| Device Problems
Insufficient Information (3190); Appropriate Term/Code Not Available (3191)
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| Patient Problems
Erythema (1840); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Joint Disorder (2373); Reaction (2414); Ambulation Difficulties (2544); Alteration In Body Temperature (2682)
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| Event Date 07/14/2014 |
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Event Type
Injury
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Event Description
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This unsolicited device case from united states was received on 17-july-2015 from a patient.This case concerns a (b)(6) male patient who developed a charcot foot, knee at stiffness, severe knee pain (both knees), knee swelling (both knees), knee warmth and could not walk after receiving treatment with synvisc one.It was reported that the patient was also injected synvisc one in shoulder (off label use).Patient was a type 2 diabetic and was seeing a podiatrist and rheumatologist.No relevant past drugs, concomitant medications and concurrent conditions were reported.On an unknown date in (b)(6) 2011, the patient initiated treatment with intra-articular synvisc one injection at a dose of 6 ml (batch/lot number and expiration date: not provided) for osteoarthritis.It was reported that the patient received three injections in his bilateral knees and one injection in the shoulder (of-label use).On (b)(6) 2014, the patient had received his last synvisc one injection.The patient stated that 2 hours after receiving the synvisc one injection, he experienced severe knee pain, knee stiffness, swelling, warmth, ankle swelling (both) and essentially could not walk.It was reported that these symptoms occurred in both knees and extended down to his feet.The patient treated the reaction with ice packs and self-medicated with furosemide (lasix) and ibuprofen to reduce inflammation and swelling.The patient stated that the reaction had resolved on the left side.Further reported, his right foot remained with oedema (swelling), redness and warm to the touch.On (b)(6) 2014, the patient visited his podiatrist and was diagnosed with "charcot foot." the patient had to wear a boot on his foot, continued icing the foot, visited the podiatrist regularly, and finally it resolved (b)(6) 2015.The patient went to his rheumatologist the day after developing this reaction and he stated that he had never seen anything like it.The patient stated that he had three years experience with the pain tracker from the synvisc-one website.Action taken: unknown.Outcome: recovered for the event of charcot foot; unknown for the events of could not walk, knee stiffness, severe knee pain (both knees), knee swelling (both knees) and knee warmth.Seriousness criteria: important medical event for the event of charcot foot.A pharmaceutical technical complaint (ptc) was initiated and results were pending for the same.
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Manufacturer Narrative
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Pharmacovigilance comment: (b)(4) comment dated 17-july-2015: this case concerns a patient who received treatment with synvisc one for osteoarthritis and was later diagnosed with charcot foot.Since the event occurred in close proximity with product stop date, the significant temporal relationship can be established and causal role of suspect cannot be excluded in occurrence of the event.However, the medical history of diabetes type 2 offers a more plausible explanation for the event as charcot foot is a known complication for this disease.
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Event Description
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Based on additional information received on 28-oct-2015 from the pharmacist, this case became medically confirmed.This unsolicited device case from united states was received on 17-jul-2015 from a patient.This case concerns a (b)(6) male patient who developed a charcot foot on right side, knee stiffness, severe knee pain (both knees), knee swelling (both knees), knee warmth, severe inflammation, essentially loss of all my self functioning around my house and could not walk/extreme difficulty in walking after receiving treatment with synvisc one.It was reported that the patient was also injected synvisc one in shoulder (off label use).Patient was a type 2 diabetic and was seeing a podiatrist and rheumatologist.On (b)(6) 2007, patient was diagnosed with osteoarthritis of knees.On (b)(6) 2010, patient was diagnosed with osteoarthritis of right shoulder.On (b)(6) 2010, patient had triamincinolone injection into right shoulder.No relevant past drugs.The patient's concomitant medications included pioglitazone hydrochloride (actos), sitagliptin phosphate (januvia), metformin hydrochloride (metformin), acarbose for diabetes, simvastatin for cholesterol, acetylsalicylic acid (aspirin) for stroke and myocardial infarction, ibuprofen and tramadol hydrochloride (tramadol) for pain of osteoarthritis, cholecalciferol (vitamin d3) for hypovitamin d, valsartan for hypertension, formoterol fumarate/mometasone furoate for asthma, salbutamol sulfate (ventolin) and aerosol inhalations for asthma rescue, montelukast (singulair) for allergy and asthma.On (b)(6) 2011, the patient initiated treatment with intra-articular synvisc one injection at a dose of 6 ml (batch/lot number and expiration date: not provided) bilaterally in knees for osteoarthritis.On (b)(6) 2012, patient received second synvisc one injection at a dose of 6 ml (batch/lot number and expiration date: not provided) bilaterally in knees.On (b)(6) 2012, patient had second x-ray of right shoulder.On (b)(6) 2012, patient again received synvisc one injection at a dose of 6 ml (batch/lot number and expiration date: not provided) into right shoulder (off label use).On (b)(6) 2014, patient had x-ray of right shoulder and both knees.On (b)(6) 2014, the patient had received his last synvisc one injection bilaterally in knees at a dose of 2 ml.The patient stated that 2 hours after receiving the synvisc one injection, he experienced severe knee pain, knee stiffness, swelling, warmth, ankle swelling (both), extreme difficulty in walking, charcot foot on right side and essentially loss of all self functioning around his house.It was reported that the physician placed a removable "boot" on her right foot and was instructed not to walk on right foot.It was reported that these symptoms occurred in both knees and extended down to his feet.The patient had to wear a boot on his foot, continued icing the foot, visited the podiatrist regularly.On (b)(6) 2014, patient's physician ordered the lab tests (c-reactive protein + comprehensive metabolic panel + sedimentation rate) that confirmed severe inflammation.On (b)(6) 2014, the patient treated the reaction with ice packs on both sides and self-medicated with furosemide (lasix) at a dose of 20 mg and ibuprofen at a dose of 400 mg/d to reduce inflammation and swelling.The patient stated that the reaction had resolved on the left side, in about one week.Further reported, his right foot remained with oedema (swelling), redness and warm to the touch (right foot and ankle).On (b)(6) 2014, patient again received treatment with furosemide and ibuprofen.On (b)(6) 2014, patient had x-ray of right foot.No fractures were observed.On (b)(6) 2014, patient had x-ray of right foot which showed no fractures.It was reported that the patient went to the physician for follow up right foot and it was not healed and the patient continued with boot.On (b)(6) 2015, patient recovered from the charcot foot and boot was removed.It was reported that there was no more signs of charcot arthropathy.The patient went to his rheumatologist the day after developing this reaction and he stated that he had never seen anything like it.The patient stated that he had three years' experience with the pain tracker from the synvisc-one website.Corrective treatment: icing for charcot foot on right side, icing and ibuprofen for knee stiffness and severe knee pain (both knees), icing, furosemide and ibuprofen for knee swelling (both knees), icing for knee warmth, ice packs, ibuprofen and furosemide for severe inflammation and not reported for could not walk/ extreme difficulty in walking, essentially loss of all my self functioning around my house.Outcome: recovered for the event of charcot foot on right side; unknown for the events of could not walk/extreme difficulty in walking, essentially loss of all my self functioning around my house, knee stiffness, severe knee pain (both knees), knee swelling (both knees) and knee warmth, not recovered for severe inflammation seriousness criteria: important medical event for the event of charcot foot on right side a pharmaceutical technical complaint (ptc) was initiated with (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.Additional information was received on 23-jul-2015.Ptc results were added and text amended accordingly.Additional information was received on 01-sep-2015.Additional events of severe inflammation and essentially loss of all my self-functioning around my house were added to the case along with the details.The event term of charcot foot was updated to charcot foot on right side and could not walk to could not walk/extreme difficulty in walking.Product start date of synvisc one was updated from (b)(6) 2011.New dosage regimens for synvisc one were added.Dosage regimen for furosemide and ibuprofen were updated.Medical history was updated.Action taken was updated.Clinical course was updated and text was amended accordingly.Additional information was received on 28-oct-2015 from the pharmacist.This case became medically confirmed the dose of the suspect product as received by the patient on (b)(6) 2014 was added.The patient's concomitant medications were added.The laboratory detail of x-ray right foot as of (b)(6) 2014 was added.Clinical course updated and text was amended accordingly.Pharmacovigilance comment: sanofi company comment for follow up dated 05-nov-2015: the follow-up information received does not change the prior assessment of the case.Sanofi company comment dated 17-jul-2015: this case concerns a patient who received treatment with synvisc one for osteoarthritis and was later diagnosed with charcot foot.Since the event occurred in close proximity with product stop date, the significant temporal relationship can be established and causal role of suspect cannot be excluded in occurrence of the event.However, the medical history of diabetes type 2 offers a more plausible explanation for the event as charcot foot is a known complication for this disease.
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Event Description
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This unsolicited device case from united states was received on 17-jul-2015 from a patient.This case concerns a (b)(6) male patient who developed a charcot foot on right side, knee stiffness, severe knee pain (both knees), knee swelling (both knees), knee warmth, severe inflammation, essentially loss of all my self functioning around my house and could not walk/extreme difficulty in walking after receiving treatment with synvisc one.It was reported that the patient was also injected synvisc one in shoulder (off label use).Patient was a type 2 diabetic and was seeing a podiatrist and rheumatologist.On (b)(6) 2007, patient was diagnosed with osteoarthritis of knees.On (b)(6) 2010, patient was diagnosed with osteoarthritis of right shoulder.On (b)(6) 2010, patient had triamcinolone injection into right shoulder.No relevant past drugs, concomitant medications and concurrent conditions were reported.On (b)(6) 2011, the patient initiated treatment with intra-articular synvisc one injection at a dose of 6 ml (batch/lot number and expiration date: not provided) bilaterally in knees for osteoarthritis.On (b)(6) 2012, patient received second synvisc one injection at a dose of 6 ml (batch/lot number and expiration date: not provided) bilaterally in knees.On (b)(6) 2012, patient had second x-ray of right shoulder.On (b)(6) 2012, patient again received synvisc one injection at a dose of 6 ml (batch/lot number and expiration date: not provided) into right shoulder (off label use).On (b)(6) 2014, patient had x-ray of right shoulder and both knees.On (b)(6) 2014, the patient had received his last synvisc one injection bilaterally in knees.The patient stated that 2 hours after receiving the synvisc one injection, he experienced severe knee pain, knee stiffness, swelling, warmth, ankle swelling (both), extreme difficulty in walking, charcot foot on right side and essentially loss of all self functioning around his house.It was reported that these symptoms occurred in both knees and extended down to his feet.The patient had to wear a boot on his foot, continued icing the foot, visited the podiatrist regularly.Patient was instructed not to walk on right foot.On (b)(6) 2014, patient's physician ordered the lab tests (c-reactive protein + comprehensive metabolic panel + sedimentation rate) that confirmed severe inflammation.On (b)(6) 2014, the patient treated the reaction with ice packs on both sides and self-medicated with furosemide (lasix) at a dose of 20 mg and ibuprofen at a dose of 400 mg/d to reduce inflammation and swelling.The patient stated that the reaction had resolved on the left side, in about one week.Further reported, his right foot remained with oedema (swelling), redness and warm to the touch (right foot and ankle).On (b)(6) 2014, patient again received treatment with furosemide and ibuprofen.On (b)(6) 2014, patient had x-ray of right foot.No fractures were observed.On (b)(6) 2014, patient had x-ray of right foot.On (b)(6) 2015, patient recovered from the charcot foot and boot was removed.The patient went to his rheumatologist the day after developing this reaction and he stated that he had never seen anything like it.The patient stated that he had three years' experience with the pain tracker from the synvisc-one website.Corrective treatment: icing for charcot foot on right side, icing and ibuprofen for knee stiffness and severe knee pain (both knees), icing, furosemide and ibuprofen for knee swelling (both knees), icing for knee warmth, ice packs, ibuprofen and furosemide for severe inflammation and not reported for could not walk/ extreme difficulty in walking, essentially loss of all my self functioning around my house outcome: recovered for the event of charcot foot on right side; unknown for the events of could not walk/ extreme difficulty in walking, essentially loss of all my self functioning around my house, knee stiffness, severe knee pain (both knees), knee swelling (both knees) and knee warmth, not recovered for severe inflammation.Seriousness criteria: important medical event for the event of charcot foot on right side 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.Additional information was received on 23-jul-2015.Ptc results were added and text amended accordingly.Additional information was received on 01-sep-2015.Additional events of severe inflammation and essentially loss of all my self-functioning around my house were added to the case along with the details.The event term of charcot foot was updated to charcot foot on right side and could not walk to could not walk/extreme difficulty in walking.Product start date of synvisc one was updated from (b)(6) 2011.New dosage regimens for synvisc one were added.Dosage regimen for furosemide and ibuprofen were updated.Medical history was updated.Action taken was updated.Clinical course was updated and text was amended accordingly.Pharmacovigilance comment: sanofi company comment for follow up dated 01-sep-2015: the follow-up information received does not change the prior assessment of the case.Sanofi company comment dated 17-jul-2015: this case concerns a patient who received treatment with synvisc one for osteoarthritis and was later diagnosed with charcot foot.Since the event occurred in close proximity with product stop date, the significant temporal relationship can be established and causal role of suspect cannot be excluded in occurrence of the event.However, the medical history of diabetes type 2 offers a more plausible explanation for the event as charcot foot is a known complication for this disease.
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Event Description
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Based on additional information received on 28-oct-2015 from the pharmacist, this case became medically confirmed.This unsolicited device case from united states was received on 17-jul-2015 from a patient.This case concerns a (b)(6) year old male patient who developed a charcot foot on right side, knee stiffness, severe knee pain (both knees), knee swelling (both knees), knee warmth, severe inflammation, essentially loss of all my self functioning around my house and could not walk/extreme difficulty in walking after receiving treatment with synvisc one.It was reported that the patient was also injected synvisc one in shoulder (off label use).Patient was a type 2 diabetic and was seeing a podiatrist and rheumatologist.On (b)(6) 2007, patient was diagnosed with osteoarthritis of knees.On (b)(6) 2010, patient was diagnosed with osteoarthritis of right shoulder.On (b)(6) -2010, patient had triamincinolone injection into right shoulder.No relevant past drugs.The patient's concomitant medications included pioglitazone hydrochloride (actos), sitagliptin phosphate (januvia), metformin hydrochloride (metformin), acarbose for diabetes, simvastatin for cholesterol, acetylsalicylic acid (aspirin) for stroke and myocardial infarction, ibuprofen and tramadol hydrochloride (tramadol) for pain of osteoarthritis, cholecalciferol (vitamin d3) for hypovitaminosis d, valsartan for hypertension, formoterol fumarate/mometasone furoate for asthma, salbutamol sulfate (ventolin) and aerosol inhalations for asthma rescue, montelukast (singulair) for allergy and asthma.On (b)(6) 2011, the patient initiated treatment with intra-articular synvisc one injection at a dose of 6 ml (batch/lot number and expiration date: not provided) bilaterally in knees for osteoarthritis.On (b)(6) 2012, patient received second synvisc one injection at a dose of 6 ml (batch/lot number and expiration date: not provided) bilaterally in knees.On (b)(6) 2012, patient had second x-ray of right shoulder.On (b)(6) 2012, patient again received synvisc one injection at a dose of 6 ml (batch/lot number and expiration date: not provided) into right shoulder (off label use).On (b)(6) 2014, patient had x-ray of right shoulder and both knees.On (b)(6) 2014, the patient had received his last synvisc one injection bilaterally in knees at a dose of 2 ml.The patient stated that 2 hours after receiving the synvisc one injection, he experienced severe knee pain, knee stiffness, swelling, warmth, ankle swelling (both), extreme difficulty in walking, charcot foot on right side and essentially loss of all self functioning around his house.It was reported that the physician placed a removable "boot" on her right foot and was instructed not to walk on right foot.It was reported that these symptoms occurred in both knees and extended down to his feet.The patient had to wear a boot on his foot, continued icing the foot, visited the podiatrist regularly.On (b)(6) 2014, patient's physician ordered the lab tests (c-reactive protein + comprehensive metabolic panel + sedimentation rate) that confirmed severe inflammation.On (b)(6) 2014, the patient treated the reaction with ice packs on both sides and self-medicated with furosemide (lasix) at a dose of 20 mg and ibuprofen at a dose of 400 mg/d to reduce inflammation and swelling.The patient stated that the reaction had resolved on the left side, in about one week.Further reported, his right foot remained with oedema (swelling), redness and warm to the touch (right foot and ankle).On (b)(6) 2014, patient again received treatment with furosemide and ibuprofen.On (b)(6) 2014, patient had x-ray of right foot.No fractures were observed.On (b)(6) 2014, patient had x-ray of right foot which showed no fractures.It was reported that the patient went to the physician for follow up right foot and it was not healed and the patient continued with boot.On (b)(6) 2015, patient recovered from the charcot foot and boot was removed.It was reported that there was no more signs of charcot arthropathy.The patient went to his rheumatologist the day after developing this reaction and he stated that he had never seen anything like it.The patient stated that he had three years' experience with the pain tracker from the synvisc-one website.On (b)(6) 2015, treatment with synvisc one was completed.Action taken: permanently discontinued.Corrective treatment: icing for charcot foot on right side, icing and ibuprofen for knee stiffness and severe knee pain (both knees), icing, furosemide and ibuprofen for knee swelling (both knees), icing for knee warmth, ice packs, ibuprofen and furosemide for severe inflammation and not reported for could not walk/ extreme difficulty in walking, essentially loss of all my self functioning around my house outcome: recovered for the event of charcot foot on right side; unknown for the events of could not walk/extreme difficulty in walking, essentially loss of all my self functioning around my house, knee stiffness, severe knee pain (both knees), knee swelling (both knees) and knee warmth, not recovered for severe inflammation seriousness criteria: important medical event for the event of charcot foot on right side 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.Additional information was received on 23-jul-2015.Ptc results were added and text amended accordingly.Additional information was received on 01-sep-2015.Additional events of severe inflammation and essentially loss of all my self-functioning around my house were added to the case along with the details.The event term of charcot foot was updated to charcot foot on right side and could not walk to could not walk/extreme difficulty in walking.Product start date of synvisc one was updated form (b)(6) 2011.New dosage regimens for synvisc one were added.Dosage regimen for furosemide and ibuprofen were updated.Medical history was updated.Action taken was updated.Clinical course was updated and text was amended accordingly.Additional information was received on 28-oct-2015 from the pharmacist.This case became medically confirmed the dose of the suspect product as received by the patient on 14-jul-2014 was added.The patient's concomitant medications were added.The laboratory detail of x-ray right foot as of (b)(6) 2014 was added.Clinical course updated and text was amended accordingly.Additional information was received on 09-nov-2015.Medical history and concomitant medications were updated.Treatment for charcot foot on right side was updated.Action taken was updated to permanently discontinued.Indication of synvisc one was updated from osteoarthritis to severe degenerative osteoarthritis.Patient's height was added.Clinical course was updated and text was amended accordingly.Pharmacovigilance comment: sanofi company comment for follow up dated 09-nov-2015: the follow-up information received does not change the prior assessment of the case.Sanofi company comment dated 17-jul-2015: this case concerns a patient who received treatment with synvisc one for osteoarthritis and was later diagnosed with charcot foot.Since the event occurred in close proximity with product stop date, the significant temporal relationship can be established and causal role of suspect cannot be excluded in occurrence of the event.However, the medical history of diabetes type 2 offers a more plausible explanation for the event as charcot foot is a known complication for this disease.
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Manufacturer Narrative
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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.Additional information was received on july 23, 2015.Ptc results were added and text amended accordingly.Pharmacovigilance comment: sanofi company comment for follow up dated july 23, 2015: the follow-up information received does not change the prior assessment of the case.
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