Based on additional information received on (b)(6) 2017, this case initially considered as non-serious was upgraded to serious.This case was cross referenced with (b)(4) (cluster).This unsolicited summary case from united states was received on (b)(6) 2017 from a non-healthcare professional.This case concerns 2 patients with unknown demographics who received treatment with synvisc one and later after unknown latency had red swelling of the knee, extreme pain of the knee and red knee.No past drug, medical history, concomitant medication or concurrent condition was provided.On an unknown date, the patients initiated treatment with intra-articular synvisc one injection once (dose and indication: unknown).On unknown dates, (within 1 day) after unknown latency, the patients experienced extreme pain and red swelling of the knee (red knee).Patient knees were drained and fluid analysis did not display infection.The patients received treatment with unspecified analgesics and steroids.Corrective treatment: unspecified analgesics and steroids for all the events outcome: recovering for all the events a pharmaceutical technical complaint (ptc) was initiated and ptc results were pending.Seriousness criterion: required intervention for all additional information was received on (b)(6) 2017 from a non-healthcare professional.Related case id was added.The case was updated from that of 4 patients to 2 patients.Event outcome was updated with its corrective treatment.Seriousness criterion was added.Clinical course was updated.Text was amended accordingly.
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Based on additional information received on 08-nov- 2017, this case initially considered as non-serious was upgraded to serious.This case was cross referenced with (b)(4) (cluster).This unsolicited summary case from united states was received on 03-nov-2017 from a non-healthcare professional.This case concerns 2 patients with unknown demographics who received treatment with synvisc one and later after unknown latency had red swelling of the knee, extreme pain of the knee and red knee.No past drug, medical history, concomitant medication or concurrent condition was provided.On an unknown date, the patients initiated treatment with intra-articular synvisc one injection once (dose and indication: unknown).On unknown dates, (within 1 day) after unknown latency, the patients experienced extreme pain and red swelling of the knee (red knee).Patient knees were drained and fluid analysis did not display infection.The patients received treatment with unspecified analgesics and steroids.Corrective treatment: unspecified analgesics and steroids for all the events.Outcome: recovering for all the events.A pharmaceutical technical complaint (ptc) was initiated with 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: required intervention for all additional information was received on 08-nov-2017 from a non-healthcare professional.Related case id was added.The case was updated from that of 4 patients to 2 patients.Event outcome was updated with its corrective treatment.Seriousness criterion was added.Clinical course was updated.Text was amended accordingly.Additional information was received on 22-nov-2017.The additional event of device malfunction was added with details.The global ptc number with ptc results was added.Clinical course updated.Text was amended accordingly.Pharmacovigilance comment: sanofi company comment dated 20-dec-2017: this case concerns a patient who has experienced localized erythema, knee pain and knee swelling after receiving synvisc one injection from the recalled lot.Although exact event dates have not been provided, temporal relationship can still be established between the events and suspect product based on the available information.Additionally, as the concerned lot number has been identified to have malfunction by the company.Hence, the pharmacological plausibility of the events to the products cannot be excluded.
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