| Lot Number UNKNOWN |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Fall (1848); Bone Fracture(s) (1870); Pain (1994); Loss of consciousness (2418); Ambulation Difficulties (2544); Limb Fracture (4518); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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| Event Date 04/25/2023 |
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Event Type
Injury
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Manufacturer Narrative
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Sanofi company comment dated 22-jun-2023: this case involves a 76 years old female patient who experienced blackout, woke up after crashing into the pavement and fracture the kneecap the second time with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one].Based on the limited information provided regarding this case, causal role of the company suspect product cannot be excluded.However, further information of past and concomitant medication, any family history and any relevant medical history of patient and any concurrent conditions would aid in better case assessment.
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Event Description
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Blackout [blackout].Woke up after crashing into the pavement [fall].Fracture the kneecap the second time [broken knee cap].Case narrative: initial information received from france on 19-jun-2023 regarding an unsolicited valid serious case received from a consumer/non-hcp.This case is linked to case (b)(4) (multiple devices suspect for same patient).This case involves a 76 years old female patient who experienced blackout, woke up after crashing into the pavement and fracture the kneecap the second time with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one].The patient's past medical history, medical treatment(s), concomitant medication(s) and family history were not provided.On (b)(6) 2023, the patient started using hylan g-f 20, sodium hyaluronate injection in left knee (with unknown strength, dose, frequency, route, batch number and expiry date) for product used for unknown indication.Information on batch number was requested.On an unknown date in 2023 (latency: few days approximately), the patient stated product helps, but each time a few days after the injection, she says that she had a blackout (loss of consciousness), she woke up after crashing into the pavement (fall) and she had a fracture of kneecap (patella fracture) and she did rehabilitation.Corrective treatment: not reported for all the events.Outcome: unknown for all the events.Seriousness criteria: medically significant for loss of consciousness.A product technical complaint (ptc) was initiated, and the results were pending for the same.
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Event Description
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Blackout [blackout] fracture the kneecap the second time [broken knee cap] woke up after crashing into the pavement/fall [fall].Case narrative: initial information received from france on 19-jun-2023 regarding an unsolicited valid serious case received from a patient.This case is linked to case (b)(4).(multiple device suspect used for the same patient; synvisc-one left knee on 15-dec-2021) this case involves a 76 years old female patient who experienced blackout, woke up after crashing into the pavement/fall and fracture the kneecap the second time with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one].The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.It was unknown if the patient had any concomitant disease or risk factor.On (b)(6) 2021 the patient received synvisc one first time.On (b)(6) 2023, the patient started using hylan g-f 20, sodium hyaluronate injection (liquid solution) in left knee of strength 48 mg/6 ml at a dose of 1 df 1x (once) (with unknown route, batch number and expiry date, indication).Information on batch number was requested.On an unknown date in (b)(6) 2023 (latency: 5 to 7 days approximately), the patient stated product helped, but each time she suffered a very serious side effects- a black out (loss of consciousness) followed by a fall as she woke up after crashing into the pavement /sidewalk (fall) after the injection and had a fracture of kneecap (patella fracture).It was reported that both times she was in hospital and then in the rehabilitation for about 6 weeks.It was unknown if the patient experienced any additional symptoms/events.It was unknown if there were lab data/results available.Action taken: not applicable for all the events.Corrective treatment: did rehabilitation for patella fracture; not reported for rest all the events outcome: unknown for all the events seriousness criteria: medically significant and hospitalization for loss of consciousness and hospitalization for patella fracture and fall a product technical complaint (ptc) was initiated on 19-jun-2023 for "synvisc-one".Batch number: unknown global ptc number: (b)(4).The sample of the ptc (product technical complaint) was not available.Ptc stated: based on the complaint from intake team, there was no quality related defect that would attribute to a malfunction, death, or serious injury.Sanofi global pharmacovigilance and epidemiology continuously monitored adverse event reports with or without lot numbers, and assessed possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals.The defect class has been updated to ii.Investigation: the product lot number was not provided.A batch record review was not possible.Based on the lack of information, no assessment was possible.It was the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result was identified and mitigated through the nonconforming material or product process.Sanofi would continue to monitor adverse events and perform trend analysis on a periodic basis to determine if a capa (corrective and preventive action) was required.The final investigation was completed on 05-jul-2023 and the summarized conclusion was "no assessment possible." additional information was received on 19-jun-2023 by quality department: ptc number added.Strength added; action taken added; operator of device added; imdrf health impact code updated;dose frequency added in narrative text amended additional information was received on 30-jun-2023 from patient.Seriousness criteria for the events loss of consciousness, fall and patella fracture was updated.Clinical course was updated and text amended accordingly.Additional information was received on 07-jul-2023 from healthcare professional via ptc department.Investigation summary added.Text amended.
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Event Description
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Blackout [blackout] woke up after crashing into the pavement [fall] fracture the kneecap the second time [broken knee cap] case narrative: initial information received from france on 19-jun-2023 regarding an unsolicited valid serious case received from a consumer/non-hcp.This case is linked to case (b)(4) (multiple devices suspect for same patient) this case involves a 76 years old female patient who experienced blackout, woke up after crashing into the pavement and fracture the kneecap the second time with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one].The patient's past medical history, medical treatment(s), concomitant medication(s) and family history were not provided.On (b)(6) 2023, the patient started using hylan g-f 20, sodium hyaluronate injection in left knee of strength 48 mg/6 ml at a dose of 1 df 1x(once)(with unknown dose, route, batch number and expiry date, indication).Information on batch number was requested.On an unknown date in 2023 (latency: few days approximately), the patient stated product helps, but each time a few days after the injection, she says that she had a blackout (loss of consciousness), she woke up after crashing into the pavement (fall) and she had a fracture of kneecap (patella fracture) and she did rehabilitation.Action taken: not applicable corrective treatment: not reported for all the events outcome: unknown for all the events seriousness criteria: medically significant for loss of consciousness a product technical complaint (ptc) was initiated on 19-jun-2023 for "synvisc-one".Batch number: unknown global ptc number: 100336864.The sample of the ptc was not available and ptc was set in process additional information was received on 19-jun-2023 by quality department: ptc number added.Strength added; action taken added; operator of device added; imdrf health impact code updated;dose frequency added in narrative text amended.
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Event Description
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Blackout [blackout] fracture the kneecap the second time [broken knee cap] woke up after crashing into the pavement/fall [fall] case narrative: initial information received from france on 19-jun-2023 regarding an unsolicited valid serious case received from a patient.This case is linked to case (b)(4) (multiple devices suspect for same patient) this case involves a 76 years old female patient who experienced blackout, woke up after crashing into the pavement/fall and fracture the kneecap the second time with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one].The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.It was unknown if the patient had any concomitant disease or risk factor.On (b)(6) 2021 the patient received synvisc one first time.On (b)(6) 2023, the patient started using hylan g-f 20, sodium hyaluronate injection in left knee of strength 48 mg/6 ml at a dose of 1 df 1x (once) (with unknown route, batch number and expiry date, indication).Information on batch number was requested.On an unknown date in apr-2023 (latency: 5 to 7 days approximately), the patient stated product helped, but each time she suffered a very serious side effects- a black out (loss of consciousness) followed by a fall as she woke up after crashing into the pavement (fall) after the injection and had a fracture of kneecap (patella fracture).It was reported that both times she was in hospital and then in the rehabilitation for about 6 weeks.It was unknown if the patient experienced any additional symptoms/events.It was unknown if there were lab data/results available.Action taken: not applicable for all the events corrective treatment: not reported for all the events outcome: unknown for all the events seriousness criteria: medically significant and hospitalization for loss of consciousness and hospitalization for patella fracture and fall a product technical complaint (ptc) was initiated on 19-jun-2023 for "synvisc-one".Batch number: unknown global ptc number: 100336864.The sample of the ptc was not available and ptc was set in process additional information was received on 19-jun-2023 by quality department: ptc number added.Strength added; action taken added; operator of device added; imdrf health impact code updated;dose frequency added in narrative text amended additional information was received on 30-jun-2023 from patient.Seriousness criteria for the events loss of consciousness, fall and patella fracture was updated.Clinical course was updated and text amended accordingly.
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Event Description
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Blackout [blackout]; drop attack [drop attacks]; fracture the kneecap the second time/ broken right patella [fracture of patella]; woke up after crashing into the pavement/fall [fall]; since the problems passed on the right side (also the hip prosthesis), i had a lot of pain on the right side [unilateral leg pain]; walking very badly, had no right support on the right leg for a month/quite a few problems with walking [difficulty in walking]; quite a few problems with fatigue [fatigue].Case narrative: initial information received from france on 19-jun-2023 regarding an unsolicited valid serious case received from a patient.This case is linked to case (b)(4) (multiple device suspect used for the same patient; synvisc-one left knee on (b)(6) 2021).This case involves 76 years old female patient who had a blackout, fracture the kneecap the second time/ broken right patella, woke up after crashing into the pavement/fall, drop attack, since the problems passed on the right side (also the hip prosthesis), she had a lot of pain on the right side, walking very badly, had no right support on the right leg for a month/quite a few problems with walking and fatigue after being treated with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one].The patient's vaccination(s) and family history were not provided.Medical history included: sleep apnea syndrome well-controlled; hypothyroidism and essential hypertension.Surgical history included: lumbar surgery, herniated disc (1983), surgery right foot, hallus valgus in (b)(6) 2018; hip prosthesis, right in 2020.Before the synvisc one infiltrations, on (b)(6) 2021 she had an infiltration of betamethasone (dipropionate) 5 mg/ml + betametasone (disodium phosphate) 2 mg/ml suspension for injection diprostene.This product made the knee worse.Concomitant medications included candesartan cilexetil; omeprazole; levothyroxine sodium; colecalciferol; paracetamol; and betamethasone.On (b)(6) 2021 the patient received synvisc one first time and had adverse event following it.On (b)(6) 2023, the patient started using hylan g-f 20, sodium hyaluronate injection (liquid solution) in left knee of strength 48 mg/6 ml at a dose of 1 df 1x (once) (with an unknown batch number, expiry date, route, indication).Information on batch number was requested.On (b)(6) 2023 (latency: 5 days), the patient stated product helped, but each time she suffered a very serious side effects- a black out (loss of consciousness) followed by a fall/ drop attack (drop attacks) as she woke up after crashing into the pavement /sidewalk (fall) after the injection.She was brought to the emergency room with a broken right patella; had a fracture of kneecap (patella fracture; onset: (b)(6) 2023, latency: 5 days).In the hospital reflecting on these 2 falls she realized that each dose of synvisc was followed by a "blackout." these are the only 2 times in her life she had a fall like that, and the only times ever been injected with synvisc one.She insisted that the doctors run some tests to try and find out why she had fallen.They had the following tests done, with no result in relation to the falls.So she thought that the falls were side effects of the synvisc one.Since the problems passed on the right side (also the hip prosthesis), she had a lot of pain on the right side and the left leg/knee (pain in extremity) (onset: 2023; latency: unknown) had to compensate.Both times (after both injections), she had no right support on the right leg for a month.A few weeks after her fall when she was still in the hospital contacted her attending physician.She stayed in hospital until (b)(6) 2023 and then in the rehabilitation for about 6 weeks.Since leaving the hospital, the patient had quite a few problems with fatigue and walking (gait disturbance) (onset: 2023; latency: few weeks).She saw her attending physician after leaving hospital.Besides suffering for 4-5 months each time, she decided to see one of the best surgeons in the region.Following his advice, she saw doctor who just gave her a prp (platelet-rich plasma) treatment.If the prp helped her she would have a second to try to improve the tendon of the broken patella and if the prp didn't work may have other treatments.The patient was not yet healed from her fall and might have to do another prp (platelet-enriched plasma) in the tendon of right leg.It depends on whether the left knee improved with the prp which was already performed.Relevant laboratory test results included: blood pressure measurement - in 2023: negative; echocardiogram - in 2023: [normal]; electrocardiogram ambulatory - in 2023: [no abnormalities]; scan brain - in 2023: [no specific lesion].Action taken: not applicable for all events.Corrective treatment: prp (platelet-rich plasma) treatment for fall, gait disturbance, pain in extremity, patella fracture and drop attacks; not reported for rest of the events.Outcome: unknown for loss of consciousness, fatigue and not recovered for rest of the events.Seriousness criteria: medically significant and hospitalization for loss of consciousness, drop attacks and hospitalization for patella fracture, fall, pain in extremity and gait disturbance.A product technical complaint (ptc) was initiated on 19-jun-2023 for "synvisc-one".Batch number: unknown global ptc number: (b)(4).The sample of the ptc (product technical complaint) was not available.Ptc stated: based on the complaint from intake team, there was no quality related defect that would attribute to a malfunction, death, or serious injury.Sanofi global pharmacovigilance and epidemiology continuously monitored adverse event reports with or without lot numbers, and assessed possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals.The defect class has been updated to ii.Investigation: the product lot number was not provided.A batch record review was not possible.Based on the lack of information, no assessment was possible.It was the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result was identified and mitigated through the nonconforming material or product process.Sanofi would continue to monitor adverse events and perform trend analysis on a periodic basis to determine if a capa (corrective and preventive action) was required.The final investigation was completed on 05-jul-2023 and the summarized conclusion was "no assessment possible." additional information was received on 19-jun-2023 by quality department: ptc number added.Strength added; action taken added; operator of device added; imdrf health impact code updated;dose frequency added in narrative text amended additional information was received on 30-jun-2023 from patient.Seriousness criteria for the events loss of consciousness, fall and patella fracture was updated.Clinical course was updated and text amended accordingly.Additional information was received on 05-jul-2023 from healthcare professional via ptc department.Investigation summary added.Text amended.Additional information was received on 06-aug-2023 from patient.The events of fatigue, pain in extremity, gait disturbance and drop attacks were added.Medical history, concomitant medications and lab data were added.Text amended accordingly.Additional information was received on 22-aug-2023 from patient.The outcome and corrective treatment of fall, gait disturbance, pain in extremity, patella fracture and drop attacks were updated.Clinical course was updated.Text amended accordingly.
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Event Description
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Hold do rw 3/17 blackout [blackout].Drop attack [drop attacks].Fracture the kneecap the second time broken right patella [fracture of patella].Woke up after crashing into the pavementfall [fall].Since the problems passed on the right side (also the hip prosthesis), i had a lot of pain on the right side [unilateral leg pain].Walking very badly, had no right support on the right leg for a month/quite a few problems with walking [difficulty in walking].Quite a few problems with fatigue [fatigue].Case narrative: initial information received from france on 19-jun-2023 regarding an unsolicited valid serious case received from a patient.This case is linked to case (b)(4) (multiple device suspect used for the same patient; synvisc-one left knee on (b)(6) 2021) this case involves 76 years old female patient who had a blackout, fracture the kneecap the second time broken right patella, woke up after crashing into the pavement/fall, drop attack, since the problems passed on the right side (also the hip prosthesis), she had a lot of pain on the right side, walking very badly, had no right support on the right leg for a month/quite a few problems with walking and fatigue after being treated with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one].The patient's vaccination(s) and family history were not provided.Medical history included: sleep apnea syndrome well-controlled; hypothyroidism and essential hypertension.Surgical history included: lumbar surgery, herniated disc (1983), surgery right foot, hallus valgus in december 2018; hip prosthesis, right in 2020.Before the synvisc one infiltrations, on (b)(6) 2021 she had an infiltration of betamethasone (dipropionate) 5 mg/ml + betametasone (disodium phosphate) 2 mg/ml suspension for injection diprostene.This product made the knee worse.Concomitant medications included candesartan cilexetil; omeprazole; levothyroxine sodium; colecalciferol; paracetamol; and betamethasone.On (b)(6) 2021 the patient received synvisc one first time and had adverse event following it.On (b)(6) 2023, the patient started using hylan g-f 20, sodium hyaluronate injection (liquid solution) in left knee of strength 48 mg/6 ml at a dose of 1 df 1x (once) (with an unknown batch number, expiry date, route, indication).Information on batch number was requested.On (b)(6) 2023 (latency: 5 days), the patient stated product helped, but each time she suffered a very serious side effects- a black out (loss of consciousness) followed by a fall, drop attack (drop attacks) as she woke up after crashing into the pavement /sidewalk (fall) after the injection.She was brought to the emergency room with a broken right patella; had a fracture of kneecap (patella fracture; onset: (b)(6) 2023, latency: 5 days).In the hospital reflecting on these 2 falls she realized that each dose of synvisc was followed by a "blackout." these are the only 2 times in her life she had a fall like that, and the only times ever been injected with synvisc one.She insisted that the doctors run some tests to try and find out why she had fallen.They had the following tests done, with no result in relation to the falls.So she thought that the falls were side effects of the synvisc one.Since the problems passed on the right side (also the hip prosthesis), she had a lot of pain on the right side and the left leg/knee (pain in extremity) (onset: 2023; latency: unknown) had to compensate.Both times (after both injections), she had no right support on the right leg for a month.A few weeks after her fall when she was still in the hospital contacted her attending physician.She stayed in hospital until (b)(6) 2023 and then in the rehabilitation for about 6 weeks.Since leaving the hospital, the patient had quite a few problems with fatigue and walking (gait disturbance) (onset: 2023; latency: few weeks).She saw her attending physician after leaving hospital.Besides suffering for 4-5 months each time, she decided to see one of the best surgeons in the region.Following his advice, she saw doctor who just gave her a prp (platelet ich plasma) treatment.If the prp helped her she would have a second to try to improve the tendon of the broken patella and if the prp didn't work may have other treatments.Relevant laboratory test results included: blood pressure measurement : in 2023: negative.Echocardiogram: in 2023: [normal].Electrocardiogram ambulatory: in 2023: [no abnormalities].Scan brain : in 2023: [no specific lesion].Action taken: not applicable for all events.Corrective treatment: prp (platelet-rich plasma) treatment for patella fracture; not reported for rest of the events.Outcome: unknown for all events.Seriousness criteria: medically significant and hospitalization for loss of consciousness, drop attacks and hospitalization for patella fracture, fall, pain in extremity and gait disturbance.A product technical complaint (ptc) was initiated on 19-jun-2023 for "synvisc-one".Batch number: unknown global ptc number: 100336864.The sample of the ptc (product technical complaint) was not available.Ptc stated: based on the complaint from intake team, there was no quality related defect that would attribute to a malfunction, death, or serious injury.Sanofi global pharmacovigilance and epidemiology continuously monitored adverse event reports with or without lot numbers, and assessed possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals.The defect class has been updated to ii.Investigation: the product lot number was not provided.A batch record review was not possible.Based on the lack of information, no assessment was possible.It was the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result was identified and mitigated through the nonconforming material or product process.Sanofi would continue to monitor adverse events and perform trend analysis on a periodic basis to determine if a capa (corrective and preventive action) was required.The final investigation was completed on 05-jul-2023 and the summarized conclusion was "no assessment possible." additional information was received on 19-jun-2023 by quality department: ptc number added.Strength added; action taken added; operator of device added; imdrf health impact code updated;dose frequency added in narrative text amended additional information was received on 30-jun-2023 from patient.Seriousness criteria for the events loss of consciousness, fall and patella fracture was updated.Clinical course was updated and text amended accordingly.Additional information was received on 05-jul-2023 from healthcare professional via ptc department.Investigation summary added.Text amended.Additional information was received on 06-aug-2023 from patient.The events of fatigue, pain in extremity, gait disturbance and drop attacks were added.Medical history, concomitant medications and lab data were added.Text amended accordingly.
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Event Description
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Blackout [blackout].Drop attack [drop attacks].Fracture the kneecap the second time/ broken right patella [fracture of patella].Woke up after crashing into the pavement/fall [fall].Since the problems passed on the right side (also the hip prosthesis), i had a lot of pain on the right side [unilateral leg pain].Walking very badly, had no right support on the right leg for a month/quite a few problems with walking [difficulty in walking] ([condition aggravated]).Quite a few problems with fatigue [fatigue].Case narrative: initial information received from france on 19-jun-2023 regarding an unsolicited valid serious case received from a patient.This case is linked to case (b)(4).(multiple device suspect used for the same patient; synvisc-one left knee on (b)(6) 2021).This case involves 76 years old female patient who had a blackout, fracture the kneecap the second time/ broken right patella, woke up after crashing into the pavement/fall, drop attack, since the problems passed on the right side (also the hip prosthesis), she had a lot of pain on the right side, walking very badly, had no right support on the right leg for a month/quite a few problems with walking, and fatigue after being treated with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one].The patient's vaccination(s) and family history were not provided.Medical history included: sleep apnea syndrome well-controlled; hypothyroidism and essential hypertension.Surgical history included: lumbar surgery, herniated disc (1983), surgery right foot, hallus valgus in (b)(6) 2018; hip prosthesis, right in 2020.Before the synvisc one infiltrations, on (b)(6) 2021 she had an infiltration of betamethasone (dipropionate) 5 mg/ml + betametasone (disodium phosphate) 2 mg/ml suspension for injection diprostene.This product made the knee worse.Concomitant medications included candesartan cilexetil; omeprazole; levothyroxine sodium; colecalciferol; paracetamol; and betamethasone.On (b)(6) 2021 the patient received synvisc one first time and had adverse event following it.On (b)(6) 2023, the patient started using hylan g-f 20, sodium hyaluronate injection (liquid solution) in left knee of strength 48 mg/6 ml at a dose of 1 df 1x (once) (with an unknown batch number, expiry date, route, indication).Information on batch number was requested.On (b)(6) 2023 (latency: 5 days), the patient stated product helped, but each time she suffered a very serious side effects- a black out (loss of consciousness) followed by a fall/ drop attack (drop attacks) as she woke up after crashing into the pavement /sidewalk (fall) after the injection.She was brought to the emergency room with a broken right patella; had a fracture of kneecap (patella fracture; onset: (b)(6) 2023, latency: 5 days).In the hospital reflecting on these 2 falls she realized that each dose of synvisc was followed by a "blackout." these are the only 2 times in her life she had a fall like that, and the only times ever been injected with synvisc one.She insisted that the doctors run some tests to try and find out why she had fallen.They had the following tests done, with no result in relation to the falls.So she thought that the falls were side effects of the synvisc one.Since the problems passed on the right side (also the hip prosthesis), she had a lot of pain on the right side and the left leg/knee (pain in extremity) (onset: 2023; latency: few weeks) had to compensate.Both times (after both injections), she had no right support on the right leg for a month.A few weeks after her fall when she was still in the hospital contacted her attending physician.She stayed in hospital until (b)(6) 2023 and then in the rehabilitation for about 6 weeks.Since leaving the hospital, the patient had quite a few problems with fatigue and walking (gait disturbance) (onset: 2023; latency: few weeks).She saw her attending physician after leaving hospital.Besides suffering for 4-5 months each time, she decided to see one of the best surgeons in the region.Following his advice, she saw doctor who just gave her a prp (platelet-rich plasma) treatment.If the prp helped her she would have a second to try to improve the tendon of the broken patella and if the prp didn't work may have other treatments.The patient was not yet healed from her fall and might have to do another prp (platelet-enriched plasma) in the tendon of right leg.It depends on whether the left knee improved with the prp which was already performed.Since an unknown date in 2023, patient reported that her situation was getting worse (condition aggravated; latency: unknown); it seemed that she would soon have to undergo an operation to put a prosthesis in both knees (the right and the left.) relevant laboratory test results included: orthostatic hypotension test- in 2023: negative.Echo-doppler of tsao (abbreviation not available) (echocardiogram)- in 2023: [normal].Holter ecg (electrocardiogram ambulatory) - in 2023: [no abnormalities].Scan brain - in 2023: [no specific lesion].Action taken: not applicable for all events.Corrective treatment: prp (platelet-rich plasma) treatment for fall, gait disturbance, pain in extremity, patella fracture and drop attacks; not reported for rest of the events.Outcome: unknown for loss of consciousness, fatigue and not recovered for rest of the events.Seriousness criteria: medically significant and hospitalization for loss of consciousness, drop attacks and hospitalization for patella fracture, fall, pain in extremity and gait disturbance.A product technical complaint (ptc) was initiated on (b)(6) 2023 for "synvisc-one".Batch number: unknown global ptc number: (b)(4).The sample of the ptc (product technical complaint) was not available.Ptc stated: based on the complaint from intake team, there was no quality related defect that would attribute to a malfunction, death, or serious injury.Sanofi global pharmacovigilance and epidemiology continuously monitored adverse event reports with or without lot numbers, and assessed possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals.The defect class has been updated to ii.Investigation: the product lot number was not provided.A batch record review was not possible.Based on the lack of information, no assessment was possible.It was the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result was identified and mitigated through the nonconforming material or product process.Sanofi would continue to monitor adverse events and perform trend analysis on a periodic basis to determine if a capa (corrective and preventive action) was required.The final investigation was completed on 05-jul-2023 and the summarized conclusion was "no assessment possible." the complaint (b)(4) has been reopened for the following reason: wrong complaint information.Additional information was received on 19-jun-2023 by quality department: ptc number added.Strength added; action taken added; operator of device added; imdrf health impact code updated;dose frequency added in narrative text amended.Additional information was received on 30-jun-2023 from patient.Seriousness criteria for the events loss of consciousness, fall and patella fracture was updated.Clinical course was updated and text amended accordingly.Additional information was received on 05-jul-2023 from healthcare professional via ptc department.Investigation summary added.Text amended.Additional information was received on 06-aug-2023 from patient.The events of fatigue, pain in extremity, gait disturbance and drop attacks were added.Medical history, concomitant medications and lab data were added.Text amended accordingly.Additional information was received on 22-aug-2023 from patient.The outcome and corrective treatment of fall, gait disturbance, pain in extremity, patella fracture and drop attacks were updated.Clinical course was updated.Text amended accordingly.Follow up information was received on 02-sep-2023 from quality department: reopening of ptc details added.Text amended additional information was received on 06-oct-2023 from patient.New event of situation is getting worse added as symptom of gait disturbance along with details.Clinical course was updated and text amended accordingly.
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Search Alerts/Recalls
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