(b)(4).This unsolicited case from united states was received on 11-dec-2017 from a non-healthcare professional.This case concerns a female patient of unknown age who received treatment with synvisc one and after 12 days had one knee reaction.Also device malfunction was identified for the reported lot number.No past drug, medical history, concomitant medication or concurrent condition was provided.On (b)(6) 2017, the patient initiated treatment with intra-articular synvisc one injection once (dose, and indication: not provided) (batch/lot number: 7rsl021; expiry date: unknown).On (b)(6) 2017, 12 days after receiving treatment with synvisc one, the patient had one knee reaction.Corrective treatment: not reported for one knee reaction.Outcome: unknown for both events.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.Seriousness criteria: important medical event for device malfunction pharmacovigilance comment: sanofi company comment dated 26-dec-2017: this case concern a female patient who received bilateral synvisc one injections from the recalled lot and had one knee reaction.A 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.
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