This spontaneous case from united states was received on (b)(6) 2017 from other non-healthcare professional.This case concerns a patient (demographics; not provided) who initiated treatment with synvisc one and after unknown latency had adverse events, also, device malfunction was identified for the reported lot number.No medical history, previous medications, concomitant medications and concurrent conditions were reported.On an unknown date, patient received treatment with intra articular synvisc one injection at a dose of 1 df once (indication: not provided; batch/ lot number: 7rsl021 and expiry date: unknown).On an unknown date, after an unknown latency, had adverse events.Corrective treatment: not reported for had adverse events.Outcome: unknown for both events.Seriousness criteria: important medical event for device malfunction: 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.Pharmacovigilance comment: sanofi company comment dated (b)(4) 2017: this case concerns a patient who has received synvisc one injection from the recalled lot and later experienced adverse event.A temporal relationship could not be established with the product administration.However, 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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