Based on additional information received on 08-dec- 2017, this case initially considered as non-serious was upgraded to serious (important medical event of device malfunction).This unsolicited case from united states was received on 08-dec-2017 from a pharmacist.This case concerns a (b)(6) male patient who received treatment with synvisc one and later after unknown latency had significant inflammation; also, device malfunction was identified for the reported lot number.No past drug, medical history, concomitant medication or concurrent condition was provided.On an unknown date, the patient initiated treatment with intra-articular synvisc one injection once at a dose of 6 ml (indication: unknown) (batch/lot number: 7rsl021; expiry date: unknown).On an unknown date, after unknown latency the patient experienced significant inflammation, pain, redness and effusion that required subsequent treatment.Corrective treatment: unspecified treatment for significant inflammation.Outcome: recovering for both.A pharmaceutical technical complaint (ptc) was initiated and (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 was under investigation.Once this investigation is completed, corrective and preventive actions would be implemented.Seriousness criterion: important medical event of device malfunction additional information was received on 08-dec-2017.Global ptc number was added.Additional event of device malfunction was added with details.Clinical course updated and text was amended accordingly.Pharmacovigilance comment: sanofi company comment for follow up dated 08-dec-2017: this case concerns a male patient who received synvisc one injection from the recalled lot and had significant inflammation with pain, redness and effusion.As the concerned lot number has been identified to have malfunction by the company, the causal relationship of suspect product cannot be ruled out with the occurrence of adverse events.
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