Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Therapeutic or Diagnostic Output Failure (3023)
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Patient Problem
Ambulation Difficulties (2544)
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Event Type
Injury
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Event Description
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Couldnt walk [unable to walk] ([device ineffective]) case narrative: initial information received from (b)(6) on (b)(6) 2021 regarding an unsolicited valid non-serious case received from a patient via social media.This case involves an unknown age patient who could not walk, while he/she was treated with hylan g-f 20, sodium hyaluronate [synvisc].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 (formulation, dose, route, frequency and batch number unknown) unknown indication.On an unknown date, after unknown latency, patient could not walk for a week (gait inability) and it did not help patient (device ineffective).It was reported that patient was on crutches for a week after using hylan g-f 20, sodium hyaluronate.This event was leading to disability.Action taken: unknown corrective treatment: crutches the patient outcome is reported as unknown.
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Event Description
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Couldnt walk [unable to walk] ([device ineffective]).Case narrative: initial information received from canada on 12-feb-2021 regarding an unsolicited valid non-serious case received from a patient via social media.This case involves an unknown age patient who could not walk, while he/she was treated with hylan g-f 20, sodium hyaluronate (synvisc).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 (formulation, dose, route, frequency and batch number unknown) unknown indication.On an unknown date, after unknown latency, patient could not walk for a week (gait inability) and it did not help patient (device ineffective).It was reported that patient was on crutches for a week after using hylan g-f 20, sodium hyaluronate.This event was leading to disability.Action taken: unknown.Corrective treatment: crutches.The patient outcome is reported as unknown.A product technical complaint (ptc) was initiated on 12-feb-2021 for synvisc for unknown batch number and global ptc number: (b)(4).The product lot number was not provided; therefore, a batch record review was not possible.Based on the lack of information provided, no capa was required.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 ncr process.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 had not indicated any safety issue.Sanofi will continue to monitor complaints to determine if a capa was required.Final investigation was completed on 25-feb-2021.Follow up received on 12-feb-2021 from healthcare professional.Global ptc number was added.Text amended accordingly.Additional information was received on 25-feb-2021 from other healthcare professional.Ptc results received and processed.Text amended accordingly.
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Search Alerts/Recalls
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