Lot Number 7RSL021 |
Device Problem
Device Contamination With Biological Material (2908)
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Patient Problems
Bacterial Infection (1735); Pain (1994)
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Event Date 11/10/2017 |
Event Type
malfunction
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Event Description
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This case is cross referenced with case: (b)(4) (cluster).This unsolicited case from united states was received on 08-dec-2017 from a nurse.This case concerns a (b)(6) year old female patient who received treatment with synvisc one and later after 1 day could barely move due to pain, a lot of stiffness and pain.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 at a dose of 1 df (batch/lot number: 7rsl021, expiry date: unknown) into the right knee for right knee arthritis.On (b)(6) 2017, 1 day after receiving synvisc one injection, the patient experienced a lot of stiffness and could barely move due to pain.It was reported that the patient had been putting heat on and off of the knee and it felt better and she could bare more weight.The patient was told to continue to rest, elevate and take anti-inflammatory drugs.Corrective treatment: rest, elevate and take anti-inflammatory drugs for could barely move due to pain, a lot of stiffness and pain.Outcome: not recovered for all the 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 would be completed, corrective and preventive actions would be implemented.Seriousness criteria: important medical event for device malfunction.Pharmacovigilance comment: sanofi company comment dated 08-jan-2017: this case concerns a female patient who received synvisc one injection from the recalled lot for right knee arthritis and had a lot of stiffness and could barely move due to pain.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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Event Description
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This case is cross referenced with case: (b)(4).This unsolicited case from united states was received on (b)(6) 2017 from a nurse.This case concerns a 66 year old female patient who received treatment with synvisc one and later after 1 day could barely move due to pain, a lot of stiffness and pain.Also device malfunction was identified for the reported lot number.No past drug or concurrent condition was provided.Medical history includes: asthma, hypertension, hypercholesterolemia and pneumonia.Concomitant medications: estradiol, naproxen, doxycycline (oracea), rosuvastatin, omeprazole on (b)(6) 2017, the patient initiated treatment with intra-articular synvisc one injection once at a dose of 1 df (batch/lot number: 7rsl021, expiry date: unknown) into the right knee for right knee arthritis.On (b)(6) 2017, the patient initiated treatment with intraarticular synvisc one injection once at a dose of 6 ml (batch/lot number: 7rsl019, expiry date: 01-may-2020).On (b)(6) 2017, 1 day after receiving synvisc one injection, the patient experienced a lot of stiffness and could barely move due to pain.Patient reported increased stiffness and knee pain in 24 hours of injection.It was reported that the patient had been putting heat on and off of the knee and it felt better and she could bare more weight.The patient was told to continue to rest, elevate and take anti-inflammatory drugs.Corrective treatment: rest, elevate and take anti-inflammatory drugs for could barely move due to pain, a lot of stiffness and pain outcome: not recovered for all the 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 would be completed, corrective and preventive actions would be implemented.Seriousness criteria: important medical event for device malfunction.Additional information was received on (b)(6) 2018 from the patient.Medical history and concomitant medication was added.Suspect information was updated.Clinical course updated and text amended accordingly.Pharmacovigilance comment: sanofi company comment follow up dated (b)(6) 2018:the follow up information does not change the prior assessment of the case.This case concerns a female patient who received synvisc one injection from the recalled lot for right knee arthritis and had a lot of stiffness and could barely move due to pain.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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Search Alerts/Recalls
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