Based on the information received on 19-dec-2017 the case was upgraded to serious as the important medical event of device malfunction was added.This case was cross reference with (b)(4) (cluster) this unsolicited case from united states was received on 04-dec-2017 from other non-health care professional this case concerns 4 patients (demographics unspecified) who received treatment with synvisc one and after an unknown latency had swollen knees.A device malfunction was also noted for the reported lot number.No medical history, past drugs, concomitant medication or concurrent condition was provided.On an unknown date in (b)(6) 2017, the patients initiated treatment with intra-articular synvisc one injection (batch/lot number: 7rsl021; dose, frequency, indication and expiry date: not reported).On an unknown date in (b)(6) 2017, after unknown latency, patients had reactions of "swollen knees".It was reported that all injections happened late last week.Action taken: unknown.Corrective treatment: not reported for swollen knees.Outcome: unknown for both events.Seriousness criteria: important medical event for device malfunction.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 19-dec-2017.Event of device malfunction was added.Global ptc umber and ptc results were added.Clinical course was updated and text amended accordingly.Pharmacovigilance comment: sanofi company comment follow up dated 19-dec-2017: this case concerns a patient who suffered with swelling of knees after receiving synvisc one injection from the recalled lot.Although exact event onset date has not been provided in the case, temporal relationship can still be established between the events and the suspect product based on the available information.Additionally, as the concerned lot number has been identified to have malfunction by the company.Therefore, pharmacological plausibility of the events to the product cannot be excluded.
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