This case was cross reference with case id: (b)(4) (cluster).This unsolicited case from united states was received on 28-feb-2018 from other non-health care professional.This case concerns a (b)(6) year old female patient who received treatment with synvisc one and after one day had increase pain in both knees/both knees have been aching and throbbing and swelling in both knees.Also, device malfunction was identified for the reported lot number.No medical history, past drug, concomitant medication or concurrent condition was provided.On (b)(6) 2017, the patient initiated treatment with single intra-articular synvisc one injection, one dosage form once (batch/lot number: 7rsl021; indication and expiry date: not reported) bilaterally.On (b)(6) 2017, after one day of receiving injection, patient had increase pain and swelling in both knees.Patient said that both knees have been aching and throbbing.Corrective treatment: not reported for all events.Outcome: unknown for all events.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 is completed, corrective and preventive actions would be implemented.Seriousness criterion: important medical event for device malfunction.Pharmacovigilance comment: sanofi company comment dated 8-mar-2018: this case concerns a patient who has received synvisc one injection from the recalled lot and later had knee pain and swelling.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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