| Lot Number UNKNOWN |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Rheumatoid Arthritis (1724); High Blood Pressure/ Hypertension (1908); Muscle Spasm(s) (1966); Pain (1994); Myalgia (2238); Arthralgia (2355); Joint Swelling (2356); Joint Disorder (2373); Neck Pain (2433); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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Sanofi company comment 24-sep-2020.This case concerns a patient who received synvisc and later rheumatoid arthritis, assessed as medically significant.Based on limited information provided, causal role of suspect product cannot be excluded.Case will be re-evaluated post further update on the patients underlying disease conditions, past medical and drug history, concurrent illnesses and concomitant medications.
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Event Description
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Rheumatoid arthritis [rheumatoid arthritis], positive ana [antinuclear antibody positive], pain in neck, lower back, hips, knees [low back pain], pain in neck, lower back, hips, knees [neck pain], muscle spasms [muscle spasms], abnormal knees [unspecified disorder of knee joint], hypertension [hypertension], bronchitis [bronchitis], osteoarthritis [osteoarthritis], muscle aches [myalgia], back surgery [back surgery], hysterectomy [hysterectomy], thyroid surgery [thyroid operation nos], joint swelling localized to one or more joints [joint swelling], pain in neck, lower back, hips, knees/arthralgia/tenderness elicited [pain in hip], pain in neck, lower back, hips, knees/arthralgia/tenderness elicited [joint pain], hylan g-f 20, sodium hyaluronate via subcutaneous route [incorrect route of product administration].Case narrative: initial information received on 21-sep-2020 regarding a solicited valid serious case received from a physician via call center, in the scope of patient support program "psp_saus.Tjo.012".Patient id: (b)(6); country: united states study title: (b)(6).This case involves a (b)(6) years old female patient who experienced rheumatoid arthritis, positive ana( antinuclear antibody), pain in neck, lower back, hips, knees (back pain and neck pain), muscle spasms, abnormal knees, hypertension, muscle aches, pain in neck, lower back, hips, knees/arthralgia/tenderness elicited, bronchitis, back surgery, hysterectomy, thyroid surgery, joint swelling localized to one or more joints, osteoarthritis and hylan g-f 20, sodium hyaluronate via subcutaneous route with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc).The patient's past medical history, medical treatment(s), concomitant medication(s), vaccination(s) and family history were not provided.On an unknown date, the patient started using hylan g-f 20, sodium hyaluronate via subcutaneous route (incorrect route of product administration) at a dosage of 8 mg, weekly, (batch and formulation: unknown) (information on batch number was requested) for osteoarthritis of knee.On an unknown date, after unknown latency, patient experienced osteoarthritis, positive ana (antinuclear antibody positive), pain in neck, lower back, hips, knees (back pain, neck pain and arthralgia), muscle spasms, adls (adl: activities of daily living), hypertension, rheumatoid arthritis (medically significant), bronchitis, back surgery (spinal operation), hysterectomy, thyroid surgery (thyroid operation), arthralgia, muscle aches (myalgia), joint swelling localized to one or more joints (joint swelling), tenderness elicited, abnormal knees (arthropathy).Action taken: not applicable for hylan g-f 20, sodium hyaluronate via subcutaneous route;no action taken for rest of the events corrective treatment: not reported for all events.Outcome: not applicable for hylan g-f 20, sodium hyaluronate via subcutaneous route; unknown for rest of the events.Reporter causality: unassessable for all events.Company causality: not reportable for all events.
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Event Description
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Rheumatoid arthritis [rheumatoid arthritis].Positive ana [antinuclear antibody positive].Pain in neck, lower back, hips, knees [low back pain].Pain in neck, lower back, hips, knees [neck pain].Hypertension [hypertension].Osteoarthritis [osteoarthritis].Bronchitis [bronchitis].Abnormal knees [unspecified disorder of knee joint].Muscle spasms [muscle spasms].Muscle aches [myalgia].Back surgery [back surgery].Hysterectomy [hysterectomy].Thyroid surgery [thyroid operation nos].Joint swelling localized to one or more joints [joint swelling].Pain in neck, lower back, hips, knees/arthralgia/tenderness elicited [pain in hip].Pain in neck, lower back, hips, knees/arthralgia/tenderness elicited [joint pain].Hylan g-f 20, sodium hyaluronate via subcutaneous route [incorrect route of product administration].Case narrative: initial information was received on (b)(6) 2020 regarding a solicited valid serious case from a physician via call center, 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 57 years old female patient who experienced rheumatoid arthritis, positive ana( antinuclear antibody), pain in neck, lower back, hips, knees (back pain and neck pain), muscle spasms, abnormal knees, hypertension, muscle aches, pain in neck, lower back, hips, knees/arthralgia/tenderness elicited, bronchitis, back surgery, hysterectomy, thyroid surgery, joint swelling localized to one or more joints, osteoarthritis and hylan g-f 20, sodium hyaluronate via subcutaneous route with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc).The patient's past medical history, medical treatment(s), concomitant medication(s), vaccination(s) and family history were not provided.On an unknown date, the patient started using hylan g-f 20, sodium hyaluronate via subcutaneous route (incorrect route of product administration) at a dosage of 8 mg, weekly, (batch and formulation: unknown) (information on batch number was requested) for osteoarthritis of knee.On an unknown date, after unknown latency, patient experienced osteoarthritis, positive ana (antinuclear antibody positive), pain in neck, lower back, hips, knees (back pain, neck pain and arthralgia), muscle spasms, adls (adl: activities of daily living), hypertension, rheumatoid arthritis (medically significant), bronchitis, back surgery (spinal operation), hysterectomy, thyroid surgery (thyroid operation), arthralgia, muscle aches (myalgia), joint swelling localized to one or more joints (joint swelling), tenderness elicited, abnormal knees (arthropathy).Action taken: not applicable for hylan g-f 20, sodium hyaluronate via subcutaneous route; no action taken for rest of the events.Corrective treatment: not reported for all events.Outcome: not applicable for hylan g-f 20, sodium hyaluronate via subcutaneous route; unknown for rest of the events.Reporter causality: unassessable for all events.Company causality: not reportable for all events.A product technical complaint (ptc) was initiated on (b)(6) 2020 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 the lack of information provided, no capa (corrective and preventive action) 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 (non-conformance) process.Sanofi global pharmacovigilance and epidemiology continuously monitors adverse event reports with or without lot numbers, and assesses possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals.This review has not indicated any safety issue.Sanofi will continue to monitor complaints as stated in sop rdg-sop-000440 "product event handling" to determine if a capa is required.Final investigation was completed on (b)(6) 2021 follow up was received on (b)(6) 2020 from other health care professional.Global ptc number was added.Additional information was received on 05-may-2021 from other healthcare professional.Gptc results were received and added.Text was amended accordingly.
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Search Alerts/Recalls
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