| Lot Number UNKNOWN |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Arthritis (1723); Erythema (1840); Inflammation (1932); Ambulation Difficulties (2544); Movement Disorder (4412); Thrombosis/Thrombus (4440); Injection Site Reaction (4562); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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| Event Date 06/15/2021 |
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Event Type
Injury
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Event Description
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Blood clotting [clot blood] ([peripheral swelling], [condition aggravated]) redness and inflammation in the knee 1.5 weeks after the injection [injection site redness] redness and inflammation in the knee 1.5 weeks after the injection [injection site joint inflammation].Initial information received on 19-jan-2022 from united states regarding an unsolicited valid serious case received from a consumer/non-hcp.This case involves a (b)(6) male patient who experienced blood clotting, redness and inflammation in the knee 1.5 weeks after the injection with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On an unknown date, the patient started using hylan g-f 20, sodium hyaluronate, (formulation, batch number, route, indication, frequency: unknown).Information for batch number requested.On the unknown date, patient experienced redness and inflammation in the knee 1.5 weeks after the injection (injection site erythema) (injection site joint inflammation).Patient was treated with steroids which caused the condition to get worse (condition aggravated).He said that he experienced blood clotting (thrombosis) and swelling in his left foot (peripheral swelling).Action taken: not applicable for both the events.Corrective treatment: steroids for redness and inflammation in the knee 1.5 weeks after the injection; not reported for blood clotting.Outcome: unknown for both the events.Seriousness: medical significant for thrombosis and its symptoms , intervention required for all events.
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Event Description
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Blood clotting [clot blood] ([peripheral swelling], [condition aggravated]) redness and inflammation in the knee 1.5 weeks after the injection [injection site redness] redness and inflammation in the knee 1.5 weeks after the injection [injection site joint inflammation] case narrative: initial information received on (b)(6) 2022 from united states regarding an unsolicited valid serious case received from a consumer/non-hcp.This case involves a 69-year-old male patient who experienced blood clotting, redness and inflammation in the knee 1.5 weeks after the injection with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On an unknown date, the patient started using hylan g-f 20, sodium hyaluronate injection liquid (solution) (strength: 48 mg/ 6ml) (batch number, route, indication, frequency: unknown).Information for batch number requested.On the unknown date, patient experienced redness and inflammation in the knee 1.5 weeks after the injection (injection site erythema) (injection site joint inflammation).Patient was treated with steroids which caused the condition to get worse (condition aggravated).He said that he experienced blood clotting (thrombosis) and swelling in his left foot (peripheral swelling).Action taken: not applicable for both the events.Corrective treatment: steroids for redness and inflammation in the knee 1.5 weeks after the injection; not reported for blood clotting.Outcome: unknown for both the events.Seriousness : medical significant for thrombosis and its symptoms , intervention required for all events.Product technical complaint (ptc) was initiated with global ptc number (b)(4) on 19-jan-2022 for product synvisc one.Batch number; unknown; sample status: not available.The investigation was in process additional information was received on 19-jan-2022.Global ptc number, form and strength added.Text amended accordingly.
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Event Description
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Blood clotting [clot blood] ([peripheral swelling], [condition aggravated]).Redness and inflammation in the knee 1.5 weeks after the injection [injection site redness].Redness and inflammation in the knee 1.5 weeks after the injection [injection site joint inflammation].Case narrative: initial information received on 19-jan-2022 from united states regarding an unsolicited valid serious case received from a consumer/non-hcp.This case involves a 69-year-old male patient who experienced blood clotting, redness and inflammation in the knee 1.5 weeks after the injection with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On an unknown date, the patient started using hylan g-f 20, sodium hyaluronate injection liquid (solution) (strength: 48 mg/ 6ml) (batch number, route, indication, frequency: unknown).Information for batch number requested.On the unknown date, patient experienced redness and inflammation in the knee 1.5 weeks after the injection (injection site erythema) (injection site joint inflammation).Patient was treated with steroids which caused the condition to get worse (condition aggravated).He said that he experienced blood clotting (thrombosis) and swelling in his left foot (peripheral swelling).Action taken: not applicable for both the events.Corrective treatment: steroids for redness and inflammation in the knee 1.5 weeks after the injection; not reported for blood clotting.Outcome: unknown for both the events.Seriousness : medical significant for thrombosis and its symptoms , intervention required for all events.A product technical complaint (ptc) was initiated with global ptc number 100193254 on 19-jan-2022 for product synvisc one.Batch number; unknown; sample status: not available.The product lot number was not provided; therefore, a batch record review is not possible.Based on the lack of information provided, no capa is required.It is 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.Sanofi will continue to monitor complaints to determine if a capa is required.Final investigation was completed on 04-feb-2022 with conclusion summarized as no assessment possible.Additional information was received on 19-jan-2022.Global ptc number, form and strength added.Text amended accordingly.Additional information was received on 04-feb-2022 from the healthcare professional.Ptc results received and processed.Text amended accordingly.
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Event Description
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Blood clotting/blood clot inflammation of entire left leg [inflammation] ([swelling of limb], [condition aggravated], [limbs stiffness], [cramp], [redness of legs]) difficulty moving [mobility decreased] redness and inflammation in the knee [injection site joint inflammation] ([injection site joint redness], [arthrocentesis], [injection site joint effusion]) case narrative: initial information was received on 19-jan-2022 from united states regarding an unsolicited valid serious case from a patient this case involves a 69 years old male patient who had blood clotting/blood clot, redness and inflammation in the knee, inflammation of entire left leg and difficulty moving after the injection with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one) and methylprednisolone.The patient's past medical treatment(s), vaccination(s) and family history were not provided.It was unknown if the patient had any medical history, concomitant disease, or risk factor.On (b)(6) 2021, the patient received hylan g-f 20, sodium hyaluronate injection liquid (solution) (strength: 48 mg/ 6ml) in left knee (batch number, route, indication, frequency: unknown).Information for batch number requested.Since (b)(6) 2021, after latency of 1 day, the patient had redness and inflammation in the knee (injection site joint erythema) (injection site joint inflammation).The patient received methylprednisolone injection (dose, frequency, route, strength, batch number: unknown) on (b)(6) 2021 (to counter reaction of synvisc).The patient mentioned that he was treated with steroids (methylprednisolone) which caused the condition to get worse (condition aggravated).He had blood clotting/blood clot (thrombosis) and swelling in his left foot (peripheral swelling).Also, the patient had symptom of swelling (peripheral swelling), redness (erythema), stiffness (musculoskeletal stiffness), inflammation of entire left leg (inflammation), cramping (muscle spasms), difficulty moving (mobility decreased) etc.The patient took medication for 2 months, and then 2 ultrasounds.Then the patient had knee surgery after 8 drainages (aspiration joint, injection site joint effusion).Reportedly, knee surgery was done 10 months later, and patient had occasional checks for blood clots.The patient recovered on (b)(6) 2022.The patient wanted to find out if there were any other side effects associated with the medication other than what was mentioned in the brochure.He also wanted to find out if the blood clotting could be associated with the synvisc-one injection.The patient was unclear if he had an adverse effect to the additive of hyaluronic acid in the synvisc injection, or because of the immediate adverse effects that the steroidal injection given to him two weeks later precipitated the negative reaction to which he suffered and endured for almost 11 months.He did not intend to pursue the either legally or in any other mode.He said pain and sufferings were always nice to receive in some sort of compensatory form, but he was truly glad that almost after a year of this experience, and full knee replacement, he was 100% healthy again.He felt that all medical professional dealing with this product should first conduct sort of allergic reaction test before administration.It was unknown if the patient experienced any additional symptoms/events.Action taken: not applicable for all the events with synvisc one unknown for all the events with methylprednisolone corrective treatment: steroids (methylprednisolone injection), knee surgery (full knee replacement) after 8 drainages for all the events; unspecified medications for blood clotting/blood clot outcome: recovered for all the events seriousness: medical significant and intervention required for all events a product technical complaint (ptc) was initiated with global ptc number (b)(4) on 19-jan-2022 for product synvisc one.Batch number; unknown; sample status: not available.The product lot number was not provided; therefore, a batch record review is not possible.Based on the lack of information provided, no capa is required.It is 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.(b)(4) 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.Sanofi will continue to monitor complaints to determine if a capa is required.Final investigation was completed on 04-feb-2022 with conclusion summarized as no assessment possible.Additional information was received on 19-jan-2022.Global ptc number, form and strength added.Text amended accordingly.Additional information was received on 04-feb-2022 from the healthcare professional.Ptc results received and processed.Text amended accordingly.Additional information was received on 01-aug-2022 from a patient.Additional company suspect product: methylprednisolone was added.Events added: inflammation of entire left leg (along with symptoms) and difficulty moving.Outcome, start date, and corrective treatment was updated for both the previously added events.Clinical course was updated.Text was amended accordingly.
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Event Description
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Blood clotting/blood clot [clot blood] inflammation of entire left leg [inflammation] ([swelling of limb], [condition aggravated], [limbs stiffness], [cramp], [redness of legs]) difficulty moving [mobility decreased] redness and inflammation in the knee [injection site joint inflammation] ([injection site joint redness], [injection site joint pain], [arthrocentesis], [injection site joint effusion], [injection site joint swelling]).Case narrative: initial information was received on 19-jan-2022 from united states regarding an unsolicited valid serious case from a patient.This case involves a 69 years old male patient who experienced blood clotting/blood clot, inflammation of entire left leg, difficulty moving and redness and inflammation in the knee while being treated with hylan g-f 20, sodium hyaluronate [synvisc one] and methylprednisolone.The patient's past medical treatment(s), vaccination(s) and family history were not provided.It was unknown if the patient had any medical history, concomitant disease, or risk factor.On (b)(6) 2021, the patient received hylan g-f 20, sodium hyaluronate injection liquid (solution) (strength: 48 mg/ 6ml) in left knee (batch number, route, indication, frequency: unknown).Information for batch number requested.Since (b)(6) 2021, after 1 day, the patient had redness and inflammation in the knee (injection site joint erythema) (injection site joint inflammation).On an unknown date in (b)(6) 2021, patient developed swelling and pain in left knee (injection site joint pain and injection site joint swelling), less than 6 days later of the injection.Patient had swelling in his left foot (peripheral swelling).Also, the patient had symptom of swelling (peripheral swelling), redness (erythema), stiffness (musculoskeletal stiffness), inflammation of entire left leg (inflammation), cramping (muscle spasms) and difficulty moving (mobility decreased) (onset: (b)(6) 2021 and latency: few days).Patient received a steroid injection to alleviate the symptoms.Received methylprednisolone injection (dose, frequency, route, strength, batch number: unknown) on (b)(6) 2021 to counter reaction of synvisc, which were inflammation and redness and inflammation in the knee.Within 1 w (unknown abbreviation) days all of the side effects of injection occurred, and within days, developed a blood clotting/blood clot (thrombosis) (onset: (b)(6) 2021 and latency: few days) between left knee and ankle.As a corrective for thrombosis, patient took unspecified medications.The patient mentioned steroids (methylprednisolone) caused the condition to get worse (condition aggravated) (onset: 2021 and latency: unknown).The patient took medication for 2 months, and then 2 ultrasounds.Then the patient had knee surgery after 8 drainages (aspiration joint, injection site joint effusion) (onset: 2021 and latency: unknown).The patient recovered on (b)(6) 2022.Did not know which injection caused the injury.The knee replacement surgery on left knee was delayed until the severity of clot and other factors could be resolved (incredible amount of swelling and fluid build-up).The knee replacement surgery was done on (b)(6) 2022, and patient had occasional checks for blood clots.The patient wanted to find out if there were any other side effects associated with the medication other than what was mentioned in the brochure.He also wanted to find out if the blood clotting could be associated with the synvisc-one injection.The patient was unclear if he had an adverse effect to the additive of hyaluronic acid in the synvisc injection, or because of the immediate adverse effects that the steroidal injection given to him two weeks later precipitated the negative reaction to which he suffered and endured for almost 11 months.He did not intend to pursue the either legally or in any other mode.He said pain and sufferings were always nice to receive in some sort of compensatory form, but he was truly glad that almost after a year of this experience, and full knee replacement, he was 100% healthy again.He felt that all medical professional dealing with this product should first conduct sort of allergic reaction test before administration.Action taken: not applicable for all the events with synvisc one; unknown for all the events with methylprednisolone.Corrective treatment: methylprednisolone injection, knee surgery (full knee replacement) after 8 drainages for inflammation, mobility decreased and injection site joint inflammation; unspecified medications for blood clotting/blood clot.Outcome: recovered/resolved for all events.Seriousness criterion: medically significant for thrombosis; medically significant and intervention required for rest of the events.A product technical complaint (ptc) was initiated with global ptc number (b)(4) on 19-jan-2022 for product synvisc one.Batch number; unknown; sample status: not available.The product lot number was not provided; therefore, a batch record review was not possible.Based on the lack of information provided, no capa (corrective and preventive action) was required.It was the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result was identified and mitigated through the ncr (non-conformance) 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 had not indicated any safety issue.Sanofi would continue to monitor complaints to determine if a capa was required.Final investigation was completed on 04-feb-2022 with conclusion summarized as no assessment possible.Additional information was received on 19-jan-2022.Global ptc number, form and strength added.Text amended accordingly.Additional information was received on 04-feb-2022 from the healthcare professional.Ptc results received and processed.Text amended accordingly.Additional information was received on 01-aug-2022 from a patient.Additional company suspect product: methylprednisolone was added.Events added: inflammation of entire left leg (along with symptoms) and difficulty moving.Outcome, start date, and corrective treatment was updated for both the previously added events.Clinical course was updated.Text was amended accordingly.Additional information received on 31-oct-2022 from patient.Patients weight and height added.Event onset dates updated for all events.Corrective treatment of methylprednisolone added for events.Event seriousness updated for thrombosis.Events of incredible amount of swelling/swelling and pain in left knee and swelling and pain in left knee added with details.Event verbatim updated to incredible amount of swelling and fluid build up/knee surgery after 8 drainages.Clinical course updated.Text amended accordingly.
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Event Description
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Blood clotting/blood clot [clot blood] inflammation of entire left leg [inflammation] ([swelling of limb], [condition aggravated], [limbs stiffness], [cramp], [redness of legs]) difficulty moving [mobility decreased] redness and inflammation in the knee [injection site joint inflammation] ([injection site joint redness], [injection site joint pain], [arthrocentesis], [injection site joint effusion], [injection site joint swelling]) case narrative: initial information was received on 19-jan-2022 from united states regarding an unsolicited valid serious case from a patient this case involves a 69 years old male patient who experienced blood clotting/blood clot, inflammation of entire left leg, difficulty moving and redness and inflammation in the knee while being treated with hylan g-f 20, sodium hyaluronate [synvisc one] and methylprednisolone.The patient's past medical treatment(s), vaccination(s) and family history were not provided.It was unknown if the patient had any medical history, concomitant disease, or risk factor.On (b)(6) 2021, the patient received hylan g-f 20, sodium hyaluronate injection liquid (solution) (strength: 48 mg/ 6ml) in left knee (batch number, route, indication, frequency: unknown).Information for batch number requested.Since (b)(6) 2021, after 1 day, the patient had redness and inflammation in the knee (injection site joint erythema) (injection site joint inflammation).On an unknown date in jun-2021, patient developed swelling and pain in left knee (injection site joint pain and injection site joint swelling), less than 6 days later of the injection.Patient had swelling in his left foot (peripheral swelling).Also, the patient had symptom of swelling (peripheral swelling), redness (erythema), stiffness (musculoskeletal stiffness), inflammation of entire left leg (inflammation), cramping (muscle spasms) and difficulty moving (mobility decreased) (onset: jun-2021 and latency: few days).Patient received a steroid injection to alleviate the symptoms.Received methylprednisolone injection (dose, frequency, route, strength, batch number: unknown) on (b)(6) 2021 to counter reaction of synvisc, which were inflammation and redness and inflammation in the knee.Within 1 w (unknown abbreviation) days all of the side effects of injection occurred, and within days, developed a blood clotting/blood clot (thrombosis) (onset: jun-2021 and latency: few days) between left knee and ankle.As a corrective for thrombosis, patient took unspecified medications.The patient mentioned steroids (methylprednisolone) caused the condition to get worse (condition aggravated) (onset: 2021 and latency: unknown).The patient took medication for 2 months, and then 2 ultrasounds.Then the patient had knee surgery after 8 drainages (aspiration joint, injection site joint effusion) (onset: 2021 and latency: unknown).The patient recovered on feb-2022.Did not know which injection caused the injury.The knee replacement surgery on left knee was delayed until the severity of clot and other factors could be resolved (incredible amount of swelling and fluid build-up).The knee replacement surgery was done on (b)(6) 2022, and patient had occasional checks for blood clots.The patient wanted to find out if there were any other side effects associated with the medication other than what was mentioned in the brochure.He also wanted to find out if the blood clotting could be associated with the synvisc-one injection.The patient was unclear if he had an adverse effect to the additive of hyaluronic acid in the synvisc injection, or because of the immediate adverse effects that the steroidal injection given to him two weeks later precipitated the negative reaction to which he suffered and endured for almost 11 months.He did not intend to pursue the either legally or in any other mode.He said pain and sufferings were always nice to receive in some sort of compensatory form, but he was truly glad that almost after a year of this experience, and full knee replacement, he was 100% healthy again.He felt that all medical professional dealing with this product should first conduct sort of allergic reaction test before administration.Action taken: not applicable for all the events with synvisc one; unknown for all the events with methylprednisolone corrective treatment: methylprednisolone injection, knee surgery (full knee replacement) after 8 drainages for inflammation, mobility decreased and injection site joint inflammation; unspecified medications for blood clotting/blood clot outcome: recovered/resolved for all events seriousness criterion: medically significant for thrombosis; medically significant and intervention required for rest of the events a product technical complaint (ptc) was initiated with global ptc number 100193254 on 19-jan-2022 for product synvisc one.Batch number; unknown; sample status: not available.The product lot number was not provided; therefore, a batch record review was not possible.Based on the lack of information provided, no capa (corrective and preventive action) was required.It was the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result was identified and mitigated through the ncr (non-conformance) 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 had not indicated any safety issue.Sanofi would continue to monitor complaints to determine if a capa was required.Final investigation was completed on 04-feb-2022 with conclusion summarized as no assessment possible.Additional information was received on 19-jan-2022.Global ptc number, form and strength added.Text amended accordingly.Additional information was received on 04-feb-2022 from the healthcare professional.Ptc results received and processed.Text amended accordingly.Additional information was received on 01-aug-2022 from a patient.Additional company suspect product: methylprednisolone was added.Events added: inflammation of entire left leg (along with symptoms) and difficulty moving.Outcome, start date, and corrective treatment was updated for both the previously added events.Clinical course was updated.Text was amended accordingly.Additional information received on 31-oct-2022 from patient.Patients weight and height added.Event onset dates updated for all events.Corrective treatment of methylprednisolone added for events.Event seriousness updated for thrombosis.Events of incredible amount of swelling/swelling and pain in left knee and swelling and pain in left knee added with details.Event verbatim updated to incredible amount of swelling and fluid build up/knee surgery after 8 drainages.Clinical course updated.Text amended accordingly.Based on the information previously received, annex e code for event mobility decreased was updated from e0122 to e2302.
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Search Alerts/Recalls
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