Based on additional information received on 14-nov-2017 and 22-feb-2018, both the information was processed together with clock start date 14-nov-2017, this case initially considered as non-serious was upgraded to serious: [event of device malfunction with seriousness criteria important medical event was added].This case was cross referenced with (b)(4) (cluster).This unsolicited case from united states was received on 14-nov-2017 from the other non-health care professional.This case concerns six patients (age and gender unspecified) who received treatment with synvisc one injection and after unknown latencies the patients could barely walk, extreme painful knee and extreme swollen knee.Also, device malfunction was identified for the reported lot number.No relevant medical history, past medications and concomitant medications were reported.On unknown dates, the patients received treatment with intra-articular synvisc one injection (dose, frequency, indication and expiration date: not reported; lot number: 7rsl021).On unknown dates, after unknown latencies the patients complained of extreme painful knee which they could barely walk on.On unknown dates, after unknown latencies patient had extreme leg pain.Action taken: unknown.Corrective treatment: not reported for all the events outcome: unknown for all the events seriousness criterion: important medical event for device malfunction a pharmaceutical technical complaint (ptc) was initiated with global ptc number 52633.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 was completed, corrective and preventive actions would be implemented.Reporter causality: related.Additional information was received on 14-nov-2017 and 22-feb-2018, both the information was processed together with clock start date 14-nov-2017.Case was upgraded to serious.Additional event of device malfunction was added.Investigation summary and gptc number was added.Text was amended accordingly.Pharmacovigilance comment: sanofi company comment dated 14-nov-2017: this case concerns a patient who received synvisc one injection from the recalled lot.A temporal relationship can be established with the product administration.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.
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