|
Based on the information received on 11-apr-2018 the case became medically confirmed.The case was upgraded to serious as a serious event of device malfunction and right knee fluid had gram stain 1+ were added.This unsolicited case from united states was received on 18-jan-2018 from patient.This case concerns a (b)(6) female patient who received treatment with synvisc one injection and after 15 days had right knee fluid had gram stain 1+, synovitis.A device malfunction was noted for the reported lot number.No past drug, concomitant medication was provided.Patient with a history of osteoarthritis (oa) in both knees.Patient able to bear weight but with pain but no need of assistant before injection.Pain before was 2 out of 10 and 10 being the worse pain.Patient did not have any prosthetic device e.G.Prosthetic hip/knee, prosthetic valve, pacemaker and or defibrillator.Patient had no previous/concomitant treatment with immunosuppressants.Patient had no allergy history: avian proteins, feathers, or egg products.Patient had no history of history of diabetes, immune-compromise, infections.T was reported that the patient was given prior steroid injection along with triamcinolone acetonide (kenalog) to treat osteoarthritis (off label use) in both knees during the procedure by physician.On (b)(6) 2017, patient received treatment with intra- articular synvisc one injection, at a dose of 6 ml once (batch/lot number: 7rsl022 and 7rsl021 and expiration date: may-2020 and apr-2020) for osteoarthritis both knees.On (b)(6) 2018, after 35 days of receiving synvisc one injection, the patient was complaining of swelling and tenderness in both knees.Patient said the physician drained 50 cc of fluid from the patient's right knee and none from her left knee.Patient had a 2 plus right knee infusion only.Patient had blood work done on (b)(6) 2018, and the wbc had no organism seen.It was reported that the right knee fluid result showed gram stain 1+.Physician told the patient to elevate and use ice compacts on the knees along with nsaid medications.On (b)(6) 2018, the patient again return with swelling and tenderness in both knees and the physician drained both knees but the amount of fluid was not known at this time.On (b)(6) 2018, patient both knee had undetermined swelling at this time.Physician again told the patient to ice and elevate her knees.Physician has not make a return appointment for the patient about her knees.It was reported that the patient was recovering.Patient did not receive any other injection prior to treatment with synvisc or other hyaluronan products.Corrective treatment: corticosteroid injection for synovitis; not reported for other events outcome: recovered for all events 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 was completed, corrective and preventive actions would be implemented.The production and quality control documentation for lot # 7rsl011 expiration date (04/2020) 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 # 7rsl011 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.Seriousness criteria: required intervention for synovitis and device malfunction; important medical event for right knee fluid had gram stain 1+ as of 13-mar-2018, there were 2 complaints on file for lot # 7rsl011: 2 adverse event reports.Sanofi would continue to monitor complaints as stated in sop rdg-sop-000440 "product complaint handling" to determine if a capa was required.The production and quality control documentation for lot # 7rsl022 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 # 7rsl022 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.As of 14-mar-2018, there were 19 complaints on file for lot # 7rsl022: (18) adverse event reports and (1) leaky syringe.Sanofi would continue to monitor complaints as stated in sop rdg-sop-000440 "product complaint handling" to determine if a capa was required.Additional information was received on 14-mar-2018.Investigation summary and gptc number was added.Text was amended accordingly.Additional information was received on 11-apr-2018 from physician.Event of device malfunction and right knee fluid had gram stain 1+ were added.Case upgraded to serious.Case became medically confirmed.Clinical course was updated and text amended accordingly.Pharmacovigilance comment: sanofi company comment dated: 11-apr-2018: based on the information received about product administration and date of event a significant temporal relationship can be established and causal role of the product cannot be denied in occurence of the events.Furthermore, the concerned lot number has been identified to have malfunction by the company.However, information regarding medical history, concomitant medications, investigation details and past drugs will aid in complete medical assessment of the case.
|
