| Device Problems
Microbial Contamination of Device (2303); Patient-Device Incompatibility (2682); Contamination of Device Ingredient or Reagent (2901); Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Dyspnea (1816); Erythema (1840); Fall (1848); Low Blood Pressure/ Hypotension (1914); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Arthralgia (2355); Joint Swelling (2356); Joint Disorder (2373); Ambulation Difficulties (2544); Test Result (2695); No Code Available (3191)
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| Event Date 11/01/2017 |
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Event Type
Injury
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Event Description
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Based on the information received on 22-dec-2017 the case initially processed as non-serious has been updated to serious because of update in seriousness criteria for the event of had a little knee swelling/ knees were huge this unsolicited case from united states was received on 14-dec-2017 from patient.This case concerns a female patient (age not provided) who received treatment with synvisc one injection and after few hours was unable to straighten out her legs, lost her balance, fell to the floor and was in extreme knee pain and after unknown latency had shortness of breath, had a little knee swelling/knees were huge, had fluid in both her knees, had flu symptoms, white blood cell count was high and blood pressure was very low no medical history, concomitant medication and concurrent condition was provided.Patient had received previous synvisc one injections.The patient had a history of osteomyelitis in her ankle.On (b)(6) 2017, patient received treatment with intraarticular synvisc one injection, once (batch/lot number and expiration date; indication, dose: not provided) in both knees for osteoarthritis.On the same day, at night around 2 am, after few hours (approximately 12 hours) after the injections, patient got up to go to the bathroom and was unable to straighten out her legs, was in extreme pain, lost her balance and fell to the floor.On an unknown date in 2017, after unknown latency, patient was experiencing shortness of breath and went to the emergency room.Patient was not admitted to the hospital.Patient also had a little swelling on an unknown date in 2017, but the swelling subsided.Patient was still having pain, it was difficult to straighten her knees and she had fluid in both her knees (onset date in 2017, latency: unknown).Patient had a follow up appointment in five days and she planned to have the physician pull fluid out of her knees and culture it.The patient was worried about potential long term effects from the unknown microbe, like effects on her heart or other organs.Also reported that the patient also heard that there was potential contamination of the needle.Patient said that she stated again that she had to go to the emergency room after she received the recalled synvisc one injections in both her knees.She was in extreme pain, her knees were huge and her blood pressure was very low (onset: 2017; latency: unknown).She took oral steroids starting on an unknown date after the injections because of her adverse reactions.Off and on since the injections, she has had a low grade fever and last week she went to her primary care doctor for flu symptoms (onset: 2017; latency: unknown) like bad fatigue, body aches and feeling like she couldn't do anything.She did not have any congestion symptoms.She was given tamiflu.She read that the bacteria is a colonizer and is concerned that it may cause an infection later.No fluid has been drawn from her knees, but she had another appointment next week.Her white blood cell count was high (onset: 2017; latency: unknown) in the emergency room, it was still slightly elevated on (b)(6) 2017, so she was supposed to have bloodwork again next week and they may draw fluid from her knee at that time.Corrective treatment: oral steroids for had a little knee swelling/knees were huge, was in extreme knee pain; oseltamivir phosphate (tamiflu) for flu symptoms; not reported for others outcome: recovering for had a little knee swelling/knees were huge; unknown for flu symptoms, blood pressure was very low; not recovered for other events a pharmaceutical technical complaint (ptc) was initiated and results were pending for the same.Additional information was received on 22-dec-2017 from the patient.Event of had a little knee swelling was updated to had a little knee swelling/knees were huge.Event of flu symptoms, white blood cell count was high and blood pressure was very low was added.Clinical course was updated and text amended accordingly.
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Event Description
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Based on the information received on 22-dec-2017 the case initially processed as non-serious has been updated to serious because of update in seriousness criteria for the event of had a little knee swelling/ knees were huge this unsolicited case from united states was received on 14-dec-2017 from patient.This case concerns a female patient (age not provided) who received treatment with synvisc one injection and after few hours was unable to straighten out her legs, lost her balance, fell to the floor and was in extreme knee pain and after unknown latency had shortness of breath, had a little knee swelling/knees were huge, had fluid in both her knees, had flu symptoms, white blood cell count was high and blood pressure was very low no medical history, concomitant medication and concurrent condition was provided.Patient had received previous synvisc one injections.The patient had a history of osteomyelitis in her ankle.On (b)(6) 2017, patient received treatment with intraarticular synvisc one injection, once (batch/lot number and expiration date; indication, dose: not provided) in both knees for osteoarthritis.On the same day, at night around 2 am, after few hours (approximately 12 hours) after the injections, patient got up to go to the bathroom and was unable to straighten out her legs, was in extreme pain, lost her balance and fell to the floor.On an unknown date in 2017, after unknown latency, patient was experiencing shortness of breath and went to the emergency room.Patient was not admitted to the hospital.Patient also had a little swelling on an unknown date in 2017, but the swelling subsided.Patient was still having pain, it was difficult to straighten her knees and she had fluid in both her knees (onset date in 2017, latency: unknown).Patient had a follow up appointment in five days and she planned to have the physician pull fluid out of her knees and culture it.The patient was worried about potential long term effects from the unknown microbe, like effects on her heart or other organs.Also reported that the patient also heard that there was potential contamination of the needle.Patient said that she stated again that she had to go to the emergency room after she received the recalled synvisc one injections in both her knees.She was in extreme pain, her knees were huge and her blood pressure was very low (onset: 2017; latency: unknown).She took oral steroids starting on an unknown date after the injections because of her adverse reactions.Off and on since the injections, she has had a low grade fever and last week she went to her primary care doctor for flu symptoms(onset: 2017; latency: unknown) like bad fatigue, body aches and feeling like she couldn't do anything.She did not have any congestion symptoms.She was given tamiflu.She read that the bacteria is a colonizer and is concerned that it may cause an infection later.No fluid has been drawn from her knees, but she had another appointment next week.Her white blood cell count was high (onset: 2017; latency: unknown) in the emergency room, it was still slightly elevated on (b)(6) 2017, so she was supposed to have bloodwork again next week and they may draw fluid from her knee at that time.Corrective treatment: oral steroids for had a little knee swelling/knees were huge, was in extreme knee pain; oseltamivir phosphate (tamiflu) for flu symptoms; not reported for others outcome: recovering for had a little knee swelling/knees were huge; unknown for flu symptoms, blood pressure was very low; not recovered for other 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.Additional information was received on 22-dec-2017 from the patient.Event of had a little knee swelling was updated to had a little knee swelling/knees were huge.Event of flu symptoms, white blood cell count was high and blood pressure was very low was added.Clinical course was updated and text amended accordingly.Additional information was received on 02-jan-2018 from the patient.Global ptc number and results were added.Clinical course was updated and text amended accordingly.
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Event Description
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Based on the information received on 22-dec-2017 the case initially processed as non-serious has been updated to serious because of update in seriousness criteria for the event of had a little knee swelling/ knees were huge this unsolicited case from united states was received on 14-dec-2017 from patient.This case concerns a 50 year old female patient who received treatment with synvisc one injection and after few hours was unable to straighten out her legs, lost her balance, fell to the floor and was in extreme knee pain and after unknown latency had shortness of breath, had a little knee swelling/knees were huge, had fluid in both her knees, had flu symptoms, white blood cell count was high and blood pressure was very low no medical history, concomitant medication and concurrent condition was provided.Patient had received previous synvisc one injections.The patient had a history of osteomyelitis in her ankle.The patient did not have any allergies.On (b)(6) 2017, patient received treatment with intraarticular synvisc one injection, once (batch/lot number and expiration date; indication, dose: not provided) in both knees for osteoarthritis.On the same day, at night around 2 am, after few hours (approximately 12 hours) after the injections, patient got up to go to the bathroom and was unable to straighten out her legs, was in extreme pain, lost her balance and fell to the floor.It was reported that the patient had done laboratory tests for the problem.On (b)(6) 2017, the patient consulted healthcare professional by telephone.It was reported that the patient visited emergency room but was not admitted to the hospital.On an unknown date in 2017, after unknown latency, patient was experiencing shortness of breath and went to the emergency room.Patient was not admitted to the hospital.Patient also had a little swelling on an unknown date in 2017, but the swelling subsided.Patient was still having pain, it was difficult to straighten her knees and she had fluid in both her knees (onset date in 2017, latency: unknown).Patient had a follow up appointment in five days and she planned to have the physician pull fluid out of her knees and culture it.The patient was worried about potential long term effects from the unknown microbe, like effects on her heart or other organs.Also reported that the patient also heard that there was potential contamination of the needle.Patient said that she stated again that she had to go to the emergency room after she received the recalled synvisc one injections in both her knees.She was in extreme pain, her knees were huge and her blood pressure was very low (onset: 2017; latency: unknown).She took oral steroids starting on an unknown date after the injections because of her adverse reactions.Off and on since the injections, she has had a low grade fever and last week she went to her primary care doctor for flu symptoms(onset: 2017; latency: unknown) like bad fatigue, body aches and feeling like she couldn't do anything.She did not have any congestion symptoms.She was given tamiflu.She read that the bacteria is a colonizer and is concerned that it may cause an infection later.No fluid has been drawn from her knees, but she had another appointment next week.Her white blood cell count was high (onset: 2017; latency: unknown) in the emergency room, it was still slightly elevated on (b)(6) 2017, so she was supposed to have bloodwork again next week and they may draw fluid from her knee at that time.Corrective treatment: oral steroids for had a little knee swelling/knees were huge, was in extreme knee pain; oseltamivir phosphate (tamiflu) for flu symptoms; not reported for others outcome: recovering for had a little knee swelling/knees were huge; unknown for flu symptoms, blood pressure was very low; not recovered for other events a pharmaceutical technical complaint (ptc) was initiated with global ptc number 51334.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.Additional information was received on 22-dec-2017 from the patient.Event of had a little knee swelling was updated to had a little knee swelling/knees were huge.Event of flu symptoms, white blood cell count was high and blood pressure was very low was added.Clinical course was updated and text amended accordingly.Additional information was received on 02-jan-2018 from the patient.Global ptc number and results were added.Clinical course was updated and text amended accordingly.Additional information was received on 01-mar-2018 from other non-healthcare professional (legal).Start date and stop date of synvisc one was updated.Patient's age was added.Clinical course was updated.Text was amended accordingly.
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Event Description
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Device malfunction [device malfunction]; had a little knee swelling/knees were huge/swelling in both left and right knee [swelling of knees]; was in extreme knee pain/tenderness in both left and right knee [joint tenderness]; unable to straighten out her legs [lower extremities discomfort]; lost her balance [balance impaired nos]; shortness of breath [shortness of breath] ; fell to the floor [fall] ; white blood cell count was high [white blood cell count high;] blood pressure was very low/blood pressure dropped to critically low level [blood pressure decreased]; redness in both left knee and right knee [localised erythema] ; flu symptoms [flu symptoms] ([fever], [fatigue], [radiating pain], [feeling abnormal]); unable to bend either knee [joint range of motion decreased]; knot above right knee [skin mass]; has fluid in both her knees [knee effusion].Case narrative: upon internal review on 27-nov-2018, the following changes were made in the case, this batch was identified in context of affiliates requests and concerns the field reporter causality which was amended from not reported to related in context of unsolicited report.Based on the information received on 22-dec-2017 the case initially processed as non-serious has been updated to serious because of update in seriousness criteria for the event of had a little knee swelling/knees were huge.This unsolicited case from united states was received on 14-dec-2017 from patient.This case concerns a 50 year old female patient who received treatment with synvisc one injection and after few hours had a little knee swelling/knees were huge/swelling in both left and right knee, was in extreme knee pain/tenderness in both left and right knee, unable to straighten out her legs, lost her balance, shortness of breath, fell to the floor, has fluid in both her knees, white blood cell count was high, blood pressure was very low/blood pressure dropped to critically low level, redness in both left knee and right knee, flu symptoms, unable to bend either knee and knot above right knee and device malfunction.The patient's past medical history included osteomyelitis, osteoarthritis, blood pressure increased and blood cholesterol increased.The patient's past medical treatment included synvisc one on (b)(6) 2014 with indication: osteoarthritis.The patient's past vaccination(s) and family history were not provided.The patient did not have any allergies.Concomitant medications included lisinopril for blood pressure increased; atenolol for blood pressure increased; and atorvastatin for blood cholesterol increased.On (b)(6) 2017, patient received treatment with intra- articular synvisc one injection, once (7rsl021, (b)(6) 2020, dose: not provided) in both knees for osteoarthritis.On the same day, at night around 2 am, after few hours (approximately 12 hours) after the injections, patient got up to go to the bathroom and was unable to straighten out her legs, was in extreme pain, lost her balance and fell to the floor.Also, patient developed little knee swelling/knees were huge/swelling in both left and right knee, redness in both left knee and right knee, was in extreme knee pain/tenderness in both left and right knee, knot above right knee.Reportedly, off and on since the injections, she has had a low-grade fever and last week she went to her primary care doctor for flu symptoms like bad fatigue, body aches and feeling like she couldn't do anything.It was reported that the patient had done laboratory tests for the problem.Also, the patient consulted healthcare professional by telephone.It was reported that the patient visited emergency room but was not admitted to the hospital.On the same day, the patient was experiencing shortness of breath and went to the emergency room.Patient was not admitted to the hospital.Patient was still having pain, it was difficult to straighten her knees and she had fluid in both her knees.Patient had a follow up appointment in five days and she planned to have the physician pull fluid out of her knees and culture it.The patient was worried about potential long term effects from the unknown microbe, like effects on her heart or other organs.Also reported that the patient also heard that there was potential contamination of the needle.Patient said that she stated again that she had to go to the emergency room after she received the recalled synvisc one injections in both her knees.She was in extreme pain, her knees were huge and her blood pressure was very low which dropped to critically low.She took oral steroids starting on an unknown date after the injections because of her adverse reactions.She did not have any congestion symptoms.She was given oseltamivir phosphate (tamiflu).She read that the bacteria is a colonizer and is concerned that it may cause an infection later.No fluid has been drawn from her knees, but she had another appointment next week.Her white blood cell count was high (onset: 2017; latency: unknown) in the emergency room, it was still slightly elevated on (b)(6) 2017, so she was supposed to have bloodwork again next week and they may draw fluid from her knee at that time.Corrective treatment: oral steroids and naproxen sodium (aleve) for had a little knee swelling/knees were huge/swelling in both left and right knee, was in extreme knee pain/tenderness in both left and right knee; oseltamivir phosphate (tamiflu) for flu symptoms; not reported for others outcome: recovering for had a little knee swelling/knees were huge; unknown for flu symptoms, not recovered for other 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 criteria: required intervention for had a little knee swelling/knees were huge/swelling in both left and right knee, was in extreme knee pain/tenderness in both left and right knee.Additional information was received on 22-dec-2017 from the patient.Event of had a little knee swelling was updated to had a little knee swelling/knees were huge.Event of flu symptoms, white blood cell count was high and blood pressure was very low was added.Clinical course was updated and text amended accordingly.Additional information was received on 02-jan-2018 from the patient.Global ptc number and results were added.Clinical course was updated and text amended accordingly.Additional information was received on 01-mar-2018 from other non-healthcare professional (legal).Start date and stop date of synvisc one was updated.Patient's age was added.Clinical course was updated.Text was amended accordingly.Additional information was received on 22-may-2018 from patient.Therapy start date updated to (b)(6) 2017, lot number and expiration date added.Event verbatim updated from had a little knee swelling/knees were huge to had a little knee swelling/knees were huge/swelling in both left and right knee, was in extreme knee pain/tenderness in both left and right knee from was in extreme knee pain, blood pressure was very low/blood pressure dropped to critically low level from blood pressure was very low.Additional events of device malfunction, redness in both left knee and right knee and unable to bend either knee and knot above right knee and knot above right knee added with details.Medical history of osteoarthritis, blood pressure increased and blood cholesterol increased added.Past drug of synvisc one added.Concomitant drugs and treatment drug added.Additional lab data added.Clinical course was updated.Text was amended accordingly.Upon internal review on 27-nov-2018, the reporter causality was updated from not reported to related.Clinical course was updated and text was amended accordingly.
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Event Description
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Device malfunction [device malfunction] walking disability [walking disability] had a little knee swelling/knees were huge/swelling in both left and right knee [swelling of knees] was in extreme knee pain/tenderness in both left and right knee/joint pain [joint tenderness] unable to straighten out her legs [lower extremities discomfort] lost her balance [balance impaired nos] shortness of breath [shortness of breath] fell to the floor [fall] flu symptoms [flu symptoms] ([fever], [fatigue], [radiating pain], [feeling abnormal]) white blood cell count was high [white blood cell count high] blood pressure was very low/blood pressure dropped to critically low level [blood pressure decreased] redness in both both left knee and right knee [localised erythema] unable to bend either knee/loss of range of motion in right knee [joint range of motion decreased] infective (teno) synovitis, left knee [tenosynovitis] knot above right knee [skin mass] has fluid in both her knees [knee effusion] case narrative: based on additional information received on 16-jan-2019 from physician, the case was medically confirmed.Upon internal review on 27-nov-2018, the following changes were made in the case, this batch was identified in context of affiliates requests and concerns the field reporter causality which was amended from not reported to related in context of unsolicited report.Based on the information received on 22-dec-2017 the case initially processed as non-serious has been updated to serious because of update in seriousness criteria for the event of had a little knee swelling/knees were huge.This unsolicited case from united states was received on 14-dec-2017 from patient.This case concerns a 50 year old female patient who received treatment with synvisc one injection and after few hours had a little knee swelling/knees were huge/swelling in both left and right knee, was in extreme knee pain/tenderness in both left and right knee/joint pain, unable to straighten out her legs, lost her balance, shortness of breath, fell to the floor, has fluid in both her knees, white blood cell count was high, blood pressure was very low/blood pressure dropped to critically low level, redness in both left knee and right knee, flu symptoms, unable to bend either knee loss of range of motion in right knee and knot above right knee and device malfunction.Also after 6 months and 29 days patient had infective (teno) synovitis, left knee and after 11 months and 16 days had walking difficulty.The patient's past medical history included high blood pressure, joint pain left knee, osteomyelitis, localized primary osteoarthritis, knee pain, current tear of medial cartilage and/or meniscus of knee, blood pressure increased and blood cholesterol increased.Patient had pain on initiation of movement and at extreme limits of range and tenderness of the medial femoral condyle, medial joint line and the medial tibial plateau in both knee joints.Surgical history included knee arthroscopy with meniscectomy (24-mar-2016), knee arthroscopy (12-dec-2013) and knee surgery (dec-2011).The patient's past medical treatment included synvisc one on 17-aug-2014 with indication: osteoarthritis.The patient did not have any allergies.Concomitant medications included lisinopril for blood pressure increased; atenolol for blood pressure increased; and atorvastatin for blood cholesterol increased, acetylsalicylic acid (aspirin 81), ubidecarenone (coq10), ibuprofen, lisinopril, methylprednisolone (medrol dosepak), metoprolol succinate, vitamin d3, ethyl chloride as anaesthetic and bifidobacterium bifidum, bifidobacterium lactis, bifidobacterium longum, lactobacillus acidophilus, lactobacillus rhamnosus (probiotic).Family history included hypertensive disorder in mother and brother, sudden death of sister, osteoarthritis in brother (onset age: 45).Patient was non-smoker.On (b)(6) 2017, patient received treatment with intra- articular synvisc one injection, 1 df, once (7rsl021, may 2020) in both knees for unilateral primary osteoarthritis, right knee and pain in right knee and left knee.The knee was prepped in the usual sterile manner.Topical anesthesia was achieved with ethyl chloride.The bilateral knee was injected without complication and a bandage was applied.Patient tolerated the procedure well.On the same day, at night around 2 am, after few hours (approximately 12 hours) after the injections, patient got up to go to the bathroom and was unable to straighten out her legs, was in extreme pain, lost her balance and fell to the floor.Also, patient developed little knee swelling/knees were huge/swelling in both left and right knee, redness in both left knee and right knee, was in extreme knee pain/tenderness in both left and right knee, knot above right knee.On (b)(6) 2017, patient's left ankle was evaluated and recommended icing, non-steroidal anti-inflammatory drugs, home exercises and bracing.Reportedly, off and on since the injections, she has had a low-grade fever and last week she went to her primary care doctor for flu symptoms like bad fatigue, body aches and feeling like she couldn't do anything.It was reported that the patient had done laboratory tests for the problem.Also, the patient consulted healthcare professional by telephone.It was reported that the patient visited emergency room but was not admitted to the hospital.On the same day, the patient was experiencing shortness of breath and went to the emergency room.Patient was not admitted to the hospital.Patient was still having pain, it was difficult to straighten her knees and she had fluid in both her knees.Patient had a follow up appointment in five days and she planned to have the physician pull fluid out of her knees and culture it.The patient was worried about potential long term effects from the unknown microbe, like effects on her heart or other organs.Also reported that the patient also heard that there was potential contamination of the needle.Patient said that she stated again that she had to go to the emergency room after she received the recalled synvisc one injections in both her knees.She was in extreme pain, her knees were huge and her blood pressure was very low which dropped to critically low.She took oral steroids starting on an unknown date after the injections because of her adverse reactions.She did not have any congestion symptoms.She was given oseltamivir phosphate (tamiflu).She read that the bacteria is a colonizer and is concerned that it may cause an infection later.No fluid has been drawn from her knees, but she had another appointment next week.Her white blood cell count was high (onset: 2017; latency: unknown) in the emergency room, it was still slightly elevated on 20-dec-2017, so she was supposed to have bloodwork again next week and they may draw fluid from her knee at that time.On 31-jan-2018, patient had knee x-ray that showed an evidence of osteoarticular abnormality but no fracture and no dislocation.On 01-feb-2018, patient had severe pain and swelling and needed to go to emergency room (er).While there patient's blood pressure decreased and had low grade fever.As of 30-may-2018, patient had swelling into the knees with prolonged standing that caused pain into both knees.Pain into the left upper left top of the knee cap hurts the most.Pain was 9/10 on pain scale at worst into the left upper knee.Also reported that patient had sharp pain into left knee and had to go to er that night.Patient's walking tolerance was 20 minutes, standing tolerance was 10-15 minutes, siting tolerance was unlimited since that initial response of pain and swelling, her knees were doing better.Patient was sent to infectious disease specialist and had no infection.On the same day, patient had knee x-ray and the findings showed an evidence of osteoarticular abnormality but no fracture and no dislocation.It was reported that bilateral knee oa right>left.Left knee continued pain after the injection.On the same day, patient was diagnosed with other infective (teno) synovitis, left knee.On 19-sep-2018, the knees were sore, right knee did not want to straighten out and patient tripped and hit left knee.Patient's pain was 3 on scale of 10.On 17-oct-2018, after unknown latency, patient also had walking disability (difficulty in walking).On 04-nov-2018, patient's left knee did not bothered her.Physical therapy was helping both of them, but noticed a loss of range of motion in right knee.On the same day, patient had x-ray of right knee that revealed bone on bone right knee medial compartmental osteoarthritis.On 12-dec-2018, patient had effusion of unspecified knee.On 13-dec-2018, patient started feeling feverish, fatigued and experienced some body aches.Patient denied any worsening pain in her knees.Patient was given tamiflu and was overall feeling better, but was experiencing some fatigue.On 21-dec-2018, patient's wbc was 12 which was down from 13.3 at her er visit on 02-nov-2018.Patient's sedimentation rate was 6 and c-reactive protein was <0.5 (both were normal).Corrective treatment: physical therapy, oral steroids and naproxen sodium (aleve) for had a little knee swelling/knees were huge/swelling in both left and right knee, was in extreme knee pain/tenderness in both left and right knee; oseltamivir phosphate (tamiflu) for flu symptoms; not reported for others outcome: recovering for white blood cell count was high, had a little knee swelling/knees were huge; unknown for flu symptoms, not recovered for other events an investigation was initiated as a result of an unexpected increase in the number of labelled adverse events received from the us market for synvisc one, lot 7rsl021.The product met all release testing at time of manufacture in june 2017.Retain samples were retested due to the unexpected increase in adverse events.Higher than expected endotoxin results were obtained.In addition, the presence of microbial contamination was also confirmed.The cause of these events is under investigation.Once this investigation is completed, corrective and preventive actions will be implemented.Seriousness criteria: required intervention for had a little knee swelling/knees were huge/swelling in both left and right knee, was in extreme knee pain/tenderness in both left and right knee; disability for walking disability additional information was received on 22-dec-2017 from the patient.Event of had a little knee swelling was updated to had a little knee swelling/knees were huge.Event of flu symptoms, white blood cell count was high and blood pressure was very low was added.Clinical course was updated and text amended accordingly.Additional information was received on 02-jan-2018 from the patient.Global ptc number and results were added.Clinical course was updated and text amended accordingly.Additional information was received on 01-mar-2018 from other non-healthcare professional (legal).Start date and stop date of synvisc one was updated.Patient's age was added.Clinical course was updated.Text was amended accordingly.Additional information was received on 22-may-2018 from patient.Therapy start date updated to 01-nov-2017 from 02-nov-2017, lot number and expiration date added.Event verbatim updated from had a little knee swelling/knees were huge to had a little knee swelling/knees were huge/swelling in both left and right knee, was in extreme knee pain/tenderness in both left and right knee from was in extreme knee pain, blood pressure was very low/blood pressure dropped to critically low level from blood pressure was very low.Additional events of device malfunction, redness in both left knee and right knee and unable to bend either knee and knot above right knee and knot above right knee added with details.Medical history of osteoarthritis, blood pressure increased and blood cholesterol increased added.Past drug of synvisc one added.Concomitant drugs and treatment drug added.Additional lab data added.Clinical course was updated.Text was amended accordingly.Upon internal review on 27-nov-2018, the reporter causality was updated from not reported to related.Clinical course was updated and text was amended accordingly.Additional information was received on 16-jan-2019 from physician.The case was medically confirmed.Patient's medical history and concomitant medications were updated.Additional events of infective (teno) synovitis, left knee and walking difficulty were added along with details.The symptom term low-grade fever was updated to low-grade fever/feverish.Lab test results were added.Indication, dose and frequency of synvisc one was added.Upon internal review investigation summary was updated.Clinical course was updated and text was amended accordingly.
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Event Description
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Device malfunction [device malfunction].Had a little knee swelling/knees were huge/swelling in both left and right knee [swelling of knees].Was in extreme knee pain/tenderness in both left and right knee [joint tenderness].Unable to straighten out her legs [lower extremities discomfort].Lost her balance [balance impaired nos].Shortness of breath [shortness of breath].Fell to the floor [fall].Has fluid in both her knees [knee effusion].White blood cell count was high [white blood cell count high].Blood pressure was very low/blood pressure dropped to critically low level [blood pressure decreased].Redness in both both left knee and right knee [localised erythema].Flu symptoms [flu symptoms] ([fever], [fatigue], [radiating pain], [feeling abnormal]).Unable to bend either knee [joint range of motion decreased].Knot above right knee [skin mass].Case narrative: based on the information received on 22-dec-2017 the case initially processed as non-serious has been updated to serious because of update in seriousness criteria for the event of had a little knee swelling/knees were huge.This unsolicited case from united states was received on 14-dec-2017 from patient.This case concerns a 50 year old female patient who received treatment with synvisc one injection and after few hours had a little knee swelling/knees were huge/swelling in both left and right knee, was in extreme knee pain/tenderness in both left and right knee, unable to straighten out her legs, lost her balance, shortness of breath, fell to the floor, has fluid in both her knees, white blood cell count was high, blood pressure was very low/blood pressure dropped to critically low level, redness in both left knee and right knee, flu symptoms, unable to bend either knee and knot above right knee and device malfunction.The patient's past medical history included osteomyelitis, osteoarthritis, blood pressure increased and blood cholesterol increased.The patient's past medical treatment included synvisc one on (b)(6) 2014 with indication: osteoarthritis.The patient's past vaccination(s) and family history were not provided.The patient did not have any allergies.Concomitant medications included lisinopril for blood pressure increased; atenolol for blood pressure increased; and atorvastatin for blood cholesterol increased.On (b)(6) 2017, patient received treatment with intra- articular synvisc one injection, once (7rsl021, (b)(6) 2020, dose: not provided) in both knees for osteoarthritis.On the same day, at night around 2 am, after few hours (approximately 12 hours) after the injections, patient got up to go to the bathroom and was unable to straighten out her legs, was in extreme pain, lost her balance and fell to the floor.Also, patient developed little knee swelling/knees were huge/swelling in both left and right knee, redness in both left knee and right knee, was in extreme knee pain/tenderness in both left and right knee, knot above right knee.Reportedly, off and on since the injections, she has had a low-grade fever and last week she went to her primary care doctor for flu symptoms like bad fatigue, body aches and feeling like she couldn't do anything.It was reported that the patient had done laboratory tests for the problem.Also, the patient consulted healthcare professional by telephone.It was reported that the patient visited emergency room but was not admitted to the hospital.On the same day, the patient was experiencing shortness of breath and went to the emergency room.Patient was not admitted to the hospital.Patient was still having pain, it was difficult to straighten her knees and she had fluid in both her knees.Patient had a follow up appointment in five days and she planned to have the physician pull fluid out of her knees and culture it.The patient was worried about potential long term effects from the unknown microbe, like effects on her heart or other organs.Also reported that the patient also heard that there was potential contamination of the needle.Patient said that she stated again that she had to go to the emergency room after she received the recalled synvisc one injections in both her knees.She was in extreme pain, her knees were huge and her blood pressure was very low which dropped to critically low.She took oral steroids starting on an unknown date after the injections because of her adverse reactions.She did not have any congestion symptoms.She was given oseltamivir phosphate (tamiflu).She read that the bacteria is a colonizer and is concerned that it may cause an infection later.No fluid has been drawn from her knees, but she had another appointment next week.Her white blood cell count was high (onset: 2017; latency: unknown) in the emergency room, it was still slightly elevated on (b)(6) 2017, so she was supposed to have bloodwork again next week and they may draw fluid from her knee at that time.Corrective treatment: oral steroids and naproxen sodium (aleve) for had a little knee swelling/knees were huge/swelling in both left and right knee, was in extreme knee pain/tenderness in both left and right knee; oseltamivir phosphate (tamiflu) for flu symptoms; not reported for others
outcome: recovering for had a little knee swelling/knees were huge; unknown for flu symptoms, not recovered for other events
a pharmaceutical technical complaint (ptc) was initiated with global ptc number 51334.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 criteria: required intervention for had a little knee swelling/knees were huge/swelling in both left and right knee, was in extreme knee pain/tenderness in both left and right knee
additional information was received on 22-dec-2017 from the patient.Event of had a little knee swelling was updated to had a little knee swelling/knees were huge.Event of flu symptoms, white blood cell count was high and blood pressure was very low was added.Clinical course was updated and text amended accordingly.Additional information was received on 02-jan-2018 from the patient.Global ptc number and results were added.Clinical course was updated and text amended accordingly.Additional information was received on 01-mar-2018 from other non-healthcare professional (legal).Start date and stop date of synvisc one was updated.Patient's age was added.Clinical course was updated.Text was amended accordingly.Additional information was received on 22-may-2018 from patient.Therapy start date updated to (b)(6) 2017 from (b)(6) 2017, lot number and expiration date added.Event verbatim updated from had a little knee swelling/knees were huge to had a little knee swelling/knees were huge/swelling in both left and right knee, was in extreme knee pain/tenderness in both left and right knee from was in extreme knee pain, blood pressure was very low/blood pressure dropped to critically low level from blood pressure was very low.Additional events of device malfunction, redness in both left knee and right knee and unable to bend either knee and knot above right knee and knot above right knee added with details.Medical history of osteoarthritis, blood pressure increased and blood cholesterol increased added.Past drug of synvisc one added.Concomitant drugs and treatment drug added.Additional lab data added.Clinical course was updated.Text was amended accordingly.
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