| Lot Number 7RSL022 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Muscle Spasm(s) (1966); Muscle Weakness (1967); Arthralgia (2355); Neck Stiffness (2434); No Code Available (3191)
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Event Type
Injury
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Event Description
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Cane to walk/difficult to walk on with right knee/leg/ambulates with a cane [walking difficulty].Pain level in his knees is 7/10, feels sore and throbs [knee pain] ([pain worsened]); dehydration [dehydration] ; leg pain [leg pain] ; muscle cramps general [muscle cramps] ([condition worsened]); weakness to bilateral leg extremities [weakness in extremity]; excessive urination [polyuria] ; urination with urgency [urination urgency of]; stiffness [stiffness] ; difficulty pulling himself up to ambulate [difficulty in standing]; neck pain [neck pain] ; hips don't hurt as much [pain in hip]; helped a little [subtherapeutic response].Case narrative: initial information received on 02-oct-2018 regarding an unsolicited valid serious case from united states received from a lawyer.This case involves a (b)(6) years old male patient who experienced cane to walk/difficult to walk on with right knee/leg/ambulates with a cane, pain level in his knees is 7/10, feels sore and throbs, hips don't hurt as much and helped a little, neck pain, difficulty pulling himself up to ambulate, stiffness, urination with urgency, excessive urination, weakness to bilateral leg extremities, muscle cramps general, leg pain, dehydration while he was treated with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one].The patient's past medical history included obesity, gerd, hypertension, obstructive sleep apnea, knee pain, crepitus, tonsillectomy, gastric bypass, smoker, left and right side flank pain, asthma, acute bilateral back pain, obstructive sleep apnea, urinary tract infection, tylenol, drug allergy to neurontin.The patient's past medical treatment(s) were ceftriaxone, ketorolac, cefuroxime sterile water vaccination(s).Patient's family history were not provided.At the time of the event, the patient had ongoing arthralgia and joint noise.Concomitant medications included diclofenac sodium, lisinopril and norco (acetaminophen-codeine).On (b)(6) 2017, the patient received treatment with intra- articular synvisc one injection with a dosage of 6 ml once (lot - unk) for osteoarthritis.On an unknown date in 2017, after unknown latency of receiving synvisc one injection, the pain level in patient's knees was 7/10 that felt sore and throbs at times.Patient used to ambulate with a cane.The patient had a lot of improvement since he started mobic.The patient stated his hips don't hurt as much.He would like to discuss possibly increasing his dose on mobic or adding an extra medication to have more relief.The patient further reported that mobic had really helped.Patient still uses a cane to walk with and did not do much activity.The pain was getting worse and difficult to walk on with right knee/leg.The patient had reported that the synvisc one injection had helped a little in his knee joint pain.On (b)(6) 2018 , patient came to emergency department with complain of weakness to bilateral leg extremities with muscular cramping onset 3 weeks ago worsening for 1 week.Also, patient reported of experiencing episodes while lying down with difficulty pulling himself up to ambulate secondary to pain and stiffness.Patient also complained of generalized back and neck pain and he was on disability for sleep apnea and did not do any labour on a daily basis.Patient reported of experiencing similar events in the past but those episodes were less severe and involved only back and hips.Patient also complained of excessive urination with urgency.He denied dysuria and reported that he was able to ambulate with cane at baseline.He reported of taking tizanidine daily for several years.On (b)(6) 2018, ekg was performed and the results were not provide dfor the same.Lab results for (b)(6) 2018 were lymphocyte % was 19.5 (low), rdw was 18.2 (high), mcv was 76.2 (low), mch was 25.5 (low), hemoglobin 12.1g.Dl 9low), hct was 36.1 (low), total ck was 278, bili total was 0.1 (low), globulin ws 4.9 (high), albumin 3.2 (low), glucose 113 mg.Dl (high), urobilinogen was 2 (high).Final diagnosis was not applicable helped a little, hips don't hurt as much, pain level in his knees is 7/10, feels sore and throbs and cane to walk/difficult to walk on with right knee/leg/ambulates with a cane, neck pain, difficulty pulling himself up to ambulate, stiffness, urination with urgency, excessive urination, weakness to bilateral leg extremities, muscle cramps general, leg pain, dehydration.Corrective treatment: meloxicam (mobic) for pain level in his knees is 7/10, feels sore and throbs; and hips don't hurt as much; and methylprednisolone for pain level in his knees is 7/10, feels sore and throbs; cane for cane to walk/difficult to walk on with right knee/leg/ambulates with a cane; baclofen for muscle spasms.Outcome: recovering for hips don't hurt as much; unknown for neck pain, difficulty pulling himself up to ambulate, stiffness, urination with urgency, excessive urination, weakness to bilateral leg extremities, muscle cramps general, leg pain, dehydration; not recovered for all other events except helped a little.Seriousness criteria: disability for cane to walk/difficult to walk on with right knee/leg/ambulates with a cane; and intervention required for pain level in his knees is 7/10, feels sore and throbs.A product technical complaint (ptc) was initiated on 08-oct-2018 for "synvisc one".Batch number unknown, global ptc number: (b)(4).The product lot number was not provided; therefore, a batch record review was not possible.Based on the lack of information provided, no capa was required.All finished batch records for specification conformance prior to release were reviewed as per the requirement.Any out of specification result need to be identified and mitigated through the ncr process.Adverse event reports with or without lot numbers were continuously monitored by sanofi global pharmacovigilance and epidemiology and possible associations with their corresponding product lot were assessed as part of routine safety surveillance effort to detect safety signals.Final investigation complete date was (b)(6) 2018.No safety issues were indicated in this review.Additional information received on 02-oct-18 from healthcare professional.Additional events neck pain, difficulty pulling himself up to ambulate, stiffness, urination with urgency, excessive urination, weakness to bilateral leg extremities, muscle cramps general, leg pain, dehydration added with details.Medical history updated.Lab information added.Clinical course completed and text amended.Additional information was received on 08-oct-2018 in the form of investigation summary.Ptc results and gptc number were added.
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Event Description
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Cane to walk/difficult to walk on with right knee/leg/ambulates with a cane [walking difficulty] pain level in his knees is 7/10, feels sore and throbs [knee pain] ([pain worsened]) dehydration [dehydration] leg pain [leg pain] muscle cramps general [muscle cramps] ([condition worsened]) weakness to bilateral leg extremities [weakness in extremity] excessive urination [polyuria] urination with urgency [urination urgency of] stiffness [stiffness] difficulty pulling himself up to ambulate [difficulty in standing] neck pain [neck pain] hips don't hurt as much [pain in hip] helped a little [subtherapeutic response].Case narrative: initial information received on 02-oct-2018 regarding an unsolicited valid serious case from united states received from a lawyer.This case involves a 51 years old male patient who experienced cane to walk/difficult to walk on with right knee/leg/ambulates with a cane, pain level in his knees is 7/10, feels sore and throbs, hips don't hurt as much and helped a little, neck pain, difficulty pulling himself up to ambulate, stiffness, urination with urgency, excessive urination, weakness to bilateral leg extremities, muscle cramps general, leg pain, dehydration while he was treated with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one].The patient's past medical history included obesity, gerd, hypertension, obstructive sleep apnea, knee pain, crepitus, tonsillectomy, gastric bypass, smoker, left and right side flank pain, asthma, acute bilateral back pain, obstructive sleep apnea, urinary tract infection, tylenol, drug allergy to neurontin.The patient's past medical treatment(s) were ceftriaxone, ketorolac, cefuroxime sterile water vaccination(s).Patient's family history were not provided.At the time of the event, the patient had ongoing arthralgia and joint noise.Concomitant medications included diclofenac sodium, lisinopril and norco (acetaminophen-codeine), ethyl chloride for anaesthesia and lidocaine.On (b)(6) 2017, the patient received treatment with intra- articular synvisc one injection, bilaterally with a dosage of 6 ml once (lot: 7rsl022; expiry-may-2020) for osteoarthritis of knees, bilateral.Alcohol was used to prep the area.Ethyl chloride spray was used as a topical anesthetic.Using sterile technique, the aspiration/injection needle was then directed from a superolateral aspect.The site was injected with 3 ml of 1% lidocaine and 6 ml of synvisc.A bandaid was applied.No complications.The patient tolerated the procedure well.Patient was instructed to avoid strenuous activity for 3 days.Patient was instructed to apply ice.On an unknown date in 2017, after unknown latency of receiving synvisc one injection, the pain level in patient's knees was 7/10 that felt sore and throbs at times.Patient used to ambulate with a cane.The patient had a lot of improvement since he started mobic.The patient stated his hips don't hurt as much.He would like to discuss possibly increasing his dose on mobic or adding an extra medication to have more relief.The patient further reported that mobic had really helped.Patient still uses a cane to walk with and did not do much activity.The pain was getting worse and difficult to walk on with right knee/leg.The patient had reported that the synvisc one injection had helped a little in his knee joint pain.On (b)(6) 2018 , patient came to emergency department with complain of weakness to bilateral leg extremities with muscular cramping onset 3 weeks ago worsening for 1 week.Also, patient reported of experiencing episodes while lying down with difficulty pulling himself up to ambulate secondary to pain and stiffness.Patient also complained of generalized back and neck pain and he was on disability for sleep apnea and did not do any labour on a daily basis.Patient reported of experiencing similar events in the past but those episodes were less severe and involved only back and hips.Patient also complained of excessive urination with urgency.He denied dysuria and reported that he was able to ambulate with cane at baseline.He reported of taking tizanidine daily for several years.On (b)(6) 2018, ekg was performed and the results were not provide dfor the same.Lab results for (b)(6) 2018 were lymphocyte % was 19.5 (low), rdw was 18.2 (high), mcv was 76.2 (low), mch was 25.5 (low), hemoglobin 12.1g.Dl 9low), hct was 36.1 (low), total ck was 278, bili total was 0.1 (low), globulin ws 4.9 (high), albumin 3.2 (low), glucose 113 mg.Dl (high), urobilinogen was 2 (high).Final diagnosis was not applicable helped a little, hips don't hurt as much, pain level in his knees is 7/10, feels sore and throbs and cane to walk/difficult to walk on with right knee/leg/ambulates with a cane, neck pain, difficulty pulling himself up to ambulate, stiffness, urination with urgency, excessive urination, weakness to bilateral leg extremities, muscle cramps general, leg pain, dehydration.Corrective treatment: meloxicam (mobic) for pain level in his knees is 7/10, feels sore and throbs; and hips don't hurt as much; and methylprednisolone for pain level in his knees is 7/10, feels sore and throbs; cane for cane to walk/difficult to walk on with right knee/leg/ambulates with a cane; baclofen for muscle spasms.Outcome: recovering for hips don't hurt as much; unknown for neck pain, difficulty pulling himself up to ambulate, stiffness, urination with urgency, excessive urination, weakness to bilateral leg extremities, muscle cramps general, leg pain, dehydration; not recovered for all other events except helped a little seriousness criteria: disability for cane to walk/difficult to walk on with right knee/leg/ambulates with a cane; and intervention required for pain level in his knees is 7/10, feels sore and throbs.A product technical complaint (ptc) was initiated on (b)(6) 2018 for "synvisc one".Batch number unknown, global ptc number: (b)(4).The product lot number was not provided; therefore, a batch record review was not possible.Based on the lack of information provided, no capa was required.All finished batch records for specification conformance prior to release were reviewed as per the requirement.Any out of specification result need to be identified and mitigated through the ncr process.Adverse event reports with or without lot numbers were continuously monitored by sanofi global pharmacovigilance and epidemiology and possible associations with their corresponding product lot were assessed as part of routine safety surveillance effort to detect safety signals.Final investigation complete date was 08-oct-2018.No safety issues were indicated in this review.Additional information received on 02-oct-18 from healthcare professional.Additional events neck pain, difficulty pulling himself up to ambulate, stiffness, urination with urgency, excessive urination, weakness to bilateral leg extremities, muscle cramps general, leg pain, dehydration added with details.Medical history updated.Lab information added.Clinical course completed and text amended.Additional information was received on 08-oct-2018 in the form of investigation summary.Ptc results and gptc number were added.Additional information was received on 19-feb-2019 from a healthcare professional.Lot number and expiry date of suspect was added.Concomitant medications (ethyl chloride and diclofenac) were added.Clinical course was updated and text was amended accordingly.
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