This spontaneous case from united states was received on 26-jan-2018 from patient this case concerns female (age: not provided) patient who initiated treatment with synvisc one and on the same day had swelling, redness, pain; after few days fluid was drawn from the knee; after an unknown latency can barely walk, also, device malfunction was identified for the reported lot number.No medical history, previous medications, concomitant medications and concurrent conditions were reported.Patient had a pacemaker on an unknown date in (b)(6) 2017, patient received treatment with intra articular synvisc one injection at a dose of 6 ml for right knee osteoarthritis once (batch/ lot number: 7rsl021 and expiry date: unknown).On the same day, had swelling, redness, and pain.On an unknown date in (b)(6) 2018, after a latency of few days, fluid was drawn from the knee.It was reported that patient could barely walk.She continued to have pain.Corrective treatment: not reported for all events.Outcome: not recovered for all 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 01-feb-2018: this case concerns a female patient who received synvisc one injection from the recalled lot and had swelling, redness, and pain, could barely walk and fluid was drawn from her knee.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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