| Lot Number UNKNOWN |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Nausea (1970); Blurred Vision (2137); Vomiting (2144); Arthralgia (2355)
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Event Type
Injury
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Event Description
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Blood in stool [blood in stool]; knee pain bilateral/pain described as dull achy, sharp, burning and throbbing in nature/tenderness with palpitation [knee pain]; osteophytosis of all compartments/small supra and infrapatellar spurs [exostosis]; arthritic, statistically primary changes right knee [knee arthritis]; multilevel degenerative changes of disc and facet joints with moderate lateral recess and foraminal stenoses [degenerative disc disease]; multilevel degenerative changes of disc and facet joints with moderate lateral recess and foraminal stenoses [vertebral foraminal stenosis]; muscle spasm [muscle spasm]; weakness [weakness]; poor appetite [decreased appetite]; insomnia [insomnia] ; blurry vision [blurry vision]; loss of hearing [hearing impaired] ; recurrent urinary infections [recurrent urinary tract infection] ; bronchitis [bronchitis] ; chest pain [chest pain] ; hypertension [hypertension]; acid reflux [acid reflux (esophageal)] ; nausea [nausea] ; vomiting [vomiting] ; constipation [constipation] ; both knee deformity [knee deformity] ; right knee crepitus [joint crepitation] ; synvisc administered intramuscularly [device use issue].Case narrative: initial information received on 03-apr-2019 regarding a solicited valid serious case received from a physician, in the scope of patient support program "(b)(4)".Patient id: (b)(6); country: united states.Study title: (b)(6).This case involves a (b)(6) years old male patient who was treated medical device hylan g-f 20, sodium hyaluronate (synvisc) and experienced blood in stool, knee pain bilateral/pain described as dull achy, sharp, burning and throbbing in nature/tenderness with palpitation, osteophytosis of all compartments/small supra and infrapatellar spurs, arthritic, statistically primary changes right knee, multilevel degenerative changes of disc and facet joints with moderate lateral recess and foraminal stenoses, muscle spasm, weakness, poor appetite, insomnia, blurry vision, loss of hearing, recurrent urinary infections, bronchitis, chest pain, hypertension, acid reflux, nausea, vomiting, constipation, both knee deformity, right knee crepitus (latency: unknown) and synvisc was administered intramuscularly (device use issue).The patient's past medical history included left knee replacement, abdomen surgery, knee arthroscopy, work related injury 11 years ago and oral surgery.The patient's family history included mother died due to heart attack and had arthritis, depression, diabetes mellitus, hypertension and high cholesterol.The patient's past medical treatment(s), vaccination(s) was not provided.At the time of the event, the patient had ongoing chronic low back pain which was aggravated by walking, cold weather, physical activity and standing, lumbar radiculopathy, sacroiliac joint pain for which patient had sij injection with few days of pain relief, bilateral, sleep apnoea syndrome, obesity, numbness/tingling, migraine, diabetes mellitus, depression, had long term opioid therapy and asthma.Concomitant medications included bupropion hydrochloride (bupropion hcl er), cyclobenzaprine hcl, hydrochlorothiazide, salbutamol sulfate (ventolin hfa).On an unknown date, the patient started using hylan g-f 20, sodium hyaluronate via intramuscular route (formulation, lot - unknown) for unknown indication.On (b)(6) 2018, x-ray showed mild osteophytosis of all compartments and small supra and infrapatellar spurs, arthritic statistically primary changes right knee.There was no acute fracture, dislocation or neoplastic process.Soft tissues were unremarkable.On an unknown date patient was diagnosed with bilateral knee pain and was injected with bupivacaine and dexamethasone.On 12-mar-2019, it was reported that l-spine magnetic resonance imaging showed multilevel degenerative changes of disc and facet joints with moderate lateral recess and foraminal stenoses and no central canal stenosis.Patient also reported he had no issues with the knees and had low back pain irradiating to lower extremity to the feet.The review of symptoms showed poor appetite, insomnia, blurry vision, loss of hearing, recurrent urinary infections, bronchitis, chest pain, hypertension, acid reflux, nausea, vomiting, blood i stool, constipation.Patient had tenderness to palpitation, deformity in both knees and crepitus in right knee.The therapy with hylan g-f 20, sodium hyaluronate was reported as ongoing.Action taken: no action taken.Corrective treatment: dexamethasone and bupivacaine for knee pain bilateral/pain described as dull achy, sharp, burning and throbbing in nature/tenderness with palpitation; not reported for rest.Outcome: unknown for all except synvisc was administered intramuscularly.A product technical complaint was initiated and results were pending for the same.Seriousness criteria: medically significant for blood in stools, intervention required for knee pain bilateral/pain described as dull achy, sharp, burning and throbbing in nature/tenderness with palpitation.Reporter causality: unassessable (unknown) for all.Company causality: not reportable for all.
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Event Description
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Blood in stool [blood in stool] knee pain bilateral/pain described as dull achy, sharp, burning and throbbing in nature/tenderness with palpitation [knee pain] osteophytosis of all compartments/small supra and infrapatellar spurs [exostosis] arthritic, statistically primary changes right knee [knee arthritis] multilevel degenerative changes of disc and facet joints with moderate lateral recess and foraminal stenoses [degenerative disc disease] multilevel degenrative changes of disc and facet joints with moderate lateral recess and foraminal stenoses [vertebral foraminal stenosis] muscle spasm [muscle spasm] weakness [weakness] poor appetite [decreased appetite] insomnia [insomnia] blurry vision [blurry vision] loss of hearing [hearing impaired] recurrent urinary infections [recurrent urinary tract infection] bronchitis [bronchitis] chest pain [chest pain] hypertension [hypertension] acid reflux [acid reflux (esophageal)] nausea [nausea] vomiting [vomiting] constipation [constipation] both knee deformity [knee deformity] right knee crepitus [joint crepitation] synvisc administered intramuscularly [device use issue] case narrative: initial information received on 03-apr-2019 regarding a solicited valid serious case received from a physician, in the scope of patient support program "psp_saus.Tjo.012".Patient id: (b)(6),country: united states.Study title: sanofi patient connection.This case involves a 55 years old male patient who was treated medical device hylan g-f 20, sodium hyaluronate (synvisc) and experienced blood in stool, knee pain bilateral/pain described as dull achy, sharp, burning and throbbing in nature/tenderness with palpitation, osteophytosis of all compartments/small supra and infrapatellar spurs, arthritic, statistically primary changes right knee, multilevel degenerative changes of disc and facet joints with moderate lateral recess and foraminal stenoses, muscle spasm, weakness, poor appetite, insomnia, blurry vision, loss of hearing, recurrent urinary infections, bronchitis, chest pain, hypertension, acid reflux, nausea, vomiting, constipation, both knee deformity, right knee crepitus (latency: unknown) and synvisc was administered intramuscularly (device use issue).The patient's past medical history included left knee replacement, abdomen surgery, knee arthroscopy, work related injury 11 years ago and oral surgery.The patient's family history included mother died due to heart attack and had arthritis, depression, diabetes mellitus, hypertension and high cholesterol.The patient's past medical treatment(s), vaccination(s) was not provided.At the time of the event, the patient had ongoing chronic low back pain which was aggravated by walking, cold weather, physical activity and standing, lumbar radiculopathy, sacroiliac joint pain for which patient had sij injection with few days of pain relief, bilateral, sleep apnoea syndrome, obesity, numbness/tingling, migraine, diabetes mellitus, depression, had long term opioid therapy and asthma.Concomitant medications included bupropion hydrochloride (bupropion hcl er), cyclobenzaprine hcl, hydrochlorothiazide, salbutamol sulfate (ventolin hfa).On an unknown date, the patient started using hylan g-f 20, sodium hyaluronate via intramuscular route (formulation, lot - unknown) for unknown indication.On 17-apr-2018, x-ray showed mild osteophytosis of all compartments and small supra and infrapatellar spurs, arthritic statistically primary changes right knee.There was no acute fracture, dislocation or neoplastic process.Soft tissues were unremarkable.On an unknown date patient was diagnosed with bilateral knee pain and was injected with bupivacaine and dexamethasone.On (b)(6) 2019, it was reported that l-spine magnetic resonance imaging showed multilevel degenerative changes of disc and facet joints with moderate lateral recess and foraminal stenoses and no central canal stenosis.Patient also reported he had no issues with the knees and had low back pain irradiating to lower extremity to the feet.The review of symptoms showed poor appetite, insomnia, blurry vision, loss of hearing, recurrent urinary infections, bronchitis, chest pain, hypertension, acid reflux, nausea, vomiting, blood i stool, constipation.Patient had tenderness to palpitation, deformity in both knees and crepitus in right knee.The therapy with hylan g-f 20, sodium hyaluronate was reported as ongoing.Action taken: no action taken.Corrective treatment: dexamethasone and bupivacaine for knee pain bilateral/pain described as dull achy, sharp, burning and throbbing in nature/tenderness with palpitation; not reported for rest.Outcome: unknown for all except synvisc was administered intramuscularly.A product technical complaint was initiated on (b)(6) 2019 for synvisc.Batch number: unknown global ptc number: (b)(4).The product lot number was not provided; therefore, a batch record review is not possible.Based on lack of information provided, no capa is required.It was the requirement to review all finished batch records for specification conformation 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 surveillance effort to detect safety signals.This review did not indicate any safety issue.Sanofi would continue to monitor adverse events to determine if a capa was required.Seriousness criteria: medically significant for blood in stools, intervention required for knee pain bilateral/pain described as dull achy, sharp, burning and throbbing in nature/tenderness with palpitation.Reporter causality: unassessable (unknown) for all.Company causality: not reportable for all.Additional information received on 01-may-2019.Investigation summary received and pc results added.Text amended accordingly.
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Event Description
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Blood in stool [blood in stool] knee pain bilateral/pain described as dull achy, sharp, burning and throbbing in nature/tenderness with palpitation [knee pain] osteophytosis of all compartments/small supra and infrapatellar spurs [exostosis] arthritic, statistically primary changes right knee [knee arthritis] multilevel degenerative changes of disc and facet joints with moderate lateral recess and foraminal stenoses [degenerative disc disease] multilevel degenrative changes of disc and facet joints with moderate lateral recess and foraminal stenoses [vertebral foraminal stenosis] muscle spasm [muscle spasm] weakness [weakness] poor appetite [decreased appetite] insomnia [insomnia] blurry vision [blurry vision] loss of hearing [hearing impaired] recurrent urinary infections [recurrent urinary tract infection] bronchitis [bronchitis] chest pain [chest pain] hypertension [hypertension] acid reflux [acid reflux (esophageal)] nausea [nausea] vomiting [vomiting] constipation [constipation] both knee deformity [knee deformity] right knee crepitus [joint crepitation] synvisc administered intramuscularly [incorrect route of product administration].Case narrative: initial information received on 03-apr-2019 regarding a solicited valid serious case received from a physician, in the scope of patient support program "psp_saus.Tjo.012".Patient id: (b)(6); country: united states.Study title: sanofi patient connection.This case involves a 55 years old male patient who was treated medical device hylan g-f 20, sodium hyaluronate (synvisc) and experienced blood in stool, knee pain bilateral/pain described as dull achy, sharp, burning and throbbing in nature/tenderness with palpitation, osteophytosis of all compartments/small supra and infrapatellar spurs, arthritic, statistically primary changes right knee, multilevel degenerative changes of disc and facet joints with moderate lateral recess and foraminal stenoses, muscle spasm, weakness, poor appetite, insomnia, blurry vision, loss of hearing, recurrent urinary infections, bronchitis, chest pain, hypertension, acid reflux, nausea, vomiting, constipation, both knee deformity, right knee crepitus (latency: unknown) and synvisc was administered intramuscularly (device use issue).The patient's past medical history included left knee replacement, abdomen surgery, knee arthroscopy, work related injury 11 years ago and oral surgery.The patient's family history included mother died due to heart attack and had arthritis, depression, diabetes mellitus, hypertension and high cholesterol.The patient's past medical treatment(s), vaccination(s) was not provided.At the time of the event, the patient had ongoing chronic low back pain which was aggravated by walking, cold weather, physical activity and standing, lumbar radiculopathy, sacroiliac joint pain for which patient had sij injection with few days of pain relief, bilateral, sleep apnoea syndrome, obesity, numbness/tingling, migraine, diabetes mellitus, depression, had long term opioid therapy and asthma.Concomitant medications included bupropion hydrochloride (bupropion hcl er), cyclobenzaprine hcl, hydrochlorothiazide, salbutamol sulfate (ventolin hfa).On an unknown date, the patient started using hylan g-f 20, sodium hyaluronate via intramuscular route (formulation, lot - unknown) for unknown indication.On 17-apr-2018, x-ray showed mild osteophytosis of all compartments and small supra and infrapatellar spurs, arthritic statistically primary changes right knee.There was no acute fracture, dislocation or neoplastic process.Soft tissues were unremarkable.On an unknown date patient was diagnosed with bilateral knee pain and was injected with bupivacaine and dexamethasone.On 12-mar-2019, it was reported that l-spine magnetic resonance imaging showed multilevel degenerative changes of disc and facet joints with moderate lateral recess and foraminal stenoses and no central canal stenosis.Patient also reported he had no issues with the knees and had low back pain irradiating to lower extremity to the feet.The review of symptoms showed poor appetite, insomnia, blurry vision, loss of hearing, recurrent urinary infections, bronchitis, chest pain, hypertension, acid reflux, nausea, vomiting, blood i stool, constipation.Patient had tenderness to palpitation, deformity in both knees and crepitus in right knee.The therapy with hylan g-f 20, sodium hyaluronate was reported as ongoing.Action taken: no action taken.Corrective treatment: dexamethasone and bupivacaine for knee pain bilateral/pain described as dull achy, sharp, burning and throbbing in nature/tenderness with palpitation; not reported for rest outcome: unknown for all except synvisc was administered intramuscularly.A product technical complaint was initiated on (b)(6)2019 for synvisc.Batch number: unknown global ptc number:(b)(4).The product lot number was not provided; therefore, a batch record review is not possible.Based on lack of information provided, no capa is required.It was the requirement to review all finished batch records for specification conformation 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 surveillance effort to detect safety signals.This review did not indicate any safety issue.Sanofi would continue to monitor adverse events to determine if a capa was required.Seriousness criteria: medically significant for blood in stools, intervention required for knee pain bilateral/pain described as dull achy, sharp, burning and throbbing in nature/tenderness with palpitation reporter causality: unassessable (unknown) for all.Company causality: not reportable for all.Additional information received on 01-may-2019.Investigation summary received and pc results added.Text amended accordingly.Upon internal review on 01-nov-2019 with the clock start date of 01-may-2019, the event coding was updated from device use issue to incorrect route of product administration.
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Search Alerts/Recalls
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