This spontaneous case from united states was received on (b)(6) 2017 from the patient.This case concern patient (demographics: not provided) who initiated treatment with synvisc one and after an unknown latency had bad reaction and patient's knee swoll and bad reaction and patient's knee hurt really bad no medical history, previous medications, concomitant medications and concurrent conditions were reported.On an unknown date, patient received treatment with intra articular synvisc one injection once (dose and indication: not provided).On an unknown date, after an unknown latency, patient had a bad reaction and patient's knee swoll & hurt really bad.The patient finally went back to orthopedic who gave the patient a cortizone shot to counteract.Patient could have used help since patient was on a fixed income & so hoped that synvisc might have kept the patient from having knee surgery.Corrective treatment: hydrocortisone (cortizone) shot for both events.Outcome: unknown for all events.A pharmaceutical technical complaint (ptc) was initiated and the result of the same was pending.
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This spontaneous case from united states was received on (b)(6) 2017 from the patient.This case concern patient (demographics: not provided) who initiated treatment with synvisc one and after an unknown latency had bad reaction and patient's knee swoll and bad reaction and patient's knee hurt really bad no medical history, previous medications, concomitant medications and concurrent conditions were reported.On an unknown date, patient received treatment with intra articular synvisc one injection once (dose and indication: not provided).On an unknown date, after an unknown latency, patient had a bad reaction and patient's knee swoll & hurt really bad.The patient finally went back to orthpedic who gave the patient a cortizone shot to counteract.Patient could have used help since patient was on a fixed income & so hoped that synvisc might have kept the patient from having knee surgery.Corrective treatment: hydrocortisone (cortizone) shot for both events.Outcome: unknown for all events.A pharmaceutical technical complaint (ptc) was initiated with 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 was the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result was identified and mitigated through the ncr process.Sanofi global pharmacovigilance and epidemiology continuously monitored 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 would continue to monitor adverse events to determine if a capa was required.Seriousness criterion: required intervention additional information was received on 08-nov-2017.Global ptc number and ptc results were added.Text was amended accordingly.
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