Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fever (1858); Pain (1994); Vertigo (2134); Chills (2191); Dizziness (2194); Joint Swelling (2356); Sweating (2444); No Code Available (3191)
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Event Type
Injury
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Event Description
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Joint swelling [joint swelling] ([swelling of limb], [tenderness], [joint stiffness], [leg edema], [knee pain], [numbness]); weighed a lot [weight increased]; dizziness [dizziness], vertigo [vertigo], fever [fever], chills [chills] , sweats [sweating]; upper respiratory infection or urinary tract infection [infection]; blotchy spots along the calf [blotchy rash], pain [pain].Case narrative: the case is related to case: (b)(4) (same patient).Initial information received from united states on 09-nov-2018 regarding an unsolicited valid serious case received from a lawyer.This case involves a (b)(6) years old male patient who experienced joint swelling, weighed a lot, dizziness, vertigo, (latency:1 month 15 days), fevers, chills, sweats, an upper respiratory infection or urinary tract infection (latency: unknown), while he was treated with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history included drug hypersensitivity with levofloxacin, knee operation, nasal congestion, headache and aspiration joint.His past medical treatment included synvisc.His past vaccination(s) and family history were not provided.At the time of the event, he was smoker, but he was considering quitting it.On (b)(6) 2017, the patient started using synvisc one (hylan g-f 20, sodium hyaluronate) dosage 6 ml via intra-articular route once only (lot - unk) for product used for unknown indication.On (b)(6) 2017, patient presented to medical care facility and said that he weighed a lot.It was also observed that his right calf was swollen and tender and seemed to be bigger than the other side.It was also reported that knee was numb.He was also observed with joint pain, joint stiffness and joint swelling.Some edema was observed with joint.On (b)(6) 2017, patient experienced with dizziness and vertigo.On the unknown date of 2017, patient experienced blotchy red spots along the calf.He also had fever, chills and sweats.These symptoms could be related to either an upper respiratory infection or urinary tract infection.Final diagnosis was vertigo, dizziness, weighed a lot, joint swelling, fevers, chills, sweats and an upper respiratory infection or urinary tract infection.Corrective treatment: pseudoephedrine hcl (pseudoephedrine hcl) for nasal congestion, cefdinir (omnicef); meclizine hcl (meclizine hcl) for dizziness; dexamethasone sodium phosphate (decadron) and methylprednisolone acetate (depomedrol) for joint swelling, hydrocodone bitartrate, paracetamol (norco) and ibuprofen (ibuprofen) for pain.Outcome: not recovered for dizziness and vertigo; unknown for rest of the events.Seriousness criteria: intervention required for joint swelling.
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Event Description
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Joint swelling [joint swelling] ([swelling of limb], [tenderness], [joint stiffness], [leg edema], [knee pain], [numbness]) weighed a lot [weight increased] dizziness [dizziness] vertigo [vertigo] fever [fever] chills [chills] sweats [sweating] upper respiratory infection or urinary tract infection [infection] blotchy spots along the calf [blotchy rash] pain [pain] case narrative: the case was related to case:(b)(4).Initial information received from united states on 09-nov-2018 regarding an unsolicited valid serious case received from a lawyer.This case involves a 45 years old male patient who experienced joint swelling, weighed a lot, dizziness, vertigo, (latency:1 month 15 days), fevers, chills, sweats, an upper respiratory infection or urinary tract infection (latency: unknown), while he was treated with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history included drug hypersensitivity with levofloxacin, knee operation, nasal congestion, headache and aspiration joint.His past medical treatment included synvisc.His past vaccination(s) and family history were not provided.At the time of the event, he was smoker, but he was considering quitting it.On (b)(6) 2017 , the patient started using synvisc one (hylan g-f 20, sodium hyaluronate) dosage 6 ml via intra-articular route once only (lot - unk) for product used for unknown indication.On (b)(6) 2017 , patient presented to medical care facility and said that he weighed a lot.It was also observed that his right calf was swollen and tender and seemed to be bigger than the other side.It was also reported that knee was numb.He was also observed with joint pain, joint stiffness and joint swelling.Some edema was observed with joint.On (b)(6) 2017 , patient experienced with dizziness and vertigo.On the unknown date of 2017, patient experienced blotchy red spots along the calf.He also had fever, chills and sweats.These symptoms could be related to either an upper respiratory infection or urinary tract infection.Final diagnosis was vertigo, dizziness, weighed a lot, joint swelling, fevers, chills, sweats and an upper respiratory infection or urinary tract infection.Corrective treatment: pseudoephedrine hcl (pseudoephedrine hcl) for nasal congestion, cefdinir (omnicef); meclizine hcl (meclizine hcl) for dizziness; dexamethasone sodium phosphate (decadron) and methylprednisolone acetate (depomedrol) for joint swelling, hydrocodone bitartrate, paracetamol (norco) and ibuprofen (ibuprofen) for pain.Outcome: not recovered for dizziness and vertigo; unknown for rest of the events.Seriousness criteria: intervention required for joint swelling.A product technical complaint (ptc) was initiated on (b)(6) 2018 for synvisc one; batch number; unknown, 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 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.Sanofi would continue to monitor adverse events to determine if a capa was required.Follow up information received on 20-nov-2018.No new information.Additional information received on 21-nov-2018.Gptc number added and results were updated for the same.Text amended accordingly.
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