| Lot Number UNKNOWN |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Arthritis (1723); Loss of Range of Motion (2032); Ambulation Difficulties (2544)
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| Event Date 03/01/2023 |
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Event Type
Injury
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Event Description
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Prolonged (several weeks) use of crutches was necessary [joint range of motion decreased] knee is worse than before the treatment [osteoarthritis aggravated] swelling [injection site joint swelling] inflammation [injection site joint inflammation] knee can still not be loaded as before or as hoped for after the treatment [device ineffective] case narrative: initial information was received from germany on 07-may-2023 regarding an unsolicited valid serious case received from an other health professional.This case is linked to case 2023sa101321(cluster).This case involves a 40-year-old female patient who had prolonged (several weeks) use of crutches was necessary, knee is worse than before the treatment, swelling, inflammation and knee can still not be loaded as before or as hoped for after the treatment while being treated with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical history, medical treatment(s), concomitant(s) and family history were not provided.On an unknown date, the patient started using synvisc (hylan g-f 20, sodium hyaluronate) injection at an unknown dosage, frequency, batch number, dose, expiration date, strength: unknown) for osteoarthritis in the knee (both sides).Information regarding batch number was requested.They should have the relevant information in their records.Regarding the complaints: 1.A prolonged (several weeks) use of crutches was necessary so that mobility was restored(joint range of motion decreased) (onset date and latency: unknown) - i.E.The swelling went down accordingly and walking without assistance was possible.Sick leave was also required.2.At the same time the inflammation(injection site joint inflammation) / swelling(injection site joint swelling)( onset date and latency: unknown)) was treated with the usual means (retterspitz, cooling, painkillers / volatren).3.The overall condition of the knee is worse than before the treatment (osteoarthritis)( onset date and latency: unknown)- this concerns, as described, both treated knees (also from the treatment before) 4.The knee can still not be loaded as before or as hoped for after the treatment(device ineffective)(onset date and latency: unknown).Due to a vacation stay with corresponding load (short distances), the condition is currently significantly worse.Action taken: not applicable for all the events.The patient was treated with zinc oxide (retterspitz zinksalbe) and diclofenac (voltaren [diclofenac]) for injection site joint inflammation and injection site joint swelling and using crutches for joint range of motion decreased.Outcome: recovered / resolved for joint range of motion decreased, unknown for osteoarthritis and device ineffective for recovering / resolving for the event for injection site joint swelling and injection site joint inflammation.Seriousness criteria: disability for joint range of motion decreased.A product technical complaint (ptc) was initiated, and the results were pending for the same.
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Manufacturer Narrative
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Sanofi company comment dated 25-may-2023.This case involves a 43 years old female patient whose complaints worsen until the knee was almost no longer able to move/moving without crutches was no longer possible, almost immobile, knee joint severely inflamed, almost immobile, knee is worse than before the treatment after the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one] via subcutaneous route (incorrect route of product administration).Reportedly, it happened for the second time in three years.The events resulted in disability as the patient had to use crutches.Based on information provided in the case, causal role of suspect product cannot be excluded for the occurrence of events.However, patient had underlying condition of osteoarthritis which is a causative factor for event osteoarthritis aggravated.Case will be re-evaluated post further update on the details of the reaction course, exact onset latency of events after date of injection, injection technique, post injection routine, past drug history, concomitant medications and other risk factors if any.
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Event Description
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Complaints worsen until the knee was almost no longer able to move/moving without crutches was no longer possible [joint range of motion decreased] almost immobile [mobility decreased] knee is worse than before the treatment [osteoarthritis aggravated] ([device ineffective]) knee joint severely inflamed [injection site joint inflammation] ([injection site joint warmth], [injection site joint discomfort], [condition aggravated], [injection site joint swelling]) synvisc one was given via subcutaneous route with no reported adverse event [incorrect route of product administration] case narrative: initial information was received from germany on 07-may-2023 regarding an unsolicited valid serious case from other health professional.This case is linked to case (b)(4) (multiple devices suspect for same patient, case for injection of 2020).This case involves a 43 years old female patient whose complaints worsen until the knee was almost no longer able to move/moving without crutches was no longer possible, almost immobile, knee is worse than before the treatment, knee joint severely inflamed after the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one] via subcutaneous route (with no reported adverse event) the patient's past medical history included pulmonary embolism in 2013 (about 10 years ago) the patient's past medical treatment(s) and family history were not provided.At the time of the event, the patient had ongoing coxarthrosis/osteoarthritis due to sport (competitive sport) and was overweight with bmi 44.08.Patient had no allergies.On (b)(6) 2023, the patient received synvisc one (hylan g-f 20, sodium hyaluronate injection once via subcutaneous route (incorrect route of product administration, latency: same day) (batch number, dose, expiration date: unknown) for osteoarthritis in the knee (both sides).Information regarding batch number was requested.Patient had a very strong and unexpected reaction to a knee injection with synvisc one.On an unknown date on 2023, after unknown latency, patients knee joint severely inflamed, almost immobile (injection site joint inflammation and mobility decreased, caused disability).Initially expected discomfort at the injection (injection site joint discomfort, caused disability) (onset: 2023 and latency: unknown), then heat build-up in the knee, swelling- all the same as before (as in 2020) (injection site joint warmth and injection site joint swelling, caused disability) (onset: 2023 and latency: unknown).Countermeasures (example: cooling, elevation, anti-inflammatory ointments).Complaints worsened until the knee was almost no longer able to move, moving without crutches was no longer possible (joint range of motion decreased, caused disability, condition aggravated) (onset: 2020 and latency: unknown).According to the doctor's statement, only extremely rare reactions of this type (when used 3 years ago in 2020), now again - similar reaction on the other knee.There are no indications in the side effects that describe such a course.The knee can still not be loaded as before or as hoped for after the treatment.Due to a vacation stay with corresponding load (short distances), the condition is currently significantly worse.A prolonged (several weeks) use of crutches was necessary so that mobility was restored - i.E.The swelling went down accordingly and walking without assistance was possible.Sick leave was also required.At the same time the inflammation / swelling was treated with the usual means (retterspitz, cooling, painkillers / volatren).The overall condition of the knee is worse than before the treatment - this concerns, as described, both treated knees (also from the treatment before) (osteoarthritis; seriousness criteria: medically significant) (device ineffective).Action taken: not applicable for all the events corrective treatment: zinc oxide (retterspitz zinksalbe) and diclofenac (voltaren) for knee joint severely inflamed, used crutched for events joint range of motion decreased, mobility decreased, and injection site joint inflammation, not reported for osteoarthritis at time of reporting, the outcome was recovering for the event knee joint severely inflamed, was not recovered for the event knee is worse than before the treatment, was recovered in 2023 for the event complaints worsen until the knee was almost no longer able to move/moving without crutches was no longer possible, was recovered in 2023 for the event almost immobile and was unknown for the event incorrect route of product administration a product technical complaint (ptc) was initiated, and the results were pending for the same.Based on the previously received information, field 4.1 (b) and 1.2 (b) in mir was filled.Based on the previously received information, events were added- almost immobile and synvisc one was given via subcutaneous route with no reported adverse event.Suspect product was updated from synvisc to synvisc one.As reported terms were updated to knee joint severely inflamed (for injection site joint inflammation) and complaints worsen until the knee was almost no longer able to move/moving without crutches was no longer possible (for joint range of motion decreased).Additional symptoms added for injection site joint inflammation.Event- knee is worse than before the treatment was considered as serious.Product start date was added as (b)(4) 2023.Medical history was added- osteoarthritis and overweight.Text was amended accordingly.
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Manufacturer Narrative
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Sanofi company comment for follow up dated 30-may-2023.Follow up information received does not change prior case assessment.This case involves a 43 years old female patient whose complaints worsen until the knee was almost no longer able to move/moving without crutches was no longer possible, almost immobile, knee joint severely inflamed, almost immobile, knee is worse than before the treatment after the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one] via subcutaneous route (incorrect route of product administration).Reportedly, it happened for the second time in three years.The events resulted in disability as the patient had to use crutches.Based on information provided in the case, causal role of suspect product cannot be excluded for the occurrence of events.However, patient had underlying condition of osteoarthritis which is a causative factor for event osteoarthritis aggravated.Case will be re-evaluated post further update on the details of the reaction course, exact onset latency of events after date of injection, injection technique, post injection routine, past drug history, concomitant medications and other risk factors if any.
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Event Description
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Complaints worsen until the knee was almost no longer able to move/moving without crutches was no longer possible [joint range of motion decreased] almost immobile [mobility decreased] knee is worse than before the treatment [osteoarthritis aggravated] ([device ineffective]) knee joint severely inflamed [injection site joint inflammation] ([injection site joint warmth], [injection site joint discomfort], [condition aggravated], [injection site joint swelling]) synvisc one was given via subcutaneous route with no reported adverse event [incorrect route of product administration] case narrative: initial information was received from germany on 07-may-2023 regarding an unsolicited valid serious case from other health professional.This case is linked to case (b)(4) (multiple devices suspect for same patient, case for injection of 2020).This case involves a 43 years old female patient whose complaints worsen until the knee was almost no longer able to move/moving without crutches was no longer possible, almost immobile, knee is worse than before the treatment, knee joint severely inflamed after the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one] via subcutaneous route (with no reported adverse event) the patient's past medical history included pulmonary embolism in 2013 (about 10 years ago) the patient's past medical treatment(s) and family history were not provided.At the time of the event, the patient had ongoing coxarthrosis/osteoarthritis due to sport (competitive sport) and was overweight with bmi 44.08.Patient had no allergies.On (b)(6) 2023, the patient received synvisc one (hylan g-f 20, sodium hyaluronate injection once via subcutaneous route (incorrect route of product administration, latency: same day) (batch number, dose, expiration date: unknown, strength: 48 mg/6 ml) for osteoarthritis in the knee (both sides).Information regarding batch number was requested.Patient had a very strong and unexpected reaction to a knee injection with synvisc one.On an unknown date on 2023, after unknown latency, patients knee joint severely inflamed, almost immobile (injection site joint inflammation and mobility decreased, caused disability).Initially expected discomfort at the injection (injection site joint discomfort, caused disability) (onset: 2023 and latency: unknown), then heat build-up in the knee, swelling- all the same as before (as in 2020) (injection site joint warmth and injection site joint swelling, caused disability) (onset: 2023 and latency: unknown).Countermeasures (example: cooling, elevation, anti-inflammatory ointments).Complaints worsened until the knee was almost no longer able to move, moving without crutches was no longer possible (joint range of motion decreased, caused disability, condition aggravated) (onset: 2020 and latency: unknown).According to the doctor's statement, only extremely rare reactions of this type (when used 3 years ago in 2020), now again - similar reaction on the other knee.There are no indications in the side effects that describe such a course.The knee can still not be loaded as before or as hoped for after the treatment.Due to a vacation stay with corresponding load (short distances), the condition is currently significantly worse.A prolonged (several weeks) use of crutches was necessary so that mobility was restored - i.E.The swelling went down accordingly and walking without assistance was possible.Sick leave was also required.At the same time the inflammation / swelling was treated with the usual means (retterspitz, cooling, painkillers / volatren).The overall condition of the knee is worse than before the treatment - this concerns, as described, both treated knees (also from the treatment before) (osteoarthritis; seriousness criteria: medically significant) (device ineffective).Action taken: not applicable for all the events.Corrective treatment: zinc oxide (retterspitz zinksalbe) and diclofenac (voltaren) for knee joint severely inflamed, used crutched for events joint range of motion decreased, mobility decreased, and injection site joint inflammation, not reported for osteoarthritis at time of reporting, the outcome was recovering for the event knee joint severely inflamed, was not recovered for the event knee is worse than before the treatment, was recovered in 2023 for the event complaints worsen until the knee was almost no longer able to move/moving without crutches was no longer possible, was recovered in 2023 for the event almost immobile and was unknown for the event incorrect route of product administration a product technical complaint (ptc) was initiated, and the results were pending for the same.Based on the previously received information, field 4.1 (b) and 1.2 (b) in mir was filled.Based on the previously received information, events were added- almost immobile and synvisc one was given via subcutaneous route with no reported adverse event.Suspect product was updated from synvisc to synvisc one.As reported terms were updated to knee joint severely inflamed (for injection site joint inflammation) and complaints worsen until the knee was almost no longer able to move/moving without crutches was no longer possible (for joint range of motion decreased).Additional symptoms added for injection site joint inflammation.Event- knee is worse than before the treatment was considered as serious.Product start date was added as 05-mar-2023.Medical history was added- osteoarthritis and overweight.Text was amended accordingly.Additional information was received on 30-may-2023 from quality department and other health care professional: strength of suspect was added.
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Event Description
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Complaints worsen until the knee was almost no longer able to move/moving without crutches was no longer possible/ extension/flexion 0-0-70 degree [joint range of motion decreased] almost immobile [mobility decreased] knee is worse than before the treatment [osteoarthritis aggravated] ([device ineffective]) knee joint severely inflamed/ inflamed condition of the knee [injection site joint inflammation] ([injection site joint warmth], [injection site joint pain], [injection site joint discomfort], [condition aggravated], [injection site joint swelling]) case narrative: initial information was received from germany on 07-may-2023 regarding an unsolicited valid serious case from other health professional.This case is linked to case (b)(4) (multiple devices suspect for same patient, case for injection of 2020).This case involves 43 years old female patient who complaints worsen until the knee was almost no longer able to move/moving without crutches was no longer possible/ extension/flexion 0-0-70 degree, almost immobile, knee is worse than before the treatment and knee joint severely inflamed/ inflamed condition of the knee after being treated with medical device hylan g-f 20, sodium hyaluronate [synvisc one].The patient received synvisc on (b)(6) 2020.The patient's past medical history included lung embolism/status post pulmonary embolism in 2013 (about 10 years ago) the patient's past medical treatment(s) and family history were not provided.At the time of the event, the patient had ongoing activated gonarthrosis on the left knee and coxarthrosis/osteoarthritis due to sport (competitive sport), thyroid disease, hypertension and was overweight with bmi (basal metabolic index) 44.08.Patient had no allergies.On (b)(6) 2023, the patient received synvisc one in left knee (hylan g-f 20, sodium hyaluronate injection once via intra-articular route (batch number, dose, expiration date: unknown, strength: 48 mg/6 ml) for osteoarthritis in the knee (both sides).There will be no information available on the batch number of this case.Patient had a very strong and unexpected reaction to a knee injection with synvisc one.There was significant increase in symptoms after injection.On an unknown date in mar-2023, after latency of few days, patients knee joint severely inflamed, almost immobile (injection site joint inflammation and mobility decreased, caused disability).Initially expected discomfort at the injection (injection site joint discomfort, caused disability), then heat build-up in the knee, swelling- all the same as before (as in 2020) (injection site joint warmth and injection site joint swelling, caused disability).Knee was said to have been swollen, overheated and inflamed.Only visited the out-patient emergency.She was at the medical emergency services at the clinic on (b)(6) 2023 on account of an inflamed condition of the knee.Countermeasures (example: cooling, elevation, anti-inflammatory ointments, antibiotics, tilidin, ibu (ibuprofen)).Complaints worsened until the knee was almost no longer able to move, moving without crutches was no longer possible (joint range of motion decreased, caused disability, condition aggravated) (onset: mar-2023 and latency: few days).According to the doctor's statement, only extremely rare reactions of this type (when used 3 years ago in 2020), now again - similar reaction on the other knee.There are no indications in the side effects that describe such a course.On (b)(6) 2023, the patient presented for progress monitoring.The patient had normal relief, no intra-articular effusion was found.On the account of extent of movement, extension/flexion 0-0-70 degrees (joint range of motion decreased), no ligament instability was observed.She had pain on forced extension and flexion, pain on pressure (injection site joint pain, onset: (b)(6) 2023; latency: 11 days).The patient had intraarticular space and pes anserinus (goose foot).Local antiphlogistic measures was recommended.No more hyaluronan infiltration was desired due to intolerance.The knee can still not be loaded as before or as hoped for after the treatment.Due to a vacation stay with corresponding load (short distances), the condition is currently significantly worse.A prolonged (several weeks) use of crutches was necessary so that mobility was restored - i.E.The swelling went down accordingly and walking without assistance was possible.Sick leave was also required.At the same time the inflammation / swelling was treated with the usual means (retterspitz, cooling, painkillers / volatren).The overall condition of the knee is worse than before the treatment - this concerns, as described, both treated knees (also from the treatment before) (osteoarthritis; seriousness criteria: medically significant) (device ineffective).Action taken: not applicable for all the events corrective treatment: local antiphlogistic measures, antibiotics zinc oxide (retterspitz zinksalbe) and diclofenac (voltaren), naloxone hydrochloride, tilidine hydrochloride (tilidin), and ibuprofen for injection site joint inflammation, used crutched for events joint range of motion decreased, mobility decreased, and injection site joint inflammation, not reported for rest of the events.Outcome: recovered in 2023 for joint range of motion decreased, mobility decreased, not recovered for osteoarthritis, and recovering for rest of the events.A product technical compliant (ptc) was initiated on (b)(6) 2023 for synvisc one (lot - unknown) with global ptc number 100331214.The sample of the ptc was not available.Ptc stated: based on the complaint from intake team, there is no quality related defect that would attribute to a malfunction a death or serious injury.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.The defect class has been updated to ii.(em (b)(6) 2023) investigation (em (b)(6) 2023).The product lot number was not provided.A batch record review is not possible.Based on the lack of information, no assessment is possible.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 nonconforming material or product process.Sanofi will continue to monitor adverse events and perform trend analysis on a periodic basis to determine if a capa (corrective and preventive action) is required.The final investigation was completed on 08-jun-2023 with summarized conclusion as no assessment possible.Based on the previously received information, field 4.1 (b) and 1.2 (b) in mir was filled.Based on the previously received information, events were added- almost immobile and synvisc one was given via subcutaneous route with no reported adverse event.Suspect product was updated from synvisc to synvisc one.As reported terms were updated to knee joint severely inflamed (for injection site joint inflammation) and complaints worsen until the knee was almost no longer able to move/moving without crutches was no longer possible (for joint range of motion decreased).Additional symptoms added for injection site joint inflammation.Event- knee is worse than before the treatment was considered as serious.Product start date was added as 05-mar-2023.Medical history was added- osteoarthritis and overweight.Text was amended accordingly.Additional information was received on 30-may-2023 from quality department and other health care professional: strength of suspect was added.Additional information was received on 31-may-2023 from physician.The event verbatim of joint range of motion decreased, injection site joint inflammation along with its symptoms injection site joint swelling, injection site joint warmth were updated.The symptom of injection site joint pain was added.The event of incorrect route of product administration was deleted.History and treatment was updated.Therapy dates was updated from (b)(6) 2023 to (b)(6) 2023 and route was updated from subcutaneous to intra-articular.Clinical course was updated and text amended accordingly.Additional information was received on 08-jun-2023 from quality department and other health care professional.Ptc results was added.Text amended accordingly.
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Manufacturer Narrative
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Sanofi company comment for follow up dated 31-may-2023.This case involves 43 years old female patient whose complaints worsen until the knee was almost no longer able to move/moving without crutches was no longer possible/ extension/flexion 0-0-70 degrees, almost immobile, knee is worse than before the treatment, knee joint severely inflamed, after the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one].Reportedly, it happened for the second time in three years.The events resulted in disability as the patient had to use crutches.Based on information provided in the case, causal role of suspect product cannot be excluded for the occurrence of events.However, patient had underlying condition of osteoarthritis which is a causative factor for event osteoarthritis aggravated.Case will be re-evaluated post further update on knee status at baseline, injection technique, post injection routine, concomitant medications and other risk factors if any.
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Event Description
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Complaints worsen until the knee was almost no longer able to move/moving without crutches was no longer possible/ extension/flexion 0-0-70 degree [joint range of motion decreased] almost immobile [mobility decreased] knee is worse than before the treatment [osteoarthritis aggravated] ([device ineffective]) knee joint severely inflamed/ inflamed condition of the knee [injection site joint inflammation] ([injection site joint warmth], [injection site joint pain], [injection site joint discomfort], [condition aggravated], [injection site joint swelling]) case narrative: initial information was received from germany on 07-may-2023 regarding an unsolicited valid serious case from other health professional.This case is linked to case (b)(4) (multiple devices suspect for same patient, case for injection of 2020).This case involves 43 years old female patient who complaints worsen until the knee was almost no longer able to move/moving without crutches was no longer possible/ extension/flexion 0-0-70 degree, almost immobile, knee is worse than before the treatment and knee joint severely inflamed/ inflamed condition of the knee while being treated with with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one].The patient received synvisc on (b)(6) 2020.The patient's past medical history included lung embolism/status post pulmonary embolism in 2013 (about 10 years ago) the patient's past medical treatment(s) and family history were not provided.At the time of the event, the patient had ongoing activated gonarthrosis on the left knee and coxarthrosis/osteoarthritis due to sport (competitive sport), thyroid disease, hypertension and was overweight with bmi (basal metabolic index) 44.08.Patient had no allergies.On (b)(6) 2023, the patient received synvisc one in left knee (hylan g-f 20, sodium hyaluronate injection once via intra-articular route (batch number, dose, expiration date: unknown, strength: 48 mg/6 ml) for osteoarthritis in the knee (both sides).There will be no information available on the batch number of this case.Patient had a very strong and unexpected reaction to a knee injection with synvisc one.There was significant increase in symptoms after injection.On an unknown date in mar-2023, after latency of few days, patients knee joint severely inflamed, almost immobile (injection site joint inflammation and mobility decreased, caused disability).Initially expected discomfort at the injection (injection site joint discomfort, caused disability), then heat build-up in the knee, swelling- all the same as before (as in 2020) (injection site joint warmth and injection site joint swelling, caused disability).Knee was said to have been swollen, overheated and inflamed.Only visited the out-patient emergency.She was at the medical emergency services at the clinic on (b)(6) 2023 on account of an inflamed condition of the knee.Countermeasures (example: cooling, elevation, anti-inflammatory ointments, antibiotics, tilidin, ibu (ibuprofen)).Complaints worsened until the knee was almost no longer able to move, moving without crutches was no longer possible (joint range of motion decreased, caused disability, condition aggravated) (onset: mar-2023 and latency: few days).According to the doctor's statement, only extremely rare reactions of this type (when used 3 years ago in 2020), now again - similar reaction on the other knee.There are no indications in the side effects that describe such a course.On (b)(6) 2023, the patient presented for progress monitoring.The patient had normal relief, no intra-articular effusion was found.On the account of extent of movement, extension/flexion 0-0-70 degrees (joint range of motion decreased), no ligament instability was observed.She had pain on forced extension and flexion, pain on pressure (injection site joint pain, onset: (b)(6) 2023; latency: 11 days).The patient had intraarticular space and pes anserinus (goose foot).Local antiphlogistic measures was recommended.No more hyaluronan infiltration was desired due to intolerance.The knee can still not be loaded as before or as hoped for after the treatment.Due to a vacation stay with corresponding load (short distances), the condition is currently significantly worse.A prolonged (several weeks) use of crutches was necessary so that mobility was restored - i.E.The swelling went down accordingly and walking without assistance was possible.Sick leave was also required.At the same time the inflammation / swelling was treated with the usual means (retterspitz, cooling, painkillers / volatren).The overall condition of the knee is worse than before the treatment - this concerns, as described, both treated knees (also from the treatment before) (osteoarthritis; seriousness criteria: medically significant) (device ineffective).Action taken: not applicable for all the events corrective treatment: local antiphlogistic measures, antibiotics zinc oxide (retterspitz zinksalbe) and diclofenac (voltaren), naloxone hydrochloride, tilidine hydrochloride (tilidin), and ibuprofen for injection site joint inflammation, used crutched for events joint range of motion decreased, mobility decreased, and injection site joint inflammation, not reported for rest of the events.Outcome: recovered in 2023 for joint range of motion decreased, mobility decreased, not recovered for osteoarthritis, and recovering for rest of the events.A product technical compliant (ptc) was initiated on 29-mar-2023 for synvisc one (lot - unknown) with global ptc number 100331214.The sample of the ptc (product technical complaint) was requested and awaited.Ptc was set in process and results were pending for the same.Based on the previously received information, field 4.1 (b) and 1.2 (b) in mir was filled.Based on the previously received information, events were added- almost immobile and synvisc one was given via subcutaneous route with no reported adverse event.Suspect product was updated from synvisc to synvisc one.As reported terms were updated to knee joint severely inflamed (for injection site joint inflammation) and complaints worsen until the knee was almost no longer able to move/moving without crutches was no longer possible (for joint range of motion decreased).Additional symptoms added for injection site joint inflammation.Event- knee is worse than before the treatment was considered as serious.Product start date was added as 05-mar-2023.Medical history was added- osteoarthritis and overweight.Text was amended accordingly.Additional information was received on 30-may-2023 from quality department and other health care professional: strength of suspect was added.Additional information was received on 31-may-2023 from physician.The event verbatim of joint range of motion decreased, injection site joint inflammation along with its symptoms injection site joint swelling, injection site joint warmth were updated.The symptom of injection site joint pain was added.The event of incorrect route of product administration was deleted.History and treatment was updated.Therapy dates was updated from (b)(6) 2023 to (b)(6) 2023 and route was updated from subcutaneous to intra-articular.Clinical course was updated and text amended accordingly.
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