|
This unsolicited case from united states was received on (b)(6) 2018 from the patient.This case concerns a 65 year old female patient who received treatment with synvisc one injection and after unknown latency experienced atrial fibrillation, he could hardly walk; fever, chills, gets redness and gets some fluid.No relevant medical history, past drugs and concurrent condition was reported.Concomitant medication included testosterone.On (b)(6) 2017, the patient received treatment with intra-articular synvisc one injection once (dose, indication: not reported) in the both knees.On an unspecified date of 2017 after unknown latency starting the day before thanksgiving day, it was reported that the patient received the injections in the afternoon and that night he had fever and chills and he was subsequently hospitalized with atrial fibrillation.On an unspecified date of 2017 after unknown latency, the day after the injections he could hardly walk.He called the doctor and he prescribed a medrol pack.The patient showed the lot number.The patient was upset that the doctor did not notify him about the recall.He found out by accident when he heard about lawsuits that were going to be filed and checked his lot number.The patient had problems for four months after the injection and was getting physical therapy now.The patient still got redness and some fluid.His right knee was worsened than the left.No additional information was provided.Corrective treatment: methylprednisolone (medrol) and physical therapy for he could hardly walk; not reported for other events.Outcome: not recovered for gets redness and gets some fluid; unknown for all the events.Seriousness criteria: hospitalization for atrial fibrillation; required intervention for he could hardly walk.A product technical complaint was initiated with global ptc number: 53024.The product lot number was not provided; therefore, a batch record review is not possible.Based on the lack of information provided, no capa is required.It is the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result is 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 has not indicated any safety issue.Sanofi will continue to monitor adverse events to determine if a capa is required.Additional information was received on 16-mar-2018.Global ptc number and results were added.Pharmacovigilance comment: sanofi follow-up company comment dated 16-mar-2018: the follow-up information received does not alter the overall case assessment.This case concern a patient who was on treatment with synvisc one and hospitalised with atrial fibrillation and experienced walking difficulty the role of the drug cannot be assessed for the occurrence of the events due to the suspect product.However, further information regarding patient's current clinical presentation, medical history, concomitant medications and other risk factors precludes the complete medical case assessment.
|
|
Device malfunction [device malfunction] atrial fibrillation [atrial fibrillation] he could hardly walk [walking difficulty] fever [fever] chills [chills] gets redness [injection site erythema] gets some fluid [knee effusion].Case narrative: this case was cross referenced to (b)(4).This unsolicited legal case from united states was received on 08-mar-2018 from the patient.This case concerns a 65 year old female patient who received treatment with synvisc one injection and after unknown latency experienced atrial fibrillation, he could hardly walk; fever, chills, gets redness and gets some fluid, device malfunction.No relevant medical history, past drugs and concurrent condition was reported.Concomitant medication included testosterone.On 30-oct-2017, the patient received treatment with intra-articular synvisc one injection, dose 6 ml, once in the both knees lateral for primary osteoarthritis in both knees (lot number 7rsl021).On an unspecified date of 2017 after unknown latency starting the day before thanksgiving day, it was reported that the patient received the injections in the afternoon and that night he had fever and chills and he was subsequently hospitalized with atrial fibrillation.On an unspecified date of 2017 after unknown latency, the day after the injections he could hardly walk.He called the doctor and he prescribed a medrol pack.The patient showed the lot number.The patient was upset that the doctor did not notify him about the recall.He found out by accident when he heard about lawsuits that were going to be filed and checked his lot number.The patient had problems for four months after the injection and was getting physical therapy now.The patient still got redness and some fluid.His right knee was worsened than the left.No additional information was provided.Also, device malfunction was identified for the reported lot number.Corrective treatment: methylprednisolone (medrol) and physical therapy for he could hardly walk; not reported for other events.Outcome: not recovered for gets redness and gets some fluid; unknown for all the events.Seriousness criteria: medically significant, hospitalization for atrial fibrillation, device malfunction; required intervention for he could hardly walk, device malfunction.A product technical complaint 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 was under investigation.Once this investigation is completed, corrective and preventive actions would be implemented.Additional information was received on 16-mar-2018.Global ptc number and results were added.Follow up information was received on 16-nov-2018.No new information was received.Additional information was received on 16-nov-2018 from non-healthcare professional.Lot number for suspect added.Event added for device malfunction added.Indication added.Related id was added.Therapy details updated.Clinical course was updated and text amended accordingly.
|
|
Device malfunction [device malfunction] he could hardly walk/ difficulty walking/gait instability/limping/ unsteady gait/loss of motion [walking difficulty] cancer [cancer] synvisc flair [inflammatory reaction] ([knee pain], [condition worsened], [joint swelling], [synovial fluid white blood cells positive], [joint stiffness], [knee effusion]) fever [fever] chills [chills] gets redness [injection site erythema] weakness [weakness] functional limitations [joint range of motion decreased] difficulty descending stairs, sitting, ascending stairs, getting up from a chair, kneeling, squatting.[activities of daily living impaired] case narrative: this case was cross referenced to (b)(4).(same patient).This unsolicited legal case from united states was received on 08-mar-2018 from the patient.This case concerns a 65 year old male patient who received treatment with synvisc one injection and after unknown latency experienced he could hardly walk/ difficulty walking/gait instability/limping/ unsteady gait/loss of motion, fever, chills, gets redness, synvisc flair, weakness, joint stiffness, functional limitations, difficulty descending stairs, sitting, ascending stairs, getting up from a chair, kneeling, squatting, cancer, device malfunction(latencies: unknown).Patient's past medical history included arthritis, non-smoker and drug allergies to sulfa (sulfonamide antibiotics- rash, swelling and nausea), gerd, hypertension, hypothyroidism, testicular cancer, atrial fibrillation, radiation therapy.Patient's surgical history included cholecystectomy and thyroidectomy.No relevant past drugs and concurrent condition was reported.Concomitant medication included testosterone, apixaban (eliquis) and sotalol.On (b)(6) 2017, the patient received treatment with intra-articular synvisc one injection, dose 6 ml, once in the both knees lateral for primary osteoarthritis in both knees (lot number 7rsl021).On an unspecified date of 2017 after unknown latency starting the day before thanksgiving day, it was reported that the patient received the injections in the afternoon and that night he had fever and chills and he was subsequently hospitalized with atrial fibrillation.On an unspecified date of 2017 after unknown latency, the day after the injections he could hardly walk.He called the doctor and he prescribed a medrol pack.The patient showed the lot number.The patient was upset that the doctor did not notify him about the recall.He found out by accident when he heard about lawsuits that were going to be filed and checked his lot number.The patient had problems for four months after the injection and was getting physical therapy now.The patient still got redness and some fluid.His right knee was worsened than the left.No additional information was provided.Also, device malfunction was identified for the reported lot number.Since an unknow date, patient had knee pain (both knees) which was located all over the knee (diffuse).This occurred in the context of gradual and insidious onset.Patient reported that knee pain occurred with weight bearing and was described as sharp, stabbing, associated with pressure, throbbing, radiating , gait instability, limping, joint swelling and weakness.Knee pain was currently 3 out of 10 but on bad days it was 8 out of 10.He also reported of functional limitations, difficulty descending/ascending stairs, sitting, getting up from a chair, kneeling, squatting, standing and walking.Based on patient's description, physician reported that patient had a synvisc flair up to both knees immediately after the injections and he felt that he had been in more pain since then.On (b)(6) 2018, x-ray results for both left knee and right knee were varus alignment, osteophytes, distal femur, osteophytes, patella and diffuse degenerative changes.Bone on bone, medial compartment.In left knee, however, soft tissue exam showed normal soft tissue.On the same day, both the knees were aspirated , patient was positioned appropriately, overlying skin was prepped with hibiciens and ethyl chloride was applied for topical anesthesia.3 cc of straw colored fluid was aspirated.The fluid was sent off for the following studies: bacterial culture, sensitivity, fungal culture and sensitivity.A total of 2 injections into the right knee and left knee were performed with 1 ml of methylprednisolone acetate(depomedrol), 40 mg with 4 ml of 1% lidocaine without epinephrine.Patient tolerated the procedure well without complications or pain.Patient was recommended therapeutic exercises.On(b)(6) 2018, lab results showed rare white blood cells in synovial fluid of right knee and for left knee the results were normal.Corrective treatment: methylprednisolone (medrol) and physical therapy for he could hardly walk; methylprednisolone acetate, lidocaine without epinephrine for synvisc flair ; not reported for other events.Outcome: not recovered for gets redness; unknown for all the events.Seriousness criteria: medically significant, hospitalization for atrial fibrillation, device malfunction; required intervention for he could hardly walk, device malfunction and synvisc flair; medically significant for cancer.A product technical complaint 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 was under investigation.Once this investigation is completed, corrective and preventive actions would be implemented.Additional information was received on 16-mar-2018.Global ptc number and results were added.Follow up information was received on 16-nov-2018.No new information was received.Additional information was received on 16-nov-2018 from non-healthcare professional.Lot number for suspect added.Event added for device malfunction added.Indication added.Related id was added.Therapy details updated.Clinical course was updated and text amended accordingly.Additional information received on 07-feb-2019 from non-healthcare professional.Additional events of synvisc flair, weakness, joint stiffness, functional limitations, difficulty descending stairs, sitting, ascending stairs, getting up from a chair, kneeling, squatting, cancer were added with details.Medical history added.Concomitant medications added.Clinical course updated and text amended accordingly.
|
