| 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
|
|
Manufacturer Narrative
|
|
Sanofi company comment dated 21-feb-2024: this case involves 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, with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one].Based on the available information, the casual role of suspect device could not be denied for the occurrence of the adverse events however, patient¿s elderly age could be the confounding factor.Also, a better description of patient medical and family history if any, concomitant medications, as well as concurrent conditions would aid in comprehensive case assessment.
|
| |
|
Event Description
|
|
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 aggravated]).Has macular degeneration in both her eyes [macular degeneration].She has a large cataract on her left eye [cataract (left)].Knees are 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 is linked with case id: (b)(4) (multiple devices used in 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, 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), concomitant medication, vaccination(s) and family history were not provided.In 2022 (approximately two years ago), the patient received hylan g-f 20, sodium hyaluronate injection in her left knee at a dose of 110ml prefilled syringe once (strength: 48mg/6ml, with an unknown route, batch number and expiry date) for bilateral primary osteoarthritis of the knee.Information on batch number and expiry date was requested.First time product used: no.The patient reported that since the last time she received the shot, she had 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, onset date and latency: unknown) 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, onset date and latency: unknown).The patient stated the other stone, was only 3mm when she had it check it went up to 7 and a quarter (condition aggravated, onset date and latency: unknown), 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, onset date and latency: unknown), 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, onset date and latency: unknown), 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 could 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, onset date and latency: unknown), and she was afraid to fall, she has already fallen a couple of times (fall, onset date and latency: unknown), 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.Patient was crying (onset date and latency: unknown) and coughing (cough, onset date and latency: unknown) 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.
|
| |
|
Event Description
|
|
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 aggravated]).Has macular degeneration in both her eyes [macular degeneration].She has a large cataract on her left eye [cataract (left)].Knees are 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 is linked with case id (b)(4) (multiple devices used in 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, 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), concomitant medication, vaccination(s) and family history were not provided.In 2022 (approximately two years ago), the patient received hylan g-f 20, sodium hyaluronate injection in her left knee at a dose of 110ml prefilled syringe once (strength: 48mg/6ml, with an unknown route, batch number and expiry date) for bilateral primary osteoarthritis of the knee.Information on batch number and expiry date was requested.First time product used: no.The patient reported that since the last time she received the shot, she had 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, onset date and latency: unknown) 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, onset date and latency: unknown).The patient stated the other stone, was only 3mm when she had it check it went up to 7 and a quarter (condition aggravated, onset date and latency: unknown), 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, onset date and latency: unknown), 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, onset date and latency: unknown), 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 could 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, onset date and latency: unknown), and she was afraid to fall, she has already fallen a couple of times (fall, onset date and latency: unknown), 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.Patient was crying (onset date and latency: unknown) and coughing (cough, onset date and latency: unknown) 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 (lot/batch number: unknown) with global ptc number: 100401286 the sample status of the ptc was not available.Ptc stated: 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 ncr (non-conformance) process.Sanofi will continue to monitor complaints and trending to determine if a capa is required.The final investigation was completed on 23-feb-2024 with summarized conclusion as no assessment 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 23-feb-2024 by quality department from other health care professional: ptc results were added.Text amended accordingly.Based on information previously received, the following information [the annex e1312 (urolithiasis) instead of e2402 was updated in the case.] has been amended.
|
| |
|
Event Description
|
|
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 aggravated]).Has macular degeneration in both her eyes [macular degeneration].She has a large cataract on her left eye [cataract (left)].Knees are 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 is linked with case id (b)(4) (multiple devices used in 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, 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), concomitant medication, vaccination(s) and family history were not provided.In 2022 (approximately two years ago), the patient received hylan g-f 20, sodium hyaluronate injection in her left knee at a dose of 110ml prefilled syringe once (strength: 48mg/6ml, with an unknown route, batch number and expiry date) for bilateral primary osteoarthritis of the knee.Information on batch number and expiry date was requested.First time product used: no.The patient reported that since the last time she received the shot, she had 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, onset date and latency: unknown) 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, onset date and latency: unknown).The patient stated the other stone, was only 3mm when she had it check it went up to 7 and a quarter (condition aggravated, onset date and latency: unknown), 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, onset date and latency: unknown), 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, onset date and latency: unknown), 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 could 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, onset date and latency: unknown), and she was afraid to fall, she has already fallen a couple of times (fall, onset date and latency: unknown), 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.Patient was crying (onset date and latency: unknown) and coughing (cough, onset date and latency: unknown) 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 (lot/batch number: unknown) with global ptc number: (b)(4).The sample status of the ptc was not available.Ptc stated: 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 ncr (non-conformance) process.Sanofi will continue to monitor complaints and trending to determine if a capa is required.The final investigation was completed on 23-feb-2024 with summarized conclusion as no assessment 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 23-feb-2024 by quality department from other health care professional: ptc results were added.Text amended accordingly.
|
| |
|
Search Alerts/Recalls
|
|
