| Lot Number UNKNOWN |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
| Patient Problems
Cataract (1766); Retinal Degeneration (2049); Arthralgia (2355); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
|
|
Event Type
Injury
|
|
Event Description
|
|
She had a kidney stone in her right kidney/was only 3mm when she had it check it went up to 7 and a quarter [kidney stone] ([kidney pain], [condition worsened]) she also has macular degeneration in both her eyes [macular degeneration] she has a large cataract on her left eye [cataract (left)] knees were bad, she walks with a walker [knee pain] she has already fallen a couple of time [fall] coughing [coughing] crying [crying] case narrative: initial information received from united states on 13-feb-2024 regarding an unsolicited valid serious case received from a patient this case involves a 77 years old female patient who had a kidney stone in her right kidney/was only 3mm when she had it check it went up to 7 and a quarter, she also has macular degeneration in both her eyes, she has a large cataract on her left eye, knees were bad, she walks with a walker, she has already fallen a couple of time, coughing and crying with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one] the patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.In 2022(approximately two years ago), the patient started using hylan g-f 20, sodium hyaluronate injection in the right knee of strength 48 mg/6ml at a dose of 110 ml pre-filled syringe once (lot, expiry date, route - unknown) for bilateral primary osteoarthritis of the knee information on batch number and expiry date was requested on an unknown date and latency, patient reported that since the last time she received the shot, she has several medical issues such as in the kidneys and eyes.The patient stated that after she got the shot, her husband was very sick and she was his caretaker, since then her husband passed away, and she had to take care of all because he did not have a will, so she had to go into "probay", so she was still dealing with that.The patient stated in between that, she had a kidney stone in her right kidney (nephrolithiasis)which they had unintelligible, the doctor, to have a stent put in.The patient stated it was the worst pain she has ever suffered in her life, it was horrible (renal pain).The patient stated the other stone, was only 3mm when she had it check it went up to 7 and a quarter (condition aggravated), so she does not want another stent to be put in, she wanted to go to another doctor, if she was qualified, so someone gave her the information to contact his doctor.The patient stated she also has macular degeneration in both her eyes(macular degeneration), she has to take care of this and the other kidney on her right side because she has been suffering from pain.The patient stated in the meantime, she has to deal with her eyes, she has a large cataract on her left eye(cataract), but she went to see the eye doctor, who stated she wants her to be referred to another doctor to make sure and see if she can take the vitamins, while she was waiting to have the kidney done, because the doctor said that it might affect the kidney.The patient stated she had to wait, and she might not be able to take the vitamins and medication for the kidneys.The patient stated she was rocking in a hard place, she has the kidney, the eyes, the large cataract, she has to make an appointment to see the eye doctor, she stated that was coming up because this all happened a day, she went to the eye doctor.The patient stated she has eye, kidney, and now other issues, with cataract, she lives in the house by herself, she got unintelligible, she lives on her husband's social security and takes care of herself, she was able to do that, but her knees were bad, she walks with a walker(arthralgia), and she was afraid to fall, she has already fallen a couple of times (fall), so far she was doing pretty good not to fall and she just need the injection for her knees because without that she was afraid to fall again.She was told she will be able to get the shot, but in october, that the medicine will be sent to the doctor, without costing her, because she was told it is (b)(6) and she cannot afford that in her income so she was hoping that she will be able to get the shot.Patient stated she does not know what to do, she cannot afford it and she would have to take a loan and pay for it on her own, she does not know if she can afford to do that.Patient stated if she falls and get hurt, she would have been having to unintelligible and she does not want to do that so she was hoping she can get the shot.Patient was told she was going to get it.Psr(patient service representative) stated that they ran her application, but it got denied because of what the insurance said, and he found out that her insurance sent her a denied later, once they get a copy of that they could rerun the application and they can get her approved.Patient was crying and coughing (cough) while making the report.At the time of the report, synvisc-one was continued from the standpoint of what the doctor said that when she was in pain, was to get a shot.Action taken: not applicable for all events corrective treatment: stent was placed for event of nephrolithiasis; used walker for arthralgia and not reported for rest events at time of reporting, the outcome was unknown for all events seriousness criteria: medically significant for all events except arthralgia, fall, crying and cough; disability for arthralgia.
|
| |
|
Manufacturer Narrative
|
|
Sanofi company comment dated 16-feb-2024: this case involves 77 years old female patient who experienced she had a kidney stone in her right kidney/was only 3mm when she had it check it went up to 7 and a quarter, she also has macular degeneration in both her eyes, she has a large cataract on her left eye, knees were bad, she walks with a walker, she has already fallen a couple of time, coughing and crying with the use of medical device hylan g-f 20, sodium hyaluronate.This case currently lack sufficient and consistent information to permit a proper assessment.A better description including chronology, as well as information on family history if any and relevant medical history of the patient, as well as concurrent conditions are currently missing.The case will be reassessed based on follow-up information that will be received.
|
| |
|
Event Description
|
|
She had a kidney stone in her right kidney/was only 3mm when she had it check it went up to 7 and a quarter [kidney stone] ([kidney pain], [condition worsened]).She also has macular degeneration in both her eyes [macular degeneration].She has a large cataract on her left eye [cataract (left)].Knees were bad, she walks with a walker [knee pain].She has already fallen a couple of time [fall].Coughing [coughing].Crying [crying].Case narrative: initial information received from united states on 13-feb-2024 regarding an unsolicited valid serious case received from a patient this case involves a 77 years old female patient who had a kidney stone in her right kidney/was only 3mm when she had it check it went up to 7 and a quarter, she also has macular degeneration in both her eyes, she has a large cataract on her left eye, knees were bad, she walks with a walker, she has already fallen a couple of time, coughing and crying with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one].The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.In 2022 (approximately two years ago), the patient started using hylan g-f 20, sodium hyaluronate injection in the right knee of strength 48 mg/6ml at a dose of 110 ml pre-filled syringe once (lot, expiry date, route - unknown) for bilateral primary osteoarthritis of the knee.Information on batch number and expiry date was requested on an unknown date and latency, patient reported that since the last time she received the shot, she has several medical issues such as in the kidneys and eyes.The patient stated that after she got the shot, her husband was very sick and she was his caretaker, since then her husband passed away, and she had to take care of all because he did not have a will, so she had to go into "probay", so she was still dealing with that.The patient stated in between that, she had a kidney stone in her right kidney (nephrolithiasis)which they had unintelligible, the doctor, to have a stent put in.The patient stated it was the worst pain she has ever suffered in her life, it was horrible (renal pain).The patient stated the other stone, was only 3mm when she had it check it went up to 7 and a quarter (condition aggravated), so she does not want another stent to be put in, she wanted to go to another doctor, if she was qualified, so someone gave her the information to contact his doctor.The patient stated she also has macular degeneration in both her eyes (macular degeneration), she has to take care of this and the other kidney on her right side because she has been suffering from pain.The patient stated in the meantime, she has to deal with her eyes, she has a large cataract on her left eye(cataract), but she went to see the eye doctor, who stated she wants her to be referred to another doctor to make sure and see if she can take the vitamins, while she was waiting to have the kidney done, because the doctor said that it might affect the kidney.The patient stated she had to wait, and she might not be able to take the vitamins and medication for the kidneys.The patient stated she was rocking in a hard place, she has the kidney, the eyes, the large cataract, she has to make an appointment to see the eye doctor, she stated that was coming up because this all happened a day, she went to the eye doctor.The patient stated she has eye, kidney, and now other issues, with cataract, she lives in the house by herself, she got unintelligible, she lives on her husband's social security and takes care of herself, she was able to do that, but her knees were bad, she walks with a walker (arthralgia), and she was afraid to fall, she has already fallen a couple of times (fall), so far she was doing pretty good not to fall and she just need the injection for her knees because without that she was afraid to fall again.She was told she will be able to get the shot, but in october, that the medicine will be sent to the doctor, without costing her, because she was told it is (b)(6) and she cannot afford that in her income so she was hoping that she will be able to get the shot.Patient stated she does not know what to do, she cannot afford it and she would have to take a loan and pay for it on her own, she does not know if she can afford to do that.Patient stated if she falls and get hurt, she would have been having to unintelligible and she does not want to do that so she was hoping she can get the shot.Patient was told she was going to get it.Psr (patient service representative) stated that they ran her application, but it got denied because of what the insurance said, and he found out that her insurance sent her a denied later, once they get a copy of that they could rerun the application and they can get her approved.Patient was crying and coughing (cough) while making the report.At the time of the report, synvisc-one was continued from the standpoint of what the doctor said that when she was in pain, was to get a shot.Action taken: not applicable for all events.Corrective treatment: stent was placed for event of nephrolithiasis; used walker for arthralgia and not reported for rest events.At time of reporting, the outcome was unknown for all events.Seriousness criteria: medically significant for all events except arthralgia, fall, crying and cough; disability for arthralgia.A product technical complaint (ptc) was initiated on 13-feb-2024 for synvisc-one.Batch number: unknown; global ptc number: (b)(4).The sample status of the ptc was not available.Ptc states: preliminary assessment: based on the complaint from intake team, there is no quality related defect that would attribute to a malfunction a death or serious injury.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 safety surveillance effort to detect safety signals.The defect class has been updated to ii - (dp 14feb24).The product lot number was not provided; therefore, a batch record review is not possible.Based on the lack of information provided, no capa(corrective and preventive action) is required.It is the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result is identified and mitigated through the process.Sanofi will continue to monitor complaints and trending "product event handling" to determine if a capa is required.Final investigation complete date: 26-feb-2024 the summarized conclusion for this case no assessment is possible.Additional information was received on 13-feb-2024 by quality department from other health care professional: ptc number added.Text amended.Additional information was received on 26-feb-2024 by quality department from other health care professional: ptc number added.Text amended based on information previously received, 'final report' in the eu/ca device webpage was ticked.
|
| |
|
Event Description
|
|
She had a kidney stone in her right kidney/was only 3mm when she had it check it went up to 7 and a quarter [kidney stone] ([kidney pain], [condition worsened]) she also has macular degeneration in both her eyes [macular degeneration] she has a large cataract on her left eye [cataract (left)] knees were bad, she walks with a walker [knee pain] she has already fallen a couple of time [fall] coughing [coughing] crying [crying] case narrative: initial information received from united states on 13-feb-2024 regarding an unsolicited valid serious case received from a patient this case involves a 77 years old female patient who had a kidney stone in her right kidney/was only 3mm when she had it check it went up to 7 and a quarter, she also has macular degeneration in both her eyes, she has a large cataract on her left eye, knees were bad, she walks with a walker, she has already fallen a couple of time, coughing and crying with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one] the patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.In 2022(approximately two years ago), the patient started using hylan g-f 20, sodium hyaluronate injection in the right knee of strength 48 mg/6ml at a dose of 110 ml pre-filled syringe once (lot, expiry date, route - unknown) for bilateral primary osteoarthritis of the knee information on batch number and expiry date was requested on an unknown date and latency, patient reported that since the last time she received the shot, she has several medical issues such as in the kidneys and eyes.The patient stated that after she got the shot, her husband was very sick and she was his caretaker, since then her husband passed away, and she had to take care of all because he did not have a will, so she had to go into "probay", so she was still dealing with that.The patient stated in between that, she had a kidney stone in her right kidney (nephrolithiasis)which they had unintelligible, the doctor, to have a stent put in.The patient stated it was the worst pain she has ever suffered in her life, it was horrible (renal pain).The patient stated the other stone, was only 3mm when she had it check it went up to 7 and a quarter (condition aggravated), so she does not want another stent to be put in, she wanted to go to another doctor, if she was qualified, so someone gave her the information to contact his doctor.The patient stated she also has macular degeneration in both her eyes(macular degeneration), she has to take care of this and the other kidney on her right side because she has been suffering from pain.The patient stated in the meantime, she has to deal with her eyes, she has a large cataract on her left eye(cataract), but she went to see the eye doctor, who stated she wants her to be referred to another doctor to make sure and see if she can take the vitamins, while she was waiting to have the kidney done, because the doctor said that it might affect the kidney.The patient stated she had to wait, and she might not be able to take the vitamins and medication for the kidneys.The patient stated she was rocking in a hard place, she has the kidney, the eyes, the large cataract, she has to make an appointment to see the eye doctor, she stated that was coming up because this all happened a day, she went to the eye doctor.The patient stated she has eye, kidney, and now other issues, with cataract, she lives in the house by herself, she got unintelligible, she lives on her husband's social security and takes care of herself, she was able to do that, but her knees were bad, she walks with a walker(arthralgia), and she was afraid to fall, she has already fallen a couple of times (fall), so far she was doing pretty good not to fall and she just need the injection for her knees because without that she was afraid to fall again.She was told she will be able to get the shot, but in october, that the medicine will be sent to the doctor, without costing her, because she was told it is $3000, and she cannot afford that in her income so she was hoping that she will be able to get the shot.Patient stated she does not know what to do, she cannot afford it and she would have to take a loan and pay for it on her own, she does not know if she can afford to do that.Patient stated if she falls and get hurt, she would have been having to unintelligible and she does not want to do that so she was hoping she can get the shot.Patient was told she was going to get it.Psr(patient service representative) stated that they ran her application, but it got denied because of what the insurance said, and he found out that her insurance sent her a denied later, once they get a copy of that they could rerun the application and they can get her approved.Patient was crying and coughing (cough) while making the report.At the time of the report, synvisc-one was continued from the standpoint of what the doctor said that when she was in pain, was to get a shot.Action taken: not applicable for all events corrective treatment: stent was placed for event of nephrolithiasis; used walker for arthralgia and not reported for rest events at time of reporting, the outcome was unknown for all events seriousness criteria: medically significant for all events except arthralgia, fall, crying and cough; disability for arthralgia a product technical complaint (ptc) was initiated on 13-feb-2024 for synvisc-one.Batch number: unknown; global ptc number: 100401287.The sample status of the ptc was not available.Ptc states: preliminary assessment: based on the complaint from intake team, there is no quality related defect that would attribute to a malfunction a death or serious injury.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 safety surveillance effort to detect safety signals.The defect class has been updated to ii - (dp (b)(6) 2024).The product lot number was not provided; therefore, a batch record review is not possible.Based on the lack of information provided, no capa(corrective and preventive action) is required.It is the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result is identified and mitigated through the process.Sanofi will continue to monitor complaints and trending "product event handling" to determine if a capa is required.Final investigation complete date: 26-feb-2024 the summarized conclusion for this case no assessment is possible.Additional information was received on 13-feb-2024 by quality department from other health care professional: ptc number added.Text amended.Additional information was received on 26-feb-2024 by quality department from other health care professional: ptc number added.Text amended.
|
| |
|
Event Description
|
|
She had a kidney stone in her right kidney/was only 3mm when she had it check it went up to 7 and a quarter [kidney stone] ([kidney pain], [condition worsened]) she also has macular degeneration in both her eyes [macular degeneration] she has a large cataract on her left eye [cataract (left)] knees were bad, she walks with a walker [knee pain] she has already fallen a couple of time [fall] coughing [coughing] crying [crying] case narrative: initial information received on 13-feb-2024 regarding an unsolicited valid serious case from a patient.This case is linked to case (b)(4) (multiple device suspect used for the same patient).This case involves a 77 years old female patient who had a kidney stone in her right kidney/was only 3mm when she had it check it went up to 7 and a quarter, she also has macular degeneration in both her eyes, she has a large cataract on her left eye, knees were bad, she walks with a walker, she has already fallen a couple of time, coughing and crying with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one] the patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.In 2022 (approximately two years ago), the patient started using hylan g-f 20, sodium hyaluronate injection in the right knee of strength 48 mg/6ml at a dose of 110 ml pre-filled syringe once (lot, expiry date, route - unknown) for bilateral primary osteoarthritis of the knee information on batch number and expiry date was requested on an unknown date and latency, patient reported that since the last time she received the shot, she has several medical issues such as in the kidneys and eyes.The patient stated that after she got the shot, her husband was very sick and she was his caretaker, since then her husband passed away, and she had to take care of all because he did not have a will, so she had to go into "probay", so she was still dealing with that.The patient stated in between that, she had a kidney stone in her right kidney (nephrolithiasis)which they had unintelligible, the doctor, to have a stent put in.The patient stated it was the worst pain she has ever suffered in her life, it was horrible (renal pain).The patient stated the other stone, was only 3mm when she had it check it went up to 7 and a quarter (condition aggravated), so she does not want another stent to be put in, she wanted to go to another doctor, if she was qualified, so someone gave her the information to contact his doctor.The patient stated she also has macular degeneration in both her eyes(macular degeneration), she has to take care of this and the other kidney on her right side because she has been suffering from pain.The patient stated in the meantime, she has to deal with her eyes, she has a large cataract on her left eye(cataract), but she went to see the eye doctor, who stated she wants her to be referred to another doctor to make sure and see if she can take the vitamins, while she was waiting to have the kidney done, because the doctor said that it might affect the kidney.The patient stated she had to wait, and she might not be able to take the vitamins and medication for the kidneys.The patient stated she was rocking in a hard place, she has the kidney, the eyes, the large cataract, she has to make an appointment to see the eye doctor, she stated that was coming up because this all happened a day, she went to the eye doctor.The patient stated she has eye, kidney, and now other issues, with cataract, she lives in the house by herself, she got unintelligible, she lives on her husband's social security and takes care of herself, she was able to do that, but her knees were bad, she walks with a walker(arthralgia), and she was afraid to fall, she has already fallen a couple of times (fall), so far she was doing pretty good not to fall and she just need the injection for her knees because without that she was afraid to fall again.She was told she will be able to get the shot, but in (b)(6), that the medicine will be sent to the doctor, without costing her, because she was told it is (b)(6), and she cannot afford that in her income so she was hoping that she will be able to get the shot.Patient stated she does not know what to do, she cannot afford it and she would have to take a loan and pay for it on her own, she does not know if she can afford to do that.Patient stated if she falls and get hurt, she would have been having to unintelligible and she does not want to do that so she was hoping she can get the shot.Patient was told she was going to get it.Psr(patient service representative) stated that they ran her application, but it got denied because of what the insurance said, and he found out that her insurance sent her a denied later, once they get a copy of that they could rerun the application and they can get her approved.Patient was crying and coughing (cough) while making the report.At the time of the report, synvisc-one was continued from the standpoint of what the doctor said that when she was in pain, was to get a shot.Upon follow-up, it is reported that that they have been waiting for her application to be approved but have to received documentation from doctor's office which has been held up since (b)(6) 2023.The patient was in pain because she had not been getting her shots.Action taken: not applicable for all events corrective treatment: stent was placed for event of nephrolithiasis; used walker for arthralgia and not reported for rest events at time of reporting, the outcome was unknown for all events seriousness criteria: medically significant for all events except arthralgia, fall, crying and cough; disability for arthralgia a product technical complaint (ptc) was initiated on 13-feb-2024 for synvisc-one.Batch number: unknown; global ptc number: (b)(4).The sample status of the ptc was not available.Ptc states: preliminary assessment: based on the complaint from intake team, there is no quality related defect that would attribute to a malfunction a death or serious injury.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 safety surveillance effort to detect safety signals.The defect class has been updated to ii - (dp 14feb24).The product lot number was not provided; therefore, a batch record review is not possible.Based on the lack of information provided, no capa(corrective and preventive action) is required.It is the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result is identified and mitigated through the process.Sanofi will continue to monitor complaints and trending "product event handling" to determine if a capa is required.Final investigation complete date: 26-feb-2024 the summarized conclusion for this case no assessment is possible.The complaint (b)(4) for usa has been reopened for the following reason: incomplete complaint information additional information was received on 13-feb-2024 by quality department from other health care professional: ptc number added.Text amended.Additional information was received on 26-feb-2024 by quality department from other health care professional: ptc number added.Text amended based on information previously received, 'final report' in the eu/ca device webpage was ticked.Additional information was received on 11-mar-2024 by quality department from other health care professional: ptc was reopened.Text amended accordingly.Based on the previously received information, imdrf annex e code for nephrolithiasis was updated from e2402 to e1312.Related case id (b)(4) was added in narrative.
|
| |
|
Search Alerts/Recalls
|
|
