Lot Number UNKNOWN |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Aspiration/Inhalation (1725); Hypersensitivity/Allergic reaction (1907); 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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Allergic reaction [allergic reaction to drug] ([injection site joint swelling], [aspiration joint], [injection site joint effusion]).Case narrative: initial information received from united states on 21-apr-2023 regarding an unsolicited valid serious case received from a physician assistant.This case involves an unknown age female patient who had allergic reaction while being treated with hylan g-f 20, sodium hyaluronate [synvisc one].The patient's past medical history, medical treatment(s), concomitant(s) and family history were not provided.She indicated that the patient is prone to allergies.On an unknown date, the patient started taking hylan g-f 20, sodium hyaluronate injection (with an unknown strength, batch number, expiry date, dose, frequency, route) for osteoarthritis.Information on the batch number was requested.She reported (unknown onset and latency) that she had a patient that had an allergic reaction with synvisc-one(drug hypersensitivity) when it was injected in both knees.The knees swelled up and needed to be aspirated a few times as a result of the swelling (injection site joint swelling) (aspiration joint) (injection site joint effusion) (unknown onset and latency).She indicated that the patient was prone to allergies.Action taken: was not applicable.It was not reported if the patient received a corrective treatment for the event.At time of reporting, the outcome was unknown for the event.Seriousness criteria: event assessed as medically significant.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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Allergic reaction [allergic reaction to drug] ([injection site joint swelling], [aspiration joint], [injection site joint effusion]).Case narrative: initial information received from united states on 21-apr-2023 regarding an unsolicited valid serious case received from a physician assistant.This case involves an unknown age female patient who had allergic reaction while being treated with hylan g-f 20, sodium hyaluronate [synvisc one].The patient's past medical history, medical treatment(s), concomitant(s) and family history were not provided.She indicated that the patient is prone to allergies on an unknown date, the patient started taking hylan g-f 20, sodium hyaluronate injection (strength: 48mg/6ml) (with an unknown batch number, expiry date, dose, frequency, route) for osteoarthritis.Information on the batch number was requested.She reported (unknown onset and latency) that she had a patient that had an allergic reaction with synvisc-one(drug hypersensitivity) when it was injected in both knees.The knees swelled up and needed to be aspirated a few times as a result of the swelling (injection site joint swelling) (aspiration joint) (injection site joint effusion) (unknown onset and latency).She indicated that the patient was prone to allergies.Action taken: was not applicable.It was not reported if the patient received a corrective treatment for the event at time of reporting, the outcome was unknown for the event.Seriousness criteria: event assessed as medically significant.A ptc (product technical complaint) was initiated on 21-apr-2023, for synvisc one (batch number and expiry date: unknown) with global ptc number (b)(4).The sample was not available.The ptc stated that it was in process.Additional information was received on 21-apr-2023 via quality department from other healthcare professional.Ptc details and strength added.Text amended.
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Event Description
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Allergic reaction with synvisc-one [allergic reaction] ([injection site joint swelling], [injection site joint effusion]) aspirated a few times as a result of the swelling [aspiration joint].Case narrative: initial information received from united states on 21-apr-2023 regarding an unsolicited valid serious case received from a physician assistant.This case is linked to case (b)(4) (multiple devices suspect for same patient) this case involves an unknown age female patient who had allergic reaction and aspirated a few times as a result of the swelling while being treated with hylan g-f 20, sodium hyaluronate [synvisc one].The patient's past medical history, medical treatment(s), concomitant(s) and family history were not provided.She indicated that the patient is prone to allergies.On an unknown date, the patient started taking hylan g-f 20, sodium hyaluronate injection (strength:48mg/6ml) (with an unknown batch number, expiry date, dose, frequency, route) for osteoarthritis.Information on the batch number was requested.She reported (unknown onset and latency) that she had a patient that had an allergic reaction with synvisc-one (hypersensitivity) when it was injected in both knees.The knees swelled up and needed to be aspirated a few times as a result of the swelling(injection site joint swelling) (aspiration joint) (injection site joint effusion) (unknown onset and latency).She indicated that the patient was prone to allergies.Action taken: was not applicable.It was not reported if the patient received a corrective treatment for the event.At time of reporting, the outcome was unknown for the event.Seriousness criteria: event assessed as medically significant.A product technical complaint (ptc) was initiated on 21-apr-2023 for synvisc one (lot/batch number: unknown) with global ptc number: (b)(4).The sample status of the ptc was not available and the ptc stated: based on the complaint from intake team, there was no quality related defect that would pose as a malfunction.This complaint does not have a quality defect that would attribute to a 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." 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 is the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result is identified and mitigated through the nonconforming material.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 16-may-2023 with summarized conclusion as no assessment possible.Additional information was received on 21-apr-2023 via quality department from other healthcare professional.Ptc details and strength added.Text amended.Additional information was received on 16-may-2023 via quality department from other healthcare professional.Ptc complete details added.Text amended.
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Manufacturer Narrative
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Sanofi company comment dated 16-may-2023 : follow-up information received does not change the prior assessment of this case.This case involves an unknown age female patient who had allergic reaction with synvisc-one (right knee) and needed to be aspirated a few times as a result of the swelling while being treated with hylan g-f 20, sodium hyaluronate [synvisc one].The causal role of suspect device cannot be excluded for the event.Also, underlying condition of osteoarthritis could be a confounding factor for same.Also, patient was prone to allergies which could also be considered as a factor for the occurrence of reported events.However, further information regarding event onset, concomitant medications, knee status at baseline, injection technique and post injection routine would aid in further assessment of the case.
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Event Description
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Allergic reaction with synvisc-one [allergic reaction] ([injection site joint swelling], [injection site joint effusion]) aspirated a few times as a result of the swelling [aspiration joint].Case narrative: initial information received from united states on 21-apr-2023 regarding an unsolicited valid serious case received from a physician assistant.This case is linked to case (b)(4) (multiple devices suspect for same patient) this case involves an unknown age female patient who had allergic reaction and aspirated a few times as a result of the swelling while being treated with hylan g-f 20, sodium hyaluronate [synvisc one].The patient's past medical history, medical treatment(s), concomitant(s) and family history were not provided.She indicated that the patient is prone to allergies.On an unknown date, the patient started taking hylan g-f 20, sodium hyaluronate injection (strength:48mg/6ml) (with an unknown batch number, expiry date, dose, frequency, route) for osteoarthritis.Information on the batch number was requested.She reported (unknown onset and latency) that she had a patient that had an allergic reaction with synvisc-one (hypersensitivity) when it was injected in both knees.The knees swelled up and needed to be aspirated a few times as a result of the swelling(injection site joint swelling) (aspiration joint) (injection site joint effusion) (unknown onset and latency).She indicated that the patient was prone to allergies.Action taken: was not applicable.It was not reported if the patient received a corrective treatment for the event.At time of reporting, the outcome was unknown for the event.Seriousness criteria: event assessed as medically significant.A product technical complaint (ptc) was initiated on 21-apr-2023 for synvisc one (lot/batch number: unknown) with global ptc number: (b)(4).The sample status of the ptc was not available and the ptc stated: based on the complaint from intake team, there was no quality related defect that would pose as a malfunction.This complaint does not have a quality defect that would attribute to a 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." 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 is the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result is identified and mitigated through the nonconforming material.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 16-may-2023 with summarized conclusion as no assessment possible.Additional information was received on 21-apr-2023 via quality department from other healthcare professional.Ptc details and strength added.Text amended.Additional information was received on 16-may-2023 via quality department from other healthcare professional.Ptc complete details added.Text amended.Based on the previously received information, annex e codes were added in mir form.
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Manufacturer Narrative
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Sanofi company comment dated 16-may-2023 : follow-up information received does not change the prior assessment of this case.This case involves an unknown age female patient who had allergic reaction with synvisc-one (right knee) and needed to be aspirated a few times as a result of the swelling while being treated with hylan g-f 20, sodium hyaluronate [synvisc one].The causal role of suspect device cannot be excluded for the event.Also, underlying condition of osteoarthritis could be a confounding factor for same.Also, patient was prone to allergies which could also be considered as a factor for the occurrence of reported events.However, further information regarding event onset, concomitant medications, knee status at baseline, injection technique and post injection routine would aid in further assessment of the case.
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Search Alerts/Recalls
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