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5 days of application began to have reactions such as pain in the knee, swelling and infection [injection site joint infection] ([pain in knee], [knee swelling]) pulsion, where a liquid was removed from his knee, but after proper analysis, no change was found [joint effusion] case narrative: initial information received on 25-jun-2021 regarding an unsolicited valid serious case received from a consumer/non-hcp from (b)(6).This case involves a (b)(6) male patient who experienced after 5 days of application began to have reactions such as pain in the knee, swelling and infection and pulsion, where a liquid was removed from his knee, but after proper analysis, no change was found while being treated with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history included surgery in (b)(6) 2020.His past medical treatment(s), vaccination(s) and family history were not provided.At the time of the event, he had concurrent condition of cholesterol.Concomitant medications included chondroitin sulfate, collagen, glucosamine (colagen) for arthrosis.On (b)(6) 2021, the patient started using hylan g-f 20, sodium hyaluronate, (formulation, dosage, lot number, route: unknown) for arthrosis.On the (b)(6) 2021, after the latency of five days of starting the treatment with hylan g-f 20, sodium hyaluronate, patient experienced that after 5 days of application began to have reactions such as pain in the knee (arthralgia), swelling (joint swelling) and infection (injection site joint infection) (medically significant) that did not pass even after the use of several antibiotics.On (b)(6) 2021, after the latency if 20 days of starting the treatment with hylan g-f 20, sodium hyaluronate, patient experienced that patient had pulsion where a liquid was removed from his knee (joint effusion), but after the proper analysis, no change was found but still the infection rates were very high and was associated the application of the product.Action taken: unknown for all the events.Corrective treatment: antibiotics for 5 days of application began to have reactions such as pain in the knee, swelling and infection; fluid extraction for pulsion, where a liquid was removed from his knee, but after proper analysis, no change was found.Outcome: unknown for pulsion where a liquid was removed from his knee; not recovered for rest all the events.A product technical compliant was initiated with global ptc number:(b)(4) and results were pending for same.
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5 days of application began to have reactions such as pain in the knee, swelling and infection [injection site joint infection] ([pain in knee], [knee swelling], [chills], [redness]) stomach pain [stomach pain] pulsion, where a liquid was removed from his knee, but after proper analysis, no change was found [arthrocentesis] pulsion, where a liquid was removed from his knee, but after proper analysis, no change was found [joint effusion] case narrative: initial information received on (b)(6) 2021 regarding an unsolicited valid serious case received from a consumer/non-hcp (non health care professional) from brazil.This case involves a 47 years old male patient who after 5 days of application began to experience reactions such as pain in the knee, swelling and infection and pulsion, where a liquid was removed from his knee, but after proper analysis, no change was found, stomach pain while being treated with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history included surgery in (b)(6) 2020.His past medical treatment(s), vaccination(s) and family history were not provided.At the time of the event, he had concurrent condition of cholesterol.Patients knee was unstable and the physician chose to use hyaluronic acid , he would have to receive it twice a year, because this acid would delay (postpone) placing a prosthesis.Concomitant medications included chondroitin sulfate, collagen, glucosamine (colagen) for arthrosis.On (b)(6) 2021, the patient started using hylan g-f 20, sodium hyaluronate, (formulation, dosage, lot number, route: unknown) for arthrosis in hospital by physician.On the (b)(6) 2021, after the latency of five days of starting the treatment with hylan g-f 20, sodium hyaluronate, patient experienced that after 5 days of application began to have reactions such as pain in the knee (arthralgia), swelling (joint swelling) and infection (injection site joint infection) (medically significant) that did not pass even after the use of several antibiotics.On (b)(6) 2021, after the latency if 20 days of starting the treatment with hylan g-f 20, sodium hyaluronate, patient experienced that patient had pulsion where a liquid was removed from his knee (joint effusion) (arthrocentesis), but after the proper analysis, no change was found but still the infection rates were very high and was associated the application of the product.Upon follow up, it was reported that he had stomach pain (abdominal pain upper; onset: 2021, latency: few days/weeks), infection which did not stop, knee pain and swelling, which took, march, april, more than 100 days, about 105 days to get rid of all the effects.He informed that he still had chills (onset: 2021, latency: few days/weeks), he also mentioned redness in the knee (erythema; onset: 2021, latency: few days/weeks), but a week ago it disappeared.A puncture was also performed in the knee, twice, once 10 days/15 days after application, with 60 ml of liquid.He also sent the liquid removed in the puncture for examination and it did not show bacteria, it was negative.During the call, it was not possible to hear all the details of this part well, the connection was bad, the patient said something like the physician said the acid was chicken comb", he informed something additional after that, but it couldn't hear well or confirm it.He informed he was on a crutch and undergoing physical therapy.Action taken: not applicable for all the events.Corrective treatment: crutch, physical therapy, antibiotics for 5 days of application began to have reactions such as pain in the knee, swelling and infection; fluid extraction for pulsion, where a liquid was removed from his knee, but after proper analysis, no change was found.Outcome: unknown for joint effusion; recovering for rest all the events.A product technical complaint (ptc) was initiated on (b)(6) 2021 for synvisc one.Batch number: unknown; comet compliant id number: (b)(4).The product lot number was not provided; therefore, a batch record review was not possible.Based on the lack of information provided, no capa was required.It was the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result is identified and mitigated through the ncr process.Sanofi global pharmacovigilance and epidemiology continuously monitors adverse event reports with or without lot numbers, and assesses possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals.This review has not indicated any safety issue.Final investigation complete date was (b)(6) 2021.No safety issues were indicated in this review.Additional information received on 07-jul-2021 from patient.Event of stomach pain added.Symptoms of injection site joint infection added, its corrective and outcome also updated.Text amended.Additional information was received on 27-jul-2021 from the quality department.Global ptc results were added.Clinical course updated and text amended accordingly.
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