b)(4).This aes occurred in canada 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.Additional information was received on 27-sep-2022 by a physician: follow up 01: new events dypsnea, renal disorder, full blood count abnormal and wheezing were reported.Captured all events as medically significant and hospitalized.Co-suspect drugs added included: budesonide, cyanocobalamin, esomeprazole magnesium trihydrate, formoterol fumarate, hyaluronate sodium, levothyroxine sodium, seawater, sodium bicarbonate, symbicort turbuhaler, tramadol, and vitamin d.Liothyronine sodium formulation (tablet) was added, mometasone route of administration, dose and frequency was added, an additional dosing regiment for mometasone was added, and trazadone formulation was added (tablet).Removed hospitalization as a separate event as per f/u received.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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Event Description
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Hypothyroidism [hypothyroidism].Cardiac disorder [cardiac disorder].Asthma [asthma].Blood test abnormal [blood test abnormal].Burning sensation [burning sensation].Carpal tunnel syndrome [carpal tunnel syndrome].Ejection fraction [ejection fraction].Fibromyalgia [fibromyalgia].Gastroesophageal reflux disease [gastrooesophageal reflux disease] loss of personal independence in daily activities [loss of personal indepe.Ndence in daily activities].Nephrectomy [nephrectomy].Polycystic ovaries [polycystic ovaries].Sensitization [sensitisation].Sleep apnea syndrome [sleep apnoea syndrome].Sleep disorder due to a general medical condition [sleep disorder due to a general medical condition].Rhinitis allergic [rhinitis allergic].Hypertension [hypertension].Dyspnea [dyspnoea].Renal disorder [renal disorder].Wheezing [wheezing].Hospitalization [hospitalisation].Headache [headache].Therapeutic product effect incomplete [therapeutic product effect incomplete].Case narrative: this serious spontaneous case from a physician via a regulatory authority in canada.This report concerns a 54-year-old female who experienced asthma, blood test abnormal, burning sensation, cardiac disorder, carpal tunnel syndrome, ejection fraction, fibromyalgia, hospitalization, gastroesophageal reflux disease, hypothyroidism, loss of personal independence in daily activities, nephrectomy, polycystic ovaries, renal disorder, rhinitis allergic, sensitization, sleep apnea syndrome, sleep disorder due to a general medical condition, hypertension, headache, dyspnea, wheezing, and therapeutic product effect incomplete during treatment with euflexxa (sodium hyaluronate) solution for injection unknown route, concentration, dose and frequency, from an unknown start date to an unknown stop date and co-suspect drugs: budesonide (brand name not reported), unknown route, formulation, dose and frequency, for an unknown indication, acyclovir, unknown route, formulation, dose, and frequency, for an unknown indication, acyclovir sodium, unknown route, formulation, dose, and frequency, for an unknown indication, apixaban, unknown route, formulation, dose, and frequency, for an unknown indication, apo-tramadol, tablets, unknown route, dose, and frequency, for an unknown indication, budesonide/ formoterol, unknown route, formulation, dose, and frequency, for an unknown indication, budesonide/formoterol fumerate, unknown route, formulation, dose, and frequency, for an unknown indication, buproprion, tablets, unknown route, dose, and frequency, for an unknown indication, clonazepam, tablets, unknown route, dose, and frequency, for an unknown indication, cyanocobalamin, unknown route, dose, formulation and frequency, for an unknown indication, ergocalciferol, unknown route, formulation, dose, and frequency, for an unknown indication, esomeprazole magnesium trihydrate, unknown route, formulation, dose and frequency, for an unknown indication, formoterol fumarate, unknown route, formulation, dose, and frequency, for an unknown indication, levothyroxine, unknown route, formulation, dose, and frequency, for an unknown indication, levothyroixine sodium, unknown route, formulation, dose and frequency, for an unknown indication, liothyronine sodium, tablets, unknown route, dose, and frequency, for an unknown indication, metoprolol, unknown route, formulation, dose, and frequency, for an unknown indication, metoprolol tartrate, unknown route, formulation, dose, and frequency, for an unknown indication, mometasone, intra-nasal, 50.0 mcg 2 every 1 days, for unknown indication, mometasone furoate, unknown route, formulation, dose, and frequency, for an unknown indication, montelukast sodium tablet, unknown route, dose, and frequency, for an unknown indication, nasonex, spray, metered dose, unknown route, formulation, dose, and frequency, for an unknown indication, perindopril, unknown route, formulation, dose, and frequency, for an unknown indication, perindopril erbumine, unknown route, formulation, dose, and frequency, for an unknown indication, prednisone, unknown route, formulation, dose, and frequency, for an unknown indication, salbutamol, unknown route, formulation, dose, and frequency, for an unknown indication, sodium bicarbonate/sodium chloride, unknown route, formulation, dose, and frequency, for an unknown indication, sprironolactone, tablets, unknown route, dose, and frequency, for an unknown indication, tramadol hydrochloride, unknown formulation, dose, route, and frequency, for an unknown indication, trazodone, unknown route, formulation, dose, and frequency, for an unknown indication, trazodone hydrochloride, unknown route, formulation, dose, and frequency, for an unknown indication, vitamin b12, unknown route, formulation, dose, and frequency, for an unknown indication, and vitamin c, unknown route, formulation, dose, and frequency, for an unknown indication.A physician reported that on an unknown date, the patient experienced asthma, blood test abnormal, burning sensation, cardiac disorder, carpal tunnel syndrome, ejection fraction, fibromyalgia, gastroesophageal reflux disease, hypothyroidism, loss of personal independence in daily activities, nephrectomy, polycystic ovaries, rhinitis allergic, sensitization, sleep apnea syndrome, sleep disorder due to a general medical condition, hypertension, headache, and therapeutic product effect incomplete.No further information was reported.On 27-sep-2022, a physician reported the patient experienced asthma, blood test abnormal, burning sensation, cardiac disorder, carpal tunnel syndrome, ejection fraction, fibromyalgia, full blood count abnormal, gastroesophageal reflux disease, hypothyroidism, loss of personal independence in daily activities, nephrectomy, polycystic ovaries, renal disorder, rhinitis allergic, sensitization, sleep apnea syndrome, sleep disorder due to a general medical condition, hypertension, headache, wheezing and therapeutic product effect incomplete.On 30-nov-2022, a healthcare professional reported that the patient experienced asthma, blood test abnormal, burning sensation, cardiac disorder, carpal tunnel syndrome, dyspnoea, ejection fraction, fibromyalgia, gastroesophageal reflux disease, hospitalization, hypothyroidism, loss of personal independence in daily activities, nephrectomy, polycystic ovaries, renal disorder, rhinitis allergic, sensitization, sleep apnea syndrome, sleep disorder due to a general medical condition, hypertension, headache, wheezing and therapeutic product effect incomplete.The patient was hospitalized on an unknown date due to an unknown reason.Action taken with euflexxa and budesonide was unknown.Action taken with all other co-suspect drugs was also unknown.On an unknown date, the outcome of all adverse events was recovered.Concomitant medications included ventolin (from unknown start date to unknown stop date) and salbutamol (from unknown start date to unknown stop date).All events in the case were reported as serious.At the time of reporting the case outcome was recovered.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.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality (euflexxa): related: therapeutic product effect incomplete.Not related: hospitalization, asthma, blood test abnormal, burning sensation, cardiac disorder, carpal tunnel syndrome, dyspnea, ejection fraction, fibromyalgia, gastroesophageal reflux disease, hypothyroidism, loss of personal independence in daily activities, nephrectomy, polycystic ovaries, renal disorder, rhinitis allergic, sensitization, sleep apnea syndrome, sleep disorder due to a general medical condition, hypertension, headache, wheezing.Company causality (budesonide): not related.Unassessable: blood test abnormal, hospitalization.Related: headache, therapeutic product effect incomplete.Ferring sender comment: important information is missing as product indication/concentration, roa, dose, frequency therapeutic dates, medical history, laba data etc.The case lists several events and several suspect products (unknown brand of naha).Based on the well-known safety profile of euflexxa all events are considered not related with exception of and 'therapeutic product effect incomplete'' which is more likely related to the rest of reported events.Concerning budesonide, the indication for use is unknown, as is the administration, dosage etc.The patient has asthma, so it might as well be the indication, as there is no information on gastrointestinal disease.Based on biological plausibility and the known safety profile of budesonide, causality is considered not related for all events except from blood test abnormal, hospitalization, headache and therapeutic product effect incomplete.Blood test abnormal and hospitalization are assessed as unassessable due to limited information provided, while headache and therapeutic product effect incomplete is assessed as related to budesonide taking a conservative approach.Updated sender comments upon follow-up 01: no information reported on medical history, therapy dates and event onset dates making difficult to perform a thorough medical evaluation.Due to clinical interpretation in alignment with known safety profile, company causality is considered not related to euflexxa for the reported events as there is no clinical evidence, but might most likely related to confounding diseases as per the numerous concomitant medication reported.(b)(4).Additional information was received on 27-sep-2022 by a physician: follow up 01: new events dypsnea, renal disorder, full blood count abnormal and wheezing were reported.Captured all events as medically significant and hospitalized.Co-suspect drugs added included: budesonide, cyanocobalamin, esomeprazole magnesium trihydrate, formoterol fumarate, hyaluronate sodium, levothyroxine sodium, seawater, sodium bicarbonate, symbicort turbuhaler, tramadol, and vitamin d.Liothyronine sodium formulation (tablet) was added, mometasone route of administration, dose and frequency was added, an additional dosing regiment for mometasone was added, and trazadone formulation was added (tablet).Removed hospitalization as a separate event as per f/u received.Additional information received on 30-nov-2022 from a healthcare professional: follow up 02: added co-suspect drugs: acyclovir sodium, budesonide/ formoterol, metoprolol tartrate, mometasone furoate, perindopril erbumine, and trazodone hydrochloride.Removed co-suspect drugs: esomeprazole, hyaluronate sodium (as this is the coded company drug euflexxa), sea water, sodium bicarbonate, symbicort turbuhaler, tramadol, tramadol hydrochloride (this was coded twice previously), and vitamin d.Removed concomitant medication salbutamol sulfate.Formulation was added for montelukast sodium.The dosing regimen for mometasone was updated.The event of full blood count abnormal was removed and the event of hospitalization was added.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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Manufacturer Narrative
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A report for this case was originally submitted by the manufacturer as 3000164186-2021-00033.This report is being submitted by the importer based on revoking of exemption e2015016 on 30-jun-2019 and discussion with the agency, reference (b)(4).
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Event Description
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Hypothyroidism [hypothyroidism].Cardiac disorder [cardiac disorder].Asthma [asthma].Blood test abnormal [blood test abnormal].Burning sensation [burning sensation].Carpal tunnel syndrome [carpal tunnel syndrome].Ejection fraction [ejection fraction].Fibromyalgia [fibromyalgia].Gastroesophageal reflux disease [gastrooesophageal reflux disease].Loss of personal independence in daily activities [loss of personal independence in daily activities].Nephrectomy [nephrectomy].Polycystic ovaries [polycystic ovaries].Sensitization [sensitisation].Sleep apnea syndrome [sleep apnoea syndrome].Sleep disorder due to a general medical condition [sleep disorder due to a general medical condition].Rhinitis allergic [rhinitis allergic].Hypertension [hypertension].Dyspnea [dyspnoea].Renal disorder [renal disorder].Wheezing [wheezing].Hospitalization [hospitalisation].Full blood count abnormal [full blood count abnormal].Adverse event [adverse event].Ejection fraction abnormal [ejection fraction abnormal].Hypertension [hypertension].Nephropathy [nephropathy].Obstructive sleep apnea syndrome [obstructive sleep apnoea syndrome].Sleep disorder due to general medical condition, insomnia type [sleep disorder due to general medical condition, insomnia type].Headache [headache].Therapeutic product effect incomplete [therapeutic product effect incomplete].Case narrative: this serious spontaneous case from a physician via a regulatory authority in canada.This report concerns a 54-year-old female who experienced asthma, blood test abnormal, burning sensation, cardiac disorder, carpal tunnel syndrome, ejection fraction, fibromyalgia, full blood count abnormal, hospitalization, gastroesophageal reflux disease, hypothyroidism, loss of personal independence in daily activities, nephrectomy, polycystic ovaries, renal disorder, rhinitis allergic, sensitization, sleep apnea syndrome, sleep disorder due to a general medical condition, hypertension, headache, dyspnea, wheezing, and therapeutic product effect incomplete during treatment with euflexxa (sodium hyaluronate) solution for injection unknown route, concentration, dose and frequency, from an unknown start date to an unknown stop date and co-suspect drugs: budesonide (brand name not reported), unknown route, formulation, dose and frequency, for an unknown indication, acyclovir, unknown route, formulation, dose, and frequency, for an unknown indication, acyclovir sodium, unknown route, formulation, dose, and frequency, for an unknown indication, apixaban, unknown route, formulation, dose, and frequency, for an unknown indication, apo-tramadol, tablets, unknown route, dose, and frequency, for an unknown indication, budesonide/ formoterol, unknown route, formulation, dose, and frequency, for an unknown indication, budesonide/formoterol fumerate, unknown route, formulation, dose, and frequency, for an unknown indication, bupropion, tablets, unknown route, dose, and frequency, for an unknown indication, bupropion hydrochloride, tablets, unknown route, dose, and frequency, for an unknown indication, clonazepam, tablets, unknown route, dose, and frequency, for an unknown indication, cyanocobalamin, unknown route, dose, formulation and frequency, for an unknown indication, ergocalciferol, unknown route, formulation, dose, and frequency, for an unknown indication, esomeprazole magnesium trihydrate, unknown route, formulation, dose and frequency, for an unknown indication, formoterol fumarate, unknown route, formulation, dose, and frequency, for an unknown indication, levothyroxine, unknown route, formulation, dose, and frequency, for an unknown indication, levothyroixine sodium, unknown route, formulation, dose and frequency, for an unknown indication, liothyronine sodium, tablets, unknown route, dose, and frequency, for an unknown indication, metoprolol, unknown route, formulation, dose, and frequency, for an unknown indication, metoprolol tartrate, unknown route, formulation, dose, and frequency, for an unknown indication, mometasone, intra-nasal, 50.0 mcg 2 every 1 days, for unknown indication, mometasone furoate, unknown route, formulation, dose, and frequency, for an unknown indication, montelukast sodium tablet, unknown route, dose, and frequency, for an unknown indication, nasonex, spray, metered dose, unknown route, formulation, dose, and frequency, for an unknown indication, perindopril, unknown route, formulation, dose, and frequency, for an unknown indication, perindopril erbumine, unknown route, formulation, dose, and frequency, for an unknown indication, prednisone, unknown route, formulation, dose, and frequency, for an unknown indication, salbutamol, unknown route, formulation, dose, and frequency, for an unknown indication, sodium bicarbonate/sodium chloride, unknown route, formulation, dose, and frequency, for an unknown indication, sodium bicarbonate, unknown route, formulation, dose, and frequency, for an unknown indication, sprironolactone, tablets, unknown route, dose, and frequency, for an unknown indication, tramadol hydrochloride, unknown formulation, dose, route, and frequency, for an unknown indication, trazodone, unknown route, formulation, dose, and frequency, for an unknown indication, trazodone hydrochloride, unknown route, formulation, dose, and frequency, for an unknown indication, vitamin b12, unknown route, formulation, dose, and frequency, for an unknown indication, and vitamin c, unknown route, formulation, dose, and frequency, symbicort turbuhaler, unknown route, powder, dose, and frequency for an unknown indication.Vitamin d, unknown route, formulation, dose, and frequency for an unknown indication, salbutamol sulfate, rosehips, rosa canina/vitamin c, perindopril arginine, sinucleanse, sodium chloride, ultram, vitamin d3, vitamin b12 and folic acid, eliquis, esomeprazole, formoterol, metoprolol fumarate, bupropion hydrobromide , and tramadol.A physician reported that on an unknown date, the patient experienced asthma, blood test abnormal, burning sensation, cardiac disorder, carpal tunnel syndrome, ejection fraction, fibromyalgia, gastroesophageal reflux disease, hypothyroidism, loss of personal independence in daily activities, nephrectomy, polycystic ovaries, rhinitis allergic, sensitization, sleep apnea syndrome, sleep disorder due to a general medical condition, hypertension, headache, and therapeutic product effect incomplete.No further information was reported.On 27-sep-2022, a physician reported the patient experienced asthma, blood test abnormal, burning sensation, cardiac disorder, carpal tunnel syndrome, ejection fraction, fibromyalgia, full blood count abnormal, gastroesophageal reflux disease, hypothyroidism, loss of personal independence in daily activities, nephrectomy, polycystic ovaries, renal disorder, rhinitis allergic, sensitization, sleep apnea syndrome, sleep disorder due to a general medical condition, hypertension, headache, wheezing and therapeutic product effect incomplete.On 30-nov-2022, a healthcare professional reported that the patient experienced asthma, blood test abnormal, burning sensation, cardiac disorder, carpal tunnel syndrome, dyspnoea, ejection fraction, fibromyalgia, gastroesophageal reflux disease, hospitalization, hypothyroidism, loss of personal independence in daily activities, nephrectomy, polycystic ovaries, renal disorder, rhinitis allergic, sensitization, sleep apnea syndrome, sleep disorder due to a general medical condition, hypertension, headache, wheezing and therapeutic product effect incomplete.On 11-jan-2023, a physician reported that the patient experienced asthma, blood test abnormal, burning sensation, cardiac disorder, carpal tunnel syndrome, dyspnoea, ejection fraction, fibromyalgia, full blood count abnormal, gastroesophageal reflux disease, hospitalization, hypothyroidism, loss of personal independence in daily activities, nephrectomy, polycystic ovaries, renal disorder, rhinitis allergic, sensitization, sleep apnea syndrome, sleep disorder due to a general medical condition, hypertension, headache, wheezing and therapeutic product effect incomplete.On 08-feb-2023, the healthcare professional reported that the patient experienced an adverse event, ejection fraction abnormal, hypertension, nephropathy, sleep disorder due to general medical condition, insomnia type, and obstructive sleep apnea syndrome.Additional suspect drugs were reported to include salbutamol sulfate, rosehips, rosa canina/vitamin c, perindopril arginine, sinucleanse, sodium chloride, ultram, vitamin d3, vitamin b12 and folic acid, eliquis, esomeprazole, formoterol, metoprolol fumarate, bupropion hydrobromide and tramadol.The patient was hospitalized on an unknown date due to an unknown reason.Action taken with euflexxa and budesonide was unknown.Action taken with all other co-suspect drugs was also unknown.At the time of this report, the outcome of all adverse events was recovered.Concomitant medications included ventolin (from unknown start date to unknown stop date) and salbutamol (from unknown start date to unknown stop date).All events in the case were reported as serious.At the time of reporting the case outcome was recovered.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.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality (euflexxa): related: therapeutic product effect incomplete, full blood count abnormal.Not related: hospitalization, asthma, blood test abnormal, burning sensation, cardiac disorder, carpal tunnel syndrome, dyspnea, ejection fraction, fibromyalgia, gastroesophageal reflux disease, hypothyroidism, loss of personal independence in daily activities, nephrectomy, polycystic ovaries, renal disorder, rhinitis allergic, sensitization, sleep apnea syndrome, sleep disorder due to a general medical condition, hypertension, headache, wheezing, adverse event, ejection fraction abnormal, hypertension, nephropathy, obstructive sleep apnea syndrome, sleep disorder due to general medical condition, insomnia type.Company causality (budesonide): not related.Unassessable (blood test abnormal, hospitalization, full blood count abnormal, adverse event).Related (headache, therapeutic product effect incomplete).Ferring sender comment: important information is missing as product indication/concentration, roa, dose, frequency therapeutic dates, medical history, lab data etc.The case lists several events and several suspect products (unknown brand of naha).Based on the well-known safety profile of euflexxa all events are considered not related with exception of 'therapeutic product effect incomplete'' which is more likely related to the rest of reported events.Concerning budesonide, this report is missing tradename of budesonide, indication for use, dosing regimen, time-to-onset, action taken with the product and outcome of event.The patient has asthma, so it might as well be the indication for budesonide, as there is no information on gastrointestinal disease.Based on biological plausibility and the known safety profile of budesonide, causality is considered not related for all events except from blood test abnormal, hospitalization, full blood count abnormal, adverse event, headache and therapeutic product effect incomplete.A relation between budesonide and blood test abnormal, hospitalization, full blood count abnormal, adverse event is unassessable due to limited information provided.A relation between budesonide and theadache and therapeutic product effect incomplete cannot be excluded.Updated sender comments upon follow-up 01: no information reported on medical history, therapy dates and event onset dates making difficult to perform a thorough medical evaluation.Due to clinical interpretation in alignment with known safety profile, company causality is considered not related to euflexxa for the reported events as there is no clinical evidence, but might most likely related to confounding diseases as per the numerous concomitant medications reported.Other case numbers: internal # - affiliate = (b)(4).Internal # - others = (b)(4).Internal # - others = (b)(4).Internal # - others = (b)(4).Mw 3500a mfr.Rpt.# = 3000164186-2021-00033.E2b company number = (b)(4).Internal # - others = (b)(4).Internal # - others = (b)(4).Internal # - others = (b)(4).Internal # - others = (b)(4).Internal # - others = (b)(4).Internal # - others = (b)(4).Internal # - others = (b)(4).74.Internal # - others = (b)(4).Internal # - others =(b)(4).Internal # - others = (b)(4).Internal # - others = (b)(4).Internal # - others = (b)(4).Internal # - others = (b)(4).Additional information was received on 27-sep-2022 by a physician: follow up 01: new events dypsnea, renal disorder, full blood count abnormal and wheezing were reported.Captured all events as medically significant and hospitalized.Co-suspect drugs added included: budesonide, cyanocobalamin, esomeprazole magnesium trihydrate, formoterol fumarate, hyaluronate sodium, levothyroxine sodium, seawater, sodium bicarbonate, symbicort turbuhaler, tramadol, and vitamin d.Liothyronine sodium formulation (tablet) was added, mometasone route of administration, dose and frequency was added, an additional dosing regimen for mometasone was added, and trazadone formulation was added (tablet).Removed hospitalization as a separate event as per f/u received.Additional information received on 30-nov-2022 from a healthcare professional: follow up 02: added co-suspect drugs: acyclovir sodium, budesonide/ formoterol, metoprolol tartrate, mometasone furoate, perindopril erbumine, and trazodone hydrochloride.Removed co-suspect drugs: esomeprazole, hyaluronate sodium (as this is the coded company drug euflexxa), sea water, sodium bicarbonate, symbicort turbuhaler, tramadol, tramadol hydrochloride (this was coded twice previously), and vitamin d.Removed concomitant medication salbutamol sulfate.Formulation was added for montelukast sodium.The dosing regimen for mometasone was updated.The event of full blood count abnormal was removed and the event of hospitalization was added.Additional information was received on 11-jan-2023 from a physician: follow up 03: added co-suspect drugs: bupropion hydrochloride, sodium bicarbonate, symbicort turbuhaler, vitamin d, and seawater.Additional information received 08-feb-2023, from a healthcare professional, follow up 04: new events of adverse event, ejection fraction abnormal, hypertension, nephropathy, sleep disorder due to general medical condition, insomnia type, and obstructive sleep apnea syndrome.Additional suspect drugs were reported to include salbutamol sulfate, rosehips, rosa canina/vitamin c, perindopril arginine, sinucleanse, sodium chloride, ultram, vitamin d3, vitamin b12 and folic acid, eliquis, esomeprazole, formoterol, metoprolol fumarate, bupropion hydrobromide , and tramadol.Suspect drug formulations reported for tramadol hydrochloride, mometasone, levothyroxine, sodium bicarbonate/sodium chloride, vitamin c, ergocalciferol, and apixaban.Route reported for acyclovir, clonazepam, levothyroxine, mometasone, perindopril, and spironolactone.Additional dosing reported for mometasone, vitamin c, sodium bicarbonate/sodium chloride, budesonide formoterol fumurate, and apixaban.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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Event Description
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Hypothyroidism [hypothyroidism]; cardiac disorder [cardiac disorder]; asthma [asthma]; blood test abnormal [blood test abnormal]; burning sensation [burning sensation]; carpal tunnel syndrome [carpal tunnel syndrome]; ejection fraction [ejection fraction]; fibromyalgia [fibromyalgia]; gastroesophageal reflux disease [gastrooesophageal reflux disease]; loss of personal independence in daily activities [loss of personal independence in daily activities]; nephrectomy [nephrectomy]; polycystic ovaries [polycystic ovaries]; sensitization [sensitisation]; sleep apnea syndrome [sleep apnoea syndrome]; sleep disorder due to a general medical condition [sleep disorder due to a general medical condition]; rhinitis allergic [rhinitis allergic]; hypertension [hypertension]; dyspnea [dyspnoea]; renal disorder [renal disorder]; wheezing [wheezing]; hospitalization [hospitalisation]; full blood count abnormal [full blood count abnormal]; headache [headache]; therapeutic product effect incomplete [therapeutic product effect incomplete].Case narrative: this serious spontaneous case from a physician via a regulatory authority in canada.This report concerns a 54-year-old female who experienced asthma, blood test abnormal, burning sensation, cardiac disorder, carpal tunnel syndrome, ejection fraction, fibromyalgia, full blood count abnormal, hospitalization, gastroesophageal reflux disease, hypothyroidism, loss of personal independence in daily activities, nephrectomy, polycystic ovaries, renal disorder, rhinitis allergic, sensitization, sleep apnea syndrome, sleep disorder due to a general medical condition, hypertension, headache, dyspnea, wheezing, and therapeutic product effect incomplete during treatment with euflexxa (sodium hyaluronate) solution for injection unknown route, concentration, dose and frequency, from an unknown start date to an unknown stop date and co-suspect drugs: budesonide (brand name not reported), unknown route, formulation, dose and frequency, for an unknown indication, acyclovir, unknown route, formulation, dose, and frequency, for an unknown indication, acyclovir sodium, unknown route, formulation, dose, and frequency, for an unknown indication, apixaban, unknown route, formulation, dose, and frequency, for an unknown indication, apo-tramadol, tablets, unknown route, dose, and frequency, for an unknown indication, budesonide/ formoterol, unknown route, formulation, dose, and frequency, for an unknown indication, budesonide/formoterol fumerate, unknown route, formulation, dose, and frequency, for an unknown indication, bupropion, tablets, unknown route, dose, and frequency, for an unknown indication, bupropion hydrochloride, tablets, unknown route, dose, and frequency, for an unknown indication, clonazepam, tablets, unknown route, dose, and frequency, for an unknown indication, cyanocobalamin, unknown route, dose, formulation and frequency, for an unknown indication, ergocalciferol, unknown route, formulation, dose, and frequency, for an unknown indication, esomeprazole magnesium trihydrate, unknown route, formulation, dose and frequency, for an unknown indication, formoterol fumarate, unknown route, formulation, dose, and frequency, for an unknown indication, levothyroxine, unknown route, formulation, dose, and frequency, for an unknown indication, levothyroixine sodium, unknown route, formulation, dose and frequency, for an unknown indication, liothyronine sodium, tablets, unknown route, dose, and frequency, for an unknown indication, metoprolol, unknown route, formulation, dose, and frequency, for an unknown indication, metoprolol tartrate, unknown route, formulation, dose, and frequency, for an unknown indication, mometasone, intra-nasal, 50.0 mcg 2 every 1 days, for unknown indication, mometasone furoate, unknown route, formulation, dose, and frequency, for an unknown indication, montelukast sodium tablet, unknown route, dose, and frequency, for an unknown indication, nasonex, spray, metered dose, unknown route, formulation, dose, and frequency, for an unknown indication, perindopril, unknown route, formulation, dose, and frequency, for an unknown indication, perindopril erbumine, unknown route, formulation, dose, and frequency, for an unknown indication, prednisone, unknown route, formulation, dose, and frequency, for an unknown indication, salbutamol, unknown route, formulation, dose, and frequency, for an unknown indication, sodium bicarbonate/sodium chloride, unknown route, formulation, dose, and frequency, for an unknown indication, sodium bicarbonate, unknown route, formulation, dose, and frequency, for an unknown indication, sprironolactone, tablets, unknown route, dose, and frequency, for an unknown indication, tramadol hydrochloride, unknown formulation, dose, route, and frequency, for an unknown indication, trazodone, unknown route, formulation, dose, and frequency, for an unknown indication, trazodone hydrochloride, unknown route, formulation, dose, and frequency, for an unknown indication, vitamin b12, unknown route, formulation, dose, and frequency, for an unknown indication, and vitamin c, unknown route, formulation, dose, and frequency, symbicort turbuhaler, unknown route, powder, dose, and frequency for an unknown indication.Vitamin d, unknown route, formulation, dose, and frequency for an unknown indication.A physician reported that on an unknown date, the patient experienced asthma, blood test abnormal, burning sensation, cardiac disorder, carpal tunnel syndrome, ejection fraction, fibromyalgia, gastroesophageal reflux disease, hypothyroidism, loss of personal independence in daily activities, nephrectomy, polycystic ovaries, rhinitis allergic, sensitization, sleep apnea syndrome, sleep disorder due to a general medical condition, hypertension, headache, and therapeutic product effect incomplete.No further information was reported.On (b)(6) 2022, a physician reported the patient experienced asthma, blood test abnormal, burning sensation, cardiac disorder, carpal tunnel syndrome, ejection fraction, fibromyalgia, full blood count abnormal, gastroesophageal reflux disease, hypothyroidism, loss of personal independence in daily activities, nephrectomy, polycystic ovaries, renal disorder, rhinitis allergic, sensitization, sleep apnea syndrome, sleep disorder due to a general medical condition, hypertension, headache, wheezing and therapeutic product effect incomplete.On (b)(6) 2022, a healthcare professional reported that the patient experienced asthma, blood test abnormal, burning sensation, cardiac disorder, carpal tunnel syndrome, dyspnoea, ejection fraction, fibromyalgia, gastroesophageal reflux disease, hospitalization, hypothyroidism, loss of personal independence in daily activities, nephrectomy, polycystic ovaries, renal disorder, rhinitis allergic, sensitization, sleep apnea syndrome, sleep disorder due to a general medical condition, hypertension, headache, wheezing and therapeutic product effect incomplete.On (b)(6) 2023, a physician reported that the patient experienced asthma, blood test abnormal, burning sensation, cardiac disorder, carpal tunnel syndrome, dyspnoea, ejection fraction, fibromyalgia, full blood count abnormal, gastroesophageal reflux disease, hospitalization, hypothyroidism, loss of personal independence in daily activities, nephrectomy, polycystic ovaries, renal disorder, rhinitis allergic, sensitization, sleep apnea syndrome, sleep disorder due to a general medical condition, hypertension, headache, wheezing and therapeutic product effect incomplete.The patient was hospitalized on an unknown date due to an unknown reason.Action taken with euflexxa and budesonide was unknown.Action taken with all other co-suspect drugs was also unknown.At the time of this report, the outcome of all adverse events was recovered.Concomitant medications included ventolin (from unknown start date to unknown stop date) and salbutamol (from unknown start date to unknown stop date).All events in the case were reported as serious.At the time of reporting the case outcome was recovered.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.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality (euflexxa): related: therapeutic product effect incomplete, full blood count abnormal.Not related: hospitalization, asthma, blood test abnormal, burning sensation, cardiac disorder, carpal tunnel syndrome, dyspnea, ejection fraction, fibromyalgia, gastroesophageal reflux disease, hypothyroidism, loss of personal independence in daily activities, nephrectomy, polycystic ovaries, renal disorder, rhinitis allergic, sensitization, sleep apnea syndrome, sleep disorder due to a general medical condition, hypertension, headache, wheezing.Company causality (budesonide): not related.Unassessable: blood test abnormal, hospitalization, headache, full blood count abnormal.Related: therapeutic product effect incomplete.Ferring sender comment: important information is missing as product indication/concentration, roa, dose, frequency therapeutic dates, medical history, lab data etc.The case lists several events and several suspect products (unknown brand of naha).Based on the well-known safety profile of euflexxa all events are considered not related with exception of 'therapeutic product effect incomplete'' which is more likely related to the rest of reported events.Concerning budesonide, the indication for use is unknown, as is the administration, dosage etc.The patient has asthma, so it might as well be the indication for budesonide, as there is no information on gastrointestinal disease.Based on biological plausibility and the known safety profile of budesonide, causality is considered not related for all events except from blood test abnormal, full blood count abnormal, hospitalization, headache, and therapeutic product effect incomplete.A relation between budesonide and headache, blood test abnormal, full blood count abnormal, and hospitalization is unassessable due to limited information.A relation between budesonide and therapeutic product effect incomplete cannot be excluded.Updated sender comments upon follow-up 01: no information reported on medical history, therapy dates and event onset dates making difficult to perform a thorough medical evaluation.Due to clinical interpretation in alignment with known safety profile, company causality is considered not related to euflexxa for the reported events as there is no clinical evidence, but might most likely related to confounding diseases as per the numerous concomitant medications reported.Other case numbers: internal # - (b)(4).Additional information was received on 27-sep-2022 by a physician: follow up 01: new events dypsnea, renal disorder, full blood count abnormal and wheezing were reported.Captured all events as medically significant and hospitalized.Co-suspect drugs added included: budesonide, cyanocobalamin, esomeprazole magnesium trihydrate, formoterol fumarate, hyaluronate sodium, levothyroxine sodium, seawater, sodium bicarbonate, symbicort turbuhaler, tramadol, and vitamin d.Liothyronine sodium formulation (tablet) was added, mometasone route of administration, dose and frequency was added, an additional dosing regimen for mometasone was added, and trazadone formulation was added (tablet).Removed hospitalization as a separate event as per f/u received.Additional information received on 30-nov-2022 from a healthcare professional: follow up 02: added co-suspect drugs: acyclovir sodium, budesonide/ formoterol, metoprolol tartrate, mometasone furoate, perindopril erbumine, and trazodone hydrochloride.Removed co-suspect drugs: esomeprazole, hyaluronate sodium (as this is the coded company drug euflexxa), sea water, sodium bicarbonate, symbicort turbuhaler, tramadol, tramadol hydrochloride (this was coded twice previously), and vitamin d.Removed concomitant medication salbutamol sulfate.Formulation was added for montelukast sodium.The dosing regimen for mometasone was updated.The event of full blood count abnormal was removed and the event of hospitalization was added.Additional information was received on 11-jan-2023 from a physician: follow up 03: added co-suspect drugs: bupropion hydrochloride, sodium bicarbonate, symbicort turbuhaler, vitamin d, and seawater.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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Search Alerts/Recalls
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