| Lot Number 7RSL019 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Abdominal Pain (1685); Fever (1858); Arthralgia (2355); Joint Swelling (2356); No Code Available (3191)
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| Event Date 11/06/2017 |
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Event Type
Injury
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Event Description
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(b)(4).This unsolicited case from united states was received on 22-jan-2018 from a patient.This case concerns a (b)(6) female patient who received treatment with synvisc one injection and later on the same day patient was sick to stomach and after 3 hours experienced pain, after 01 day drain my knee/ took fluid out of knee and after unknown latency knee was hot, knee swollen, couldn't walk, fever, fluid was thick burgundy color.Patient had synvisc one injection before in both knees and never had a reaction to this.Patient had it 3 times before.On (b)(6) 2016 in her left knee, on (b)(6) 2016 in her right knee and on (b)(6) 2016 in her left knee.Concomitant medications included oxycodone hydrochloride/paracetamol (percocet).No relevant medical history and concurrent conditions were reported.On (b)(6) 2017, patients initiated treatment with intra- articular synvisc one injection at a dose of 1 df (dosage form) once (lot no.: 7rsl019; expiry: 31- may-2020; indication: not reported).On same date, patient received the shot and went home, elevated, iced his knee and fell asleep on the couch watching tv.On the same day, after 03 hours, patient woke up and was in so much pain that it made me sick to my stomach.On (b)(6) 2017, 01 days after the infusion, the patient had a total of 290 ccs removed of fluid from his knee from when he got the shot.At every visit, they were taking out fluid from my knee.On an unknown date in (b)(6) 2017, after unknown latency, the patient couldn't walk for a week and his knee was very hot, very swollen and he started running a fever.On an unknown date in (b)(6) 2017, after unknown latency, first time that had fluid taken out, the physician took the fluid to the lab and it was only there for 2 days and came back negative for whatever they were looking for and fluid was a thick burgundy color.Patient had all the documentation from both doctors that he saw and what their opinion.On (b)(6) 2017, patient went to an orthopedist because his original doctor went out of town.The second doctor took 30cc off his knee and put me on ciprofloxacin (cipro).On (b)(6) 2017, the doctor took 30 cc off.Doctor also gave him a hydrocortisone (cortisone)shot and methylprednisolone (medrol) dose pack.On (b)(6) 2017 45 cc was drained.On (b)(6) 2017, another 30 ccs was drained.On (b)(6) 2017, 38cc was drained.On (b)(6) 2017 they did an mri because the doctors were worried about his knee and the amount of fluid was getting ridiculous (unknown results of mri).On (b)(6) 2017, another 30 cc drained and he got another hydrocortisone (cortisone) shot.On (b)(6) 2018, 15 ccs were drained so that doctor could make sure there was no infection.They knew there was no infection because he had been on ciprofloxacin.Patient was now to the point where he just had a bad knee that was in need of another gel shot.Patient was terrified to do this.Patient couldn't walk for a week.On an unknown date in (b)(6) 2017, after unknown latency, patient had to use a walker and wheel chair and couldn't even use crutches.Patient kept my leg up and iced.In the middle of night one night, patient had to get up to go to the bathroom.It took him 50 minutes to get off the couch.His experience was very bad.He was not sure if he would get another gel shot.He was the first one of doctor's patients who had reaction to the synvisc one and he had 7 other patients who had reactions.Doctor said that patient was the worst out of all his patients.No further information was known about these patients.Corrective treatment: not reported for fluid was thick burgundy color, had to use a walker and wheel chair and sick to stomach; ciprofloxacin, hydrocortisone (cortisone), methylprednisolone for pain, knee was hot, knee swollen; ciprofloxacin, hydrocortisone (cortisone), methylprednisolone, fluid was drained for drain my knee/ took fluid out of knee; ciprofloxacin for fever; outcome: not recovered/ not resolved for drain my knee/ took fluid out of knee; unknown for rest of the events seriousness criteria: disability for couldn't walk; required intervention for pain, knee was hot, knee swollen and drain my knee/ took fluid out of knee.Pharmacovigilance comment: sanofi company comment dated 31-jan-2018: this case concerns a female patient who received synvisc one injection and later had knee pain, swelling, warmth.Based upon the temporal gap, the causal role of the product cannot be denied with the occurrence of events.Further information regarding patient's current clinical presentation, medical history, concomitant medications and other risk factors would aid in the complete medical assessment of the case.
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Event Description
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This case is cross-referred to case id: (b)(4) same reporter.This unsolicited case from united states was received on 22-jan-2018 from a patient.This case concerns a 61 year old female patient who received treatment with synvisc one injection and later on the same day patient was sick to stomach and after 3 hours experienced pain, after 01 day drain my knee/ took fluid out of knee and after unknown latency knee was hot, knee swollen, couldn't walk, fever, fluid was thick burgundy color.Patient had synvisc one injection before in both knees and never had a reaction to this.Patient had it 3 times before.On (b)(6) 2016 in her left knee, on (b)(6) 2016 in her right knee and on (b)(6) 2016 in her left knee.Concomitant medications included oxycodone hydrochloride/paracetamol (percocet).No relevant medical history and concurrent conditions were reported.On (b)(6) 2017, patients initiated treatment with intra- articular synvisc one injection at a dose of 1 df (dosage form) once (lot no.: 7rsl019; expiry: 31- may-2020; indication: not reported).On same date, patient received the shot and went home, elevated, iced his knee and fell asleep on the couch watching tv.On the same day, after 03 hours, patient woke up and was in so much pain that it made me sick to my stomach.On (b)(6) 2017, 01 days after the infusion, the patient had a total of 290 ccs removed of fluid from his knee from when he got the shot.At every visit, they were taking out fluid from my knee.On an unknown date in (b)(6) 2017, after unknown latency, the patient couldn't walk for a week and his knee was very hot, very swollen and he started running a fever.On an unknown date in (b)(6) 2017, after unknown latency, first time that had fluid taken out, the physician took the fluid to the lab and it was only there for 2 days and came back negative for whatever they were looking for and fluid was a thick burgundy color.Patient had all the documentation from both doctors that he saw and what their opinion.On (b)(6) 2017, patient went to an orthopedist because his original doctor went out of town.The second doctor took 30cc off his knee and put me on ciprofloxacin (cipro).On (b)(6) 2017, the doctor took 30 cc off.Doctor also gave him a hydrocortisone (cortisone)shot and methylprednisolone (medrol) dose pack.On (b)(6) 2017 45 cc was drained.On (b)(6) 2017, another 30 ccs was drained.On (b)(6) 2017, 38cc was drained.(b)(6) 2017 they did an mri because the doctors were worried about his knee and the amount of fluid was getting ridiculous (unknown results of mri).On (b)(6) 2017, another 30 cc drained and he got another hydrocortisone (cortisone) shot.On (b)(6) 2018, 15 ccs were drained so that doctor could make sure there was no infection.They knew there was no infection because he had been on ciprofloxacin.Patient was now to the point where he just had a bad knee that was in need of another gel shot.Patient was terrified to do this.Patient couldn't walk for a week.On an unknown date in (b)(6) 2017, after unknown latency, patient had to use a walker and wheel chair and couldn't even use crutches.Patient kept my leg up and iced.In the middle of night one night, patient had to get up to go to the bathroom.It took him 50 minutes to get off the couch.His experience was very bad.He was not sure if he would get another gel shot.He was the first one of doctor's patients who had reaction to the synvisc one and he had 7 other patients who had reactions.Doctor said that patient was the worst out of all his patients.No further information was known about these patients.Corrective treatment: not reported for fluid was thick burgundy color, had to use a walker and wheel chair and sick to stomach; ciprofloxacin, hydrocortisone (cortisone), methylprednisolone for pain, knee was hot, knee swollen; ciprofloxacin, hydrocortisone (cortisone), methylprednisolone, fluid was drained for drain my knee/ took fluid out of knee; ciprofloxacin for fever; outcome: not recovered/ not resolved for drain my knee/ took fluid out of knee; unknown for rest of the events a pharmaceutical technical complaint (ptc) was initiated with global ptc number: 52153 the production and quality control documentation for lot # 7rsl019 expiration date (05/2020) 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 # 7rsl019 no capa was required.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 has not indicated any safety issue.Sanofi would continue to monitor complaints in order to determine if a capa was required.Seriousness criteria: disability for couldn't walk; required intervention for pain, knee was hot, knee swollen and drain my knee/ took fluid out of knee.Additional information was received on 22-feb-2018.Global ptc number and ptc results were added.Clinical course updated.Text was amended accordingly.Pharmacovigilance comment: sanofi company comment for follow up dated 22-feb-2018: the follow up information received does not change the previous case assessment.This case concerns a female patient who received synvisc one injection and later had knee pain, swelling, warmth.Based upon the temporal gap, the causal role of the product cannot be denied with the occurrence of events.Further information regarding patient's current clinical presentation, medical history, concomitant medications and other risk factors would aid in the complete medical assessment of the case.
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Event Description
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Couldn't walk/ unable to walk [unable to walk], left knee pseudoseptic reaction [pseudosepsis] ([knee pain], [joint warmth], [swelling of l knee], [effusion (l) knee], [fever], [weight bearing difficulty], [mobility decreased], [joint stiffness]) fluid was thick burgundy color [synovial fluid analysis abnormal].Sick to stomach [stomach discomfort], chills [chills], weakness [weakness], difficult sleeping [sleep difficult], joint cracking [joint crepitation], joint locking and catching [joint lock], calf pain [calf pain].Case narrative: based on additional information received on 10-aug-2018, this case became medically confirmed.This case is cross-referred to case id: (b)(4) (same reporter).This unsolicited case from united states was received on (b)(6) 2018 from a patient.This case concerns a 61 year old female patient who received treatment with synvisc one injection and later on the same day patient was sick to stomach, couldn't walk/ unable to walk, fluid was thick burgundy color, left knee pseudoseptic reaction (9 days); chills (2 days); weakness (9 days); difficult sleeping (1 month 5 days), joint locking and catching, joint cracking (unknown).Patient had synvisc one injection before in both knees and never had a reaction to this.Patient had it 3 times before.On (b)(6) 2016 in her left knee, on (b)(6) 2016 in her right knee and on (b)(6) 2016 in her left knee.Concomitant medications included oxycodone hydrochloride/paracetamol (percocet), coumadin (warfarin sodium), nortriptyline hcl, tobramycin-dexamethasone(dexamethasone, tobramycin), zetia (ezetimibe).The patient's past medical history included obesity, osteoarthritis.The patient's past medical treatment included hylan g-f 20 from on (b)(6) 2016.No relevant medical history and concurrent conditions were reported.The patient's past vaccination(s) and family history were not provided.At the time of the event, the patient had ongoing non-tobacco user, rhinitis allergic, asthma, hyperlipidaemia, hernia, rhinitis allergic, osteoarthritis, coagulopathy, peripheral venous disease, vitamin d deficiency, myalgia, hiatus hernia and diverticulum, lumbar spinal stenosis and hypersensitivity.On (b)(6) 2017, patients initiated treatment with intra- articular synvisc one injection at a dose of 1 df (dosage form) once (lot no: 7rsl019; expiry: 31-may-2020; indication: not reported).On same date, patient received the shot and went home, elevated, iced his knee and fell asleep on the couch watching tv.On the same day, after 03 hours, patient woke up and was in so much pain that it made me sick to my stomach.On (b)(6) 2017, 01 days after the infusion, the patient had a total of 290 ccs removed of fluid from his knee from when he got the shot.At every visit, they were taking out fluid from my knee.On an unknown date in nov-2017, after unknown latency, the patient couldn't walk for a week and his knee was very hot, very swollen and he started running a fever.On an unknown date in nov-2017, after unknown latency, first time that had fluid taken out, the physician took the fluid to the lab and it was only there for 2 days and came back negative for whatever they were looking for and fluid was a thick burgundy color.Patient had all the documentation from both doctors that he saw and what their opinion.On (b)(6) 2017, patient went to an orthopedist because his original doctor went out of town.The second doctor took 30cc off his knee and put me on ciprofloxacin (cipro).On (b)(6) 2017, the doctor took 30 cc off.Doctor also gave him a hydrocortisone (cortisone)shot and methylprednisolone (medrol) dose pack.On (b)(6) 2017 45 cc was drained.On (b)(6) 2017, another 30 ccs was drained.On (b)(6) 2017, 38cc was drained.On (b)(6) 2017 they did an mri because the doctors were worried about his knee and the amount of fluid was getting ridiculous (unknown results of mri).On (b)(6) 2017, another 30 cc drained and he got another hydrocortisone (cortisone) shot.On (b)(6) 2018, 15 ccs were drained so that doctor could make sure there was no infection.They knew there was no infection because he had been on ciprofloxacin.Patient was now to the point where he just had a bad knee that was in need of another gel shot.Patient was terrified to do this.Patient couldn't walk for a week.Patient kept my leg up and iced.In the middle of night one night, patient had to get up to go to the bathroom.It took him 50 minutes to get off the couch.His experience was very bad.He was not sure if he would get another gel shot.He was the first one of doctor's patients who had reaction to the synvisc one and he had 7 other patients who had reactions.Doctor said that patient was the worst out of all his patients.No further information was known about these patients.On (b)(6) 2018 at 16:00 hours, after few hours, patient had chills.On (b)(6) 2017 patient had unable to bear weight and was on wheelchair.There was large effusion and knee was swollen and hot and had chills.On (b)(6) 2017 patient was able to bear weight and used walker.Knee was swollen and warm.Patient was only able to bend 5-110 degrees with little difficulty.Patient had white blood cell count around 8000.Synovial fluid analysis - on (b)(6) 2017: negative and thick burgundy color fluid unk [units (non-ucum): negative and thick burgundy color fluid na, protein total (high), rheumatoid factor positive] then bloody and cloudy.On (b)(6) 2017 bloody and cloudy; synovial fluid white blood cells positive (0 - 24 %): 85 %.On (b)(6) 2017 patient was ambulatory but had weakness/instability of the left lower extremity.On (b)(6) 2017 patient was feeling well after aspiration and cortisone injection.However, swelling returned.Able to ambulate without assistive device.45 cc clear fluid was aspirated.On (b)(6) 2017: bloody and cloudy, synovial fluid white blood cells positive (0 - 24 %): 54%, on (b)(6) 2017: bloody and cloudy and turbid, protein high, synovial fluid white blood cells 1 % [high].On (b)(6) 2017 patient was feeling well after aspiration and cortisone injection.However, swelling returned able to ambulate without assistive device.38 cc clear fluid was aspirated.On unknown of nov-2017 date patient had joint locking and catching, joint cracking.On an unknown date in nov-2017, after unknown latency, patient had to use a walker and wheel chair and couldn't even use crutches.On (b)(6) 2017 patient reports sleeping due to pain.Pain that awakens from sleep, joint pain, swelling, was doing well after aspiration, swelling returned, return of calf pain.Mri showed tricompartmental osteoarthritis, worse in the anterior and medial compartments/ unilateral primary osteoarthritis.Corrective treatment: not reported for joint locking and catching, joint cracking, fluid was thick burgundy color, had to use a walker and wheel chair and sick to stomach; ciprofloxacin, hydrocortisone (cortisone), methylprednisolone for pain, knee was hot, knee swollen; ciprofloxacin, hydrocortisone (cortisone), methylprednisolone, fluid was drained for drain my knee/ took fluid out of knee; ciprofloxacin for fever; cortisone for left knee pseudoseptic reaction outcome: recovering for left knee pseudoseptic reaction, couldn't walk/ unable to walk; unknown for rest of the events.A pharmaceutical technical complaint (ptc) was initiated with global ptc number: (b)(4).The production and quality control documentation for lot#: 7rsl019 expiration date (05/2020) 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#: 7rsl019 no capa was required.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 has not indicated any safety issue.Sanofi would continue to monitor complaints in order to determine if a capa was required.Seriousness criteria: disability for couldn't walk; required intervention for left knee pseudoseptic reaction.Additional information was received on 22-feb-2018.Global ptc number and ptc results were added.Clinical course updated.Text was amended accordingly.Additional information was received on 10-aug-2018 from health care professional.Based on additional information received, this case became medically confirmed.Events of joint locking and catching, joint cracking, left knee pseudoseptic reaction; chills; weakness; difficult sleeping.Event verbatim of couldn't walk/ unable to walk; knee swollen/swelling has returned/localized swelling; drain my knee/ took fluid out of knee/large effusion.Lab added.Indication added.Clinical course updated.Text was amended accordingly.Additional information was received on 10-aug-2018 from health care professional.Event corrective treatment for left knee pseudoseptic reaction was added.Concurrent conditions were added.Labs dated on (b)(6) 2018 were added.Event start date for chills was updated.Concomitant medications were added.Text was amended accordingly.
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