| Catalog Number 6301182010 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Thrombosis/Thrombus (4440); Muscle/Tendon Damage (4532); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Type
Injury
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Event Description
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Diagnosed with blood clot in the whole leg [thrombosis] tendonitis on the left foot [tendonitis] case narrative: this is a serious spontaneous case received via a phone call from a consumer in the united states.This report concerns a 67-year-old female who was diagnosed with blood clot in the whole leg and tendonitis on the left foot after administration with euflexxa (sodium hyaluronate) solution for injection, via unknown route of administration, unknown concentration, for an unknown indication.The patient had injections on both knees, weekly for three weeks, from (b)(6) 2024.On (b)(6) 2024, the patient had the euflexxa injection on both knees.The patient mentioned having tendonitis on the right foot but after the administration of euflexxa, on an unknown date in (b)(6)2024, she developed tendonitis on the left foot.She also reported swelling on the left lower leg along with a huge bruise below the left knee on (b)(6) 2024.Additionally, pain started from the calf then goes to the midthigh to the lower leg which lasted a week and a half.On (b)(6) 2024, she experienced persistent swelling lasting until (b)(6) 2024.Although the bruise from the second dose of euflexxa only lasted ten days, she reported ongoing pain and swelling in the left leg during the call.On an unknown date, she contacted the ortho doctor and underwent a venous doppler, which diagnosed a blood clot in the entire leg.The patient started eliquis the day before the call.No further information was provided.The event of blood clot in the whole leg was considered medically significant.Action taken with euflexxa was not applicable.At the time of this report the outcome of blood clot in the whole leg and tendonitis on the left foot were unknown.The patient's medical history includes ongoing tendonitis in the right foot, with the onset date remaining unknown.On an unknown date, the patient underwent a venous doppler procedure, which indicated the presence of blood clots in the whole leg.No concomitant medication was reported.The event of blood clot in the whole leg was reported as serious.The event of tendonitis on the left foot was reported as non-serious.Overall listedness (core label) is unlisted.Reporter causality: related company causality: related other case numbers: internal # - others = (b)(4).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 mdd (european council directive of 14 june 1993, 93/42/eec concerning medical devices) / mdr (eu) 2017/745 and/or because it did not occur in an eu + efta country + tr and ni 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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Diagnosed with blood clot in the whole leg [thrombosis].Tendonitis on the left foot [tendonitis].Case narrative: this is a serious spontaneous complaint case received via a phone call from a consumer in the united states.This report concerns a 67-year-old female who was diagnosed with blood clot in the whole leg and tendonitis on the left foot after administration with euflexxa (sodium hyaluronate) solution for injection, via unknown route of administration, unknown concentration, for an unknown indication.The patient had injections on both knees, weekly for three weeks, from (b)(6) 2024.On (b)(6) 2024, the patient had the euflexxa injection on both knees.The patient mentioned having tendonitis on the right foot but after the administration of euflexxa, on an unknown date in mar-2024, she developed tendonitis on the left foot.She also reported swelling on the left lower leg along with a huge bruise below the left knee on (b)(6) 2024.Additionally, pain started from the calf then goes to the midthigh to the lower leg which lasted a week and a half.On (b)(6) 2024, she experienced persistent swelling lasting until (b)(6) 2024.Although the bruise from the second dose of euflexxa only lasted ten days, she reported ongoing pain and swelling in the left leg during the call.The patient reported these symptoms started anytime within the second and third dose of the medication.According to the patient, she had a painful blood clot and egg-like swelling of her left leg, starting from her groin to her left foot.On an unknown date, she contacted the ortho doctor and underwent a venous doppler, which diagnosed a blood clot in the entire leg.The patient started eliquis the day before the call.Patient reported taking eliquis as remedy for the side effect she had gotten from euflexxa.On 20-apr-2024, the patient contacted ferring again claiming that she had not been informed about a blood clot being a possible adverse event of euflexxa, and that it was not listed anywhere in pamphlet.The patient expressed dissatisfaction of euflexxa because of inadequate listing of side effects.She reported that she did some research on this, and found out that deep vein thrombosis is a rare adverse effect.She mentioned that she would have never taken euflexxa if she had known this was a side effect.The patient stated that she was distraught that after three weeks of phone calls to ferring she had not received a call back.She also reported she had endured a lot and was hoping for some compensation.No further information was provided.The event of blood clot in the whole leg was considered medically significant.Action taken with euflexxa was not applicable.At the time of this report the outcome of blood clot in the whole leg and tendonitis on the left foot were unknown.The patient's medical history includes ongoing tendonitis in the right foot, allergy on vicodin, thyroid nodules and hypertension with the onset date remaining unknown.The reported concomitant medications include cortisone taken from (b)(6) 2024, to an unknown stop date.Additionally, the patient reported ongoing therapies with thyroid therapy and antihypertensives (start date unknown).The event of blood clot in the whole leg was reported as serious.The event of tendonitis on the left foot was reported as non-serious.Sender comment; a causal relationship cannot be ruled out between euflexxa and thrombosis based on temporal relationship.However confounding information are present - it is unclear what thyroid condition the patient has both hypo-/hyperthyroidism are risk factors for venous thrombosis, concomitant medication of cortisone is also risk factor for venous thrombosis.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: related.Other case numbers: (b)(4).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 mdd (european council directive of (b)(6) 1993, 93/42/eec concerning medical devices) / mdr (eu) 2017/745 and/or because it did not occur in an eu + efta country + tr and ni 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 received on 15-apr-2024 and 20-apr-2024 from the initial reporter: patient's date of birth updated, weight and height added.Medical history updated.Intensity for the event of 'diagnosed with blood clot in the whole leg' added as severe.Concomitant products added.New local ids and qr number added: (b)(4).Case narrative updated accordingly.
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Event Description
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Diagnosed with blood clot in the whole leg [thrombosis] ; tendonitis on the left foot [tendonitis]; on blood thinners which she claimed has affected her quality of life.[impaired quality of life].Case narrative: this is a serious spontaneous complaint case received via a phone call from a consumer in the united states.This report concerns a 67-year-old female who was diagnosed with blood clot in the whole leg and tendonitis on the left foot; the patient also reported being on blood thinners which she claimed had affected her quality of life, after administration with euflexxa (sodium hyaluronate) solution for injection, via unknown route of administration, unknown concentration, for an unknown indication.The patient had injections on both knees, weekly for three weeks, (b)(6) 2024.On (b)(6) 2024, the patient had the euflexxa injection on both knees.The patient mentioned having tendonitis on the right foot but after the administration of euflexxa, on an unknown date in (b)(6) 2024, she developed tendonitis on the left foot.She also reported swelling on the left lower leg along with a huge bruise below the left knee on (b)(6) 2024.Additionally, pain started from the calf then goes to the midthigh to the lower leg which lasted a week and a half.On (b)(6) 2024, she experienced persistent swelling lasting until (b)(6) 2024.Although the bruise from the second dose of euflexxa only lasted ten days, she reported ongoing pain and swelling in the left leg during the call.The patient reported these symptoms started anytime within the second and third dose of the medication.According to the patient, she had a painful blood clot and egg-like swelling of her left leg, starting from her groin to her left foot.On an unknown date, she contacted the ortho doctor and underwent a venous doppler, which diagnosed a blood clot in the entire leg.The patient started eliquis the day before the call.Patient reported taking eliquis as remedy for the side effect she had gotten from euflexxa.On (b)(6) 2024, the patient contacted ferring again claiming that she had not been informed about a blood clot being a possible adverse event of euflexxa, and that it was not listed anywhere in pamphlet.The patient expressed dissatisfaction of euflexxa because of inadequate listing of side effects.She reported that she did some research on this, and found out that deep vein thrombosis is a rare adverse effect.She mentioned that she would have never taken euflexxa if she had known this was a side effect.The patient stated that she was distraught that after three weeks of phone calls to ferring she had not received a call back.She also reported she had endured a lot and was hoping for some compensation.No further information was provided.On (b)(6) 2024, the patient called back medical information line for an update on her adverse event report regarding euflexxa.At the time of the call, she still had the adverse event symptoms of blood clot from her left groin to her left foot, and she was still on blood thinners which she claimed had affected her quality of life.The patient said she demanded an explanation on why the product was still on the market, and why the side effect of blood clots had not been listed in the product information leaflet.The patient demanded that someone from the safety team call her back within the day, at the time of her call, stating that otherwise, she would be filing a lawsuit next week.The event of blood clot in the whole leg was considered medically significant.Action taken with euflexxa was not applicable.At the time of this report the outcome of blood clot in the whole leg was not recovered.The outcome of the event of tendonitis on the left foot and on blood thinners which she claimed had affected her quality of life was unknown.The patient's medical history included ongoing tendonitis in the right foot, allergy on vicodin, thyroid nodules and hypertension with the onset date remaining unknown.The reported concomitant medications include cortisone taken from (b)(6) 2024, to an unknown stop date.Additionally, the patient reported ongoing therapies with thyroid therapy and antihypertensives (start date unknown).The event of blood clot in the whole leg was reported as serious.The event of tendonitis on the left foot and on blood thinners which she claimed has affected her quality of life were reported as non-serious.Sender comment; a causal relationship cannot be ruled out between euflexxa and thrombosis based on temporal relationship.However confounding information are present - it is unclear what thyroid condition the patient has both hypo-/hyperthyroidism are risk factors for venous thrombosis, hypertension and her concomitant medication of cortisone are risk factors for venous thrombosis.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: related.Other case numbers: (b)(4).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 mdd (european council directive of 14 june 1993, 93/42/eec concerning medical devices) / mdr (eu) 2017/745 and/or because it did not occur in an eu + efta country + tr and ni 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 received on 15-apr-2024 and 20-apr-2024 from the initial reporter: patient's date of birth updated, weight and height added.Medical history updated.Intensity for the event of 'diagnosed with blood clot in the whole leg' added as severe.Concomitant products added.New local ids and qr number added: (b)(4).Case narrative updated accordingly.Additional information received on 26-apr-2024 from the initial reporter: new event added: on blood thinners which she claimed has affected her quality of life.The outcome for the event of diagnosed with blood clot in the whole leg was updated from unknown to not recovered.Case narrative updated accordingly.Case correction on 03-may-2024: concomitant drugs: thyroid therapy and antihypertensives deleted from the product tab (mentioned only in the narrative).
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Event Description
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Diagnosed with blood clot in the whole leg [thrombosis].Tendonitis on the left foot [tendonitis].On blood thinners which she claimed has affected her quality of life.[impaired quality of life].Case narrative: this is a serious spontaneous complaint case received via a phone call from a consumer in the united states.This report concerns a 67-year-old female who was diagnosed with blood clot in the whole leg and tendonitis on the left foot; the patient also reported being on blood thinners which she claimed had affected her quality of life, after administration with euflexxa (sodium hyaluronate) solution for injection, via unknown route of administration, unknown concentration, for an unknown indication.The patient had injections on both knees, weekly for three weeks, from (b)(6) 2024.On (b)(6) 2024, the patient had the euflexxa injection on both knees.The patient mentioned having tendonitis on the right foot but after the administration of euflexxa, on an unknown date in (b)(6) 2024, she developed tendonitis on the left foot.She also reported swelling on the left lower leg along with a huge bruise below the left knee on (b)(6)2024.Additionally, pain started from the calf then goes to the midthigh to the lower leg which lasted a week and a half.On (b)(6) 2024, she experienced persistent swelling lasting until (b)(6) 2024.Although the bruise from the second dose of euflexxa only lasted ten days, she reported ongoing pain and swelling in the left leg during the call.The patient reported these symptoms started anytime within the second and third dose of the medication.According to the patient, she had a painful blood clot and egg-like swelling of her left leg, starting from her groin to her left foot.On an unknown date, she contacted the ortho doctor and underwent a venous doppler, which diagnosed a blood clot in the entire leg.The patient started eliquis the day before the call.Patient reported taking eliquis as remedy for the side effect she had gotten from euflexxa.On (b)(6) 2024, the patient contacted ferring again claiming that she had not been informed about a blood clot being a possible adverse event of euflexxa, and that it was not listed anywhere in pamphlet.The patient expressed dissatisfaction of euflexxa because of inadequate listing of side effects.She reported that she did some research on this, and found out that deep vein thrombosis is a rare adverse effect.She mentioned that she would have never taken euflexxa if she had known this was a side effect.The patient stated that she was distraught that after three weeks of phone calls to ferring she had not received a call back.She also reported she had endured a lot and was hoping for some compensation.No further information was provided.On (b)(6) 2024, the patient called back medical information line for an update on her adverse event report regarding euflexxa.At the time of the call, she still had the adverse event symptoms of blood clot from her left groin to her left foot, and she was still on blood thinners which she claimed had affected her quality of life.The patient said she demanded an explanation on why the product was still on the market, and why the side effect of blood clots had not been listed in the product information leaflet.The patient demanded that someone from the safety team call her back within the day, at the time of her call, stating that otherwise, she would be filing a lawsuit next week.On (b)(6) 2024, the patient mentioned that the blood clot went from her groin to her foot and "she was living in misery living in blood thinner".On 15-may-2024, the lso in the usa called the patient.The patient said she was very upset and wanted compensation from ferring.She wanted answers as to why this happened to her after taking euflexxa and stated that she knew this was the reason why she had the blood clots.The patient stated that she had an appointment on (b)(6) 2024 with a hematologist and that at the time of that call she was currently taking eliquis 5mg twice daily for the blood clots.She also reported taking concomitant drugs: methimazole, carvedilol and norvasc.The event of blood clot in the whole leg was considered medically significant.Action taken with euflexxa was not applicable.At the time of this report the outcome of blood clot in the whole leg was not recovered.The outcome of the event of tendonitis on the left foot and on blood thinners which she claimed had affected her quality of life was unknown.The patient's medical history included ongoing tendonitis in the right foot, allergy on vicodin, thyroid nodules and hypertension with the onset date remaining unknown.The patient also reported medical history of degenerative disc disease.The reported concomitant medications include cortisone taken from (b)(6) 2024, to an unknown stop date.Additionally, the patient reported ongoing therapies for thyroid nodules [methimazole 5 mg daily, the patient has been taking this drug for five years), for hypertension [carvedilol 12.5 mg two times daily], for blood pressure [norvasc 5 mg daily].The event of blood clot in the whole leg was reported as serious.The event of tendonitis on the left foot and on blood thinners which she claimed has affected her quality of life were reported as non-serious.Sender comment: multiple confounding factors are present in the case, the patient has hyperthyroidism and hypertension that increase the risk for thromboembolism.The concomitant medication of cortisone is also a risk factors for venous thrombosis.The indication for euflexxa in the patient was not reported, but the patient reports receiving euflexxa in both knees.Osteoarthritis is associated with hypercoagulability and decreased fibrinolysis that can cause or contribute to thromboembolism; immobility due to knee pain from oa may also contribute to thromboembolism.Based on presence of multiple confounders a clear causal relationship cannot be assessed between euflexxa and the reported thrombosis.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: unassessable.Other case numbers: internal # - others = fmc-(b)(4).Internal # - others = fmc-event-002241.Mw 3500a mfr.Rpt.# = 3000164186-2024-00025.Internal # - others = 0002244564-2024-00025.Internal # - complaint = (b)(4).Internal # - others = fmc-(b)(4).Internal # - others = fmc-event-002283.Internal # - others = fmc-event-002284.Internal # - others = fmc-(b)(4).Internal # - others = fmc-event-002433.Internal # - others = fmc-event-002434.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 mdd (european council directive of 14 june 1993, 93/42/eec concerning medical devices) / mdr (eu) 2017/745 and/or because it did not occur in an eu + efta country + tr and ni 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 received on 15-apr-2024 and 20-apr-2024 from the initial reporter: patient's date of birth updated, weight and height added.Medical history updated.Intensity for the event of 'diagnosed with blood clot in the whole leg' added as severe.Concomitant products added.New local ids and qr number added: fmc-(b)(4), fmc-event-002283, fmc-event-002284, (b)(4).Case narrative updated accordingly.Additional information received on 26-apr-2024 from the initial reporter: new event added: on blood thinners which she claimed has affected her quality of life.The outcome for the event of diagnosed with blood clot in the whole leg was updated from unknown to not recovered.Case narrative updated accordingly.Case correction on 03-may-2024: concomitant drugs: thyroid therapy and antihypertensives deleted from the product tab (mentioned only in the narrative).New information received on 10-may-2024 and 15-may-2024 from the initial reporter: new concomitant drugs added: methimazole, carvedilol and norvasc.Medical history of degenerative disc disease added.New local id numbers added: fmc-(b)(4), fmc-event-002433, fmc-event-002434.Case narrative updated accordingly.Company causality updated from related to unassessable.Sender comment updated.
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Event Description
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Diagnosed with blood clot in the whole leg [thrombosis] tendonitis on the left foot [tendonitis] on blood thinners which she claimed has affected her quality of life.[impaired quality of life] feeling cold all the time [feeling cold] case narrative: this is a serious spontaneous complaint case received via a phone call from a consumer in the united states.This report concerns a 67-year-old female who was diagnosed with blood clot in the whole leg and tendonitis on the left foot; the patient also reported feeling cold all the time and being on blood thinners which she claimed had affected her quality of life after administration with euflexxa (sodium hyaluronate) solution for injection, via unknown route of administration, unknown concentration, for an unknown indication.The patient had injections on both knees, weekly for three weeks, from (b)(6) 2024 to (b)(6)2024.On (b)(6) 2024, the patient had the euflexxa injection on both knees.The patient mentioned having tendonitis on the right foot but after the administration of euflexxa, on an unknown date in (b)(6) 2024, she developed tendonitis on the left foot.She also reported swelling on the left lower leg along with a huge bruise below the left knee on (b)(6)2024.Additionally, pain started from the calf then goes to the midthigh to the lower leg which lasted a week and a half.On (b)(6) 2024, she experienced persistent swelling lasting until (b)(6) 2024.Although the bruise from the second dose of euflexxa only lasted ten days, she reported ongoing pain and swelling in the left leg during the call.The patient reported these symptoms started anytime within the second and third dose of the medication.According to the patient, she had a painful blood clot and egg-like swelling of her left leg, starting from her groin to her left foot.On an unknown date, she contacted the ortho doctor and underwent a venous doppler, which diagnosed a blood clot in the entire leg.The patient started eliquis the day before the call.Patient reported taking eliquis as remedy for the side effect she had gotten from euflexxa.On 20-apr-2024, the patient contacted ferring again claiming that she had not been informed about a blood clot being a possible adverse event of euflexxa, and that it was not listed anywhere in pamphlet.The patient expressed dissatisfaction of euflexxa because of inadequate listing of side effects.She reported that she did some research on this, and found out that deep vein thrombosis is a rare adverse effect.She mentioned that she would have never taken euflexxa if she had known this was a side effect.The patient stated that she was distraught that after three weeks of phone calls to ferring she had not received a call back.She also reported she had endured a lot and was hoping for some compensation.No further information was provided.On 26-apr-2024, the patient called back medical information line for an update on her adverse event report regarding euflexxa.At the time of the call, she still had the adverse event symptoms of blood clot from her left groin to her left foot, and she was still on blood thinners which she claimed had affected her quality of life.The patient said she demanded an explanation on why the product was still on the market, and why the side effect of blood clots had not been listed in the product information leaflet.The patient demanded that someone from the safety team call her back within the day, at the time of her call, stating that otherwise, she would be filing a lawsuit next week.On (b)(6) 2024, the patient mentioned that the blood clot went from her groin to her foot and "she was living in misery living in blood thinner".On 15-may-2024, the lso in the usa called the patient.The patient said she was very upset and wanted compensation from ferring.She wanted answers as to why this happened to her after taking euflexxa and stated that she knew this was the reason why she had the blood clots.The patient stated that she had an appointment on (b)(6) 2024 with a hematologist and that at the time of that call she was currently taking eliquis 5mg twice daily for the blood clots.She also reported taking concomitant drugs: methimazole, carvedilol and norvasc.On 29-may-2024, the patient called the local safety officer in us and stated that she had been calling for weeks about the progress of her case.She previously reported this adverse event ((b)(4)).She mentioned that the ferring employee reached out to her last may 15th and informed her that the internal team was handling her case already.The patient stated she had not received an update again.She wanted to be connected to the safety team and wanted to know if what compensation would be made for her case.She felt like she had been blown off by the company.Additionally, she expressed she had been wearing compression socks, and been on blood thinners for quite a while at the time of this call.She had blood test by her hematologist to link any genetic cause of the bleeding, but it was negative.She reported that her doctor believed that the bleeding from her groin to foot was caused by euflexxa.She mentioned that she did not find any adverse event or warnings in the leaflet of the product about the dvt and pulmonary embolism which should be included so that the consumers were aware.Refused to provide further information.On 31-may-2024, the patient called mentioning that she had blood clot in her legs because of euflexxa.She needed to wear a sweatshirt and jacket under a blanket because of feeling cold all the time even if it was 75 degrees.She mentioned that she needed to talk to someone from safety and was insistent in asking for someone from pv/safety to call her back, as soon as possible.No further information provided.The event of blood clot in the whole leg was considered medically significant.Action taken with euflexxa was not applicable.At the time of this report the outcome of blood clot in the whole leg was not recovered.The outcome of the event of tendonitis on the left foot, feeling cold all the time, and on blood thinners which she claimed had affected her quality of life was unknown.The patient's medical history included ongoing tendonitis in the right foot, allergy on vicodin, thyroid nodules and hypertension with the onset date remaining unknown.The patient also reported medical history of degenerative disc disease.The reported concomitant medications include cortisone taken from (b)(6) 2024, to an unknown stop date.Additionally, the patient reported ongoing therapies for thyroid nodules [methimazole 5 mg daily, the patient has been taking this drug for five years), for hypertension [carvedilol 12.5 mg two times daily], for blood pressure [norvasc 5 mg daily].The event of blood clot in the whole leg was reported as serious.The event of tendonitis on the left foot, feeling cold all the time, and on blood thinners which she claimed has affected her quality of life were reported as non-serious.Sender comment: multiple confounding factors are present in the case, the patient has hyperthyroidism and hypertension that increase the risk for thromboembolism.The concomitant medication of cortisone is also a risk factors for venous thrombosis.The indication for euflexxa in the patient was not reported, but the patient reports receiving euflexxa in both knees.Osteoarthritis is associated with hypercoagulability and decreased fibrinolysis that can cause or contribute to thromboembolism; immobility due to knee pain from oa may also contribute to thromboembolism.Based on presence of multiple confounders a clear causal relationship cannot be assessed between euflexxa and the reported thrombosis.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: unassessable.Other case numbers: internal # - others = fmc-case-(b)(4).Internal # - others = fmc-event-002241.Mw 3500a mfr.Rpt.# = 3000164186-2024-00025.(b)(4).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 mdd (european council directive of 14 june 1993, 93/42/eec concerning medical devices) / mdr (eu) 2017/745 and/or because it did not occur in an eu + efta country + tr and ni 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 received on 15-apr-2024 and 20-apr-2024 from the initial reporter: patient's date of birth updated, weight and height added.Medical history updated.Intensity for the event of 'diagnosed with blood clot in the whole leg' added as severe.Concomitant products added.New local ids and qr number added: (b)(4).Case narrative updated accordingly.Additional information received on 26-apr-2024 from the initial reporter: new event added: on blood thinners which she claimed has affected her quality of life.The outcome for the event of diagnosed with blood clot in the whole leg was updated from unknown to not recovered.Case narrative updated accordingly.Case correction on 03-may-2024: concomitant drugs: thyroid therapy and antihypertensives deleted from the product tab (mentioned only in the narrative).Additional information received on 10-may-2024 and 15-may-2024 from the initial reporter: new concomitant drugs added: methimazole, carvedilol and norvasc.Medical history of degenerative disc disease added.New local id numbers added: (b)(4).Case narrative updated accordingly.Company causality updated from related to unassessable.Sender comment updated.Additional information received on 29-may-2024 and 31-may-2024 from the initial reporter: new event added: feeling cold all the time.Blood test added.New local id numbers added: (b)(4).Case narrative updated accordingly.
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