Lot Number 7RSL021 |
Device Problem
Device Contamination With Biological Material (2908)
|
Patient Problems
Pain (1994); Swelling (2091); Reaction, Injection Site (2442); Ambulation Difficulties (2544)
|
Event Date 12/06/2017 |
Event Type
malfunction
|
Event Description
|
Based on additional information received on 27-feb- 2018, this case initially processed as non-serious was upgraded to serious as additional event of device malfunction was added.Additionally, the case became medically confirmed.This unsolicited case from united states was received on 16-jan-2018 from the patient.This case concerns a (b)(6) female patient with unspecified age who received treatment with synvisc one injection and 01 day later the patient had a whole lot of swelling/swelling/swelling that bad and it was awful/unbelievably swollen, had device malfunction, pain in left knee; few days later was a little itchy and couldn't even walk/couldn't walk/couldn't put her feet on the floor.The patient was a non-smoker, had no history of alcohol or drug use and was sexually active.Concomitant medications included naproxen sodium (aleve) and ibuprofen for arthritic pain in both knees; gabapentin (neurontin), metoprolol succinate (toprol xl), furosemide (lasix), hydrochlorothiazide/losartan potassium (hyzaar) and dyazide (maxzide).The patient had no known allergies.The patient had primary osteoarthritis of both knees.The patient had a long history of arthritic pain in both knees.She previously applied a cream to her knees, but found this quite expensive and not very helpful.She has had both hyaluronic acid (orthovisc) and cortisone steroid injections into her knees in the past.She reports that she got no relief from this and in fact her pain was worse.She then had a visco supplementation injection scheduled for right knee in (b)(6) 2017, but her doctor advised her not to proceed with it.The patient had essential hypertension (since 1996), fibroids, enthesopathy of hip region - l troch, osteoarthritis l thumb mp joint, hot flashes, sprain of foot, unspecified site, osteoarthrosis involving lower leg, oligomenorrhea, sebaceous cyst, pruritus ani, primary osteoarthritis of both knees, patellofemoral arthritis and migraine.Medical history included tricuspid regurgitation, mitral regurgitation, lvh (left ventricular hypertrophy), carcinoma in situ of cervix uteri (1999), leiomyoma (2005), severe knee crepitus and cold sore.Surgical history included wisdom tooth extraction, cervix conization ((b)(6) 1999), diagnostic colonoscopy ((b)(6) 2013) and full routine obstetrician care with vaginal delivery.On (b)(6) 2017, the patient was at the hospital for right knee pain and the patient received treatment with intra-articular synvisc one injection at a dose of 06 ml for osteoarthritis and knee pain once (lot number: 7rsl021) (expiration date: not reported) after sterile prep in right knee.The patient tolerated the procedure without complications.Post injection pain was discussed.On (b)(6) 2017, 01 day after first dose of synvisc one injection, at 09:44 hours, the patient stated that her right knee was really swollen and hurting.Patient stated that she would like to speak with the nurse regarding if this was normal or if she should be concerned.The same day, at 10:02 hours, the patient was spoken to at length and stated she was not made aware of the symptoms that were associated with the gel injection and states she was having pain and swelling to the left knee.The injection resulted in a "whole lot of swelling" and patient couldn't even walk (latency: unknown).The patient wasn't sure if she had received the recalled lot.Patient stated that she thought it was odd and that she was on crutches for 3-4 days.Patient stated that she called the provider and they told her it was common to have swelling but she never had swelling that bad and it was "awful".Patient stated that she normally gets the three injections that were given a week apart but they told her that this was one for the price of three.Patient stated that she never had a shot before were she couldn't walk.Patient stated that it was unbelievably swollen and that it was a little itchy (latency: unknown).Patient stated that she couldn't put her feet on the floor.Patient stated that she was due for a knee replacement.Patient stated that it had "went down" in terms of the swelling.On 22-dec-2017, the patient was looking for the a copy of the procedure order for her knee replacement being done on (b)(6) 2018.Patient was requesting her records from medical records.Informed patient she would need to sign a release of information and we will send it to medical records.On 18-jan-2018, the patient states she received a letter regarding the synvisc injection she received on.She received an injection from the recalled lot 7rsl021 and was asking how she should proceed with this and was guided.The same day, the pain in left knee and swelling in knee recovered.Action taken: unknown corrective treatment: crutches for couldn't even walk/couldn't walk/couldn't put her feet on the floor; not reported for rest.Outcome: recovered for pain in left knee and device malfunction, whole lot of swelling/swelling/swelling that bad and it was awful/unbelievably swollen; unknown for rest seriousness criteria: disability for device malfunction and couldn't even walk/couldn't walk/couldn't put her feet on the floor a pharmaceutical technical complaint (ptc) was initiated with (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 23-jan-2018.Global ptc number and ptc results added.Text was amended accordingly.Follow up information was received on 30-jan-2018.No new information was received.Additional information was received on 27-feb-2018 from a medical doctor.Case became medically confirmed.Additional events of device malfunction and pain in left knee were added.Suspect product therapy regimen was updated.Concomitant medications were added.Investigation summary results were updated.Event latencies were updated.Clinical course was updated and text was amended accordingly.Pharmacovigilance comment: sanofi company comment follow up dated 27-feb-2018: this case concerns a patient who has received synvisc one injection from the recalled lot and later experienced knee swelling and knee pain.Temporal relationship can be established with the product administration.Furthermore, the concerned lot number has been identified to have malfunction by the company.Therefore, the causal relationship of the events to the products cannot be excluded.
|
|
Event Description
|
Based on additional information received on 27-feb- 2018, this case initially processed as non-serious was upgraded to serious as additional event of device malfunction was added.Additionally, the case became medically confirmed.This unsolicited case from united states was received on 16-jan-2018 from the patient.This case concerns a 55 year old female patient with unspecified age who received treatment with synvisc one injection and 01 day later the patient had redness around the injection site, a whole lot of whole lot of swelling/swelling/swelling that bad and it was awful/ unbelievably swollen/ swelling to left knee, pain in left knee/knee very sore and tender; few days later was a little itchy and couldn't even walk/couldn't walk couldn't put her feet on the floor;.Device malfunction was reported for the provided lot number.The patient was a non-smoker, had no history of alcohol or drug use & was sexually active.Concomitant medications included naproxen sodium (aleve) and ibuprofen for arthritic pain in both knees; diclofenac sodium (diclofenac) for knee pain, gabapentin (neurontin), metoprolol succinate (toprol xl), furosemide (lasix), hydrochlorothiazide/losartan potassium (hyzaar) and dyazide (maxzide).The patient had no known allergies.The patient had primary osteoarthritis of both knees.The patient had a long history of arthritic pain in both knees.She previously applied a cream to her knees, but found this quite expensive and not very helpful.She has had both hyaluronic acid (orthovisc) and cortisone steroid injections into her knees in the past.She reports that she got no relief from this and in fact her pain was worse.She then had a viscosupplementation injection scheduled for right knee in (b)(6) 2017, but her doctor advised her not to proceed with it.The patient had essential hypertension (since 1996), fibroids, enthesopathy of hip region - l troch, osteoarthritis l thumb mp joint, hot flashes, sprain of foot, unspecified site, osteoarthrosis involving lower leg, oligomenorrhea, sebaceous cyst, pruritus ani, primary osteoarthritis of both knees, patellofemoral arthritis and migraine.Medical history included tricuspid regurgitation, mitral regurgitation, lvh (left ventricular hypertrophy), carcinoma in situ of cervix uteri (1999), leiomyoma (2005), severe knee crepitus and cold sore.Surgical history included wisdom tooth extraction, cervix conization (jan-1999), diagnostic colonoscopy ((b)(6) 2013) and full routine obstetrician care with vaginal delivery.On (b)(6) 2017, the patient was at the hospital for right knee pain and the patient received treatment with intra-articular synvisc one injection at a dose of 06 ml for osteoarthritis and knee pain once (lot number: 7rsl021) (expiration date: not reported) after sterile prep in right knee.The patient tolerated the procedure without complications.Post injection pain was discussed.On (b)(6) 2017, 01 day after first dose of synvisc one injection, at 09:44 hours, the patient stated that her right knee was really swollen and hurting.It was reported that the patient had severe swelling in the knee and redness around the injection site.Also, reported that the patient couldn't walk after receiving the injection.Patient stated that she would like to speak with the nurse regarding if this was normal or if she should be concerned.The same day, at 10:02 hours, the patient was spoken to at length and stated she was not made aware of the symptoms that were associated with the gel injection and states she was having pain and swelling to the left knee.The injection resulted in a "whole lot of swelling" and patient couldn't even walk (latency: unknown).The patient wasn't sure if she had received the recalled lot.On (b)(6) 2018, the knee was very sore and tender for around couple of weeks.Patient stated that she thought it was odd and that she was on crutches for 3-4 days.Patient stated that she called the provider and they told her it was common to have swelling but she never had swelling that bad and it was "awful".Patient stated that she normally gets the three injections that were given a week apart but they told her that this was one for the price of three.Patient stated that she never had a shot before were she couldn't walk.Patient stated that it was unbelievably swollen and that it was a little itchy (latency: unknown).Patient stated that she couldn't put her feet on the floor.Patient stated that she was due for a knee replacement.Patient stated that it had "went down" in terms of the swelling.On (b)(6) 2017, the patient was looking for the a copy of the procedure order for her knee replacement being done on (b)(6) 2018.Patient was requesting her records from medical records.Informed patient she would need to sign a release of information and we will send it to medical records.On (b)(6) 2018, the patient states she received a letter regarding the synvisc injection she received on.She received an injection from the recalled lot 7rsl021 and was asking how she should proceed with this and was guided.The same day, the pain in left knee and swelling in knee recovered.On an unknown date, patient recovered from redness around the injection site.Corrective treatment: crutches for couldn't even walk/couldn't walk/couldn't put her feet on the floor; none for the events of whole lot of swelling/swelling/swelling that bad and it was awful/unbelievably swollen/ swelling to left knee and redness around the injection site; not reported for rest outcome: recovered for redness around the injection site, pain in left knee and device malfunction, whole lot of whole lot of swelling/swelling/swelling that bad and it was awful/unbelievably swollen/ swelling to left knee; not recovered/ not resolved for couldn't even walk/couldn't walk/couldn't put her feet on the floor; unknown for rest seriousness criteria: disability for device malfunction and couldn't even walk/couldn't walk/couldn't put her feet on the floor a pharmaceutical technical complaint (ptc) was initiated 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 23-jan-2018.Global ptc number and ptc results added.Text was amended accordingly.Follow up information was received on 30-jan-2018.No new information was received.Additional information was received on 27-feb-2018 from a medical doctor.Case became medically confirmed.Additional events of device malfunction and pain in left knee were added.Suspect product therapy regimen was updated.Concomitant medications were added.Investigation summary results were updated.Event latencies were updated.Clinical course was updated and text was amended accordingly.Additional information was received 06-mar-2018 from the patient.Patient's concomitant medication updated.Additional event of redness around the injection site was added with details.Event verbatim for whole lot of swelling/swelling/swelling that bad and it was awful/unbelievably swollen was updated to whole lot of swelling/swelling/swelling that bad and it was awful/unbelievably swollen/ swelling to left knee and for pain in left knee was updated to pain in left knee/knee very sore and tender.Event onset date for whole lot of swelling/swelling/swelling that bad and it was awful/unbelievably swollen/ swelling to left knee and couldn't even walk/couldn't walk/couldn't put her feet on the floor were updated from (b)(6) 2017 and its corrective treatment updated.Outcome for the event of couldn't even walk/couldn't walk/couldn't put her feet on the floor was updated from unknown to not recovered.Action taken was updated from unknown to not applicable.Patient's clinical course was updated and text was amended accordingly.Pharmacovigilance comment: sanofi company comment follow up dated 06-mar2018: follow up received doesnot change previous case assessment.This case concerns a patient who has received synvisc one injection from the recalled lot and later experienced knee swelling and knee pain.Temporal relationship can be established with the product administration.Furthermore, the concerned lot number has been identified to have malfunction by the company.Therefore, the causal relationship of the events to the products cannot be excluded.
|
|
Search Alerts/Recalls
|
|