| Lot Number UNKNOWN |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Chest Pain (1776); Pyrosis/Heartburn (1883); Hepatitis (1897); Pain (1994); Anxiety (2328); Discomfort (2330); Contact Dermatitis (4546); Swelling/ Edema (4577); Peripheral Edema (4578); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Type
Injury
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Event Description
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Pain in right knee.Swelling of r knee.Vaginal odor.Chest pain, unspecified type.Foul smelling urine.Perioral dermatitis.Hemorrhoids.Abdominal discomfort.Anxiety.Bloating.Hepatitis b.Case narrative: initial information received on 30-jan-2023 processed as non-case and later on upgraded to valid case with the clock start date of 01-feb-2023 regarding an unsolicited valid legal case serious case received from a lawyer from united states.This case involves a 57 years old female patient who experienced pain in right knee, swollen knee, vaginal odor, chest pain, unspecified type, foul smelling urine, perioral dermatitis, hemorrhoids, abdominal discomfort, anxiety, bloating and hepatitis b while being treated with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc).The patient's past medical history included diverticulosis, neck pain, meniscal degeneration, baker's cyst and fall in 2018.Patient is a non-smoker.The patient's past medical treatment(s), vaccination(s) and family history were not provided.At the time of the event, the patient had ongoing bell's palsy in 2018 with since 2018, tinnitus, drug hypersensitivity with rash to cymbalta; shortness of breath to codeine, neck pain, gastrooesophageal reflux disease, uterine leiomyoma, chronic sinusitis, skin lesion, overweight, osteoarthritis, pain in extremity with pain in left foot, gallbladder polyp, depression, impaired fasting glucose, hyperlipidaemia and fibromyalgia, costochondritis for the past 20 years.Concomitant medications included ipratropium bromide (ipratropium bromide); famotidine (famotidine); meloxicam (meloxicam); omeprazole (omeprazole); ketotifen fumarate and elasomeran (covid-19 vaccine moderna) for immunisation.On an unknown date of (b)(6) 2018, the patient started using hylan g-f 20, sodium hyaluronate injection, (dosage, batch number, frequency, expiry date: unknown).On the unknown date, after the unknown latency of starting the treatment with hylan g-f 20, sodium hyaluronate, patient had pain in right knee (arthralgia), swollen knee (joint swelling), vaginal odor (vaginal odour), chest pain, unspecified type, foul smelling urine (urine odour abnormal), perioral dermatitis, hemorrhoids, abdominal discomfort, anxiety, bloating (abdominal distension) and hepatitis b virus (hepatitis b; onset date: (b)(6) 2021).For the cure of arthralgia and joint swelling, patient used braces.Relevant laboratory test results included: alanine aminotransferase (6 - 29 u/l) - on (b)(6) 2021: 34 u/l [34]; on (b)(6) 2021: 34 u/l [34]; on (b)(6) 2021: 41 u/l [41].Aspartate aminotransferase (10 - 35 u/l) - on (b)(6) 2021: 42 u/l [42].Blood cholesterol - on (b)(6) 2021: 239 mg/dl [239]; on (b)(6) 2021: 239 mg/dl [239]; on (b)(6) 2021: 255 mg/dl [255].Blood glucose (65 - 99 mg/dl) - on (b)(6) 2021: 109 mg/dl [109]; on 0(b)(6) 2021: 109 mg/dl [109].Blood triglycerides - on (b)(6) 2021: 198 mg/dl [198]; on (b)(6) 2021: 198 mg/dl [198]; on (b)(6) 2021: 225 mg/dl [225].Cardiovascular evaluation - on an unknown date: negative.Glycosylated haemoglobin - on (b)(6) 2021: 6.5 [6.5]; on (b)(6) 2021: 6.5 [6.5]; on (b)(6) 2021: 6.4 [6.4].High density lipoprotein - (b)(6) 2021: 47 [47]; on (b)(6) 2021: 47 [47]; on (b)(6) 2021: 47 [47].Low density lipoprotein - on (b)(6) 2021: 156 [156]; on (b)(6) 2021: 156 [156]; on (b)(6) 2021: 170 [170].Magnetic resonance imaging - on (b)(6) 2022: [meniscal tear with baker cyst].Urine analysis - on an unknown date: [foul smelling urine].Action taken: unknown for rest all the events.Corrective treatment: braces for swollen knee, pain in right knee; suppositories for hemorrhoids; painkillers for vaginal odour.Not reported for rest all the events.Outcome: unknown for all the events.Seriousness criteria: disability for arthralgia, joint swelling.Additional information was received 01-feb-2023 from the lawyer.Case initially processed as non-case upgraded to valid case.Text amended accordingly.
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Event Description
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Hepatitis b virus [hepatitis b] swelling & inflammation [injection site joint inflammation] ([injection site joint pain], [injection site joint swelling]) vaginal odor [vaginal odor] chest pain, unspecified type [chest pain] foul smelling urine [urine odor abnormal] perioral dermatitis [perioral dermatitis] abdominal discomfort [abdominal discomfort] anxiety [anxiety] bloating [bloating] deformation of r knee [injection site deformation] depression [depression] hemorrhoids [hemorrhoids].Case narrative: initial information received on 30-jan-2023 processed as non-case and later on upgraded to valid case with the clock start date of (b)(6) 2023 regarding an unsolicited valid legal serious case received from a lawyer from united states.The case was linked with (b)(4) (duplicate).This case involves 57 years old female patient who had swelling & inflammation, hepatitis b virus, vaginal odor, chest pain, unspecified type, foul smelling urine, perioral dermatitis, hemorrhoids, abdominal discomfort, anxiety, bloating, deformation of r (right) knee and depression while being treated with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history included diverticulosis, neck pain, meniscal degeneration, right meniscal tear with baker's cyst and 2 times fall in 2018.Patient is a non-smoker.The patient's past medical treatment(s), vaccination(s) and family history were not provided.At the time of the event, the patient had ongoing chronic left bell's palsy since 2018, chronic tinnitus, drug hypersensitivity with rash to cymbalta; shortness of breath to codeine, cervicalgia, gastrooesophageal reflux disease (gerd), fibroids, chronic sinusitis, skin lesion, overweight, primary osteoarthritis (knees), pain in extremity with pain in left foot, gallbladder polyp, mild depression, impaired fasting glucose, hyperlipidaemia and fibromyalgia, costochondritis for the past 20 years.Concomitant medications included ipratropium bromide (ipratropium bromide); famotidine (famotidine); meloxicam (meloxicam); omeprazole (omeprazole); ketotifen fumarate and elasomeran (covid-19 vaccine moderna) for immunisation.On an unknown date of (b)(6) 2018, the patient started using hylan g-f 20, sodium hyaluronate injection, in right knee via intra-articular route (strength: 48mg/6ml, with dosage, batch number, frequency, expiry date: unknown) for osteoarthritis.Information on batch number was requested.On the unknown date, after the unknown latency of starting the treatment with hylan g-f 20, sodium hyaluronate, patient had pain in right knee (injection site joint pain), swollen knee (injection site joint swelling), deformation of r knee, vaginal odor (vaginal odour), chest pain unspecified type (chest pain), foul smelling urine (urine odour abnormal), perioral dermatitis, hemorrhoids (haemorrhoids), abdominal discomfort, bloating (abdominal distension).There were continuous pain, swelling, inflammation (injection site joint inflammation), deformation (injection site deformation).There were anxieties ad depression (onset; latency: unknown) caused by this injury.He was diagnosed with hepatitis b virus (hepatitis b; onset date: (b)(6) 2021).For the cure of arthralgia and joint swelling, patient used braces.Relevant laboratory test results included: alanine aminotransferase (6 - 29 u/l) - on (b)(6) 2021: 34 u/l [34]; on (b)(6) 2021: 34 u/l [34]; on (b)(6) 2021: 41 u/l [41].Aspartate aminotransferase (10 - 35 u/l) - on (b)(6) 2021: 42 u/l [42].Blood cholesterol - on (b)(6) 2021: 239 mg/dl [239]; on (b)(6) 2021: 239 mg/dl [239]; on (b)(6) 2021: 255 mg/dl [255].Blood glucose (65 - 99 mg/dl) - on (b)(6) 2021: 109 mg/dl [109]; on (b)(6) 2021: 109 mg/dl [109].Blood triglycerides - on (b)(6) 2021: 198 mg/dl [198]; on (b)(6) 2021: 198 mg/dl [198]; on (b)(6) 2021: 225 mg/dl [225].Cardiovascular evaluation - on an unknown date: negative.Glycosylated haemoglobin - on (b)(6) 2021: 6.5 [6.5]; on (b)(6) 2021: 6.5 [6.5]; on (b)(6) 2021: 6.4 [6.4].High density lipoprotein - on (b)(6) 2021: 47 [47]; on (b)(6) 2021: 47 [47]; on (b)(6) 2021: 47 [47].Low density lipoprotein - on (b)(6) 2021: 156 [156]; on (b)(6) 2021: 156 [156]; on (b)(6) 2021: 170 [170].Magnetic resonance imaging - on (b)(6) 2022: [meniscal tear with baker cyst].Urine analysis - on an unknown date: [foul smelling urine].Action taken: not applicable for all the events.Corrective treatment: the patient used braces for injection site joint inflammation; suppositories for hemorrhoids; painkillers for vaginal odour and not reported for rest of the events.Outcome: recovering for the event vaginal odor and was unknown for rest of the events.Seriousness criteria: disability for injection site joint inflammation and medically significant for hepatitis b.A product technical complaint (ptc) was initiated on 30-jan-2023 for synvisc one (batch number: unknown) with global ptc number (b)(4).The sample status was not available.Ptc stated: complaint: adverse event preliminary assessment ((b)(6) 2023) based on the complaint from intake team, there is no quality related defect that would attribute to a malfunction, 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.Investigation ((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 26-jun-2023 with summarized conclusion as no assessment possible.Additional information was received 01-feb-2023 from the lawyer.Case initially processed as non-case upgraded to valid case.Text amended accordingly.Upon internal review on 29-jun-2023, the cases (b)(4) (to be deleted) were identified to be duplicate of (b)(4) (to be retained).All the information from the case (b)(4) has been merged in the case (b)(4).Case (b)(4) received with csd of 10-aug-2022, and case (b)(4) with csd of 30-aug-2022, would be deleted.The event of depression, injection site joint inflammation and injection site deformation was added.Verbatim was update to swollen knee/ swelling & inflammation.Ptc number along with strength were added.Text amended accordingly.Additional information was received on 26-jun-2023 from healthcare professional (quality department).Ptc results was added.Text amended accordingly.
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Event Description
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Hepatitis b virus [hepatitis b] swelling & inflammation [injection site joint inflammation] ([injection site joint pain], [injection site joint swelling]) vaginal odor [vaginal odor] chest pain, unspecified type [chest pain] foul smelling urine [urine odor abnormal] perioral dermatitis [perioral dermatitis] abdominal discomfort [abdominal discomfort] anxiety [anxiety] bloating [bloating] deformation of r knee [injection site deformation] depression [depression] hemorrhoids [hemorrhoids] case narrative: initial information received on 30-jan-2023 processed as non-case and later on upgraded to valid case with the clock start date of (b)(6) 2023 regarding an unsolicited valid legal serious case received from a lawyer from united states.The case was linked with (b)(4) (duplicate).This case involves 57 years old female patient who had swelling & inflammation, hepatitis b virus, vaginal odor, chest pain, unspecified type, foul smelling urine, perioral dermatitis, hemorrhoids, abdominal discomfort, anxiety, bloating, deformation of r (right) knee and depression while being treated with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history included diverticulosis, neck pain, meniscal degeneration, right meniscal tear with baker's cyst and 2 times fall in 2018.Patient is a non-smoker.The patient's past medical treatment(s), vaccination(s) and family history were not provided.At the time of the event, the patient had ongoing chronic left bell's palsy since 2018, chronic tinnitus, drug hypersensitivity with rash to cymbalta; shortness of breath to codeine, cervicalgia, gastrooesophageal reflux disease (gerd), fibroids, chronic sinusitis, skin lesion, overweight, primary osteoarthritis (knees), pain in extremity with pain in left foot, gallbladder polyp, mild depression, impaired fasting glucose, hyperlipidaemia and fibromyalgia, costochondritis for the past 20 years concomitant medications included ipratropium bromide (ipratropium bromide); famotidine (famotidine); meloxicam (meloxicam); omeprazole (omeprazole); ketotifen fumarate and elasomeran (covid-19 vaccine moderna) for immunisation.On an unknown date of aug-2018, the patient started using hylan g-f 20, sodium hyaluronate injection, in right knee via intra-articular route (strength: 48mg/6ml, with dosage, batch number, frequency, expiry date: unknown) for osteoarthritis.Information on batch number was requested.On the unknown date, after the unknown latency of starting the treatment with hylan g-f 20, sodium hyaluronate, patient had pain in right knee (injection site joint pain), swollen knee (injection site joint swelling), deformation of r knee, vaginal odor (vaginal odour), chest pain unspecified type (chest pain), foul smelling urine (urine odour abnormal), perioral dermatitis, hemorrhoids (haemorrhoids), abdominal discomfort, bloating (abdominal distension).There were continuous pain, swelling, inflammation (injection site joint inflammation), deformation (injection site deformation).There were anxieties ad depression (onset; latency: unknown) caused by this injury.He was diagnosed with hepatitis b virus (hepatitis b; onset date: nov-2021).For the cure of arthralgia and joint swelling, patient used braces.Relevant laboratory test results included: alanine aminotransferase (6 - 29 u/l) - on (b)(6) 2021: 34 u/l [34]; on (b)(6) 2021: 34 u/l [34]; on (b)(6)2021: 41 u/l [41] aspartate aminotransferase (10 - 35 u/l) - on (b)(6) 2021: 42 u/l [42] blood cholesterol - on (b)(6) 2021: 239 mg/dl [239]; on (b)(6) 2021: 239 mg/dl [239]; on (b)(6) 2021: 255 mg/dl [255] blood glucose (65 - 99 mg/dl) - on (b)(6) 2021: 109 mg/dl [109]; on (b)(6) 2021: 109 mg/dl [109] blood triglycerides - on (b)(6) 2021: 198 mg/dl [198]; on (b)(6) 2021: 198 mg/dl [198]; on (b)(6) 2021: 225 mg/dl [225] cardiovascular evaluation - on an unknown date: negative glycosylated haemoglobin - on (b)(6) 2021: 6.5 [6.5]; on (b)(6) 2021: 6.5 [6.5]; on (b)(6) 2021: 6.4 [6.4] high density lipoprotein - on (b)(6) 2021: 47 [47]; on (b)(6) 2021: 47 [47]; on (b)(6) 2021: 47 [47] low density lipoprotein - on (b)(6) 2021: 156 [156]; on (b)(6) 2021: 156 [156]; on (b)(6) 2021: 170 [170] magnetic resonance imaging - on (b)(6) 2022: [meniscal tear with baker cyst] urine analysis - on an unknown date: [foul smelling urine] action taken: not applicable for all the events corrective treatment: the patient used braces for injection site joint inflammation; suppositories for hemorrhoids; painkillers for vaginal odour and not reported for rest of the events.Outcome: recovering for the event vaginal odor and was unknown for rest of the events.Seriousness criteria: disability for injection site joint inflammation and medically significant for hepatitis b.A product technical complaint (ptc) was initiated on 30-jan-2023 for synvisc one (batch number: unknown) with global ptc number 100338121.The sample status was not available.Ptc was set in process and results were pending for the same.Additional information was received 01-feb-2023 from the lawyer.Case initially processed as non-case upgraded to valid case.Text amended accordingly.Upon internal review on 29-jun-2023, the cases (b)(4) (to be deleted) were identified to be duplicate of (b)(4) (to be retained).All the information from the case (b)(4) has been merged in the case (b)(4).Case (b)(4) received with csd of (b)(6) 2022, and case (b)(4) with csd of (b)(6) 2022, would be deleted.The event of depression, injection site joint inflammation and injection site deformation was added.Verbatim was update to swollen knee/ swelling & inflammation.Ptc number along with strength were added.Text amended accordingly.
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Search Alerts/Recalls
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