This spontaneous case from united states was received on (b)(6) 2018 from the patient.This case concerns a patient (demographics not provided) who initiated treatment with synvisc one and after unknown latency had device malfunction and increased pain.No medical history, previous medications, concurrent conditions or concomitant medications were reported.On an unknown date, patient received treatment with intra articular synvisc one injection (unknown dose) (batch/ lot number: 7rsl021 and expiry date: unknown).On unknown dates, after unknown latencies, the patient had device malfunction and increased pain.The patient had increased pain for 3 weeks.Later it was found that this lot number had been recalled.Event abated after use stopped or dose reduced.Action taken: unknown corrective treatment: not reported for both 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 27-feb-2018: this case concerns a patient who has received synvisc one injection from the recalled lot and later experienced increased pain.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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