Lot Number 7RSL021 |
Device Problems
Device Contamination With Biological Material (2908); Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Erythema (1840); Swelling (2091); Arthralgia (2355)
|
Event Date 11/01/2017 |
Event Type
malfunction
|
Event Description
|
(b)(4).This unsolicited case from united states was received on 03-nov-2017 from a non-healthcare professional.This case concerns a (b)(6) patient of unknown gender who received treatment with synvisc one and later after unknown latency the patient redness, had difficult weight bearing on injected leg, pain and swelling.No past drug, medical history, concomitant medication or concurrent condition was provided.On (b)(6) 2017, the patient initiated treatment with intra-articular synvisc one injection once (dose and indication: unknown) (batch/lot number: 7rsl021; expiry date: may-2020) into the left knee.On an unknown date in (b)(6) 2017, after unknown latency, the patient experienced swelling, redness, pain, difficult weight bearing on injected leg.The patient was told to ice affected knees, elevate affected legs, all were given steroid packs and pain medicines.Corrective treatment: ice the affected knees, elevate affected legs, steroid packs for redness, difficult weight bearing on injected leg, swelling; ice the affected knees, elevate affected legs, steroid packs; pain medicines for pain outcome: unknown for all the events seriousness criteria: required intervention for all the events a pharmaceutical technical complaint (ptc) was initiated and ptc results were pending.Pharmacovigilance comment: sanofi company comment dated 10-nov-2017: this case concerns a patient who received treatment with synvisc one and later experienced weight bearing difficulty with knee pain, swelling and redness.A significant temporal relationship can be established on the basis of temporal gap.Furthermore, on the basis of site of reactions causal role of suspect product cannot be denied in occurrence of the event.However, due to lack of information regarding medical history, concurrent condition and past drugs precludes complete medical assessment of the case.
|
|
Event Description
|
This case is cross referenced with case: (b)(4) (cluster).This unsolicited case from united states was received on 03-nov-2017 from a non-healthcare professional.This case concerns a (b)(6) year old patient of unknown gender who received treatment with synvisc one and later after unknown latency the patient redness, had difficult weight bearing on injected leg, pain and swelling.Also device malfunction was identified for the reported lot number.No past drug, medical history, concomitant medication or concurrent condition was provided.On (b)(6) 2017, the patient initiated treatment with intra-articular synvisc one injection once (dose and indication: unknown) (batch/lot number: 7rsl021; expiry date: may-2020) into the left knee.On an unknown date in (b)(6) 2017, after unknown latency, the patient experienced swelling, redness, pain, difficult weight bearing on injected leg.The patient was told to ice affected knees, elevate affected legs, all were given steroid packs and pain medicines.Corrective treatment: ice the affected knees, elevate affected legs, steroid packs for redness, difficult weight bearing on injected leg, swelling; ice the affected knees, elevate affected legs, steroid packs; pain medicines for pain.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 is under investigation.Once this investigation is completed, corrective and preventive actions will be implemented.Seriousness criteria: required intervention for all the events.Additional information was received on 22-nov-2017.Additional event of device malfunction was added along with details.Global ptc number and results were added.Clinical course was updated and text was amended accordingly.Pharmacovigilance comment: sanofi company comment for follow up dated 22-nov-2017: this case concerns a patient who received treatment with synvisc one and later experienced weight bearing difficulty with knee pain, swelling and redness.A significant temporal relationship can be established on the basis of temporal gap.Furthermore, on the basis of site of reactions causal role of suspect product cannot be denied in occurrence of the event.In addition, the concerned lot number has been identified to have malfunction by the company, hence, the causal relationship of the events to the product cannot be excluded.
|
|
Search Alerts/Recalls
|
|