Based upon additional information received on 22-nov- 2017, the case initially assessed as non-serious was upgraded to serious as the serious event of device malfunction with the seriousness criterion of important medical events was added.This unsolicited case from united states was received on 15-nov-2017 from the other non-health care professional.This case concerns a male patient (age unspecified) who received treatment with synvisc one injection and after unknown latency the patient experienced increased leg pain and leg swelling; also, device malfunction was identified for the reported lot number.No relevant medical history, past medication and concomitant medications were reported.On (b)(6) 2017, the patient received treatment with intra-articular synvisc one injection, at the dose of 48 mg once (lot number: 7rsl021 and expiration date: not reported) for knee osteoarthritis.On an unknown date in (b)(6) 2017, after unknown latency the patient experienced increased leg pain and leg swelling.Corrective treatment: icing, hydrocodone for increased leg pain; not reported for leg swelling and device malfunction.Outcome: unknown for all the events.A pharmaceutical technical complaint (ptc) was initiated with global ptc number: (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 would be completed, corrective and preventive actions would be implemented.Seriousness criterion: important medical event (ime) for device malfunction additional information was received on 22-nov-2017.The serious event of device malfunction with the seriousness criterion of ime was added with details and the case was upgraded to serious.The ptc results were added and text amended accordingly.Pharmacovigilance comment: sanofi company comment for follow up dated 22-nov-2017: this case concerns a patient who has received synvisc one injection from the recalled lot and later had pain and swelling in leg.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.
|