| Lot Number BRSL023 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Fall (1848); Bone Fracture(s) (1870); Loss of consciousness (2418); Ambulation Difficulties (2544); Limb Fracture (4518)
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| Event Date 12/23/2021 |
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Event Type
Injury
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Manufacturer Narrative
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Sanofi company comment dated (b)(6) 2023: this case involves a 76 years old female patient who had blackout, crashing into the pavement and she had a fracture in the pelvis the first time while being treated with hylan g-f 20, sodium hyaluronate injection [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] : she had a fracture in the pelvis the first time [fracture of pelvis] crashing into the pavement [fall] case narrative: initial information received from france on (b)(6) 2023 regarding an unsolicited valid serious case received from a consumer/non-hcp.This case is linked to case 2023sa189604 (multiple devices suspect for same patient).This case involves a 76 years old female patient who had blackout, crashing into the pavement and she had a fracture in the pelvis the first time while being treated with hylan g-f 20, sodium hyaluronate injection [synvisc one].The patient's past medical history, medical treatment(s), concomitant medication(s) and family history were not provided.On (b)(6) 2021, the patient started using hylan g-f 20, sodium hyaluronate injection in left knee (with unknown strength, dose, frequency, route, indication, batch number and expiry date) for product used for unknown indication.Information on batch number was requested.On an unknown date in 2021 (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 in the pelvis the first time (pelvic fracture) and she did rehabilitation.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 for loss of consciousness and pelvic fracture 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] she had a fracture in the pelvis the first time [fracture of pelvis] crashing into the pavement [fall].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 2023sa189604 (multiple devices suspect for same patient).This case involves a 76 years old female patient who had blackout, crashing into the pavement and she had a fracture in the pelvis the first time while being treated with hylan g-f 20, sodium hyaluronate injection [synvisc one].The patient's past medical history, medical treatment(s), concomitant medication(s) and family history were not provided.On (b)(6) 2021, the patient started using hylan g-f 20, sodium hyaluronate injection of strength 48 mg/6 ml in left knee at a dose of 1df 1x (once) (with unknown dose, route, indication, batch number and expiry date) for product used for unknown indication.Information on batch number was requested.On an unknown date in 2021 (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 in the pelvis the first time (pelvic fracture) and she did rehabilitation.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 for loss of consciousness and pelvic fracture.A product technical complaint (ptc) was initiated on 19-jun-2023 for synvisc one (lot/batch number: unknown) with global ptc number: (b)(4) the sample status 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 was added, text amended.
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Event Description
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Blackout [blackout] she had a fracture in the pelvis the first time [fracture of pelvis] crashing into the pavement [fall] 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 of same patient).This case involves a 76-year-old female patient who had blackout, crashing into the pavement and she had a fracture in the pelvis the first time while being treated with hylan g-f 20, sodium hyaluronate injection [synvisc one].The patient's past medical history, medical treatment(s), concomitant medication(s) and family history were not provided.On 15-dec-2021, the patient started using hylan g-f 20, sodium hyaluronate injection of strength 48 mg/6 ml in left knee at a dose of 1df 1x (once) (with unknown dose, route, batch number and expiry date) for product used for unknown indication.Information on batch number was requested.On an unknown date in dec-2021 (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 in the pelvis the first time (pelvic fracture) and she did rehabilitation.Upon, follow up, patient reported he bought synvisc one twice, the 1st time in november 2021 and then on (b)(6) 2023( no longer have the date of the first purchase, and it was no longer available from the bank.) both times she though she suffered a very serious side effect: a "black-out" followed by a fall 5 to 7 days after the infiltration.The 1st time she fractured her pelvis and the 2nd time she broke her kneecap.Both times she was in hospital, and then in the ssr(unspecified term) for about 6 weeks 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 for loss of consciousness and pelvic fracture; hospitalization for all events a product technical complaint (ptc) was initiated on 19-jun-2023 for "synvisc-one".Batch number; unknown global ptc number: 100338866.Sample status of ptc was not available, and 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 monitors adverse event reports with or without lot numbers, and assesses 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.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.Sanofi will continue to monitor adverse events and perform trend analysis on a periodic basis to determine if a capa(corrective and preventive actions) was required.The final investigation was completed on 03-jul-2023 with summarized conclusion as no assessment possible additional information was received on 19-jun-2023 by quality department: ptc number added.Strength was added, text amended additional information was received on 30-jun-2023 from patient and on 03-jul-2023 by quality department (both processed as significant with csd of (b)(6) 2023): ptc complete details added.Additional seriousness criteria of hospitalization was added for events of fall, pelvic fracture, and loss of consciousness.Event onset date was updated for all the events.Text amended accordingly.
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Event Description
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Blackout [blackout] she had a fracture in the pelvis the first time/cracked/broken pelvis on the right side [fracture of pelvis] drop attack [drop attacks] crashing into the pavement/fall [fall] 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 devices suspect of same patient).This case involves a 76-year-old female patient who had blackout, had a fracture in the pelvis the first time/cracked/broken pelvis on the right side, drop attack, crashing into the pavement/fall, had no right support on the right leg for a month/quite a few problems with walking and quite a few problems with fatigue after being treated with hylan g-f 20, sodium hyaluronate injection [synvisc one].The patient's past medical history 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.The patient's family history were not provided.Concomitant medications included candesartan cilexetil; omeprazole; levothyroxine sodium; colecalciferol; paracetamol; and betamethasone.On (b)(6) 2021, the patient started using hylan g-f 20, sodium hyaluronate injection of strength 48 mg/6 ml in left knee at a dose of 1df (dosage form) 1x (once) (batch number: brsl023 and expiry date: 31-jul-2024, with unknown route, indication).Information on batch number was requested.The patient stated product helps, but each time a few days after the injection, she suffered a very serious side effect a "black-out" (loss of consciousness) followed by a fall or drop attack (drop attacks) as she woke up after crashing into the pavement after the injection.She was brought to the emergency room with a cracked/broken pelvis on the right side/ fracture in the pelvis the first time (pelvic fracture) (onset: 23-dec-2021, latency: 10 days) and stayed in the hospital until (b)(6) 2022.She did rehabilitation for it.She had to do a few months of physiotherapy afterwards to be able to walk well.After the injection, she had no right support on the right leg for a month.Since leaving the hospital, the patient had quite a few problems with walking (gait disturbance) (onset: dec-2021; latency: unknown) and fatigue (onset; latency: unknown).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.Action taken: not applicable for all events corrective treatment: prp (platelet-rich plasma) treatment for pelvic fracture; physiotherapy for gait disturbance and not reported for rest of the events.Outcome: unknown for all the events seriousness criteria: medically significant and hospitalization for loss of consciousness, drop attacks and hospitalization for pelvic fracture, fall, 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).Sample status of ptc was not available, and 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 monitors adverse event reports with or without lot numbers, and assesses 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.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.Sanofi will continue to monitor adverse events and perform trend analysis on a periodic basis to determine if a capa(corrective and preventive actions) was required.The final investigation was completed on 03-jul-2023 with summarized conclusion as no assessment possible additional information was received on 19-jun-2023 by quality department: ptc number added.Strength was added, text amended.Additional information was received on 30-jun-2023 from patient and on 03-jul-2023 by quality department (both processed as significant with csd of 30-jun-2023): ptc complete details added.Additional seriousness criteria of hospitalization was added for events of fall, pelvic fracture, and loss of consciousness.Event onset date was updated for all the events.Text amended accordingly.Additional information was received on 06-aug-2023 from patient.The events of fatigue, gait disturbance and drop attacks were added.Medical history, concomitant medications were added.Text amended accordingly.
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Event Description
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Blackout [blackout]; she had a fracture in the pelvis the first time/cracked/broken pelvis on the right side [fracture of pelvis]; drop attack [drop attacks]; crashing into the pavement/fall [fall]; 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 devices suspect of same patient).This case involves a 76-year-old female patient who had blackout, had a fracture in the pelvis the first time/cracked/broken pelvis on the right side, drop attack, crashing into the pavement/fall, had no right support on the right leg for a month/quite a few problems with walking and quite a few problems with fatigue after being treated with hylan g-f 20, sodium hyaluronate injection [synvisc one].The patient's past medical history 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.The patient's family history were not provided.Concomitant medications included candesartan cilexetil; omeprazole; levothyroxine sodium; colecalciferol; paracetamol; and betamethasone.On (b)(6) 2021, the patient started using hylan g-f 20, sodium hyaluronate injection of strength 48 mg/6 ml in left knee at a dose of 1df (dosage form) 1x (once) (batch number: brsl023 and expiry date: 31-jul-2024, with unknown route, indication).The patient stated product helps, but each time a few days after the injection, she suffered a very serious side effect a "black-out" (loss of consciousness) followed by a fall or drop attack (drop attacks) as she woke up after crashing into the pavement after the injection.She was brought to the emergency room with a cracked/broken pelvis on the right side/ fracture in the pelvis the first time (pelvic fracture) (onset: (b)(6) 2021, latency: 10 days) and stayed in the hospital until (b)(6) 2022.She did rehabilitation for it.She had to do a few months of physiotherapy afterwards to be able to walk well.After the injection, she had no right support on the right leg for a month.Since leaving the hospital, the patient had quite a few problems with walking (gait disturbance) (onset: (b)(6) 2021; latency: unknown) and fatigue (onset; latency: unknown).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.Upon follow on (b)(6) 2023, patient stated she might had to do another prp (platelet-enriched plasma) in the tendon of her right leg.It depends on whether the left knee improved with the prp already done.Action taken: not applicable for all events.Corrective treatment: prp (platelet-rich plasma) treatment for pelvic fracture; physiotherapy for gait disturbance; and not reported for rest of the events.Outcome: unknown for all the events.Seriousness criteria: medically significant and hospitalization for loss of consciousness, drop attacks and hospitalization for pelvic fracture, fall, and gait disturbance.A ptc was initiated on (b)(6) 2023 for synvisc one batch number; brsl023, expiry date: 31-jul-2024 global ptc number: (b)(4).Sample status of ptc was not available, and ptc stated complaint: complaint: adverse event: preliminary assessment ((b)(4) )based on the complaint from intake team, there is no quality related defect that would attribute to a malfunction, death, or serious injury.Sanofi global pharmacovigilance and epidemiology continuously monitors adverse event reports with or without lot numbers, and assesses 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.The production and quality control documentation for lot # brsl023 expiration date (2024-07) was manufactured on 25aug21 packaged (b)(4) singles was reviewed.The investigation showed that the product met specifications.No associated non-conformances were noted.Based on the lot # batch record review & lot # frequency analysis for lot # brsl023 no capa (corrective and preventive action) is required.As of 21aug2023 there are 4 complaints on file for lot# brsl023 and all related sublots.3 complaints are on file for lot# brsl023: (1) tip breakage, (1) adverse event report and (1) box damage (unsealed blister).1 complaint is on file for lot# brsl023a: (1) contamination foreign material.Sanofi will continue to monitor complaints and trending to determine if a capa is required.The final investigation was completed on 28-aug-2023 with summarized conclusion as no assessment possible additional information was received on 19-jun-2023 by quality department: ptc number added.Strength was added, text amended.Additional information was received on 30-jun-2023 from patient and on 03-jul-2023 by quality department (both processed as significant with csd of 30-jun-2023): ptc complete details added.Additional seriousness criteria of hospitalization was added for events of fall, pelvic fracture, and loss of consciousness.Event onset date was updated for all the events.Text amended accordingly.Additional information was received on 06-aug-2023 from patient.The events of fatigue, gait disturbance and drop attacks were added.Medical history, concomitant medications were added.Text amended accordingly.Follow up information was received on 22-aug-2023 from patient.No significant information was received.Clinical course was updated.Additional information was received on 28-aug-2023 by quality department from other health care professional: ptc complete details added, text amended accordingly.
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Event Description
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Blackout [blackout].She had a fracture in the pelvis the first time/cracked/broken pelvis on the right side [fracture of pelvis].Drop attack [drop attacks].Crashing into the pavement/fall [fall].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 devices suspect of same patient).This case involves a 76-year-old female patient who had blackout, had a fracture in the pelvis the first time/cracked/broken pelvis on the right side, drop attack, crashing into the pavement/fall, had no right support on the right leg for a month/quite a few problems with walking and quite a few problems with fatigue after being treated with hylan g-f 20, sodium hyaluronate injection [synvisc one].The patient's past medical history 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 19-sep-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.The patient's family history were not provided.Concomitant medications included candesartan cilexetil; omeprazole; levothyroxine sodium; colecalciferol; paracetamol; and betamethasone.On (b)(6) 2021, the patient started using hylan g-f 20, sodium hyaluronate injection of strength 48 mg/6 ml in left knee at a dose of 1df (dosage form) 1x (once) (batch number: brsl023 and expiry date: 31-jul-2024, with unknown route, indication).The patient stated product helps, but each time a few days after the injection, she suffered a very serious side effect a "black-out" (loss of consciousness) followed by a fall or drop attack (drop attacks) as she woke up after crashing into the pavement after the injection.She was brought to the emergency room with a cracked/broken pelvis on the right side/ fracture in the pelvis the first time (pelvic fracture) (onset: (b)(6) 2021, latency: 10 days) and stayed in the hospital until (b)(6) 2022.She did rehabilitation for it.She had to do a few months of physiotherapy afterwards to be able to walk well.After the injection, she had no right support on the right leg for a month.Since leaving the hospital, the patient had quite a few problems with walking (gait disturbance) (onset: (b)(6) 2021; latency: unknown) and fatigue (onset; latency: unknown).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.Upon follow on (b)(6) 2023, patient stated she might had to do another prp (platelet-enriched plasma) in the tendon of her right leg.It depends on whether the left knee improved with the prp already done.Since an unknown date, 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).Action taken: not applicable for all events.Corrective treatment: prp (platelet-rich plasma) treatment for pelvic fracture; physiotherapy for gait disturbance; and not reported for rest of the events.Outcome: unknown for all the events.Seriousness criteria: medically significant and hospitalization for loss of consciousness, drop attacks and hospitalization for pelvic fracture, fall, and gait disturbance.A ptc was initiated on 19-jun-2023 for synvisc one.Batch number; brsl023, expiry date: 31-jul-2024.Global ptc number: 100338866.Sample status of ptc was not available, and ptc stated complaint: complaint: adverse event: preliminary assessment (tj 28jun2023) based on the complaint from intake team, there is no quality related defect that would attribute to a malfunction, death, or serious injury.Sanofi global pharmacovigilance and epidemiology continuously monitors adverse event reports with or without lot numbers, and assesses 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.The production and quality control documentation for lot # brsl023 expiration date (2024-07) was manufactured on 25aug21 packaged 9000 singles was reviewed.The investigation showed that the product met specifications.No associated non-conformances were noted.Based on the lot # batch record review & lot # frequency analysis for lot # brsl023 no capa (corrective and preventive action) is required.As of 21aug2023 there are 4 complaints on file for lot# brsl023 and all related sublots.3 complaints are on file for lot# brsl023: (1) tip breakage, (1) adverse event report and (1) box damage (unsealed blister).1 complaint is on file for lot# brsl023a: (1) contamination foreign material.Sanofi will continue to monitor complaints and trending to determine if a capa is required.The final investigation was completed on 28-aug-2023 with summarized conclusion as no assessment possible.The complaint (b)(4) for france 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 was added, text amended.Additional information was received on 30-jun-2023 from patient and on 03-jul-2023 by quality department (both processed as significant with csd of 30-jun-2023): ptc complete details added.Additional seriousness criteria of hospitalization was added for events of fall, pelvic fracture, and loss of consciousness.Event onset date was updated for all the events.Text amended accordingly.Additional information was received on 06-aug-2023 from patient.The events of fatigue, gait disturbance and drop attacks were added.Medical history, concomitant medications were added.Text amended accordingly.Follow up information was received on 22-aug-2023 from patient.No significant information was received.Clinical course was updated.Additional information was received on 28-aug-2023 by quality department from other health care professional: ptc complete details added, text amended accordingly.Additional information was received on 04-sep-2023 by quality department from other health care professional: ptc reopened.Text amended accordingly.Additional information was received on 06-oct-2023 from patient.New event of situation is getting worse added.Clinical course was updated and text amended accordingly.
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Search Alerts/Recalls
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