|
This unsolicited case from united states was received on 31-jan-2018 from the patient.This case concerns a (b)(6) female patient who received treatment with synvisc one injection and on the same day experienced redness, swollen/swelling, pain worse than before the injection and fever feeling.It was reported that the patient had no pain relief/she did not get relief.Also, device malfunction was identified for the reported lot number.No medical history, past drugs, concomitant medications and concurrent conditions were reported.It was reported that the patient had received synvisc one at least three times in the past.The first time she received it in her left knee and the effect lasted two years.Sometimes she had received it in both knees.The patient had corticosteroid injection in her knee within the last year.The patient did not have allergy to avian proteins, eggs, or feathers.On (b)(6) 2017, patient received treatment with intraarticular synvisc one injection, once (dose and indication: not provided) (batch/lot number: 7rsl021) for left knee osteoarthritis.On the same day, within 12 hours of having the injection, the patient experienced redness, swelling, and fever.The patient was notified by her doctor that she received the recalled lot.The patient was surprised that she did not get relief.She was notified by her doctor that she received the recalled lot.She felt that this was an explanation for why she did not get relief.Patient did not remember if she took her temperature, or what it was.She did not have any fluid drawn off the knee.It was reported that the patient got no relief from the injection.On an unknown date, after unknown latency, the patient had pain and the pain was worse than before the injection.She was able to bear weight on the knee and was able to bear weight before the injection but it was painful.Corrective treatment: not reported for all the events except device malfunction.Outcome: recovered/resolved for the events of device malfunction, redness, swollen/swelling; not recovered for pain worse than before the injection; unknown for fever feeling.A pharmaceutical technical complaint (ptc) was initiated and results were pending.Seriousness criteria: important medical event for device malfunction pharmacovigilance comment: sanofi company comment dated 6-feb-2018: this case concerns a patient who has received synvisc one injection from the recalled lot and later experienced knee swelling, knee pain, erythema, fever and reported lack of effect.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.
|
|
Device malfunction [device malfunction] redness/knee red [lower legs erythematous] fever feeling/feverish to touch [fever] very stiff, swollen and sore when walking or standing [joint stiffness] swelling/very stiff, swollen and sore when walking or standing [swelling of l knee] pain worse than before the injection/very stiff, swollen and sore when walking or standing [knee pain] ([condition aggravated]) had no pain relief/she did not get relief [device ineffective] case narrative: this unsolicited case from united states was received on 31-jan-2018 from the patient.This case concerns a 49 year old female patient who received treatment with synvisc one injection and on the same day experienced redness, swollen/swelling/very stiff, swollen and sore when walking or standing, pain worse than before the injection/very stiff, swollen and sore when walking or standing and fever feeling/feverish to touch, very stiff, swelling/very stiff, swollen and sore when walking or standing.It was reported that the patient had no pain relief/she did not get relief.Also, device malfunction was identified for the reported lot number.No past drugs, concurrent conditions were reported.It was reported that the patient had received synvisc one at least three times in the past.The first time she received it in her left knee and the effect lasted two years.Sometimes she had received it in both knees.The patient had corticosteroid injection in her knee within the last year.The patient did not have allergy to avian proteins, eggs, or feathers.Concomitant medications were bupropion hydrochloride (wellbutrin), duloxetine hydrochloride (cymbalta), temazepam, diclofenac sodium (diclofenac), tizanidine.Medical history was insomnia, fibromyalgia, depression, chronic pain and arthritis.On (b)(6) 2017, patient received treatment with intra- articular synvisc one injection, once (dose and indication: not provided) (batch/lot number: 7rsl021) for left knee osteoarthritis.On the same day, within 12 hours of having the injection, the patient experienced redness, swelling, fever, very stiff, swollen and sore when walking or standing.The patient was notified by her doctor that she received the recalled lot.The patient was surprised that she did not get relief.She was notified by her doctor that she received the recalled lot.She felt that this was an explanation for why she did not get relief.Patient did not remember if she took her temperature, or what it was.She did not have any fluid drawn off the knee.It was reported that the patient got no relief from the injection.On an unknown date, after unknown latency, the patient had pain and the pain was worse than before the injection.She was able to bear weight on the knee and was able to bear weight before the injection but it was painful.Corrective treatment: not reported for all the events except device malfunction.Outcome: recovered/resolved for the events of fever feeling/feverish to touch, swelling/very stiff, swollen and sore when walking or standing, device malfunction, redness, swollen/swelling/very stiff, swelling/very stiff, very stiff, swollen and sore when walking or standing; not recovered for pain worse than before the injection/very stiff, swollen and sore when walking or standing.A product 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 was under investigation.Once this investigation would be completed, corrective and preventive actions would be implemented.Seriousness criteria: important medical event for device malfunction follow up information was received on 01-mar-2018 and 02-mar-2018.Global ptc number was added.Additional information was received on 07-may-2018 from patient.Event of joint stiffness added.Verbatim updated for fever, knee swelling and pain.Concomitant medications and medical history was added.Outcome for fever feeling/feverish to touch updated.
|
