This unsolicited case from united states was received on 12-dec-2017 from nurse.This case concerns 12 patients who received treatment with synvisc one injection and after unknown latency had redness, swelling and pain.Also device malfunction was identified for the reported lot number.No medical history, past drug, concomitant medication and concurrent condition was provided.On unknown dates, patients received treatment with intra- articular synvisc one injection, (batch/lot number: 7rsl021 and expiration date, dose, frequency, indication: not provided).On unknown dates, after unknown latencies, patients had reactions i.E redness, swelling and pain.Action taken: unknown corrective treatment: not reported for redness, swelling and pain outcome: unknown for device malfunction, redness, swelling and pain 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.
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