| Lot Number 8RSP006F |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Pain (1994); Arthralgia (2355); Joint Disorder (2373); Neck Pain (2433); Neck Stiffness (2434); No Code Available (3191)
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| Event Date 02/09/2019 |
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Event Type
Injury
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Manufacturer Narrative
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Sanofi company comment 19-apr-2019.Patient experienced couldn't get around without a walker, could not breathe normally, couldn't bend my knees, muscle grew stiff, especially neck and all muscles around midriff, worst pain is in my neck, hard for me even to stand, still have pain and stiffness in my neck, shoulders, lower back and knees, have no energy/weak, tire very easily, feel bad, do not feel well, concentration is not what it usually is, lower back hurts, balance still isn't excellent, hard time sleeping, joint stiffness and joints extremely painful with synvisc.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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Couldn't get around without a walker [walking difficulty], could not breathe normally [difficulty breathing], couldn't bend my knees [joint range of motion decreased], muscles grew stiff, especially neck and all muscles around midriff [muscle stiffness], worst pain is in my neck [neck pain], hard for me even to stand [difficulty in standing], still have pain and stiffness in my neck, shoulders, lower back and knees [pain], have no energy/weak [loss of energy], tire very easily [tiredness], feel bad [feeling bad], do not feel well [feeling unwell], concentration is not what it usually is [concentration impaired], balance still isn't excellent [balance difficulty], lower back hurt [low back pain], hard time sleeping [difficulty sleeping], joint stiffness [joint stiffness], joints extremely painful [joint pain].Case narrative: initial information received on 15-apr-2019 regarding an unsolicited valid serious case received from health authorities of united states under reference mw5085161.This case involves a patient of unknown demographics who experienced "couldn't get around without a walker, could not breathe normally, couldn't bend my knees, muscle grew stiff, especially neck and all muscles around midriff, worst pain is in my neck, hard for me even to stand, still have pain and stiffness in my neck, shoulders, lower back and knees, have no energy/weak, tire very easily, feel bad, do not feel well, concentration is not what it usually is, lower back hurts, balance still isn't excellent, hard time sleeping, joint stiffness and joints extremely painful" with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc).The patient's past medical history included thyroid surgery in 1984 and anterior cervical discectomy and fusion in 2016.The patient's past medical treatment(s), vaccination(s) and family history were not provided.Concomitant medications included losartan; levothyroxine; diclofenac; atorvastatin; potassium chloride (klor-con); solifenacin succinate (vesicare); allopurinol; metformin hydrochloride; vitamin a; vitamin d; vitamin e; thiamine hydrochloride (vitamin b1 [thiamine hydrochloride]); vitamin b12; chromium picolinate; vaccinium macrocarpon (cranberry extract [vaccinium macrocarpon]); folic acid; allium sativum bulb (garlic extract); apple cider vinegar; calcium; magnesium phosphate, potassium phosphate dibasic, sodium sulfate anhydrous (magnesium compound); chondroitin sulfate, glucosamine sulfate (glucosamine chondroitin sulfate); valerian extract (valerian extract), lubrisyn and loratadine (loratadine).On (b)(6) 2019, the patient received intra-articular injection of hylan g-f 20, sodium hyaluronate at 2ml dosage (batch - 8rsp006f, exp 03-jan-2021) (frequency, indication: unknown) in left knee.The patient reported that the other two injections were still in the box.On the same day, within 24 hours of receiving the injection, patient experienced all joints were extremely painful (latency: same day).On (b)(6) 2019, patient experienced couldn't bend my knees (latency: 1 day) to sit/stand, muscles grew stiff, especially neck and all muscles around midriff (latency: 1 day).Further, it felt like as if were breathing out against a reverse iron lung.Patient reported that the lungs and respiratory system were ok but the muscles from below their bust down front, back and sides were so tight they could not breathe normally (latency: 1 day).The patient contacted their physician who advised them to visit the emergency room.The patient reported severe pain and stiffness in all their joints, throughout their back and was unable to bend their knees at all to sit down or get up from a chair.The patient couldn't turn their neck which had a titanium plate, left or right at all due to the joint pain and muscle stiffness.The patient had joint stiffness (latency: 1 day) and reported that the muscles around the large swath of their midriff grew completely stiff and painful.Patient felt as if they were breathing out against an iron lung that was pressing in, however, they could tell that their lungs, bronchial tubes and esophagus were functioning normally and this was due to the stiff muscles around their mid riff that made breathing difficult.The stiffness and pain in the midriff eased up after about 48 hours, the other extreme pain lasted about 6 days and then very gradually began to ease as well for days.The patient reported that couldn't even get up or down from a chair without huge effort and couldn't get around without a walker (latency: 1 day) for the first few weeks.Patient added that even after a month later, still have still have pain and stiffness in my neck, shoulders, lower back and knees (latency: 1 day) and the worst pain is in my neck (latency: 1 day), right shoulder and left knee.The lower back hurts (latency: 1 day) worse in the morning and its hard for me even to stand (latency: 1 day).They tire very easily (latency: 1 day), have no energy (latency: 1 day), do not feel well (latency: 1 day) and feel bad (latency: 1 day).Patient gets exhausted doing tasks that were not tiring before and their concentration is not what it usually is (latency: 1 day).They can not sit, stand or walk for too long and have a hard time sleeping (latency: 1 day).Patient reported that the joint pain kept them from falling asleep and sometimes they can not find a comfortable position for sleeping.The patient attributed this reaction of theirs to hylan g-f 20, sodium hyaluronate to any of the four factors such as allergic reaction to injection, having received a contaminated lot number, due to the similarity between catgut and the injection or that the injection and reactions were unrelated and they just happened at the same time.The patient added that currently, they get around their apartment just fine but their balance still isn't excellent (latency: unknown) and they use the walker whenever they get tired or have to go out.The patient was undergoing chiropractic therapy for their back and was doing way better than the first week and was not as weak as before.They stated that the most serious situation currently was in their neck because their neck muscles were still very stiff.The patient still did not feel well at all.The tight muscles around their midriff were better within 2 days, the bad joint pain was less in 6 days but some joints were still stiff and painful.The patients neck was still painful, stiff and did not turn well, the right shoulder and left knee were still quite painful and stiff and the patient was on disability leave for now.Action taken: unknown.Corrective treatment: walker for couldn't get around without a walker; chiropractic therapy for lower back hurts; not reported for rest.Outcome: not recovered for worst pain is in my neck and still have pain, do not feel well and stiffness in my neck, shoulders, lower back and knees; recovering/resolving for muscles grew stiff, especially neck and all muscles around midriff, have no energy/weak and joints extremely painful; unknown for rest seriousness criterion: disability for couldn't get around without a walker; medically significant for all events a product technical complaint was initiated with global ptc (b)(4) and results were pending for the same.
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Event Description
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Couldnt get around without a walker [walking difficulty].Could not breathe normally [difficulty breathing].Couldnt bend my knees [joint range of motion decreased].Muscles grew stiff, especially neck and all muscles around midriff [muscle stiffness].Worst pain is in my neck [neck pain].Hard for me even to stand [difficulty in standing].Still have pain and stiffness in my neck, shoulders, lower back and knees [pain].Have no energy/weak [loss of energy].Tire very easily [tiredness].Feel bad [feeling bad].Do not feel well [feeling unwell].Concentration is not what it usually is [concentration impaired].Balance still isnt excellent [balance difficulty].Lower back hurt [low back pain].Hard time sleeping [difficulty sleeping].Joint stiffness [joint stiffness].Joints extremely painful [joint pain].Case narrative: initial information received on 15-apr-2019 regarding an unsolicited valid serious case received from health authorities of united states under reference mw5085161.This case involves a patient of unknown demographics who experienced couldnt get around without a walker, could not breathe normally, couldnt bend my knees, muscle grew stiff, especially neck and all muscles around midriff, worst pain is in my neck, hard for me even to stand, still have pain and stiffness in my neck, shoulders, lower back and knees, have no energy/weak, tire very easily, feel bad, do not feel well, concentration is not what it usually is, lower back hurts, balance still isnt excellent, hard time sleeping, joint stiffness and joints extremely painful with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc).The patient's past medical history included thyroid surgery in 1984 and anterior cervical disectomy and fusion in 2016.The patient's past medical treatment(s), vaccination(s) and family history were not provided.Concomitant medications included losartan; levothyroxine; diclofenac; atorvastatin; potassium chloride (klor-con); solifenacin succinate (vesicare); allopurinol; metformin hydrochloride; vitamin a; vitamin d; vitamin e; thiamine hydrochloride (vitamin b1 [thiamine hydrochloride]); vitamin b12; chromium picolinate; vaccinium macrocarpon (cranberry extract [vaccinium macrocarpon]); folic acid; allium sativum bulb (garlic extract); apple cider vinegar; calcium; magnesium phosphate, potassium phosphate dibasic, sodium sulfate anhydrous (magnesium compound); chondroitin sulfate, glucosamine sulfate (glucosamine chondroitin sulfate); valerian extract (valerian extract), lubrisn and loratadine (loratadin).On (b)(6) 2019, the patient received intra-articular injection of hylan g-f 20, sodium hyaluronate at 2ml dosage (batch - 8rsp006f, exp 03-jan-2021) (frequency, indication: unknown) in left knee.The patient reported that the other two injections were still in the box.On the same day, within 24 hours of receiving the injection, patient experienced all joints were extremely painful (latency: same day).On(b)(6) 2019, patient experienced couldnt bend my knees (latency: 1 day) to sit/stand, muscles grew stiff, especially neck and all muscles around midriff (latency: 1 day).Further, it felt like as if were breathing out against a reverse iron lung.Patient reported that the lungs and respiratory system were ok but the muscles from below their bust down front, back and sides were so tight they could not breathe normally (latency: 1 day).The patient contacted their physician who advised them to visit the emergency room.The patient reported severe pain and stiffness in all their joints, throughout their back and was unable to bend their knees at all to sit down or get up from a chair.The patient couldnt turn their neck which had a titanium plate, left or right at all due to the joint pain and muscle stiffness.The patient had joint stiffness (latency: 1 day) and reported that the muscles around the large swath of their midriff grew completely stiff and painful.Patient felt as if they were breathing out against an iron lung that was pressing in, however, they could tell that their lungs, bronchial tubes and esophagus were functioning normally and this was due to the stiff muscles around their mid riff that made breathing difficult.The stiffness and pain in the midriff eased up after about 48 hours, the other extreme pain lasted about 6 days and then very gradually began to ease as well for days.The patient reported that couldnt even get up or down from a chair without huge effort and couldnt get around without a walker (latency: 1 day) for the first few weeks.Patient added that even after a month later, still have still have pain and stiffness in my neck, shoulders, lower back and knees (latency: 1 day) and the worst pain is in my neck (latency: 1 day), right shoulder and left knee.The lower back hurts (latency: 1 day) worse in the morning and its hard for me even to stand (latency: 1 day).They tire very easily (latency: 1 day), have no energy (latency: 1 day), do not feel well (latency: 1 day) and feel bad (latency: 1 day).Patient gets exhausted doing tasks that were not tiring before and their concentration is not what it usually is (latency: 1 day).They can not sit, stand or walk for too long and have a hard time sleeping (latency: 1 day).Patient reported that the joint pain kept them from falling asleep and sometimes they can not find a comfortable position for sleeping.The patient attributed this reaction of theirs to hylan g-f 20, sodium hyaluronate to any of the four factors such as allergic reaction to injection, having received a contaminated lot number, due to the similarity between catgut and the injection or that the injection and reactions were unrelated and they just happened at the same time.The patient added that currently, they get around their apartment just fine but their balance still isnt excellent (latency: unknown) and they use the walker whenever they get tired or have to go out.The patient was undergoing chiropractic therapy for their back and was doing way better than the first week and was not as weak as before.They stated that the most serious situation currently was in their neck because their neck muscles were still very stiff.The patient still did not feel well at all.The tight muscles around their midriff were better within 2 days, the bad joint pain was less in 6 days but some joints were still stiff and painful.The patients neck was still painful, stiff and did not turn well, the right shoulder and left knee were still quite painful and stiff and the patient was on disability leave for now.Patient reported that they spent 11 weeks on medical leave following the injection and was still doing both pt and ot and was far from back to normal.Patient further added that nothing like this had ever happened to them before and it was not an allergic reaction as per bloodwork done in the er less than 24 hours after the injection, but was definitely a reaction.Action taken: unknown.Corrective treatment: walker for couldnt get around without a walker; chiropractic therapy for lower back hurts, not reported for rest of events.Outcome: not recovered for worst pain is in my neck and still have pain, do not feel well and stiffness in my neck, shoulders, lower back and knees; recovering/resolving for muscles grew stiff, especially neck and all muscles around midriff, have no energy/weak and joints extremely painful; unknown for rest a product technical complaint was initiated on 03-may-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 criterion: disability for couldnt get around without a walker; medically significant for all events additional information received on 27-may-2019 from patient.Clinical course updated.Text amended accordingly.Additional information received on 30-may-2019.Investigation summary received and ptc results added.Text amended accordingly.
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