| Lot Number 7RSL021 |
| Device Problems
Microbial Contamination of Device (2303); Device Contamination With Biological Material (2908)
|
| Patient Problem
No Code Available (3191)
|
| Event Date 12/08/2017 |
|
Event Type
Injury
|
|
Event Description
|
|
Based on additional information received on 21-mar- 2018, this case initially considered as non-serious was upgraded to serious as earlier added non-serious event unable to walk at all on that leg updated as serious event (disability).Also additional serious event of device malfunction was added with details (disability).This unsolicited case from united states was received on 12-jan-2018 from the patient.This case concerns a (b)(6) female patient who received treatment with synvisc one injection and after few hours the patient experienced significant swelling/ swelling was mid quadriceps and down to my ankle and had pain; the same day patient was unable to walk at all on that leg, unable to bear weight, did not feel well/slept whole weekend because of not feeling well; after unknown latencies patient had atrophy of quadriceps, pain in left leg and swelling of left leg and a device malfunction was noted for reported lot number.No relevant medical history, past drugs and concurrent condition was reported.On (b)(6) 2017, at 08:00 in the morning the patient received treatment with intra-articular synvisc one injection (dose, indication, frequency and expiration date: not reported; batch/lot number: 7rsl021).By 2 pm in the afternoon patient had significant swelling and pain (latency: few hours).Patient was unable to walk at all on that leg due to the pain (latency: 0 day).By 6 pm that evening patient could not use the quadriceps or calf muscles.The swelling was up to the mid quadriceps and down to the ankle.Patient was unable to bear any weight and did not feel well (latency: 0 day).For the next 2 days, patient had 8/10 pain and slept most of the weekend due to not feeling well.On (b)(6) 2017, patient contacted the medical doctor (md) and was told to ice and elevate.On (b)(6) 2017 (wednesday; 6 days later) patient went in to see the doctor because patient still was unable to bear weight or fire the quadriceps or calf muscle.At this point patient was told about the product recall.It took another week to be able to walk with one crutch.Patient missed 4 weeks of work because by the time patient could finally bear weight.Patient had atrophy of my quadriceps.Patient was still working to rebuild the quadriceps.It was reported that, as a result of the synvisc one injection, patient had suffered, among other damages, pain and swelling of her left leg (both on unknown dates, after unknown latencies), medical expenses and wage loss action taken: unknown corrective treatment: ice and elevate for significant swelling/swelling was mid quadriceps and down to my ankle; using cutch for unable to walk at all on that leg; not reported for rest outcome: not recovered for unable to bear weight and device malfunction; unknown for rest a pharmaceutical technical complaint (ptc) was initiated with (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 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 had not indicated any safety issue.Sanofi would continue to monitor adverse events to determine if a capa was required.Seriousness criteria: disability for unable to walk at all on that leg and device malfunction additional information was received on 18-jan-2018.Global ptc number and ptc results added.Text was amended accordingly.Follow up was received on 18-jan-2018.No new information was received.Additional information was received on 21-mar-2018 from senior legal specialist.This case initially considered as non-serious was upgraded to serious as earlier added non-serious event unable to walk at all on that leg updated as serious event (disability).Also additional serious event of device malfunction was added with details (disability).Suspect drug synvisc one batch/lot number added.Additional events of device malfunction, pain in left leg and swelling of left leg were added with details.Patient age, gender and date of birth added.Clinical course was updated.Text amended accordingly.Pharmacovigilance comment: sanofi company comment dated 30-mar-2018: this case concerns a patient who received synvisc one injection from the recalled lot and later experienced pain, peripheral swelling and difficulty in walking.Since events occured on the same day of product administration a temporal relationship can be established with the product.Furthermore, the concerned lot number has been identified to have malfunction by the company.However, due to lack of information regarding medical history, concomitant medications, investigation details and past drugs complete medical assessment of the case is difficult.Therefore, the causal relationship of the events to the products cannot be excluded.
|
| |
|
Event Description
|
|
Based on additional information received on 21-mar- 2018, this case initially considered as non-serious was upgraded to serious as earlier added non-serious event unable to walk at all on that leg updated as serious event (disability).Also additional serious event of device malfunction was added with details (disability).This unsolicited case from united states was received on 12-jan-2018 from the patient.This case concerns a 54 year old female patient who received treatment with synvisc one injection and after few hours the patient experienced significant swelling/ swelling was mid quadriceps and down to my ankle and had pain; the same day patient was unable to walk at all on that leg, unable to bear weight, did not feel well/slept whole weekend because of not feeling well; after unknown latencies patient had atrophy of quadriceps, pain in left leg and swelling of left leg and a device malfunction was noted for reported lot number.No relevant medical history, past drugs and concurrent condition was reported.On (b)(6) 2017, at 08:00 in the morning the patient received treatment with intra-articular synvisc one injection (dose, indication, frequency and expiration date: not reported; batch/lot number: 7rsl021).By 2 pm in the afternoon patient had significant swelling and pain (latency: few hours).Patient was unable to walk at all on that leg due to the pain (latency: 0 day).By 6 pm that evening patient could not use the quadriceps or calf muscles.The swelling was up to the mid quadriceps and down to the ankle.Patient was unable to bear any weight and did not feel well (latency: 0 day).For the next 2 days, patient had 8/10 pain and slept most of the weekend due to not feeling well.On (b)(6) 2017, patient contacted the medical doctor (md) and was told to ice and elevate.On (b)(6) 2017 (wednesday; 6 days later) patient went in to see the doctor because patient still was unable to bear weight or fire the quadriceps or calf muscle.At this point patient was told about the product recall.It took another week to be able to walk with one crutch.Patient missed 4 weeks of work because by the time patient could finally bear weight.Patient had atrophy of my quadriceps.Patient was still working to rebuild the quadriceps.It was reported that, as a result of the synvisc one injection, patient had suffered, among other damages, pain and swelling of her left leg (both on unknown dates, after unknown latencies), medical expenses and wage loss action taken: unknown corrective treatment: ice and elevate for significant swelling/swelling was mid quadriceps and down to my ankle; using cutch for unable to walk at all on that leg; not reported for rest outcome: not recovered for unable to bear weight and device malfunction; unknown for rest a pharmaceutical technical complaint (ptc) was initiated with global ptc number: 51973 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: disability for unable to walk at all on that leg and device malfunction additional information was received on 18-jan-2018.Global ptc number and ptc results added.Text was amended accordingly.Follow up was received on 18-jan-2018.No new information was received.Additional information was received on 21-mar-2018 from senior legal specialist.This case initially considered as non-serious was upgraded to serious as earlier added non-serious event unable to walk at all on that leg updated as serious event (disability).Also additional serious event of device malfunction was added with details (disability).Suspect drug synvisc one batch/lot number added.Additional events of device malfunction, pain in left leg and swelling of left leg were added with details.Patient age, gender and date of birth added.Clinical course was updated.Text amended accordingly.Additional information was received on 05-apr-2018.Pharmacovigilance comment: sanofi company comment dated 30-mar-2018: this case concerns a patient who received synvisc one injection from the recalled lot and later experienced pain, peripheral swelling and difficulty in walking.Since events occured on the same day of product administration a temporal relationship can be established with the product.Furthermore, the concerned lot number has been identified to have malfunction by the company.However, due to lack of information regarding medical history, concomitant medications, investigation details and past drugs complete medical assessment of the case is difficult.Therefore, the causal relationship of the events to the products cannot be excluded.
|
| |
|
Event Description
|
|
Device malfunction [device malfunction].Unable to walk at all on that leg [unable to walk].Post symrisc injection reaction, possibly allergic versus infectious [joint infection].Significant swelling/swelling was mid quadricep and down to my ankle [peripheral swelling].Had trouble straightening and bending her leg/cannot flex her knee fully [joint range of motion decreased].Unable to bear weight/still having trouble putting full weight on left knee [weight bearing difficulty].Swelling of left leg [leg edema].Pain in left leg [unilateral leg pain].Didnot feel well/slept whole weekend because of not feeling well [unwell].Atrophy of quadricep [atrophy].Associated weakness in her quads from the swelling [muscle weakness].Pain [pain nos].Significant redness left knee/mild erythema around her prepatellar bursa [injection site joint erythema].Swelling left knee [swelling of l knee].Moderate-sized effusion [joint effusion].Significant pain- left knee [aching (l) knee].Post symrisc injection reaction, possibly allergic versus infectious [allergic reaction].Case narrative: based on additional information received on 21-mar-2018, this case initially considered as non-serious was upgraded to serious as earlier added non-serious event unable to walk at all on that leg updated as serious event (disability).Also additional serious event of device malfunction was added with details (disability).This unsolicited serious valid case from united states was received on 12-jan-2018 from the patient.This case concerns a 54 year old female patient who received treatment with synvisc one injection and after few hours the patient experienced significant swelling/swelling was mid quadriceps and down to my ankle (latency: same day) and had pain (latency: same day); the same day patient was unable to walk at all on that leg, unable to bear weight (latency: same day), did not feel well/slept whole weekend because of not feeling well (latency: same day) ; after unknown latencies patient had atrophy of quadriceps, pain in left leg and swelling of left leg (latency: unknown), weakness in her quads from the swelling (latency: few days), significant pain- left knee (latency: few days), significant redness left knee/mild erythema around her prepatellar bursa (latency: few days), swelling left knee (latency: few days), post synvisc injection reaction, possibly allergic versus infectious (latency: few days) and a device malfunction was noted for reported lot number.No relevant medical history, past drugs and concurrent condition was reported.On (b)(6) 2017, at 08:00 in the morning the patient received treatment with intra-articular synvisc one injection (dose, frequency and expiration date: not reported; batch/lot number: 7rsl021) for left knee osteoarthritis.It was reported that the patient tolerated the procedure well.By 2 pm in the afternoon patient had significant swelling and pain (latency: few hours).Patient was unable to walk at all on that leg due to the pain (latency: 0 day).By 6 pm that evening patient could not use the quadriceps or calf muscles.The swelling was up to the mid quadriceps and down to the ankle.Patient was unable to bear any weight and did not feel well (latency: 0 day).For the next 2 days, patient had 8/10 pain and slept most of the weekend due to not feeling well.On (b)(6) 2017, patient contacted the medical doctor (md) and was told to ice and elevate.On (b)(6) 2017 (wednesday; 6 days later) patient went in to see the doctor because patient still was unable to bear weight or fire the quadriceps or calf muscle and reported that had significant pain, redness, swelling over the weekend, had trouble straightening and bending her leg, and noted associated weakness in her quads from the swelling.At this point patient was told about the product recall.It took another week to be able to walk with one crutch (disability for unable to walk at all on that leg and device malfunction).Patient missed 4 weeks of work because by the time patient could finally bear weight.Patient had atrophy of my quadriceps.Patient was still working to rebuild the quadriceps.It was reported that, as a result of the synvisc one injection, patient had suffered, among other damages, pain and swelling of her left leg (both on unknown dates, after unknown latencies), medical expenses and wage loss.Since that time, the patient had gotten better, but had been put off by these episodes as she was still having trouble putting full weight on it and has not fully recovered on (b)(6) 2017.The patient had no fever, no chills, chest pain, shortness of breath.On physical examination, it was revealed that the patient had slightly limited range of motion, was not fully able to straighten past the last 10, 15 degrees and could not flex her knee fully secondary to swelling and had some mild erythema around her prepatellar bursa, but it did not extend around the entirety of the joint.It was assessed that there was post synvisc injection reaction, possibly allergic versus infectious (medically significant).On (b)(6) 2018, the patient elected to proceed with a left knee intraarticular corticosteroid injection, 6 cc of 0.5% bupivacaine and 5 cc of 40 mg/ml of depo-medrol were injected into the left knee via an inferolateral approach to improve pain and function.Action taken: not applicable for all events.Corrective treatment: ice and elevate for significant swelling/swelling was mid quadriceps and down to my ankle; using cutch for unable to walk at all on that leg; not reported for rest.Outcome: not recovered for unable to bear weight and device malfunction, recovering for associated weakness in her quads from the swelling, significant pain- left knee, significant redness left knee/mild erythema around her prepatellar bursa, swelling left knee, swelling left knee; unknown for rest of the events.A pharmaceutical technical complaint (ptc) was initiated for synvisc one (lot number 7rsl021) with global ptc number: (b)(4).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.Additional information was received on 18-jan-2018.Global ptc number and ptc results added.Text was amended accordingly.Follow up was received on 18-jan-2018.No new information was received.Additional information was received on 21-mar-2018 from senior legal specialist.This case initially considered as non-serious was upgraded to serious as earlier added non-serious event unable to walk at all on that leg updated as serious event (disability).Also additional serious event of device malfunction was added with details (disability).Suspect drug synvisc one batch/lot number added.Additional events of device malfunction, pain in left leg and swelling of left leg were added with details.Patient age, gender and date of birth added.Clinical course was updated.Text amended accordingly.Additional information was received on 05-apr-2018.Investigation summary results were updated.Clinical course was updated and text was amended accordingly.Additional information was received on 10-feb-2020 from lawyer.Events added for associated weakness in her quads from the swelling, significant pain- left knee, significant redness left knee/mild erythema around her prepatellar bursa, swelling left knee, swelling left knee, post synvisc injection reaction, possibly allergic versus infectious.Action taken updated.Suspect indication added.Clinical course was updated.Text amended accordingly.
|
| |
|
Search Alerts/Recalls
|
|
