This unsolicited case from united states was received on 22-jan-2018 from a non-healthcare professional.This case concerns a patient with unknown demographics who received treatment with synvisc one and 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 at a dose of 1 df once (indication: unknown; bilateral injection) (batch/ lot number: 7rsl021, expiry date: unknown) with affected lot.Device malfunction was identified for the reported lot number.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 would be completed, corrective and preventive actions would be implemented.Seriousness criteria: important medical event for device malfunction.Pharmacovigilance comment: sanofi company comment for follow up dated 27-jan-2018: this case concerns a patient who received bilateral synvisc one injections from the recalled lot.The concerned lot number has been identified to have malfunction by the company.
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