Lot Number ARSL019B |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Arthralgia (2355)
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Event Date 01/01/2021 |
Event Type
Injury
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Event Description
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Joint was aspirated [joint aspiration].Feeling increasing pain [arthralgia aggravated].Case narrative: initial information received on (b)(6) 2021 regarding an unsolicited valid serious case received from a physician from (b)(6).This case is linked to case (b)(4) (same patient).This case involves male patient who was feeling increasing pain and joint was aspirated 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.On an unknown date, the patient received treatment with hylan g-f 20, sodium hyaluronate injection (frequency, dose, route and indication: unknown) (lot - arsl019b with unknown expiration date) in left knee.On an unknown date of (b)(6) 2021, after unknown latency patient was feeling increasing pain in knee (arthralgia).On an unknown date in 2021, after unknown latency the left knee joint was aspirated (aspiration joint).Analysis of left knee revealed no bacteria.Both the events were assessed as serious with seriousness criteria of intervention required.Action taken: not applicable for both events.Corrective treatment: not reported for both events.Outcome: unknown for both events.
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Event Description
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Joint was aspirated [joint aspiration].Feeling increasing pain [arthralgia aggravated].Case narrative: initial information received on 01-oct-2021 regarding an unsolicited valid serious case received from a physician from canada.This case is linked to case (b)(4) (same patient).This case involves male patient who was feeling increasing pain and joint was aspirated 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.On an unknown date, the patient received treatment with hylan g-f 20, sodium hyaluronate solution for injection (strength: 16 mg/ 2 ml) ( (frequency, dose, route and indication: unknown); (lot - arsl019b; expiry date: apr-2022) in left knee.On an unknown date of (b)(6) 2021, after unknown latency patient was feeling increasing pain in knee (arthralgia).On an unknown date in 2021, after unknown latency the left knee joint was aspirated (aspiration joint).Analysis of left knee revealed no bacteria.Both the events were assessed as serious with seriousness criteria of intervention required.Action taken: not applicable for both events.Corrective treatment: not reported for both events.Outcome: unknown for both events.A product technical complaint (ptc) was initiated for synvisc with global ptc number (b)(4) on (b)(6) 2021 for product.Batch number; unknown.Sample status: not available.The production and quality control documentation for lot number arsl019b; expiration date (2023-04) was reviewed.The investigation showed that the product met specifications.No associated non-conformances were noted.Based on the lot number batch record review & lot number frequency analysis for lot number arsl019b no capa was required.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.This review had not indicated any safety issue.As of 01-nov-2021 there were 7 complaints on file for lot number arsl019 and all related sublots.1 complaint was on file for lot number: arsl019c: (1) tips breakage.6 complaints were on file for lot number: arsl019b: (6) adverse event reports.Sanofi will continue to monitor adverse events to determine if a capa was required final investigation complete date: 01-nov-2021 with summary code as no assessment possible.Additional information was received on 01-nov-2021 from the quality department.Global ptc number and ptc results added.Formulation and strength added.Text amended accordingly.
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Search Alerts/Recalls
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