| Lot Number UNKNOWN |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Erythema (1840); Fall (1848); Arthralgia (2355); Joint Swelling (2356); No Code Available (3191)
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| Event Date 11/10/2017 |
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Event Type
Injury
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Manufacturer Narrative
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Sanofi company comment 14-aug-2018.Based on the limited information provided regarding this case, causal role of the suspect product cannot be excluded.Case will be re-evaluated post further update on patient's underlying conditions, past medical and drug history, concurrent illness and concomitant medications.
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Event Description
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Synovitis [synovitis] ([knee swelling], [joint warmth], [joint effusion], [arthralgia]) hemiplegia [hemiplegia]; tried to stand up but almost fell due to left knee weakness secondary to pain [difficulty in standing] ; almost fell [fall] ; left knee weakness secondary to pain [weakness in extremity] ; mild numbness of her left toes [numbness in toes] ; limited range of motion due to pain [joint range of motion decreased] ([condition worsened]); slight erythema of left leg [localized erythema] ; white blood cell count increased [white blood cell count increased] ; blood glucose increased [blood glucose increased] ; blood urea nitrogen increased [blood urea nitrogen increased] ; patient developed throbbing sensation located from her left knee; half down the lower leg pulsating pain [throbbing pain].Case narrative: upon internal review done on (b)(6) 2018, this case has been updated to serious from non-serious due to hospitalization for synovitis.Initial information received on (b)(6) 2018 regarding an unsolicited valid serious case of united states received from a physician.This case involves a (b)(6) female patient who experienced, tried to stand up but almost fell due to left knee weakness secondary to pain, almost fell, left knee weakness secondary to pain, left knee was warmer than normal, mild numbness of her left toes, limited range of motion due to pain, slight erythema of left leg, , white blood cell count increased, blood glucose increased, hemiplegia and blood urea nitrogen increased, synovitis, while she was treated with hylan g-f 20, sodium hyaluronate (synvisc).(latency unknown) the patient's past medical history included drug hypersensitivity on (b)(6) 2010 with allergy with biaxin (clarithromycin), codeine, vicodin (hydrocodone-acetaminophen) causing nausea/vomiting.Anaemia, intracranial aneurysm, bursitis, headache, continuous positive airway pressure, cerebrovascular accident, eczema, gastric banding in 2015, gastrooesophageal reflux disease, hemiplegia, intervertebral disc protrusion, hypothyroidism, memory impairment, neuropathy peripheral, obesity, sleep apnoea syndrome, hyperlipidaemia, craniotomy, laparoscopy on (b)(6) 2010, hernia repair, neuroma, aneurysm repair, hysterectomy, disability, tobacco user, neoplasm malignant.Family history included mother had cancer, arthritis, father had cardiac failure, obesity, diabetes mellitus, arthritis, sister and brother had obesity, diabetes mellitus with paternal grandfather, coagulopathy with paternal uncle and pulmonary embolism with paternal uncle.The patient's family history included cerebrovascular accident with mother had stroke.The patient's past medical treatment(s), vaccination(s) was not provided.Concomitant medications included ranitidine (ranitidine hydrochloride) for dyspepsia, baclofen, calcium, diazepam, estradiol, folic acid, levothyroxine sodium, ascorbic acid, ergocalciferol, folic acid, retinol, tocopherol, vitamin b nos (multiple vitamins); ascorbic acid, ergocalciferol, folic acid, retinol, tocopherol, vitamin b nos (multiple vitamins), trospium and ergocalciferol.On (b)(6) 2017, the patient started taking synvisc (hylan g-f 20, sodium hyaluronate) unknown dosage intra-articular (with an unknown batch number).On (b)(6) 2017, patient developed a non-serious acute pain of left knee/ severe burning pain.On the same day, patient experienced tried to stand up but almost fell due to left knee weakness secondary to pain.On (b)(6) 2017, patient suffered from almost fell and on the same day she experienced left knee weakness secondary to pain.On (b)(6) 2018, patient developed synovitis, left knee is more swollen / edema of left leg.On the same day, patient experienced left knee was warmer than normal.O unknown date, patient experienced mild numbness of her left toes.On (b)(6) 2018, patient also showed limited range of motion due to pain and slight erythema of left leg.The same day, the patient was hospitalized foe knee pain.On unknown date, patient experienced left knee aspiration.This event was leading to intervention.On unknown date, patient suffered from white blood cell count increased.On (b)(6) 2017, patient developed blood glucose increased and blood urea nitrogen increased.Relevant laboratory test results included: - x-ray - on (b)(6) 2017 showed mild soft tissue edema, blood glucose was abnormal, white blood cell count was abnormal and blood urea nitrogen was abnormal.On (b)(6) 2017, the patient was discharged from the hospital.On unknown date, patient developed throbbing sensation located from her left knee; half down the lower leg pulsating pain and developed hemiplegia.Final diagnosis was blood urea nitrogen increased, blood glucose increased, slight erythema of left leg, limited range of motion due to pain, almost fell, tried to stand up but almost fell due to left knee weakness secondary to pain, acute pain of left knee/ severe burning pain, white blood cell count increased, left knee aspiration, hemiplegia, mild numbness of her left toes, left knee was warmer than normal and left knee weakness secondary to pain.Action taken: unknown.Corrective treatment: the patient was treated with acetaminophen, hydrocodone bitartrate, omeprazole, tylenol, tramadol, morphine and motrin for acute pain of left knee/ severe burning pain.Outcome: unknown for all the events.Seriousness criteria: hospitalization for synovitis, medically significant for hemiplegia.A product technical complaint (ptc) was initiated on (b)(6) 2018 for synvisc; batch number ; unknown; local ptc number: (b)(4); global ptc number: (b)(4) 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 adverse events to determine if a capa is required.Upon internal review done on (b)(6) 2018, this case has been updated to serious from non-serious due to hospitalization.New event of hemiplegia was added.Date of administration of synvisc was updated to (b)(6) 2017.New test results done one (b)(6) 2017 were added.Clinical course was updated.Text was amended accordingly.Additional information was received on 14-aug-2018.Global ptc number and ptc results were added.
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Event Description
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Synovitis [synovitis] ([knee swelling], [joint warmth], [joint effusion], [arthralgia]) hemiplegia [hemiplegia] tried to stand up but almost fell due to left knee weakness secondary to pain [difficulty in standing] almost fell [fall] left knee weakness secondary to pain [weakness in extremity] mild numbness of her left toes [numbness in toes] limited range of motion due to pain [joint range of motion decreased] ([condition worsened]) slight erythema of left leg [localized erythema] white blood cell count increased [white blood cell count increased] blood glucose increased [blood glucose increased] blood urea nitrogen increased [blood urea nitrogen increased] patient developed throbbing sensation located from her left knee; half down the lower leg pulsating pain [throbbing pain] case narrative: upon internal review done on 14-aug-2018, this case has been updated to serious from non-serious due to hospitalization for synovitis.Initial information received on 07-aug-2018 regarding an unsolicited valid serious case of united states received from a physician.This case involves a 65 years old female patient who experienced, tried to stand up but almost fell due to left knee weakness secondary to pain, almost fell, left knee weakness secondary to pain, left knee was warmer than normal, mild numbness of her left toes, limited range of motion due to pain, slight erythema of left leg, , white blood cell count increased, blood glucose increased, hemiplegia and blood urea nitrogen increased, synovitis, while she was treated with hylan g-f 20, sodium hyaluronate (synvisc).(latency unknown).The patient's past medical history included drug hypersensitivity on (b)(6) 2010 with allergy with biaxin (clarithromycin), codeine, vicodin (hydrocodone-acetaminophen) causing nausea/vomiting.Anaemia, intracranial aneurysm, bursitis, headache, continuous positive airway pressure, cerebrovascular accident, eczema, gastric banding in 2015, gastrooesophageal reflux disease, hemiplegia, intervertebral disc protrusion, hypothyroidism, memory impairment, neuropathy peripheral, obesity, sleep apnoea syndrome, hyperlipidaemia, craniotomy, laparoscopy on 03-jun-2010, hernia repair, neuroma, aneurysm repair, hysterectomy, disability, tobacco user, neoplasm malignant.Family history included mother had cancer, arthritis, father had cardiac failure, obesity, diabetes mellitus, arthritis, sister and brother had obesity, diabetes mellitus with paternal grandfather, coagulopathy with paternal uncle and pulmonary embolism with paternal uncle.The patient's family history included cerebrovascular accident with mother had stroke.The patient's past medical treatment(s), vaccination(s) was not provided.Concomitant medications included ranitidine (ranitidine hydrochloride) for dyspepsia, baclofen, calcium, diazepam, estradiol, folic acid, levothyroxine sodium, ascorbic acid, ergocalciferol, folic acid, retinol, tocopherol, vitamin b nos (multiple vitamins); ascorbic acid, ergocalciferol, folic acid, retinol, tocopherol, vitamin b nos (multiple vitamins), trospium and ergocalciferol.On (b)(6) 2017, the patient started taking synvisc (hylan g-f 20, sodium hyaluronate) unknown dosage intra-articular (with an unknown batch number).On 10-nov-2017, patient developed a non-serious acute pain of left knee/ severe burning pain.On the same day, patient experienced tried to stand up but almost fell due to left knee weakness secondary to pain.On (b)(6) 2017, patient suffered from almost fell and on the same day she experienced left knee weakness secondary to pain.On (b)(6) 2018, patient developed synovitis, left knee is more swollen / edema of left leg.On the same day, patient experienced left knee was warmer than normal.O unknown date, patient experienced mild numbness of her left toes.On (b)(6) 2018, patient also showed limited range of motion due to pain and slight erythema of left leg.The same day, the patient was hospitalized foe knee pain.On unknown date, patient experienced left knee aspiration.This event was leading to intervention.On unknown date, patient suffered from white blood cell count increased.On (b)(6) 2017, patient developed blood glucose increased and blood urea nitrogen increased.Relevant laboratory test results included: - x-ray - on (b)(6) 2017 showed mild soft tissue edema, blood glucose was abnormal, white blood cell count was abnormal and blood urea nitrogen was abnormal.On (b)(6) 2017, the patient was discharged from the hospital.On unknown date, patient developed throbbing sensation located from her left knee; half down the lower leg pulsating pain and developed hemiplegia.Final diagnosis was blood urea nitrogen increased, blood glucose increased, slight erythema of left leg, limited range of motion due to pain, almost fell, tried to stand up but almost fell due to left knee weakness secondary to pain, acute pain of left knee/ severe burning pain, white blood cell count increased, left knee aspiration, hemiplegia, mild numbness of her left toes, left knee was warmer than normal and left knee weakness secondary to pain.Action taken: unknown.Corrective treatment: the patient was treated with acetaminophen, hydrocodone bitartrate, omeprazole, tylenol, tramadol, morphine and motrin for acute pain of left knee/ severe burning pain.Outcome: unknown for all the events.Seriousness criteria: hospitalization for synovitis, medically significant for hemiplegia.A product technical complaint (ptc) was initiated on (b)(6) 2018 for synvisc; batch number ; unknown; local ptc number: (b)(4); global ptc number: (b)(4).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 adverse events to determine if a capa is required.Upon internal review done on (b)(6) 2018, this case has been updated to serious from non-serious due to hospitalization.New event of hemiplegia was added.Date of administration of synvisc was updated to (b)(6) 2017.New test results done one (b)(6) 2017 were added.Clinical course was updated.Text was amended accordingly.Additional information was received on 14-aug-2018.Global ptc number and ptc results were added.
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Manufacturer Narrative
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Sanofi company comment (b)(6) 2018.Based on the limited information provided regarding this case, causal role of the suspect product cannot be excluded.Case will be re-evaluated post further update on patient's underlying conditions, past medical and drug history, concurrent illness and concomitant medications.
|
| |
|
Event Description
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|
Synovitis [synovitis] ([knee swelling], [arthralgia], [joint effusion], [joint warmth]) hemiplegia [hemiplegia] tried to stand up but almost fell due to left knee weakness secondary to pain [difficulty in standing] almost fell [fall] left knee weakness secondary to pain [weakness in extremity] mild numbness of her left toes [numbness in toes] limited range of motion due to pain [joint range of motion decreased] ([condition worsened]) slight erythema of left leg [localized erythema] white blood cell count increased [white blood cell count increased] blood glucose increased [blood glucose increased] blood urea nitrogen increased [blood urea nitrogen increased] patient developed throbbing sensation located from her left knee; half down the lower leg pulsating pain [throbbing pain] case narrative: upon internal review done on 14-aug-2018, this case has been updated to serious from non-serious due to hospitalization for synovitis.Initial information received on 07-aug-2018 regarding an unsolicited valid serious case of united states received from a physician.This case involves a 65 years old female patient who experienced, tried to stand up but almost fell due to left knee weakness secondary to pain, almost fell, left knee weakness secondary to pain, left knee was warmer than normal, mild numbness of her left toes, limited range of motion due to pain, slight erythema of left leg, , white blood cell count increased, blood glucose increased, hemiplegia and blood urea nitrogen increased, synovitis, while she was treated with hylan g-f 20, sodium hyaluronate (synvisc).(latency unknown).The patient's past medical history included drug hypersensitivity on (b)(6) 2010 with allergy with biaxin (clarithromycin), codeine, vicodin (hydrocodone-acetaminophen) causing nausea/vomiting.Anaemia, intracranial aneurysm, bursitis, headache, continuous positive airway pressure, cerebrovascular accident, eczema, gastric banding in 2015, gastrooesophageal reflux disease, hemiplegia, intervertebral disc protrusion, hypothyroidism, memory impairment, neuropathy peripheral, obesity, sleep apnoea syndrome, hyperlipidaemia, craniotomy, laparoscopy on (b)(6) 2010, hernia repair, neuroma, aneurysm repair, hysterectomy, disability, tobacco user, neoplasm malignant.Family history included mother had cancer, arthritis, father had cardiac failure, obesity, diabetes mellitus, arthritis, sister and brother had obesity, diabetes mellitus with paternal grandfather, coagulopathy with paternal uncle and pulmonary embolism with paternal uncle.The patient's family history included cerebrovascular accident with mother had stroke.The patient's past medical treatment(s), vaccination(s) was not provided.Concomitant medications included ranitidine (ranitidine hydrochloride) for dyspepsia, baclofen, calcium, diazepam, estradiol, folic acid, levothyroxine sodium, ascorbic acid, ergocalciferol, folic acid, retinol, tocopherol, vitamin b nos (multiple vitamins); ascorbic acid, ergocalciferol, folic acid, retinol, tocopherol, vitamin b nos (multiple vitamins), trospium and ergocalciferol.On (b)(6) 2017, the patient started taking synvisc (hylan g-f 20, sodium hyaluronate) unknown dosage intra-articular (with an unknown batch number).On (b)(6) 2017, patient developed a non-serious acute pain of left knee/ severe burning pain.On the same day, patient experienced tried to stand up but almost fell due to left knee weakness secondary to pain.On (b)(6) 2017, patient suffered from almost fell and on the same day she experienced left knee weakness secondary to pain.On (b)(6) 2018, patient developed synovitis, left knee is more swollen / edema of left leg.On the same day, patient experienced left knee was warmer than normal.O unknown date, patient experienced mild numbness of her left toes.On (b)(6) 2018, patient also showed limited range of motion due to pain and slight erythema of left leg.The same day, the patient was hospitalized foe knee pain.On unknown date, patient experienced left knee aspiration.This event was leading to intervention.On unknown date, patient suffered from white blood cell count increased.On (b)(6) 2017, patient developed blood glucose increased and blood urea nitrogen increased.Relevant laboratory test results included: - x-ray - on (b)(6) 2017 showed mild soft tissue edema, blood glucose was abnormal, white blood cell count was abnormal and blood urea nitrogen was abnormal.On (b)(6) 2017, the patient was discharged from the hospital.On unknown date, patient developed throbbing sensation located from her left knee; half down the lower leg pulsating pain and developed hemiplegia.Final diagnosis was blood urea nitrogen increased, blood glucose increased, slight erythema of left leg, limited range of motion due to pain, almost fell, tried to stand up but almost fell due to left knee weakness secondary to pain, acute pain of left knee/ severe burning pain, white blood cell count increased, left knee aspiration, hemiplegia, mild numbness of her left toes, left knee was warmer than normal and left knee weakness secondary to pain.Action taken: unknown.Corrective treatment: the patient was treated with acetaminophen, hydrocodone bitartrate, omeprazole, tylenol, tramadol, morphine and motrin for acute pain of left knee/ severe burning pain.Outcome: unknown for all the events.Seriousness criteria: hospitalization for synovitis, medically significant for hemiplegia.A product technical complaint (ptc) was initiated on (b)(6) 2018 for synvisc; batch number ; unknown; local ptc number: (b)(4).; global ptc number: (b)(4).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 adverse events to determine if a capa is required.Upon internal review done on (b)(6) 2018, this case has been updated to serious from non-serious due to hospitalization.New event of hemiplegia was added.Date of administration of synvisc was updated to (b)(6) 2017.New test results done one 10-nov-2017 were added.Clinical course was updated.Text was amended accordingly.Additional information was received on 14-aug-2018.Global ptc number and ptc results were added.Upon internal review on (b)(6) 2019 processed with clock start date of (b)(6) 2018 the malfunction field previously captured as yes was removed.
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Search Alerts/Recalls
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