Based on additional information received on 28-mar- 2018, this case initially processed as non-serious was upgraded to serious as important medical event of device malfunction was added.This case was cross referenced with (b)(4) (cluster).This unsolicited case from united states was received on 14-dec-2017 from the nurse.This case concerns a patient (age and gender unspecified) who received treatment with synvisc one and after unknown latency had pain and swelling.In this case event of device malfunction was also identified.No medical history, past drug, concomitant medication or concurrent condition was provided.On an unknown date, the patient initiated treatment with intra-articular 6 ml once of synvisc one injection (indication: unknown) (batch/lot number: 7rsl021 and expiry date: may-2020).On an unknown date, (after unknown latency), patient was said to have pain and swelling.Corrective treatment: not reported for all events outcome: unknown for all events.Seriousness criteria: important medical event for device malfunction a pharmaceutical technical complaint (ptc) was initiated with (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 is under investigation.Once this investigation is completed, corrective and preventive actions will be implemented.Follow-up information was received on 21-dec-2017.No new information was received additional information was received on 23-jan-2018.Global ptc number and results were added.Expiry date of synvisc one was added.Clinical course was updated and text was amended accordingly.Follow-up information was received on 13-mar-2018.No new information was received.Follow-up information was received on 15-mar-2018.No new information was received additional information was received on 28-mar-2018 from a nurse.Lot number was updated.Additional event of device malfunction was added.Case became serious.Clinical course was updated.Text was amended accordingly.
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