| Lot Number UNKNOWN |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Pain (1994); Ambulation Difficulties (2544); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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| Event Date 01/01/2023 |
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Event Type
Injury
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Event Description
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After receiving synvisc one she cannot walk on her right leg has to use crutches or a walker/right knee way is worse, and she uses crutches or a walker [walking difficulty] shuffle like a99-year old with back problems/hurts so badly that she needs to get a brace [back pain] ([condition worsened]) nerve ablation [therapeutic nerve ablation] a rash it started small and then it spread out and kept getting bigger and bigger states that the rash is still spreading at the time of the call mostly on the left side of her right leg/painful in areas very raw and flares up again [rash aggravated] antifungal spray burns like hell [burning skin] doctor administered the synvisc one injection could feel it go through nerves the nerve pain made her jerk during the injection like needle went through nerves and meat [nerve pain] ([nerve injury]) disc degeneration [degenerative disc disease] stomach is gurgling gi is all screwed up/after synvisc one injection, started having gi issues again [abdominal noises] ([stress], [diarrhea]) doctor administered the synvisc one injection without applying any lidocaine or spray could feel it go through nerves the nerve pain made her jerk during the injection like needle went through nerves and meat/damn painful when administered [injection site joint pain] ([condition worsened]) epidural and test nerve block which also did not work [epidural anaesthesia] synvisc one possibly being injected to her bloodstream/thinks it might have got into her vein.[incorrect product administration technique] case narrative: initial information received from united states on 06-feb-2024 regarding an unsolicited valid serious case received from a patient.This case is linked to (b)(4)(same patient).This case involves a 71 years old female patient who after receiving synvisc one cannot walk on her right leg has to use crutches or a walker, nerve ablation, a rash it started small and then it spread out and kept getting bigger and bigger states that the rash is still spreading at the time of the call mostly on the left side of her right leg/painful in areas very raw and flares up again, antifungal spray burns like hell, doctor administered the synvisc one injection could feel it go through nerves the nerve pain made her jerk during the injection like needle went through nerves and meat, shuffle like a 99-year old with back problems, disc degeneration, stomach is gurgling gi(gastrointestinal) is all screwed up/after synvisc one injection, started having gi issues again, doctor administered the synvisc one injection without applying any lidocaine or spray could feel it go through nerves the nerve pain made her jerk during the injection like needle went through nerves and meat/damn painful when administered, epidural and test nerve block which also did not work and synvisc one possibly being injected to her bloodstream/thinks it might have got into her vein with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one] and unspecified antifungal spray medication.The patient's past medical history included cholecystectomy.The patient's past medical treatment(s), vaccination(s) and family history were not provided.At the time of the event, the patient reports that her gi system had been "screwed up" prior to taking synvisc one because she had her gallbladder removed; reports that it was starting to get better and she did not need to use her medication for diarrhea anymore and at the time of the injection, the pain in her right knee was worse than her left knee and also prior to the synvisc one injection, she had some limitations(back pain).In (b)(6) or (b)(6) 2023, the patient started using hylan g-f 20, sodium hyaluronate injection in the right knee (strength 48 mg/6ml)(frequency: once) administered the synvisc one injection without applying any lidocaine or spray; she could feel it going through nerves, and she does not know if some of it went into her bloodstream; she thinks it might have got into her vein (lot, expiry date, dose- unknown) for osteoarthritis (wrong technique in product usage process) (same day: latency) information on batch number and expiry date was requested on an unknown date in 2023, patient started using unknown antifungal spray (unknown dose, frequency, strength, route, batch number, expiry date) for rash on an unknown date and latency; patient has taken synvisc one before with from a rheumatologist, and this this time it was from a pain clinic.They put it in her knee with no lidocaine, no nothing.She could feel it going through nerves, and she does not know if some of it went into her bloodstream.His left side was so bad.She had several nerves hit(nerve injury), and she said it was a reaction by her knee.She could feel it go through her nerves; the nerve pain (neuralgia)made her jerk during the injection; it felt like "the needle went through nerves and meat"; she thinks it might have got into her vein.The patient doesn't think that the synvisc one was applied correctly or some kind of contamination; thinks it damaged her right knee.The patient states that the doctor did not use an x-ray guide to administer the synvisc one injection; advised the patient that the labelling does not require an x-ray guide to administer synvisc one.The patient reported that at the time of the injection, the pain in her right knee was worse than her left knee, so she only received synvisc one to her right knee.After receiving synvisc one she developed a rash; it started small and then it "spread out and kept getting bigger and bigger"; states that the rash is still spreading at the time of the call(rash).She reports that she has "never had a rash like this"; she has been using an antifungal spray on it; the spray seems to relieve it some, but it doesn't take it away.She reports that the antifungal spray "burns like hell(skin burning sensation)"; she doesn't know if it is the right product to use; it helps the rash for a bit, and then it gets "bad" again.She reports that it's mostly on the left side of her right leg.It is extremely painful in areas very raw and flares up again, and she has never had it.Every time she eats, she wants to have it out.She does not feel nauseous, just feel gurgling.She reports that after receiving synvisc one she cannot walk on her right leg; she has to use crutches or a walker(gait disturbance; seriousness criteria: disability); her right knee way is worse, and she uses crutches or a walker.It was so damn painful when administered/it was more painful than before she had the injection(injection site joint pain)( condition aggravated).She reports that she has to "shuffle like a 99-year old with back problems"; reports that prior to the synvisc one injection, she had some limitations, but nothing like this.She reports that it hurts so badly that she needs to get a brace(back pain;seriousness criteria:disability)(condition aggravated; seriousness criteria: disability).She also reports that after receiving synvisc one, she started having diarrhea; she cannot hold her food in; her stomach is "gurgling"; her gi is "all screwed up" (gastrointestinal sounds abnormal).She currently have unresolved diarrhea and a lot of grumbling on her stomach, unless she takes medicine that her gastroenterologist gave her.The patient reports that her gi system had been "screwed up" prior to taking synvisc one because she had her gallbladder removed.She is on ivf from having her gallbladder removed; reports that it was starting to get better and she did not need to use her medication for diarrhea anymore.When she had the synvisc one injection, she started having gi issues again and had to start taking the medication for diarrhea again(diarrhoea).At first she thought it was stress(stress), but then she kept having it.She has gi issues not matter what she eats; reports that she was on a plant-based diet most of the time or chicken and vegetables as instructed by her gastroenterologist.The patient noted that she also has disc degeneration(intervertebral disc degeneration).The consumer wanted to know if these were possible side effects of the synvisc one possibly being injected to her bloodstream.The patient also reports that after the synvisc one injection, she received a nerve ablation on (b)(6) 2023(therapeutic nerve ablation; onset: (b)(6) 2023; latency: few weeks; seriousness criteria : medically significant); it did not work.She also reports receiving an epidural and test nerve block which also did not work(epidural anaesthesia)(onset: (b)(6) 2023; latecy: few weeks) action taken: not applicable for all events corrective treatment: use crutches or a walker for gait disturbance; unspecified antifungal spray for rash; unknown diarrhea medication for gastrointestinal sounds abnormal; braces for back pain; not reported for rest events at time of reporting, the outcome was not recovered for all events except wrong technique in product usage process, epidural anaesthesia and therapeutic nerve ablation.
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Manufacturer Narrative
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Sanofi company comment dated 13-feb-2024: this case involves 71 years old female patient who after receiving synvisc one cannot walk on her right leg has to use crutches or a walker, nerve ablation, a rash it started small and then it spread out and kept getting bigger and bigger states that the rash is still spreading at the time of the call mostly on the left side of her right leg/painful in areas very raw and flares up again, antifungal spray burns like hell, doctor administered the synvisc one injection could feel it go through nerves the nerve pain made her jerk during the injection like needle went through nerves and meat, shuffle like a 99-year old with back problems, disc degeneration, stomach is gurgling gi(gastrointestinal) is all screwed up/after synvisc one injection, started having gi issues again, doctor administered the synvisc one injection without applying any lidocaine or spray could feel it go through nerves the nerve pain made her jerk during the injection like needle went through nerves and meat/damn painful when administered, epidural and test nerve block which also did not work and synvisc one possibly being injected to her bloodstream/thinks it might have got into her vein 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.
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Event Description
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After receiving synvisc one she cannot walk on her right leg has to use crutches or a walker/right knee way is worse, and she uses crutches or a walker [walking difficulty] shuffle like a 99-year old with back problems/hurts so badly that she needs to get a brace [back pain] ([condition worsened]) nerve ablation [therapeutic nerve ablation] a rash it started small and then it spread out and kept getting bigger and bigger states that the rash is still spreading at the time of the call mostly on the left side of her right leg/painful in areas very raw and flares up again [rash aggravated] antifungal spray burns like hell [burning skin] doctor administered the synvisc one injection could feel it go through nerves the nerve pain made her jerk during the injection like needle went through nerves and meat [nerve pain] ([nerve injury]) disc degeneration [degenerative disc disease] stomach is gurgling gi is all screwed up/after synvisc one injection, started having gi issues again [abdominal noises] ([stress], [diarrhea]) doctor administered the synvisc one injection without applying any lidocaine or spray could feel it go through nerves the nerve pain made her jerk during the injection like needle went through nerves and meat/damn painful when administered [injection site joint pain] ([condition worsened]) epidural and test nerve block which also did not work [epidural anaesthesia] synvisc one possibly being injected to her bloodstream/thinks it might have got into her vein.[incorrect product administration technique] case narrative: initial information received from united states on 06-feb-2024 regarding an unsolicited valid serious case received from a patient.This case is linked to case (b)(4) (same patient).This case involves a 71 years old female patient who after receiving synvisc one cannot walk on her right leg has to use crutches or a walker, nerve ablation, a rash it started small and then it spread out and kept getting bigger and bigger states that the rash is still spreading at the time of the call mostly on the left side of her right leg/painful in areas very raw and flares up again, antifungal spray burns like hell, doctor administered the synvisc one injection could feel it go through nerves the nerve pain made her jerk during the injection like needle went through nerves and meat, shuffle like a 99-year old with back problems, disc degeneration, stomach is gurgling gi(gastrointestinal) is all screwed up/after synvisc one injection, started having gi issues again, doctor administered the synvisc one injection without applying any lidocaine or spray could feel it go through nerves the nerve pain made her jerk during the injection like needle went through nerves and meat/damn painful when administered, epidural and test nerve block which also did not work and synvisc one possibly being injected to her bloodstream/thinks it might have got into her vein with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one] and unspecified antifungal spray medication the patient's past medical history included cholecystectomy.The patient's past medical treatment(s), vaccination(s) and family history were not provided.At the time of the event, the patient reports that her gi system had been "screwed up" prior to taking synvisc one because she had her gallbladder removed; reports that it was starting to get better and she did not need to use her medication for diarrhea anymore and at the time of the injection, the pain in her right knee was worse than her left knee and also prior to the synvisc one injection, she had some limitations(back pain) in (b)(6) 2023, the patient started using hylan g-f 20, sodium hyaluronate injection in the right knee (strength: 48 mg/6ml)(frequency: once) administered the synvisc one injection without applying any lidocaine or spray; she could feel it going through nerves, and she does not know if some of it went into her bloodstream; she thinks it might have got into her vein (lot, expiry date, dose- unknown) for osteoarthritis (wrong technique in product usage process) (same day: latency) information on batch number and expiry date was requested on an unknown date in 2023, patient started using unknown antifungal spray (unknown dose, frequency, strength, route, batch number, expiry date) for rash on an unknown date and latency; patient has taken synvisc one before with from a rheumatologist, and this this time it was from a pain clinic.They put it in her knee with no lidocaine, no nothing.She could feel it going through nerves, and she does not know if some of it went into her bloodstream.His left side was so bad.She had several nerves hit(nerve injury), and she said it was a reaction by her knee.She could feel it go through her nerves; the nerve pain (neuralgia) made her jerk during the injection; it felt like "the needle went through nerves and meat"; she thinks it might have got into her vein.The patient doesn't think that the synvisc one was applied correctly or some kind of contamination; thinks it damaged her right knee.The patient states that the doctor did not use an x-ray guide to administer the synvisc one injection; advised the patient that the labelling does not require an x-ray guide to administer synvisc one.The patient reported that at the time of the injection, the pain in her right knee was worse than her left knee, so she only received synvisc one to her right knee.After receiving synvisc one she developed a rash; it started small and then it "spread out and kept getting bigger and bigger"; states that the rash is still spreading at the time of the call(rash).She reports that she has "never had a rash like this"; she has been using an antifungal spray on it; the spray seems to relieve it some, but it doesn't take it away.She reports that the antifungal spray "burns like hell(skin burning sensation)"; she doesn't know if it is the right product to use; it helps the rash for a bit, and then it gets "bad" again.She reports that it's mostly on the left side of her right leg.It is extremely painful in areas very raw and flares up again, and she has never had it.Every time she eats, she wants to have it out.She does not feel nauseous, just feel gurgling.She reports that after receiving synvisc one she cannot walk on her right leg; she has to use crutches or a walker(gait disturbance; seriousness criteria: disability); her right knee way is worse, and she uses crutches or a walker.It was so damn painful when administered/it was more painful than before she had the injection(injection site joint pain)( condition aggravated).She reports that she has to "shuffle like a 99-year old with back problems"; reports that prior to the synvisc one injection, she had some limitations, but nothing like this.She reports that it hurts so badly that she needs to get a brace(back pain;seriousness criteria:disability)(condition aggravated; seriousness criteria: disability).She also reports that after receiving synvisc one, she started having diarrhea; she cannot hold her food in; her stomach is "gurgling"; her gi is "all screwed up" (gastrointestinal sounds abnormal).She currently have unresolved diarrhea and a lot of grumbling on her stomach, unless she takes medicine that her gastroenterologist gave her.The patient reports that her gi system had been "screwed up" prior to taking synvisc one because she had her gallbladder removed.She is on ivf from having her gallbladder removed; reports that it was starting to get better and she did not need to use her medication for diarrhea anymore.When she had the synvisc one injection, she started having gi issues again and had to start taking the medication for diarrhea again(diarrhoea).At first she thought it was stress(stress), but then she kept having it.She has gi issues not matter what she eats; reports that she was on a plant-based diet most of the time or chicken and vegetables as instructed by her gastroenterologist.The patient noted that she also has disc degeneration(intervertebral disc degeneration).The consumer wanted to know if these were possible side effects of the synvisc one possibly being injected to her bloodstream.The patient also reports that after the synvisc one injection, she received a nerve ablation on 13-dec-2023(therapeutic nerve ablation; onset: 13-dec-2023; latency: few weeks; seriousness criteria : medically significant); it did not work.She also reports receiving an epidural and test nerve block which also did not work(epidural anaesthesia)(onset: dec-2023; latecy: few weeks) she got a weird rash in a completely different area of the body, and it has lasted for a long time, it was now getting better.Action taken: not applicable for all events.Corrective treatment: use crutches or a walker for gait disturbance; unspecified antifungal spray for rash; unknown diarrhea medication for gastrointestinal sounds abnormal; braces for back pain; not reported for rest events at time of reporting, the outcome was recovering for rash, was not recovered for all events except wrong technique in product usage process, epidural anaesthesia and therapeutic nerve ablation a product technical complaint (ptc) was initiated on 06-feb-2024 for synvisc one.Batch number; unknown global ptc number: (b)(4).Sample status of ptc was not available, and 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.(rc 08feb24) investigation: (rc 16feb24) the product lot number was not provided.A batch record review is not possible.Based on the lack of information, no assessment is possible.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 nonconforming material or product process.Sanofi will continue to monitor adverse events and perform trend analysis on a periodic basis to determine if a capa (corrective and preventive actions) was required.The final investigation was completed on 19-feb-2024 with summarized conclusion as no assessment possible additional information was received on 06-feb-2024 from quality department: ptc details with global ptc number added.Text was amended accordingly.Additional information was received on 19-feb-2024 by quality department from other health care professional: ptc complete details added; text amended.Additional information was received on 27-feb-2024 by quality department from other health care professional: the complaint (b)(4) for usa has been reopened for the following reason: incomplete complaint information; no new significant information received; text amended.Additional information was received on 22-feb-2024 from patient.Outcome of rash was updated.Text amended accordingly.
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Event Description
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After receiving synvisc one she cannot walk on her right leg has to use crutches or a walker/right knee way is worse, and she uses crutches or a walker [walking difficulty] shuffle like a 99-year old with back problems/hurts so badly that she needs to get a brace [back pain] ([condition worsened]).Nerve ablation [therapeutic nerve ablation].A rash it started small and then it spread out and kept getting bigger and bigger states that the rash is still spreading at the time of the call mostly on the left side of her right leg/painful in areas very raw and flares up again [rash aggravated].Antifungal spray burns like hell [burning skin].Doctor administered the synvisc one injection could feel it go through nerves the nerve pain made her jerk during the injection like needle went through nerves and meat [nerve pain] ([nerve injury]).Disc degeneration [degenerative disc disease].Stomach is gurgling gi is all screwed up/after synvisc one injection, started having gi issues again [abdominal noises] ([stress], [diarrhea]).Doctor administered the synvisc one injection without applying any lidocaine or spray could feel it go through nerves the nerve pain made her jerk during the injection like needle went through nerves and meat/damn painful when administered [injection site joint pain] ([condition worsened]).Epidural and test nerve block which also did not work [epidural anaesthesia].Synvisc one possibly being injected to her bloodstream/thinks it might have got into her vein.[incorrect product administration technique].Case narrative: initial information received from united states on 06-feb-2024 regarding an unsolicited valid serious case received from a patient.This case is linked to case (b)(4) (same patient).This case involves a 71 years old female patient who after receiving synvisc one cannot walk on her right leg has to use crutches or a walker, nerve ablation, a rash it started small and then it spread out and kept getting bigger and bigger states that the rash is still spreading at the time of the call mostly on the left side of her right leg/painful in areas very raw and flares up again, antifungal spray burns like hell, doctor administered the synvisc one injection could feel it go through nerves the nerve pain made her jerk during the injection like needle went through nerves and meat, shuffle like a 99-year old with back problems, disc degeneration, stomach is gurgling gi(gastrointestinal) is all screwed up/after synvisc one injection, started having gi issues again, doctor administered the synvisc one injection without applying any lidocaine or spray could feel it go through nerves the nerve pain made her jerk during the injection like needle went through nerves and meat/damn painful when administered, epidural and test nerve block which also did not work and synvisc one possibly being injected to her bloodstream/thinks it might have got into her vein with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one] and unspecified antifungal spray medication the patient's past medical history included cholecystectomy.The patient's past medical treatment(s), vaccination(s) and family history were not provided.At the time of the event, the patient reports that her gi system had been "screwed up" prior to taking synvisc one because she had her gallbladder removed; reports that it was starting to get better and she did not need to use her medication for diarrhea anymore and at the time of the injection, the pain in her right knee was worse than her left knee and also prior to the synvisc one injection, she had some limitations(back pain) in november or december 2023, the patient started using hylan g-f 20, sodium hyaluronate injection in the right knee (strength: 48 mg/6ml)(frequency: once) administered the synvisc one injection without applying any lidocaine or spray; she could feel it going through nerves, and she does not know if some of it went into her bloodstream; she thinks it might have got into her vein (lot, expiry date, dose- unknown) for osteoarthritis (wrong technique in product usage process) (same day: latency).Information on batch number and expiry date was requested.On an unknown date in 2023, patient started using unknown antifungal spray (unknown dose, frequency, strength, route, batch number, expiry date) for rash.On an unknown date and latency; patient has taken synvisc one before with from a rheumatologist, and this time it was from a pain clinic.They put it in her knee with no lidocaine, no nothing.She could feel it going through nerves, and she does not know if some of it went into her bloodstream.His left side was so bad.She had several nerves hit(nerve injury), and she said it was a reaction by her knee.She could feel it go through her nerves; the nerve pain (neuralgia)made her jerk during the injection; it felt like "the needle went through nerves and meat"; she thinks it might have got into her vein.The patient doesn't think that the synvisc one was applied correctly or some kind of contamination; thinks it damaged her right knee.The patient states that the doctor did not use an x-ray guide to administer the synvisc one injection; advised the patient that the labelling does not require an x-ray guide to administer synvisc one.The patient reported that at the time of the injection, the pain in her right knee was worse than her left knee, so she only received synvisc one to her right knee.After receiving synvisc one she developed a rash; it started small and then it "spread out and kept getting bigger and bigger"; states that the rash is still spreading at the time of the call(rash).She reports that she has "never had a rash like this"; she has been using an antifungal spray on it; the spray seems to relieve it some, but it doesn't take it away.She reports that the antifungal spray "burns like hell(skin burning sensation)"; she doesn't know if it is the right product to use; it helps the rash for a bit, and then it gets "bad" again.She reports that it's mostly on the left side of her right leg.It is extremely painful in areas very raw and flares up again, and she has never had it.Every time she eats, she wants to have it out.She does not feel nauseous, just feel gurgling.She reports that after receiving synvisc one she cannot walk on her right leg; she has to use crutches or a walker(gait disturbance; seriousness criteria: disability); her right knee way is worse, and she uses crutches or a walker.It was so damn painful when administered/it was more painful than before she had the injection(injection site joint pain)( condition aggravated).She reports that she has to "shuffle like a 99-year old with back problems"; reports that prior to the synvisc one injection, she had some limitations, but nothing like this.She reports that it hurts so badly that she needs to get a brace(back pain;seriousness criteria:disability)(condition aggravated; seriousness criteria: disability).She also reports that after receiving synvisc one, she started having diarrhea; she cannot hold her food in; her stomach is "gurgling"; her gi is "all screwed up" (gastrointestinal sounds abnormal).She currently have unresolved diarrhea and a lot of grumbling on her stomach, unless she takes medicine that her gastroenterologist gave her.The patient reports that her gi system had been "screwed up" prior to taking synvisc one because she had her gallbladder removed.She is on ivf from having her gallbladder removed; reports that it was starting to get better and she did not need to use her medication for diarrhea anymore.When she had the synvisc one injection, she started having gi issues again and had to start taking the medication for diarrhea again(diarrhoea).At first she thought it was stress(stress), but then she kept having it.She has gi issues not matter what she eats; reports that she was on a plant-based diet most of the time or chicken and vegetables as instructed by her gastroenterologist.The patient noted that she also has disc degeneration(intervertebral disc degeneration).The consumer wanted to know if these were possible side effects of the synvisc one possibly being injected to her bloodstream.The patient also reports that after the synvisc one injection, she received a nerve ablation on (b)(6) 2023(therapeutic nerve ablation; onset: (b)(6) 2023; latency: few weeks; seriousness criteria : medically significant); it did not work.She also reports receiving an epidural and test nerve block which also did not work(epidural anaesthesia)(onset: (b)(6) 2023; latecy: few weeks).Action taken: not applicable for all events.Corrective treatment: use crutches or a walker for gait disturbance; unspecified antifungal spray for rash; unknown diarrhea medication for gastrointestinal sounds abnormal; braces for back pain; not reported for rest events.At time of reporting, the outcome was not recovered for all events except wrong technique in product usage process, epidural anaesthesia and therapeutic nerve ablation.A product technical complaint (ptc) was initiated on 06-feb-2024 for synvisc one.Batch number; unknown global ptc number: 100399501.Sample status of ptc was not available, and 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.(rc 08feb24) investigation: (rc 16feb24) the product lot number was not provided.A batch record review is not possible.Based on the lack of information, no assessment is possible.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 nonconforming material or product process.Sanofi will continue to monitor adverse events and perform trend analysis on a periodic basis to determine if a capa (corrective and preventive actions) was required.The final investigation was completed on 19-feb-2024 with summarized conclusion as no assessment possible.Additional information was received on 06-feb-2024 from quality department: ptc details with global ptc number added.Text was amended accordingly.Additional information was received on 19-feb-2024 by quality department from other health care professional: ptc complete details added; text amended.
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Search Alerts/Recalls
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