| Lot Number 7RSL013 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Dyspnea (1816); Erythema (1840); Fatigue (1849); Arthralgia (2355); Joint Swelling (2356); Confusion/ Disorientation (2553); No Code Available (3191)
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| Event Date 12/26/2017 |
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Event Type
Injury
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Event Description
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Pseudosepsis/ pseudoseptic infection [pseudosepsis] ([injection site allergic reaction], [aching (l) knee], [swelling of l knee], [joint effusion], [injection site joint erythema]), limited range of motion/mobility affected [joint range of motion decreased], leg was three times its normal size [unilateral leg swelling], immune deficiencies [immune system disorder], trouble sleeping [difficulty sleeping], sinus pain [sinus pain], snoring [snoring], shortness of breath/difficulty breathing/short of breath doing certain tasks [shortness of breath], bruise easily [bruise], anxiety [anxiety], heartburn [heartburn], urinary urgency and gets up at night to urinate [urinary urgency], difficulty climbing stairs [movement disorder nos], changes in hair [hair texture abnormal], low grade temperature [fever], does feel unsteady on their feet [gait unsteady], weakness or fatigue [fatigue], weakness or fatigue [weakness].Case narrative: this case is cross referred with cases (b)(4) (same patient).Initial information received from united states on 05-aug-2019 regarding an unsolicited valid non-serious case received from a non-healthcare professional.This case involves a 56 years old female patient who started treatment with hylan g-f 20, sodium hyaluronate (synvisc one) and experienced after few months, patient had pseudosepsis/pseudoseptic infection, leg was three times its normal size, limited range of motion/mobility affected, weakness or fatigue, immune deficiencies, trouble sleeping, sinus pain, snoring, shortness of breath/difficulty breathing/short of breath doing certain tasks, bruise easily, anxiety, heartburn, urinary urgency and gets up at night to urinate, difficulty climbing stairs, does feel unsteady on their feet, changes in hair and low grade temperature.The patient's past medical history included aneurysm of the ascending aorta, anxiety, echo aortic valve bicuspid, gastro oesophageal reflux disease, mixed connective tissue disease, thyroid disease, internal derangement of knee, palpitations, raynaud's phenomenon, hysterectomy, thyroid surgery sub total thyroidectomy, low blood pressure, back pain, pneumonia, heat intolerance, non-smoker, left ankle pain/right ankle pain , chest pain, palpitations, leg swelling, lightheadedness, social drinker, stress fracture, right foot pain, likely foci of degenerative/bony stress reactive changes in right greater than left posterior inferior calcaneus, left greater than right anterior talus, right first and left fifth metatarsophalangeal joint, and left first interphalangeal joint, drug allergy with sulfa drugs and cedax caps.Patient had ongoing chronic primary osteoarthritis of left and right knee and left and right knee pain.The patient's family history included diabetes mellitus with mother, father and cardiac disorder/heart disease with mother, father and breast cancer with age during first menstrual period: 11.Concomitant medications included atenolol (atenolol); flecainide acetate (flecainide acetate); folic acid (folic acid); hydroxychloroquine sulfate (plaquenil); omeprazole (prilosec); levothyroxine sodium (synthroid); torsemide (torsemide); and rivaroxaban (xarelto).The patient's past medical treatment(s), vaccination(s) was not provided.On (b)(6) 2017, the patient received intra-articular hylan g-f 20, sodium hyaluronate injection in left knee, formulation injection, once dosage unknown intra-articular (lot - 7rsl013, expiry apr-2020)) for osteoarthritis of left knee.On 26-dec-2017, after few days of latency, patient had above normal swelling in left knee causing limited range of motion.On and unknown date, after unknown latency allergy injection reaction to synvisc one, weakness or fatigue, immune deficiencies, trouble sleeping, sinus pain, snoring, bruise easily, anxiety, heartburn, urinary urgency and gets up at night to urinate, difficulty climbing stairs, does feel unsteady on their feet, changes in hair, shortness of breath/difficulty breathing and short of breath doing certain tasks pain and erythema.It was reported that swelling/effusion and increased pain was most likely a pseudosepsis from injection.Patient's mobility was affected, and she had a low -grade temperature.She also developed fluid in her left knee which needed to be aspirated.By, (b)(6) 2018, patient's leg was three times its normal size.It was also reported that, photos were taken, and it was snow storms that week, so it was difficult to get out and travel.Patient was told he received contaminated injection and had a pseudoseptic infection.Patient was elevating her knee, applying ice.Patient had left knee aspirated and injected with steroid which she noted moderate improvement and better function.It was further reported that, examination of the left knee demonstrated no visible abnormalities.No tenderness.Rom examination of the left knee demonstrated full range of motion and 5/5 motor strength in all directions.Special test of the left knee revealed a negative anterior drawer sign, a negative posterior drawer sign, stable to valgus stress at 30 degrees flexion and stable to various stress at 30 degrees flexion.Action taken: not applicable.Corrective treatment: depo-medrol, ice, elevation, ibuprofen for pseudosepsis/ pseudoseptic infection; not reported for rest all events.Outcome: unknown for all the events.
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Event Description
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Immune deficiencies [immunodeficiency].Pseudosepsis/ pseudoseptic infection [pseudosepsis] ([injection site allergic reaction], [aching (l) knee], [swelling of l knee], [effusion (l) knee], [injection site joint erythema]) limited range of motion/mobility affected [joint range of motion decreased].Trouble sleeping [difficulty sleeping].Sinus pain [sinus pain].Snoring [snoring].Shortness of breath/difficulty breathing/short of breath doing certain tasks [shortness of breath].Bruise easily [bruise].Anxiety [anxiety].Heartburn [heartburn].Urinary urgency and gets up at night to urinate [urinary urgency] difficulty climbing stairs [movement disorder nos] changes in hair [hair texture abnormal] low grade temperature [low grade fever] does feel unsteady on their feet [gait unsteady] leg was three times its normal size [unilateral leg swelling] weakness or fatigue [fatigue] weakness or fatigue [weakness] case narrative: this case is cross referred with (b)(4).Initial information received from united states on 05-aug-2019 regarding an unsolicited valid non-serious case received from a lawyer this case involves a 56 years old female patient who started treatment with hylan g-f 20, sodium hyaluronate (synvisc one) and experienced after few months, patient had pseudosepsis/pseudospetic infection, leg was three times its normal size, limited range of motion/mobility affected, weakness or fatigue, immune deficiencies, trouble sleeping, sinus pain, snoring, shortness of breath/difficulty breathing/short of breath doing certain tasks, bruise easily, anxiety, heartburn, urinary urgency and gets up at night to urinate, difficulty climbing stairs, does feel unsteady on their feet, changes in hair and low grade temperature.The patient's past medical history included aneurysm of the ascending aorta, anxiety, echo aortic valve bicuspid, gastro oesophageal reflux disease, mixed connective tissue disease, thyroid disease, internal derangement of knee, palpitations, raynaud's phenomenon, hysterectomy, thyroid surgery sub total thyroidectomy, low blood pressure, back pain, pneumonia, heat intolerance, non-smoker, left ankle pain/right ankle pain , chest pain, palpitations, leg swelling, lightheadedness, social drinker, stress fracture, right foot pain, likely foci of degenerative/bony stress reactive changes in right greater than left posterior inferior calcaneus, left greater than right anterior talus, right first and left fifth metatarsophalangeal joint, and left first interphalangeal joint, drug allergy with sulfa drugs and cedax caps.Patient had ongoing chronic primary osteoarthritis of left and right knee and left and right knee pain.The patient's family history included diabetes mellitus with mother, father and cardiac disorder/heart disease with mother, father and breast cancer with age during first menstrual period: 11.Concomitant medications included atenolol (atenolol); flecainide acetate (flecainide acetate); folic acid (folic acid); hydroxychloroquine sulfate (plaquenil); omeprazole (prilosec); levothyroxine sodium (synthroid); torsemide (torsemide); and rivaroxaban (xarelto).The patient's past medical treatment(s), vaccination(s) was not provided.On (b)(6) 2017, the patient received intra-articular hylan g-f 20, sodium hyaluronate injection in left knee, formulation injection, once dosage unknown intra-articular (lot - 7rsl013, expiry apr-2020)) for osteoarthritis of left knee.On (b)(6) 2017, after few days of latency, patient had above normal swelling in left knee causing limited range of motion.On and unknown date, after unknown latency allergy injection reaction to synvisc one, weakness or fatigue, immune deficiencies, trouble sleeping, sinus pain, snoring, , bruise easily, anxiety, heartburn, urinary urgency and gets up at night to urinate, difficulty climbing stairs, does feel unsteady on their feet, changes in hair, shortness of breath/difficulty breathing and short of breath doing certain tasks pain and erythema.It was reported that swelling/effusion and increased pain was most likely a pseudosepsis from injection.Patient's mobility was affected, and she had a low -grade temperature.She also developed fluid in her left knee which needed to be aspirated.By, (b)(6) 2018, patient's leg was three times its normal size.It was also reported that, photos were taken, and it was snow storms that week, so it was difficult to get out and travel.Patient was told he received contaminated injection and had a pseudoseptic infection.Patient was elevating her knee, applying ice.Patient had left knee aspirated and injected with steroid which she noted moderate improvement and better function.It was further reported that, examination of the left knee demonstrated no visible abnormalities.No tenderness.Rom examination of the left knee demonstrated full range of motion and 5/5 motor strength in all directions.Special test of the left knee revealed a negative anterior drawer sign, a negative posterior drawer sign, stable to valgus stress at 30 degrees flexion and stable to various stress at 30 degrees flexion.Action taken: not applicable.Corrective treatment: depo-medrol, ice, elevation, ibuprofen for pseudosepsis/ pseudoseptic infection; not reported for rest all events.Outcome: unknown for all the events.A product technical complaint was initiated on (b)(6) 2019 for synvisc one.Batch number: 7rsl013 global ptc number:(b)(4).The production and quality control documentation for lot # 7rsl013 expiration date (2020-04) was reviewed.The investigation showed that the product met specifications.No associated non-conformances were noted.Based on the lot # batch record review & lot # frequency analysis for lot # 7rsl013 no capa is required.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.As of (b)(6) 2019, there are 7 complaints on file for lot # 7rsl013: 1 missing syringe and 6 adverse event reports.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 complete date: (b)(6) 2019.Additional information received on 28-aug-2019.Investigation summary received and ptc results added.
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