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Activities of daily living affected [activities of daily living impaired].Imbalance [balance difficulty].Eye redness [eye redness].Difficulty urinating [urination difficulty].Back pain [back pain].Neck pain [neck pain].Neck stiffness [neck stiffness].Weakness [weakness].Numbness; bilateral hand numbness [numbness in hand].Headaches [headache].Dental problem [dental disorder nos].Acute uti [urinary tract infection] ([urine culture positive]).Difficulty with fine motor "cordination" [motor dysfunction].Tingling into her hands [tingling feet/hands].Dropped things that she was gripping without her knowing [grip strength decreased].Difficulty with fine motor coordination [coordination impaired].Knees are painful [knee pain].Case narrative: this case is cross referenced with cases (b)(4) (same patient).Initial information received on 02-oct-2018 regarding an unsolicited valid non-serious case from united states received from lawyer.This case involves a (b)(6) female patient (height 154.9 cm and weight (b)(6)) who experienced knees are painful, imbalance, eye redness, difficulty urinating, back pain, neck pain, neck stiffness, weakness, numbness; bilateral hand numbness, headaches, dropped things that she was gripping without her knowledge, coordination impaired, dental problem and acute uti, with the use of hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history included drug hypersensitivity with erythromycin - nausea, colonoscopy, mammogram , gastroesophageal reflux disease, hyperlipidemia, pancreatitis, anterior fusion cervical spine, caesarean section, cholecystectomy, drug allergy with augmentin, cervical trauma, acdf surgery, gall bladder surgery, irritable bowel syndrome, heart disease, gall stones, high cholesterol, pneumonia and bile duct surgery.Also, patient reported of having knee cortisone injection on (b)(6) 2015 with only 1 week of pain relief.Patient had a 2 year history of progressive pain to her neck and increased pain, numbness and tingling into her hands, l more r.At the time of the event, the patient was a smoker and smoked 1 pack per day, left and right hip bursitis, osteoarthritis of patellofemoral joint, nitrate responsive chest pain at rest, knee pain, back pain.The patient's past vaccination(s) included hepatitis c vaccine, hiv screen, tetanus vaccine, shingrix on (b)(6) 2014.The patient's family history included father diagnosed with cirrhosis in 1978, brother diagnosed with skin cancer in 2000, hepatic cirrhosis in 2012, mother diagnosed with hypertension and rheumatoid arthritis.The patient's past medical treatment(s) was not provided.Concomitant medications included amitriptyline; atorvastatin; fenofibric acid; norco (hydrocodone bitartrate, paracetamol); nitroglycerin; ondansetron; tizanidine; clonazepam for anxiety; ipratropium bromide, salbutamol sulfate (combivent respimat); promethazine; and oxycodone hydrochloride, oxycodone terephthalate, percocet (oxycodone hydrochloride; oxycodone terephthalate; paracetamol]).On (b)(6) 2017, the patient was administered synvisc one (hylan g-f 20, sodium hyaluronate) intra-articular injection of 6 ml dosage 1x intra-articular (lot - 6rsl052a) for primary osteoarthritis of left and right knee.On (b)(6) 2017, patient reported of left knee pain for the past 10 years which was worsening recently.Patient was referred to physiotherapy when she came last time but patient went only 1-2 times because it flared up her back pain.Patient came today requesting for a left and right knee syndic one injection as the pain score was 6/10.The patient was placed in a supine or seated position and gave verbal consent to proceed with injection.The skin was sterile prepped following freeze spray.A single syringe of synvisc one was injected into the left and the right knee using a 22 gauge 1.5 inch needle.No complications were noted as a result of the injection.Patient was warned of possible side effects of injection prior to administration.The patient was informed that it might take upto 4 weeks to be fully effective and these injections could not be repeated no sooner than 6 months if needed.Ice every 1-2 hours for 20 minutes at a time as needed for swelling and pain.Compression to be done if swelling occurred and elevate as needed to help decrease swelling.On (b)(6) 2017, patient was diagnosed with acute urinary tract infection (latency: 3 months 30 days).On (b)(6) 2017, lab results revealed escherichia coli in urine (latency: 4 months 1 day).On (b)(6) 2017, patient reported a 2 year history of progressive pain to her neck (4 months 3 days) and increased pain, numbness and tingling into her hands, l more than r.Patient reported that she dropped things that she was gripping without her knowing and had some difficulty with fine motor coordination.Numbness was worsening to where her hand was asleep.On (b)(6) 2017, patient reported knees were painful and mild imbalance (latencies: 4 months 3 days ).Patient wanted to know if there were any surgical problem that could be addressed that would help her symptoms and headaches.On (b)(6) 2017, x-ray imaging spine results were uncovertebral joint hypertrophy and foraminal narrowing noted above the level of the fusion at c4-c5.Patient had a non-instrumented solid appearing fusion at c5-c6, kyphosis when neck was erect.No dynamic instability, degenerative changes throughout.On (b)(6) 2017, patient reported of bilateral shoulder pain along with neck pain, redness in eyes, difficulty urinating, back pain, neck pain , neck stiffness, weakness, bilateral hand numbness and headaches (latencies: 5 months 8 days).Patient was not interested in getting epidural injections at this point.She would continue to work with pain management and discussed exercises to work on her cervical kyphosis.On (b)(6) 2017, patient again reported of having knee pain with a pain score of 8/10.Patient stated that the pain was mostly along the anterior aspects of both her knees.She took ibuprofen as and when it was required and denied any catching or popping in the left and lower extremity edema.Patient reported that it had affected patient's activities of daily living.Also, patient reported of dental problem on the same day (latency: 5 months 29 days).Final diagnosis was acute uti, dental problem, headaches, numbness; bilateral hand numbness, weakness, neck stiffness, neck pain, back pain, difficulty urinating, eye redness, mild imbalance, activities of daily living affected, dropped things that she was gripping without her knowledge, coordination impaired and knees are painful.Action taken: not applicable.Corrective treatment: naproxen and ibuprofen for knee pain.Outcome: recovered for weakness, numbness, headaches; not recovered for difficulty urinating, back pain, neck pain; unknown for other events.A product technical complaint (ptc) was initiated on 19-oct-2018 for synvisc one batch number: 6rsl052a; unknown local ptc number: (b)(4).The production and quality control documentation for lot # 6rsl052 expiration date (2020-04-30) 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 # 6rsl052 no capa was 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 had not indicated any safety issue.As of 19-oct-18, there were 6 complaints on file for lot# 6rsl052 and all related sub-lots.6 complaints are on file for lot# 6rsl052a: (1) broken syringe, (1) leaky syringe, (1) detached luer-lok hub, (1) broken luer-lok hub and (2) adverse event reports.Sanofi would continue to monitor complaints as stated in sop rdg-sop-000440 product event handling to determine if a capa was required.Seriousness criteria: disability for daily activities of living affected.Follow up information was received on 08-oct-2018.No new information was received.Follow up information was received on 15-oct-2018.No new information received.Additional information was received on 19-oct-2018.Global ptc number and ptc result was added.
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