Lot Number 5RSA021Z |
Device Problem
Aborted Charge (2288)
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Patient Problem
Joint Disorder (2373)
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Event Date 01/01/2016 |
Event Type
Injury
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Event Description
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This unsolicited device case from united states was received on (b)(6) 2016 from a nurse.This case concerns a (b)(6) female patient who initiated treatment with synvisc on (b)(6) 2016 and later experienced recurrent left knee effusion/ severe effusion/ 3plus effusion in patient's left knee and was non weight bearing on crutches.No medical history, concomitant medications and concurrent conditions were reported.The patient had no known allergies.Past drug included four sets of sodium hyaluronate (supartz) injections given at six to nine month intervals.On (b)(6) 2016, the patient initiated treatment with intra-articular synvisc injection twice (dose: not provided) (batch/lot number: (b)(4) and expiration date: 31-aug-2018) in her left knee for osteoarthritis.On an unknown date in (b)(6) 2016, for a couple of days, the patient experienced left knee effusion.On (b)(6) 2016, the patient saw her doctor and it was decided to hold synvisc.The left knee effusion resolved and on (b)(6) 2016, the patient received the second injection of synvisc.The same day, in the evening, patent had reaction with the second series injection of synvisc and experienced a severe effusion of her left knee.On (b)(6) 2016, the doctor diagnosed a "3plus" effusion in the patient's left knee which he drained and then injected dexamethasone.On an unknown date in 2016, the patient was non-weight bearing on crutches.Five days later, the patient's left knee was back to normal with no other adverse effects.Action taken: stopped temporarily corrective treatment: dexamethasone and drained for recurrent left knee effusion/ severe effusion/ 3plus effusion in patient's left knee; not reported for patient was non weight bearing on crutches outcome: recovered/ resolved for all events a pharmaceutical technical complaint (ptc) was initiated and results were pending for the same.Seriousness criteria: required intervention for recurrent left knee effusion/ severe effusion/ 3plus effusion in patient's left knee.
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Event Description
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This unsolicited device case from united states was received on 03-mar-2016 from a nurse.This case concerns a (b)(6) female patient who initiated treatment with synvisc on(b)(6) 2016 and later experienced recurrent left knee effusion/ severe effusion/ 3plus effusion in patient's left knee and was non weight bearing on crutches.No medical history, concomitant medications and concurrent conditions were reported.The patient had no known allergies.Past drug included four sets of sodium hyaluronate (supartz) injections given at six to nine month intervals.On (b)(6) 2016, the patient initiated treatment with intra-articular synvisc injection twice (dose: not provided) (batch/lot number: 5rsa021z and expiration date: 31-aug-2018) in her left knee for osteoarthritis.On an unknown date in jan-2016, for a couple of days, the patient experienced left knee effusion.On (b)(6) 2016, the patient saw her doctor and it was decided to hold synvisc.The left knee effusion resolved and on (b)(6) 2016, the patient received the second injection of synvisc.The same day, in the evening, patent had reaction with the second series injection of synvisc and experienced a severe effusion of her left knee.On (b)(6) 2016, the doctor diagnosed a "3plus" effusion in the patient's left knee which he drained and then injected dexamethasone.On an unknown date in 2016, the patient was non-weight bearing on crutches.Five days later, the patient's left knee was back to normal with no other adverse effects.Action taken: stopped temporarily.Corrective treatment: dexamethasone and drained for recurrent left knee effusion/ severe effusion/ 3plus effusion in patient's left knee; not reported for patient was non weight bearing on crutches.Outcome: recovered/ resolved for all events.A pharmaceutical technical complaint (ptc) was initiated with global ptc umber: (b)(4).The production and quality control documentation for lot # 5rsa021z expiration date (08/2018) 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 # 5rsa021z no capa was required.Sanofi genzyme 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 08-mar-16, there were a total of (b)(4) complaints on file for lot# 5rsa021z: (b)(4) adverse event reports, (b)(4) extrusion difficulty and (b)(4) detached luer-lok hub.(b)(4) genzyme would continue to monitor complaints as stated in product complaint handling to determine if a capa was required.Seriousness criteria: required intervention for recurrent left knee effusion/ severe effusion/ 3plus effusion in patient's left knee.Additional information was received on 08-mar-2016.Global ptc number with results was added and the text was amended accordingly.
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