| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Muscular Rigidity (1968); Pain (1994); Arthralgia (2355)
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| Event Date 07/01/2015 |
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Event Type
Injury
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Manufacturer Narrative
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Another injection received on (b)(6) 2015.
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Event Description
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Based upon additional information received on 03-mar- 2017, the case initially assessed as non-serious was upgraded to serious as the seriousness criterion of required intervention was added for the events of enduring pain in legs/extreme pain in leg above and below knee, stiff like a robot/stiffness in leg above and below knee and it caused her a lot of pain/pain in knee joint after injection.Based on additional information received on 24-jul- 2015, this case initially processed as unsolicited is now considered as solicited case.This sponsored solicited case was received on 24-jul- 2015 from a patient via patient support program.Patient id: (b)(6); country: united states.Study title: (b)(4).This case concerns a (b)(6) female patient who received treatment with synvisc one and after few days experienced minimal pain with injection in left knee, it caused her a lot of pain/pain in knee joint after injection, quad was swollen/ swelling below her knee, she had tightness, had stiffness in her right knee and swelling in her right knee, gait was abnormal, was feeling weak, experienced enduring pain in legs/extreme pain in leg above and below knee, malaise/ general malaise, was stiff like a robot/stiffness in leg above and below knee.The patient had been receiving synvisc one in both knees since (b)(6) 2014 to provide cushion in knee joints/diminishing pain with positive results.The patient also had past treatment with steroids.It was reported that the patient's knees were bent when she received the injection.The medical history was significant for stent placement in 2012 and stem cells from own bone marrow were injected in right knee in 2015.The patient's concurrent conditions were not reported.The patient was not allergic to eggs or poultry.The concomitant medication included fish oil, benzoic acid/methenamine/salicylate sodium (cystex), cyamopsis tetragonolobus gum (benefiber), ascorbic acid/chondroitin sulfate sodium/glucosamine hydrochloride/manganese ascorbate (cosamin ds), ascorbic acid (vitamin c), tocopherol (vitamin e), mature multi & minerals, cyanocobalamin (vitamin b12), senna (senna plus), acetylsalicylic acid (aspirin), paracetamol (acetaminophen), melatonin, magnesium, biotin, ubidecarenone (coq10), xantofyl (lutein), hydrochlorothiazide, estrogens esterified/methyltestosterone (estrogen-methyltestos), simvastatin, valaciclovir hydrochloride (valtrex), aciclovir (acyclovir), cefalexin (cephalexin), losartan potassium, metoprolol tartrate (metoprolol), nitroglycerin, desvenlafaxine succinate (pristiq), estradiol (vagifem), tramadol hydrochloride and levothyroxine sodium (levoxyl).On an unknown date in (b)(6) 2015, the patient received treatment with intra-articular synvisc one injection, at a dose of 6 ml, in her left knee, with the leg straight, once (batch/lot number and expiration date: not provided) for osteoarthritis and to provide cushion in knee joints/diminishing pain.It was reported that the injection caused minimal pain.It was further reported that the patient's left knee was fine.Also, a week later, on (b)(6) 2015 (monday), the patient again received intra-articular synvisc one injection above her right knee (outside the knee joint, in the middle) instead of directly into the knee joint by an orthopedic surgeon with leg straight and it caused her a lot of pain.The same day, in the morning after the synvisc one injection, the patient's quad was swollen and had tightness and swelling below her knee.Since the same day, the patient experienced stiffness, pain and swelling in her right knee.The injection resulted in months long extreme pain and stiffness in leg, above and below the knee.It was reported that the patient was still experiencing pain.The patient received cortisone injection in bursa medial, below knee by another doctor.On unknown dates in 2015, the patient was feeling weak with malaise, her gait was affected and was stiff like a robot.It was reported that the patient received treatment with paracetamol (tylenol) and some other medication (unspecified) to treat the pain.No laboratory tests were done for the events and the patient did not visit the emergency room.It was reported that the patient was scheduled for a visit with another physician for arthroscopic evaluation.On an unknown date, the patient recovered from the knee pain.Corrective treatment: cortisone for enduring pain in legs/extreme pain in leg above and below knee, stiff like a robot/stiffness in leg above and below knee, it caused her a lot of pain/pain in knee joint after injection; paracetamol for minimal pain with injection in left knee and it caused her a lot of pain/pain in knee joint after injection; not reported for rest of the events outcome: recovered for enduring pain in legs/extreme pain in leg above and below knee, stiff like a robot/stiffness in leg above and below knee, it caused her a lot of pain/pain in knee joint after injection and minimal pain with injection in left knee; not recovered/not resolved for feeling weak, malaise/ general malaise; unknown for rest of the events.A pharmaceutical technical complaint (ptc) was initiated with 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.It was the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result was identified and mitigated through the ncr process.Genzyme global pharmacovigilance and epidemiology continuously monitored adverse event reports with or without lot numbers, and assessed 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.Genzyme biosurgery would continue to monitor adverse events to determine if a capa was required.Reporter causality: not reported for all the events.Company causality: associated for all the events.Seriousness criterion: required intervention for the events of enduring pain in legs/extreme pain in leg above and below knee, stiff like a robot/stiffness in leg above and below knee, it caused her a lot of pain/pain in knee joint after injection.Additional information was received on 24-jul-2015 from the patient via patient support program.This case initially processed as unsolicited is now considered as solicited case.The additional events of "stiffness in her right knee" and "swelling in her right knee" were added with details.The onset date of the event of "minimal pain with injection/it caused her a lot of pain/pain in knee joint after injection" was updated from (b)(6) 2015.Clinical course updated and text was amended accordingly.Additional information was received on 05-aug-2015.Ptc results were added and text amended accordingly.Additional information was received on 24-aug-2015 from the patient.The additional events of quad was swollen/ swelling below her knee, gait abnormal, feeling weak, malaise/ general malaise, stiff like a robot, she had tightness and enduring pain in legs were added with details.Clinical course updated and text was amended accordingly.Additional information was received on 03-mar-2017 from the patient.The medical history and concomitant medication was added.The verbatim for the event of enduring pain in legs was updated to enduring pain in legs/extreme pain in leg above and below knee and that of the event of stiff like a robot was updated to stiff like a robot/stiffness in leg above and below knee.The event of minimal pain with injection/it caused her a lot of pain/pain in knee joint after injection (knee pain) was updated to events of minimal pain with injection in left knee (left knee pain) and it caused her a lot of pain/pain in knee joint after injection (right knee pain).Corrective treatment of cortisone was added for the events of enduring pain in legs/extreme pain in leg above and below knee, stiff like a robot/stiffness in leg above and below knee, it caused her a lot of pain/pain in knee joint after injection.The outcome for the events of enduring pain in legs/extreme pain in leg above and below knee and stiff like a robot/stiffness in leg above and below knee was updated from unknown to recovered and that of the events of it caused her a lot of pain/pain in knee joint after injection and minimal pain with injection in left knee was updated from not recovered to recovered.The seriousness criterion of required intervention was added for the events of enduring pain in legs/extreme pain in leg above and below knee, stiff like a robot/stiffness in leg above and below knee, it caused her a lot of pain/pain in knee joint after injection and the case was upgraded to serious.Clinical course updated and text amended accordingly.Pharmacovigilance comment: sanofi company comment for follow up dated 03-mar-2017: this case concerns a female patient who received treatment with synvisc one and later had pain in leg and muscle stiffness.Based on temporal relationship with the treatment and close proximity with the site of injection, causality cannot be ruled out completely.
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Manufacturer Narrative
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Another injection received on (b)(6) 2015.
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Event Description
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Based upon additional information received on 03-mar- 2017, the case initially assessed as non-serious was upgraded to serious as the seriousness criterion of required intervention was added for the events of enduring pain in legs/extreme pain in leg above and below knee, stiff like a robot/stiffness in leg above and below knee and it caused her a lot of pain/pain in knee joint after injection.Based on additional information received on 24-jul- 2015, this case initially processed as unsolicited is now considered as solicited case.This sponsored solicited case was received on 24-jul- 2015 from a patient via patient support program.Patient id: (b)(6); country: united states study title: patient support program involving synvisc one.This case concerns a (b)(6) female patient who received treatment with synvisc one and after few days experienced minimal pain with injection in left knee, it caused her a lot of pain/pain in knee joint after injection, quad was swollen/ swelling below her knee, she had tightness, had stiffness in her right knee and swelling in her right knee, gait was abnormal, was feeling weak, experienced enduring pain in legs/extreme pain in leg above and below knee, malaise/ general malaise, was stiff like a robot/stiffness in leg above and below knee.The patient had been receiving synvisc one in both knees since (b)(6) 2014 to provide cushion in knee joints/diminishing pain with positive results.The patient also had past treatment with steroids.It was reported that the patient's knees were bent when she received the injection.The medical history was significant for stent placement in 2012 and stem cells from own bone marrow were injected in right knee in 2015.The patient's concurrent conditions were not reported.The patient was not allergic to eggs or poultry.The concomitant medication included fish oil, benzoic acid/methenamine/salicylate sodium (cystex), cyamopsis tetragonolobus gum (benefiber), ascorbic acid/chondroitin sulfate sodium/glucosamine hydrochloride/manganese ascorbate (cosamin ds), ascorbic acid (vitamin c), tocopherol (vitamin e), mature multi and minerals, cyanocobalamin (vitamin b12), senna (senna plus), acetylsalicylic acid (aspirin), paracetamol (acetaminophen), melatonin, magnesium, biotin, ubidecarenone (coq10), xantofyl (lutein), hydrochlorothiazide, estrogens esterified/methyltestosterone (estrogen-methyltestos), simvastatin, valaciclovir hydrochloride (valtrex), aciclovir (acyclovir), cefalexin (cephalexin), losartan potassium, metoprolol tartrate (metoprolol), nitroglycerin, desvenlafaxine succinate (pristiq), estradiol (vagifem), tramadol hydrochloride and levothyroxine sodium (levoxyl).On an unknown date in (b)(6) 2015, the patient received treatment with intra-articular synvisc one injection, at a dose of 6 ml, in her left knee, with the leg straight, once (batch/lot number and expiration date: not provided) for osteoarthritis and to provide cushion in knee joints/diminishing pain.It was reported that the injection caused minimal pain.It was further reported that the patient's left knee was fine.Also, a week later, on (b)(6) 2015 (monday), the patient again received intra-articular synvisc one injection above her right knee (outside the knee joint, in the middle) instead of directly into the knee joint by an orthopedic surgeon with leg straight and it caused her a lot of pain.The same day, in the morning after the synvisc one injection, the patient's quad was swollen and had tightness and swelling below her knee.Since the same day, the patient experienced stiffness, pain and swelling in her right knee.The injection resulted in months long extreme pain and stiffness in leg, above and below the knee.It was reported that the patient was still experiencing pain.The patient received cortisone injection in bursa medial, below knee by another doctor.On unknown dates in 2015, the patient was feeling weak with malaise, her gait was affected and was stiff like a robot.It was reported that the patient received treatment with paracetamol (tylenol) and some other medication (unspecified) to treat the pain.No laboratory tests were done for the events and the patient did not visit the emergency room.It was reported that the patient was scheduled for a visit with another physician for arthroscopic evaluation.On an unknown date, the patient recovered from the knee pain.Corrective treatment: cortisone for enduring pain in legs/extreme pain in leg above and below knee, stiff like a robot/stiffness in leg above and below knee, it caused her a lot of pain/pain in knee joint after injection; paracetamol for minimal pain with injection in left knee and it caused her a lot of pain/pain in knee joint after injection; not reported for rest of the events outcome: recovered for enduring pain in legs/extreme pain in leg above and below knee, stiff like a robot/stiffness in leg above and below knee, it caused her a lot of pain/pain in knee joint after injection and minimal pain with injection in left knee; not recovered/not resolved for feeling weak, malaise/ general malaise; unknown for rest of the events.A pharmaceutical technical complaint (ptc) was initiated with 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.It was the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result was identified and mitigated through the ncr process.Genzyme global pharmacovigilance and epidemiology continuously monitored adverse event reports with or without lot numbers, and assessed 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.Genzyme biosurgery would continue to monitor adverse events to determine if a capa was required.Reporter causality: not reported for all the events.Company causality: associated for all the events.Seriousness criterion: required intervention for the events of enduring pain in legs/extreme pain in leg above and below knee, stiff like a robot/stiffness in leg above and below knee, it caused her a lot of pain/pain in knee joint after injection additional information was received on 24-jul-2015 from the patient via patient support program.This case initially processed as unsolicited is now considered as solicited case.The additional events of "stiffness in her right knee" and "swelling in her right knee" were added with details.The onset date of the event of "minimal pain with injection/it caused her a lot of pain/pain in knee joint after injection" was updated from (b)(6) 2015 to (b)(6) 2015.Clinical course updated and text was amended accordingly.Additional information was received on 05-aug-2015.Ptc results were added and text amended accordingly.Additional information was received on 24-aug-2015 from the patient.The additional events of quad was swollen/ swelling below her knee, gait abnormal, feeling weak, malaise/ general malaise, stiff like a robot, she had tightness and enduring pain in legs were added with details.Clinical course updated and text was amended accordingly.Additional information was received on 03-mar-2017 from the patient.The medical history and concomitant medication was added.The verbatim for the event of enduring pain in legs was updated to enduring pain in legs/extreme pain in leg above and below knee and that of the event of stiff like a robot was updated to stiff like a robot/stiffness in leg above and below knee.The event of minimal pain with injection/it caused her a lot of pain/pain in knee joint after injection (knee pain) was updated to events of minimal pain with injection in left knee (left knee pain) and it caused her a lot of pain/pain in knee joint after injection (right knee pain).Corrective treatment of cortisone was added for the events of enduring pain in legs/extreme pain in leg above and below knee, stiff like a robot/stiffness in leg above and below knee, it caused her a lot of pain/pain in knee joint after injection.The outcome for the events of enduring pain in legs/extreme pain in leg above and below knee and stiff like a robot/stiffness in leg above and below knee was updated from unknown to recovered and that of the events of it caused her a lot of pain/pain in knee joint after injection and minimal pain with injection in left knee was updated from not recovered to recovered.The seriousness criterion of required intervention was added for the events of enduring pain in legs/extreme pain in leg above and below knee, stiff like a robot/stiffness in leg above and below knee, it caused her a lot of pain/pain in knee joint after injection and the case was upgraded to serious.Clinical course updated and text amended accordingly.Additional information was received on 15-mar-2017.The ptc results for upgraded seriousness were added.Text amended accordingly.Pharmacovigilance comment: sanofi company comment for follow up dated 15-mar-2017: the follow up information received does not change previous case assessment.Sanofi company comment for follow up dated 03-mar-2017: this case concerns a female patient who received treatment with synvisc one and later had pain in leg and muscle stiffness.Based on temporal relationship with the treatment and close proximity with the site of injection, causality cannot be ruled out completely.
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