Lot Number 9RSL023Z |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 01/01/2021 |
Event Type
Injury
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Event Description
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Joint infection, swelling of l knee, aching (l) knee, unable to walk.Case narrative: initial information received on (b)(6) 2021 regarding a solicited valid serious case received from a consumer/non-hcp, in the scope of post-marketing sponsored study "spon i synvisc one".Patient id: unknown; country: (b)(6).Study title: patient support program involving synvisc one.This case involves a (b)(6) male patient who experienced infection and was unable to walk 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 (b)(6) 2021, the patient started using hylan g-f 20, sodium hyaluronate, injection at the dose of 6 ml for once only via unknown route (lot 9rsl023z) for osteoarthritis in the left knee and meniscus injury.On the unknown route of 2021, after the unknown latency of starting the treatment with hylan g-f 20, sodium hyaluronate, patient had a severe reaction to the injection.His knee became swollen (joint swelling), was unable to walk (gait inability) (intervention required), lots of pain (arthralgia) and possible infection (arthritis infective) (medically significant).Patient got surgery to clean out his knee.Action taken: not applicable for all the events.Corrective treatment: surgery for all the events.Outcome: recovered for all the events.Reporter causality: not reported for all the events.Company causality: reportable for all the events.
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Event Description
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Joint infection, swelling of l knee, aching (l) knee, unable to walk.Case narrative: initial information received on (b)(6) 2021 regarding a solicited valid serious case received from a consumer/non-hcp, in the scope of post-marketing sponsored study "spon i synvisc one".Patient id: unknown; country: (b)(6).Study title: patient support program involving synvisc one.This case involves a (b)(6) male patient who experienced infection and was unable to walk 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 (b)(6) 2021, the patient started using hylan g-f 20, sodium hyaluronate, injection at the dose of 6 ml for once only via unknown route (lot 9rsl023z) for osteoarthritis in the left knee and meniscus injury.On the unknown route of 2021, after the unknown latency of starting the treatment with hylan g-f 20, sodium hyaluronate, patient had a severe reaction to the injection.His knee became swollen (joint swelling), was unable to walk (gait inability) (intervention required), lots of pain (arthralgia) and possible infection (arthritis infective) (medically significant).Patient got surgery to clean out his knee.Action taken: not applicable for all the events.Corrective treatment: surgery for all the events.Outcome: recovered for all the events.Reporter causality: not reported for all the events.Company causality: reportable for all the events.
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Event Description
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Infection [joint infection] ([swelling of l knee], [aching (l) knee]).Unable to walk [unable to walk].Case narrative: initial information received on 15-nov-2021 regarding a solicited valid serious case received from a consumer/non-hcp, in the scope of post-marketing sponsored study "spon_i_synvisc one".Patient id: unknown; country: canada.Study title: patient support program involving synvisc one.This case involves a 66-year-old male patient who experienced infection and was unable to walk 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 (b)(6) 2021, the patient started using hylan g-f 20, sodium hyaluronate, injection, liquid solution (strength: 48 mg/6ml) at the dose of 6 ml for once only via unknown route (lot - 9rsl023z; expiration date: 31-may-2021) for osteoarthritis in the left knee and meniscus injury.On the unknown route of 2021, after the unknown latency of starting the treatment with hylan g-f 20, sodium hyaluronate, patient had a severe reaction to the injection.His knee became swollen (joint swelling), was unable to walk (gait inability) (intervention required), lots of pain (arthralgia) and possible infection (arthritis infective) (medically significant).Patient got surgery to clean out his knee.Action taken: not applicable for all the events.Corrective treatment: surgery for all the events.Outcome: recovered for all the events.A product technical complaint (ptc) was initiated on 16-nov-2021 for synvisc one (lot number 9rsl023z) with global ptc number: (b)(4).The production and quality control documentation for lot # 9rsl023z expiration date (2022-05) 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 # 9rsl023z no capa is required.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.This review has not indicated any safety issue.As of 30nov21 there is1 complaint on file for lot# 9rsl023z and all related sub-lots.1 complaint is on file for lot# 9rsl023z: (1) adverse event report.Sanofi will continue to monitor complaints to determine if a capa was required.The final investigation was completed on 30-nov-2021 with summarized conclusion as no assessment possible.Reporter causality: not reported for all the events.Company causality: reportable for all the events.Additional information was received on 30-nov-2021 from the quality department.Ptc results received and processed.
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Search Alerts/Recalls
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