Based on the information received on 28-nov-2017 the case initially processed as non-serious has been updated to serious because of addition of a serious event of device malfunction.(b)(4).This unsolicited case from united states was received on 28-nov-2017 from a nurse.This case concerns (b)(6) female patient who received treatment with synvisc one and later after unknown latency had right knee swelling no medical history, concomitant medication or concurrent condition was provided.Patient had repeat synvisc one injection.On (b)(6) 2017, the patient initiated treatment with intra-articular synvisc one injection once (dose and indication: unknown) (batch/lot number: 7rsl021, expiry date: may-2020) in right knee.On an unknown date in (b)(6) 2017, after unknown latency, patient complained of knee swelling corrective treatment: not reported.Outcome: unknown.(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 is under investigation.Once this investigation is completed, corrective and preventive actions will be implemented.Seriousness criteria: important medical event for device malfunction.Additional information was received on 28-nov-2017 and 17-dec-2017 (both the information were processed with the clock start date of 28-nov-2017).Global ptc number and ptc results were added.An additional event of device malfunction was added with details.Clinical course was updated and text was amended accordingly.Pharmacovigilance comment: sanofi company comment for follow up dated 28-nov-2017: this case concerns a patient who has received synvisc one injection from the recalled lot and experienced right knee swelling.The events are temporally related to device.Moreover, 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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