| Lot Number 7RSL021 |
| Device Problems
Microbial Contamination of Device (2303); Device Contamination With Biological Material (2908)
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| Patient Problems
Fall (1848); Arthralgia (2355); No Code Available (3191)
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Event Type
Injury
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Event Description
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This sponsored solicited case from was received on (b)(6) 2018 from a patient via patient support program.Patient id: (b)(6); country: united states study title: sanofi patient connection this case concerns a (b)(6) female patient who received treatment with synvisc one and after unknown latency knees becoming infected; after 47 days had a fall, after 1 day not be able to move for three days, legs became weak, few hours later was hurting/extreme pain, had inability to walk for 48 hours; after unknown latency had extreme leg numbness, felt worse and disoriented.Event of device malfunction was identified in the case.The patient had mild diabetes, severe arthritis and sciatica.Concomitant medications included omeprazole for reflux, ramipril for blood pressure and buspirone for anxiety.No past drugs were reported.On (b)(6) 2017, the patient initiated treatment with intra-articular synvisc one injection (dose, batch/lot number 7rsl021 and expiry date: unknown) once in each knee for pain in both legs.The same day, few hours after first dose of synvisc one, the patient experienced extreme pain, inability to walk for 48 hours, felt worse after the procedure.On (b)(6) 2017, one day after the synvisc-one was administered, patient had an injection in both of her knees that caused her to not be able to move for three days, her legs became weak, and "it was like they went dead on me", and she was hurting.On (b)(6) 2017, 47 days after first dose of synvisc one, patient had a fall followed by hospitalization.The patient proceeded to get worse until this fall and had to be hospitalized.On unknown dates, after unknown latencies, the patient at that time had extreme leg numbness and was disoriented.Treatment included two different antibiotics (unspecified) and calling her doctor for a hospitalization following a fall, having an injection in both of her knees that caused her to not be able to move for three days, her legs became weak, and "it was like they went dead on me", and she was hurting.The having an injection in both of her knees that caused her to not be able to move for three days, her legs became weak, and "it was like they went dead on me", and she was hurting were ongoing.It was unknown if the hospitalization following a fall was ongoing or resolved.Patient reported that the day she received her injections, she came home and laid down on the couch and could not get up of move for three days.Patient reported her doctor told her there was a product recall of the synvisc-one, that she was hurting before but not like this; patient could not get really anything done to legs now.Patient also stated that she had heard other people that got the injections and just did great.On an unknown date, latency unknown, patient experienced a reaction to synvisc- one characterized by her knees becoming infected.Treatment included receiving an antibiotic(unspecified) that was the wrong antibiotic and switching to another antibiotic(unspecified) for a reaction to synvisc-one characterized by her knees becoming infected.It was unknown to reporter if a reaction to synvisc-one characterized by her knees becoming infected was ongoing.It was unknown to reporter if the consumer has a history of this event.It is unknown to reporter if the synvisc-one was ongoing.Corrective treatment: ciprofloxacin hydrochloride (ciprofloxacin) and hydrocodone for knees becoming infected; not reported for rest all events outcome: unknown for knees becoming infected, device malfunction, extreme leg numbness, inability to walk for 48 hours; not recovered for rest events a pharmaceutical technical complaint was initiated and results for the same were received.An investigation was initiated as a result of an unexpected increase in the number of labelled adverse events received from the us market for synvisc one, lot 7rsl021.The product met all release testing at time of manufacture in june 2017.Retain samples were retested due to the unexpected increase in adverse events.Higher than expected endotoxin results were obtained.In addition, the presence of microbial contamination was also confirmed.The cause of these events is under investigation.Once this investigation is completed, corrective and preventive actions will be implemented.Reporter causality: not reported for all events company causality: associated for device malfunction; not associated for rest all events seriousness criterion: important medical event for knees becoming infected; hospitalization for device malfunction, fall, not be able to move for three days, legs became weak and hurting/extreme pain additional information was received on (b)(6) 2018.Investigation summary and gptc number was added.Text was amended accordingly.Additional information was received on (b)(6) 2018 from the patient's granddaughter.Suspect product lot number was added.Additional events of device malfunction, felt worse, disoriented, inability to walk for 48 hours and extreme leg numbness were added.Event term of hurting was updated to hurting/extreme pain.Outcome of fall was updated from unknown to not recovered and its event start date was updated.Corrective treatment of knees becoming infected was added.Medical history, concomitant medications and concurrent conditions were added.Suspect product therapy regimen was updated.Clinical course was updated and text was amended accordingly.Pharmacovigilance comment: sanofi company comment for follow up dated 28-mar-2018: this case concerns a patient who has received synvisc one injection from the recalled lot.The events are temporally related to device.Moreover, the concerned lot number has been identified to have malfunction by the company.Therefore, the causal relationship of the events to the products cannot be excluded.
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Event Description
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This sponsored solicited case from was received on 27- feb-2018 from a patient via patient support program.Patient id: (b)(6); country: united states.Study title: (b)(6).This case concerns a (b)(6) female patient who received treatment with synvisc one and after unknown latency knees becoming infected; after 47 days had a fall, after 1 day not be able to move for three days, legs became weak, few hours later was hurting/extreme pain, had inability to walk for 48 hours; after unknown latency had extreme leg numbness, felt worse and disoriented.Also device malfunction was reported for the same lot.Patient also had severe pain and couldn't move legs on the same day.The patient had mild diabetes, severe arthritis, and sciatica.Concomitant medications included omeprazole for reflux, ramipril for blood pressure and buspirone for anxiety, metformin hydrochloride (metformin) for diabetes and omeprazole for digestion.No past drugs were reported.On (b)(6) 2017, the patient initiated treatment with intra-articular synvisc one injection (dose, batch/lot number 7rsl021 and expiry date: unknown) once in each knee for pain in both legs.The same day, few hours after first dose of synvisc one, the patient experienced extreme, severe pain, couldn't move legs, inability to walk for 48 hours, felt worse after the procedure.On (b)(6) 2017, one day after the synvisc-one was administered, patient had an injection in both of her knees that caused her to not be able to move for three days, her legs became weak, and "it was like they went dead on me", and she was hurting.On (b)(6) 2017, 47 days after first dose of synvisc one, patient had a fall followed by hospitalization.The patient proceeded to get worse until this fall and had to be hospitalized.On unknown dates, after unknown latencies, the patient at that time had extreme leg numbness and was disoriented.Treatment included two different antibiotics (unspecified) and calling her doctor for a hospitalization following a fall, having an injection in both of her knees that caused her to not be able to move for three days, her legs became weak, and "it was like they went dead on me", and she was hurting.The having an injection in both of her knees that caused her to not be able to move for three days, her legs became weak, and "it was like they went dead on me", and she was hurting were ongoing.It was unknown if the hospitalization following a fall was ongoing or resolved.Patient reported that the day she received her injections, she came home and laid down on the couch and could not get up of move for three days.Patient reported her doctor told her there was a product recall of the synvisc-one, that she was hurting before but not like this; patient could not get really anything done to legs now.Patient also stated that she had heard other people that got the injections and just did great.On an unknown date, latency unknown, patient experienced a reaction to synvisc-one characterized by her knees becoming infected.Treatment included receiving an antibiotic(unspecified) that was the wrong antibiotic and switching to another antibiotic(unspecified) for a reaction to synvisc-one characterized by her knees becoming infected.It was unknown to reporter if a reaction to synvisc-one characterized by her knees becoming infected was ongoing.It was unknown to reporter if the consumer has a history of this event.It is unknown to reporter if the synvisc- one was ongoing.Corrective treatment: ciprofloxacin hydrochloride (ciprofloxacin) and hydrocodone for knees becoming infected; not reported for rest all events.Outcome: unknown for knees becoming infected, device malfunction, extreme leg numbness, inability to walk for 48 hours; not recovered for rest events a pharmaceutical technical complaint was initiated with global ptc number (b)(4).An investigation was initiated as a result of an unexpected increase in the number of labelled adverse events received from the us market for synvisc one, lot 7rsl021.The product met all release testing at time of manufacture in june 2017.Retain samples were retested due to the unexpected increase in adverse events.Higher than expected endotoxin results were obtained.In addition, the presence of microbial contamination was also confirmed.The cause of these events is under investigation.Once this investigation is completed, corrective and preventive actions will be implemented.Reporter causality: not reported for all events.Company causality: associated for device malfunction; not associated for rest all events seriousness criterion: important medical event for knees becoming infected; hospitalization for device malfunction, fall, not be able to move for three days, legs became weak and hurting/extreme pain additional information was received on 06-mar-2018.Investigation summary and gptc number was added.Text was amended accordingly.Additional information was received on 28-mar-2018 from the patient's granddaughter.Suspect product lot number was added.Additional events of device malfunction, felt worse, disoriented, inability to walk for 48 hours and extreme leg numbness were added.Event term of hurting was updated to hurting/extreme pain.Outcome of fall was updated from unknown to not recovered and its event start date was updated.Corrective treatment of knees becoming infected was added.Medical history, concomitant medications and concurrent conditions were added.Suspect product therapy regimen was updated.Clinical course was updated and text was amended accordingly.Follow up information was received on 06-apr-2018.Global ptc number was added.Text amended accordingly.Additional information was received on 10-apr-2018 from patient.Additional events of severe pain and couldn't move legs were added along with details.Concomitant medications (metformin hydrochloride and omeprazole) were added.Clinical course was updated and text was amended accordingly.Pharmacovigilance comment: sanofi company comment for follow up dated 10-apr-2018: the new follow up information received does not change previous case assessment.This case concerns a patient who has received synvisc one injection from the recalled lot.The events are temporally related to device.Moreover, the concerned lot number has been identified to have malfunction by the company.Therefore, the causal relationship of the events to the products cannot be excluded.
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Event Description
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Device malfunction [device malfunction] paralysed for almost 4 days [paralysed] fall [fall] not be able to move for three days [joint range of motion decreased] legs became weak/weakness when she is up on her feet [muscle weakness lower limb] hurting/extreme pain; bad bad problems with my legs [leg pain] knees becoming infected [joint infection] ambulates with cane/pain when she is walking [difficulty in walking] couldn't move legs [movement disorder] inability to walk for 48 hours [difficulty in walking] extreme leg numbness [numbness in leg] felt worse [feeling unwell] disoriented [disorientated] hit her head [head injury] unable to bear weight [weight bearing difficulty] knees significantly worse than prior to injections [condition worsened] tender around medial joint line of right knee [joint tenderness] severe pain/right knee worse than left knee/bilateral knee pain [knee pain].Case narrative: this sponsored solicited case from was received on 27-feb-2018 from a patient via patient support program.Patient id: si0119e6; country: united states.Study title: sanofi patient connection.This case concerns a 81 year old female patient who received treatment with synvisc one and after unknown latency knees becoming infected; after 47 days had a fall, after 1 day not be able to move for three days, legs became weak, few hours later was hurting/extreme pain, had inability to walk for 48 hours; after unknown latency had extreme leg numbness, felt worse and disoriented, hit her head and paralysed for almost 4 days, ambulates with cane/pain when she is walking, knees significantly worse than prior to injections, minimal tender around left knee and unable to bear weight also device malfunction was reported for the same lot.Patient also had severe pain/right knee worse than left knee/bilateral knee pain and couldn't move legs on the same day.The patient had mild diabetes, severe arthritis, sciatica, hypertension, esophageal reflux, diabetes mellitus, depression, tonsillectomy, appendectomy, arthritis, weakness and was a non smoker.Family history of diabetes mellitus and arthritis.Concomitant medications included omeprazole for reflux, ramipril for blood pressure and buspirone for anxiety, metformin hydrochloride (metformin) for diabetes and omeprazole for digestion, ramipril (altace); acetylsalicylic acid (aspirin 81); simvastatin (zocor); and meloxicam (meloxicam), centrum silver and cvs iron.No past drugs were reported.On (b)(6) 2017, the patient initiated treatment with intra-articular synvisc one injection (dose, batch/lot number 7rsl021 and expiry date: 31-may-2020) once in each knee for bilateral knee osteoarthritis.The patients knees were sterilely prepped, infiltrated with local anesthetic, aspirated and injected intra-articularly with one syringe of synvisc one, patient tolerated the procedure well.The same day, few hours after first dose of synvisc one, the patient experienced extreme, severe pain, couldn't move legs, inability to walk for 48 hours, felt worse after the procedure.On (b)(6) 2017, one day after the synvisc-one was administered, patient had an injection in both of her knees that caused her to not be able to move for three days, her legs became weak, and "it was like they went dead on me", and she was hurting.On (b)(6) 2017, patient reported to the clinic and upon examination it was noticed that she was tender around medial joint line of right knee (latency: 1 month 12 days) and stated that her knees are significantly worse than prior to injections (latency: 1 month 12 days) and that her right knee was worse than the left knee (latency: 1 month 12 days).Further it was reported that the patient ambulates with a cane (latency: 1 month 12 days) and was unable to bear weight (latency: 1 month 12 days) for a few days after receiving the injection.The patient was informed that she had received the recalled lot of synvisc one and was prescribed bactrim.On (b)(6) 2017, 47 days after first dose of synvisc one, patient had a fall followed by hospitalization.The patient proceeded to get worse until this fall and had to be hospitalized.On (b)(6) 2018, patient reported for her follow up for her bilateral knees, and it was reported that the patient had suffered a fall around christmas subsequent to which she had broken her ribs on left side and punctured her left lung and was suggested to stop using bactrim by her attending healthcare professional.On (b)(6) 2018, lab results of the patient were performed which revealed her rbc count was 3.87 (reference range: 3.9-5.3 unk) (low), hemoglobin was 11.2 g/dl (reference range: 12-16) (low) and hematocrit was 34% (reference range: 35-45) (low).On (b)(6) 2018, patient reported again for her follow up visit and stated that her knees were doing better since her last office visit.Her blood work had come in negative for infection and some tenderness around her medial right knee was still present.On (b)(6) 2018, during her follow up visit, patient stated that she had significantly improved and her pain was at four to five out of ten today and that her pain would get worse throughout the day.Further, stated that she would like to try the monovisc injection as next option as she had a reaction to synvisc in the past.On (b)(6) 2018, patient visited the clinic again with complaint of bilateral knee pain and instability and stated that she would like to get her monovisc injections.On unknown dates, after unknown latencies, the patient at that time had extreme leg numbness and was disoriented.Treatment included two different antibiotics (unspecified) and calling her doctor for a hospitalization following a fall, having an injection in both of her knees that caused her to not be able to move for three days, her legs became weak, and "it was like they went dead on me", and she was hurting.The having an injection in both of her knees that caused her to not be able to move for three days, her legs became weak, and "it was like they went dead on me", and she was hurting were ongoing.It was unknown if the hospitalization following a fall was ongoing or resolved.Patient reported that the day she received her injections, she came home and laid down on the couch and could not get up of move for three days.Patient reported her doctor told her there was a product recall of the synvisc-one, that she was hurting before but not like this; patient could not get really anything done to legs now.Patient also stated that she had heard other people that got the injections and just did great.On an unknown date, latency unknown, patient experienced a reaction to synvisc-one characterized by her knees becoming infected.Treatment included receiving an antibiotic(unspecified) that was the wrong antibiotic and switching to another antibiotic(unspecified) for a reaction to synvisc-one characterized by her knees becoming infected.It was unknown to reporter if a reaction to synvisc-one characterized by her knees becoming infected was ongoing.It was unknown to reporter if the consumer has a history of this event.It is unknown to reporter if the synvisc-one was ongoing.Patient reported that she was hospitalized and paralyzed for almost 4 days and fell and hit her head and had iv antibiotics.Reports she was still having bad problems with legs.Corrective treatment: ciprofloxacin hydrochloride (ciprofloxacin), bactrim and hydrocodone for knees becoming infected; not reported for rest all events outcome: unknown for knees becoming infected, device malfunction, extreme leg numbness, inability to walk for 48 hours, hit her head and paralysed for almost 4 days; not recovered for rest events a pharmaceutical technical complaint (ptc) was initiated with global ptc number: (b)(4).Product technical complaint (ptc) was initiated on (b)(6) 2018 for product.Batch number; the reporter stated that the device complaint resulted in adverse event/handling error.Device not returned.Final investigation complete date: (b)(6) 2018.An investigation was initiated as a result of an unexpected increase in the number of labelled adverse events received from the us market for synvisc one, lot 7rsl021.The product met all release testing at time of manufacture in june 2017.Retain samples were retested due to the unexpected increase in adverse events.Higher than expected endotoxin results were obtained.In addition, the presence of microbial contamination was also confirmed.The cause of these events is under investigation.Once this investigation is completed, corrective and preventive actions will be implemented.Reporter causality: not reported for all events.Company causality: reportable for minimal tender around left knee and unable to bear weight , device malfunction, severe pain/right knee worse than left knee/bilateral knee pain, knees significantly worse than prior to injections couldn't move legs; not reportable for rest all events.Seriousness criterion: medically significant for knees becoming infected; hospitalization for device malfunction, fall, not be able to move for three days, legs became weak and hurting/extreme pain; disability for ambulates with cane/pain when she is walking additional information was received on 06-mar-2018.Investigation summary and gptc number was added.Text was amended accordingly.Additional information was received on 28-mar-2018 from the patient's granddaughter.Suspect product lot number was added.Additional events of device malfunction, felt worse, disoriented, inability to walk for 48 hours and extreme leg numbness were added.Event term of hurting was updated to hurting/extreme pain.Outcome of fall was updated from unknown to not recovered and its event start date was updated.Corrective treatment of knees becoming infected was added.Medical history, concomitant medications and concurrent conditions were added.Suspect product therapy regimen was updated.Clinical course was updated and text was amended accordingly.Follow up information was received on 06-apr-2018.Global ptc number was added.Text amended accordingly.Additional information was received on 10-apr-2018 from patient.Additional events of severe pain and couldn't move legs were added along with details.Concomitant medications (metformin hydrochloride and omeprazole) were added.Clinical course was updated and text was amended accordingly.Additional information was received on 06-jul-2018 from the patient.Event of hit her head and paralysed for almost 4 days was added.Event of hurting/extreme pain was updated to hurting/extreme pain; bad problems with my legs.Clinical course was updated and text amended accordingly.Additional information received on 09-nov-2018 from lawyer.Case classification of legal added.Medical history of hypertension, esophageal reflux, diabetes mellitus, depression, tonsillectomy, appendectomy, arthritis, weakness, non smoker.Family history of diabetes mellitus and arthritis added.Suspect product indication added.Lab test results added.Concomitant medications of ramipril (altace); acetylsalicylic acid (aspirin 81); simvastatin (zocor); and meloxicam (meloxicam), centrum silver and cvs iron added.Events of ambulates with cane/pain when she is walking, knees significantly worse than prior to injections, minimal tender around left knee and unable to bear weight added with details.Event verbatim of severe pain updated to severe pain/right knee worse than left knee/bilateral knee pain.Clinical course updated.Text amended accordingly.
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Search Alerts/Recalls
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