| Lot Number 9RSL017 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
| Patient Problems
Abdominal Pain (1685); Hypersensitivity/Allergic reaction (1907); Swelling (2091); Therapeutic Response, Decreased (2271); No Code Available (3191)
|
| Event Date 01/01/2020 |
|
Event Type
Injury
|
|
Manufacturer Narrative
|
|
Sanofi company comment dated 09-sep-2020: this case concerns a patient who received initial treatment with hylan g-f 20, sodium hyaluronate reported that it did not give the expected result.She later received treatment with prednisone and reported having face and body swelling, an absurd jowl, an allergy in the middle of the face which was a type of acne typically caused by corticosteroids and increased pressure.All these symptoms were reported as onset of a cushing's syndrome and patient also experienced stomach pain and vitamin d increased.Based on the temporal relationship the causal relationship of the device in the occurrence of events cannot be denied and based on the pharmacological plausibility and dechallenge results the causal relationship of prednisone in the occurrence of the events can be evidently established.However, further information regarding patient's current medical condition, concomitant medications and technique used while administration of injection precludes complete medical assessment of the case.
|
| |
|
Event Description
|
|
Could be the onset of cushing's syndrome [cushing's syndrome, steroid-induced], ([swelling of face], [swelling], [acne steroid-induced], [blood pressure increased]) stomach pain [stomach pain], vitamin d3 (hydroxy 25) was 110 which is above the desirable one that is up to 100 (reference value), [vitamin d increased], expected result/ lack of result [device ineffective], received the application on the left hip [product administered at inappropriate site], doctor placed a medicine next to the application called triancil [off label use], case narrative: initial information received on 01-sep-2020 from (b)(6) regarding an unsolicited valid serious case received from the patient.This case is linked to cases (b)(4) (multiple devices) (same patient).This case involves an unknown age female patient who did not obtain the expected result/ lack of result and received the application on the left hip, stomach pain, doctor placed a medicine next to the application called triancil, vitamin d3 (hydroxy 25) was 110 which is above the desirable one that is up to 100 (reference value) and could be the onset of a cushing's syndrome, while she was treated with medical device hylan g-f 20, sodium hyaluronate (synvisc one), prednisone (meticorten) her past medical treatment included on hylan g-f 20, sodium hyaluronate received on (b)(6) 2020 which she received her left knee.Her past medical history, vaccination(s) and family history were not provided.Concomitant medication included triamcinolone hexacetonide (triancil).On (b)(6) 2020, the patient started using hylan g-f 20, sodium hyaluronate, (formulation, dosage, batch number, indication: unknown) for once on the left hip.(product administered at inappropriate site).On the same day, her doctor placed a medicine next to the application called triancil (off label use).On the unknown date of 2020, after 1 and a half months of taking of the product, patient did not obtain the expected result (device ineffective).As corrective of the lack of result of application of product, the patient was prescribed with prednisone (meticortem) and ketoprofen (profenid).On the unknown date in 2020, patient took prednisone (formulation, strength, dosage, indication, frequency: unknown).Patient informed that after the use of the medication he turned into a monster, because he presented with all possible side effects.On the unknown date in 2020, after unknown latency, the patient's face and body swelled absurdly, got an absurd jowl (swelling face) (swelling).The patient also presented an allergy in the middle of face.Due to allergy, patient went to general practitioner, who reported that this allergy was a type of acne typically caused by corticosteroids (acne) and could be the onset of a cushing's syndrome (cushing's syndrome) (medically significant).In addition to these events, the patient also reports that she had stomach pain (abdominal pain upper) and the pressure increased (blood pressure increased).She was instructed by the doctor to wean the corticosteroid and continue the use of profenid.The patient related the events presented to the use of corticosteroids, because when she weaned the events began to improve visibly but reported that profenid was very weak because her pains had returned.Currently the patient was only in use of profenid 150mg, two tablets a day.It was also reported that the fan and rheumatoic factor tests were negative, but vitamin d3 (hydroxy 25) was 110 which was above the desirable one that was up to 100 (reference value) (vitamin d increased).The clinic informed the patient that the vitamin test might have given this alteration, because it was related to some pain of this whole situation.Patient was waiting for a period to retake vitamin d and would return to rheumatologist.The patient informed that she was currently locked and in pain.The patient did recommend synvisc one to everyone and further said that she did not want to undergo a surgery because as soon as the pain start, she would already perform the application.Final diagnosis was did not obtain the expected result/ lack of result and received the application on the left hip, vitamin d3 (hydroxy 25) was 110 which is above the desirable one that is up to 100 (reference value), doctor placed a medicine next to the application called triancil, stomach pain and could be the onset of a cushing's syndrome.Action taken: not applicable for all the events with hylan g-f 20, sodium hyaluronate; not applicable for device ineffective, off label use and product administered at inappropriate site; unknown for vitamin d3 (hydroxy 25) was 110 which is above the desirable one that is up to 100 (reference value) and drug withdrawn for all events with prednisone corrective treatment: not reported for all events.Outcome: recovering for could be the onset of a cushing's syndrome; not recovered for stomach pain; unknown for vitamin d3 (hydroxy 25) was 110 which is above the desirable one that is up to 100 (reference value); not applicable for rest of the events.A product technical compliant was initiated and results were pending for same.
|
| |
|
Event Description
|
|
Could be the onset of cushing's syndrome [cushing's syndrome, steroid-induced] ([swelling of face], [swelling], [acne steroid-induced], [blood pressure increased]) stomach pain [stomach pain] vitamin d3 (hydroxy 25) was 110 which is above the desirable one that is up to 100 (reference value), [vitamin d increased] expected result/ lack of result [device ineffective] received the application on the left hip [product administered at inappropriate site] doctor placed a medicine next to the application called triancil [off label use] case narrative: initial information received on 01-sep-2020 from brazil regarding an unsolicited valid serious case received from the patient.This case is linked to cases (b)(4) (multiple devices) and (b)(4).(same patient) this case involves an unknown age female patient who did not obtain the expected result/ lack of result and received the application on the left hip, stomach pain, doctor placed a medicine next to the application called triancil, vitamin d3 (hydroxy 25) was 110 which is above the desirable one that is up to 100 (reference value) and could be the onset of a cushing's syndrome, while she was treated with medical device hylan g-f 20, sodium hyaluronate (synvisc one), prednisone (meticorten).Her past medical treatment included on hylan g-f 20, sodium hyaluronate received on (b)(6) 2020 which she received her left knee.Her past medical history, vaccination(s) and family history were not provided.Concomitant medication included triamcinolone hexacetonide (triancil).On (b)(6) 2020, the patient started using hylan g-f 20, sodium hyaluronate, (formulation, dosage, batch number, indication: unknown) for once on the left hip (product administered at inappropriate site).On the same day, her doctor placed a medicine next to the application called triancil (off label use).On the unknown date of 2020, after 1 and a half months of taking of the product, patient did not obtain the expected result (device ineffective).As corrective of the lack of result of application of product, the patient was prescribed with prednisone (meticortem) and ketoprofen (profenid).On the unknown date in 2020, patient took prednisone (formulation, strength, dosage, indication, frequency: unknown).Patient informed that after the use of the medication he turned into a monster, because he presented with all possible side effects.On the unknown date in 2020, after unknown latency, the patient's face and body swelled absurdly, got an absurd jowl (swelling face) (swelling).The patient also presented an allergy in the middle of face.Due to allergy, patient went to general practitioner, who reported that this allergy was a type of acne typically caused by corticosteroids (acne) and could be the onset of a cushing's syndrome (cushing's syndrome) (medically significant).In addition to these events, the patient also reports that she had stomach pain (abdominal pain upper) and the pressure increased (blood pressure increased).She was instructed by the doctor to wean the corticosteroid and continue the use of ketoprofen.The patient related the events presented to the use of corticosteroids, because when she weaned the events began to improve visibly but reported that ketoprofen was very weak because her pains had returned.Currently the patient was only in use of ketoprofen 150mg, two tablets a day.It was also reported that the fan and rheumatoic factor tests were negative, but vitamin d3 (hydroxy 25) was 110 which was above the desirable one that was up to 100 (reference value) (vitamin d increased).The clinic informed the patient that the vitamin test might have given this alteration, because it was related to some pain of this whole situation.Patient was waiting for a period to retake vitamin d and would return to rheumatologist.The patient informed that she was currently locked and in pain.The patient did recommend hylan g-f 20, sodium hyaluronate to everyone and further said that she did not want to undergo a surgery because as soon as the pain start, she would already perform the application.Action taken: not applicable for all the events with hylan g-f 20, sodium hyaluronate; not applicable for device ineffective, off label use and product administered at inappropriate site; unknown for vitamin d3 (hydroxy 25) was 110 which is above the desirable one that is up to 100 (reference value) and drug withdrawn for rest of the events with prednisone corrective treatment: not reported for all events outcome: recovering for could be the onset of a cushing's syndrome; not recovered for stomach pain; unknown for vitamin d3 (hydroxy 25) was 110 which is above the desirable one that is up to 100 (reference value); not applicable for rest of the events.A product technical complaint (ptc) was initiated on 01-sep-2020 for synvisc one for unknown batch number and global ptc number: 100067203 the product lot number was not provided; therefore, a batch record review was not possible.It was the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result was identified and mitigated through the ncr (non-conformances report) process.Adverse event reports with or without lot numbers were continuously monitored, and possible associations with their corresponding product lot are assessed, as part of routine safety surveillance effort to detect safety signals.This review had not indicated any safety issue.Sanofi would continue to monitor adverse events to determine if a capa (corrective and preventive action) was required.Investigation completion date: 22-sep-2020 additional information was received on 22-sep-2020 from healthcare professional.Global ptc number and its results were added.Text amended accordingly.
|
| |
|
Event Description
|
|
This was because of the corticosteroid, that she must have some allergy to her [drug allergy] ([head discomfort], [eye discomfort], [heart racing], [swelling of face], [cushing's syndrome, steroid-induced], [blood pressure high], [swelling], [acne steroid-induced]), stomach pain [stomach pain] , vitamin d3 (hydroxy 25) was 110 which is above the desirable one that is up to 100 (reference value), [vitamin d increased], did not obtain expected result/ lack of result/ had zero results [device ineffective], received the application on the left hip [product administered at inappropriate site], doctor placed a medicine next to the application called triancil [off label use] distrusts the product, thinks that the original drug was not applied this time were added [suspected counterfeit product].Case narrative: initial information received on 01-sep-2020 from brazil regarding an unsolicited valid serious case received from the patient.This case is linked to cases (b)(4) (multiple devices) and (b)(4).(same patient).This case involves an unknown age female patient who did not obtain the expected result/ lack of result/ had zero results and received the application on the left hip, stomach pain, doctor placed a medicine next to the application called triancil, vitamin d3 (hydroxy 25) was 110 which is above the desirable one that is up to 100 (reference value) and this was because of the corticosteroid, that she must have some allergy to her; distrusts the product, thinks that the original drug was not applied this time, while she was treated with medical device hylan g-f 20, sodium hyaluronate (synvisc one), prednisone (meticorten).Her past medical treatment included on hylan g-f 20, sodium hyaluronate received on 20-jul-2020 which she received her left knee.Her past vaccination(s) and family history were not provided.Concomitant medication included triamcinolone hexacetonide (triancil).Past medical history included shoulder pain.On (b)(6) 2020, the patient started using hylan g-f 20, sodium hyaluronate, (formulation, dosage, batch number, indication: unknown) for once on the left hip (product administered at inappropriate site).On the same day, her doctor placed a medicine next to the application called triancil (off label use).On the unknown date of 2020, after 1 and a half months of taking of the product, patient did not obtain the expected result (device ineffective).As corrective of the lack of result of application of product, the patient was prescribed with prednisone (meticortem) and ketoprofen (profenid).On the unknown date in 2020, patient took prednisone (formulation, strength, dosage, indication, frequency: unknown).Patient informed that after the use of the medication he turned into a monster, because he presented with all possible side effects.On the unknown date in 2020, after unknown latency, the patient's face and body swelled absurdly, got an absurd jowl (swelling face) (swelling), heart was racing (palpitations),.The patient also presented an allergy in the middle of face.Due to allergy, patient went to general practitioner, who reported that this allergy was a type of acne typically caused by corticosteroids (acne) and could be the onset of a cushing's syndrome (cushing's syndrome) (medically significant).In addition to these events, the patient also reports that she had stomach pain (abdominal pain upper) and the pressure increased/ high blood pressure (hypertension).The patient had never had palpitations, blood pressure increased and it upset her.The patient discontinued the medication on her own and called the doctor who had done her hylan g-f 20, sodium hyaluronate application and prescribed the drug and said she would no longer take the corticosteroid.She was instructed by the doctor to wean the corticosteroid and continue the use of ketoprofen.The patient related the events presented to the use of corticosteroids, because when she weaned the events began to improve visibly but reported that ketoprofen was very weak because her pains had returned.The patient was only in use of ketoprofen 150mg, two tablets a day.As she improved after discontinuing prednisone, she believed that this had nothing to do with hylan g-f 20, sodium hyaluronate.The pressure still fluctuated and it was low before.The patient got a snap to her head (head discomfort).The general practitioner prescribed her the drug corus as a treatment and told her to only take this medicine when she had any symptoms, so when she had high blood pressure, she took a tablet.On an unknown date the doctor said this was because of the corticosteroid, that she must have some allergy to her (drug hypersensitivity; medically significant and intervention required).It was also reported that the fan and rheumatoic factor tests were negative, but vitamin d3 (hydroxy 25) was 110 which was above the desirable one that was up to 100 (reference value) (vitamin d increased).The clinic informed the patient that the vitamin test might have given this alteration, because it was related to some pain of this whole situation.Patient was waiting for a period to retake vitamin d and would return to rheumatologist.The patient informed that she was currently locked and in pain.The patient did recommend hylan g-f 20, sodium hyaluronate to everyone and further said that she did not want to undergo a surgery because as soon as the pain start, she would already perform the application.The patient did not understand why the doctor prescribed these drugs meticorten and biprofenid and reportedly the other times she used synvisc with other doctors, the doctor had not passed anything, nor anti-inflammatory and told her to take dipyrone only if she had pain.The other times the applications were very fast and this time, it was time consuming, she applied a corticosteroid together and an anesthetic and it until she did the application on her shoulders that the doctor had given her anesthesia before.About hylan g-f 20, sodium hyaluronate, said it really had no effect on the application.The other times the patient used it, it had a very fast effect and had done application on both shoulders, has done behind, has done on her knees twice, and had always had a very good result but this time, it had no effect, she felt like crying.It's been three months since she did the application now and had zero results (device ineffective).The patient had doubts about the origin of hylan g-f 20, sodium hyaluronate of this application.It's been 3 years since she used hylan g-f 20, sodium hyaluronate and always had the best results, always fast, on the second day after application she forgot she had the pain.This time the effect was zero and was just passing ointment on her arm, took miorrelax and novalgina because she was throbbing her shoulders and knees.The patient had said she did the application of hylan g-f 20, sodium hyaluronate on her knees and hips this time only, was going to do on the shoulders later but as she had problem with hylan g-f 20, sodium hyaluronate , she did not want to return to the clinic and she applied osteonil plus on the shoulders this time, but it product was not good as hylan g-f 20, sodium hyaluronate , because she was already with shoulder pain, did not help anything.The patient said she saw that they sell hylan g-f 20, sodium hyaluronate on the internet in any corner, so she distrusts the product, thinks that the original drug was not applied this time (suspected counterfeit product).Action taken: not applicable for all the events with hylan g-f 20, sodium hyaluronate; not applicable for device ineffective, off label use and product administered at inappropriate site; unknown for vitamin d3 (hydroxy 25) was 110 which is above the desirable one that is up to 100 (reference value) and drug withdrawn for rest of the events with prednisone corrective treatment: corus for this was because of the corticosteroid, that she must have some allergy to her; not reported for rest of the events outcome: not recovered for stomach pain, gets a snap to her head and pressure increased/high blood pressure; unknown for vitamin d3 (hydroxy 25) was 110 which is above the desirable one that is up to 100 (reference value and this was because of the corticosteroid, that she must have some allergy to her; not applicable for off label use, device ineffective, product administered at inappropriate site and suspected counterfeit product; recovered for other events a product technical complaint (ptc) was initiated on 01-sep-2020 for synvisc one for unknown batch number and global ptc number: (b)(4).The product lot number was not provided; therefore, a batch record review was not possible.It was the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result was identified and mitigated through the ncr (non-conformances report) process.Adverse event reports with or without lot numbers were continuously monitored, and possible associations with their corresponding product lot are assessed, as part of routine safety surveillance effort to detect safety signals.This review had not indicated any safety issue.Sanofi would continue to monitor adverse events to determine if a capa (corrective and preventive action) was required.Investigation completion date: 22-sep-2020.Additional information was received on 22-sep-2020 from healthcare professional.Global ptc number and its results were added.Text amended accordingly.Additional information was received on 20-oct-2020 from patient.Events of this was because of the corticosteroid, that she must have some allergy to her; distrusts the product, thinks that the original drug was not applied this time were added.Symptoms and their details updated.Verbatim of did not obtain expected result/ lack of result/ had zero results updated.Reporter causality updated for the cushing syndrome and its symptoms to not related for synvisc one.Clinical course updated.Text amended accordingly.
|
| |
|
Event Description
|
|
This was because of the corticosteroid, that she must have some allergy to her [drug allergy] ([head pressure], [eye discomfort], [heart racing], [swelling of face], [cushing's syndrome, steroid-induced], [blood pressure high], [swelling], [acne steroid-induced]) stomach pain [stomach pain] vitamin d3 (hydroxy 25) was 110 which is above the desirable one that is up to 100 (reference value), [vitamin d increased] did not obtain the expected result/ lack of result/ had zero results/negative result/ no effect/didn't get any results [device ineffective] received the application on the right hip via im route [off label use of device] doctor placed a medicine next to the application called triancil [off label use] distrusts the product, thinks that the original drug was not applied this time were added [suspected counterfeit product] case narrative: initial information received on 01-sep-2020 from brazil regarding an unsolicited valid serious case received from the patient.This case is linked to cases (b)(4), (multiple devices) and (same patient).This case involves 68 years old female patient (165 cm and 60 kg) who did not obtain the expected result/ lack of result/ had zero results/negative result/ no effect/didn't get any results, received the application on the right hip via im route, stomach pain, doctor placed a medicine next to the application called triancil, vitamin d3 (hydroxy 25) was 110 which is above the desirable one that is up to 100 (reference value) and this was because of the corticosteroid, that she must have some allergy to her; distrusts the product, thinks that the original drug was not applied this time while she was treated with medical device hylan g-f 20, sodium hyaluronate (synvisc one), prednisone (meticorten).Her past medical treatment included; hylan g-f 20, sodium hyaluronate received on (b)(6) 2020 in left knee, (b)(6) 2020 in left hip and on (b)(6) 2020 in her right knee.Her past vaccination(s) and family history were not provided.Concomitant medication included triamcinolone hexacetonide (triancil) and calcium collagen for vitamin.Past medical history included shoulder pain.On (b)(6) 2020, the patient received treatment with hylan g-f 20, sodium hyaluronate once by a physician (formulation, dosage, unknown) (batch number: 9rsl017, expiration date- 30-apr-2022) in the right hip via im (intramuscular) route (off label use of device) for viscosupplementation of joint.It was reported that hip procedures were guided by ultrasound and everything went well.On the same day, her doctor placed a medicine next to the application called triancil (off label use).On the unknown date of 2020, after 1 and a half months of taking of the product, patient did not obtain the expected result (device ineffective).As corrective of the lack of result of application of product, the patient was prescribed with prednisone (meticortem) and ketoprofen (profenid).On the unknown date in 2020, patient took prednisone (formulation, strength, dosage, indication, frequency: unknown).Patient informed that after the use of the medication he turned into a monster, because he presented with all possible side effects.On the unknown date in 2020, after unknown latency, the patient's face and body swelled absurdly, got an absurd jowl (swelling face) (swelling), heart was racing (palpitations).The patient also presented an allergy in the middle of face.Due to allergy, patient consulted general practitioner, who reported that this allergy was a type of acne typically caused by corticosteroids (acne) and could be the onset of a cushing's syndrome (cushing's syndrome) (medically significant).In addition to these events, the patient also reports that she had stomach pain (abdominal pain upper) and the pressure increased/ high blood pressure (hypertension).The patient had never had palpitations, blood pressure increased and it upset her.The patient discontinued the medication on her own and called the doctor who had done her hylan g-f 20, sodium hyaluronate application and prescribed the drug and said she would no longer take the corticosteroid.She was instructed by the doctor to wean the corticosteroid and continue the use of ketoprofen.The patient related the events presented to the use of corticosteroids, because when she weaned the events began to improve visibly, swelling reduced, patient recovered from all symptoms and no longer had any signs she had before, before her eye would not event open but reported that ketoprofen was very weak because her pains had returned.The patient was only in use of ketoprofen 150mg, two tablets a day.As she improved after discontinuing prednisone, she believed that this had nothing to do with hylan g-f 20, sodium hyaluronate.The pressure still fluctuated and it was low before.The patient felt a pressure in her head (head discomfort).The general practitioner prescribed her the drug corus as a treatment and told her to only take this medicine when she had any symptoms, so when she had high blood pressure, she took a tablet.On an unknown date the doctor said this was because of the corticosteroid, that she must have some allergy to her (drug hypersensitivity; medically significant and intervention required).She said that some people presented reactions with this corticosteroid, but never as sharp as it was for the patient.It was also reported that the fan (not specified) and rheumatoic factor tests were negative, but vitamin d3 (hydroxy 25) was 110 which was above the desirable one that was up to 100 (reference value) (vitamin d increased).The clinic informed the patient that the vitamin test might have given this alteration, because it was related to some pain of this whole situation.Patient was waiting for a period to retake vitamin d and would return to rheumatologist.The patient informed that she was currently locked and in pain.The patient did recommend hylan g-f 20, sodium hyaluronate to everyone and further said that she did not want to undergo a surgery because as soon as the pain start, she would already perform the application.The patient did not understand why the doctor prescribed these drugs meticorten and biprofenid and reportedly the other times she used synvisc with other doctors, the doctor had not passed anything, nor anti-inflammatory and physician told her to take dipyrone only if she had pain.The other times the applications were very fast and this time, it was time consuming, she applied a corticosteroid together and an anesthetic and it was only when she did the application on her shoulders that the doctor had given her anesthesia before synvisc.About hylan g-f 20, sodium hyaluronate, said it really had no effect on the application.The other times the patient used it, it had a very fast effect and had done application on both shoulders, has done behind, has done on her knees twice, and had always had a very good result but this time, it had no effect, she felt like crying.It's been three months since she did the application now and had zero results (device ineffective).The patient had doubts about the origin of hylan g-f 20, sodium hyaluronate of this application.It's been 3 years since she used hylan g-f 20, sodium hyaluronate and always had the best results, always fast, on the second day after application she forgot she had the pain.This time the effect was zero and was just passing ointment on her arm, took miorrelax and novalgina because she was throbbing her shoulders and knees.The patient had said she did the application of hylan g-f 20, sodium hyaluronate on her knees and hips this time only, was going to do on the shoulders later but as she had problem with hylan g-f 20, sodium hyaluronate , she did not want to return to the clinic and she applied osteonil plus on the shoulders this time, but it product was not good as hylan g-f 20, sodium hyaluronate, because she was already with shoulder pain, did not help anything.The patient said she saw that they sell hylan g-f 20, sodium hyaluronate on the internet in any corner, so she distrusts the product, thinks that the original drug was not applied this time (suspected counterfeit product).As of (b)(6) 2020, the patient did not get any results.The result, according to the site and package insert, would be for after a month, which did not happen.The patient followed the guidelines of the post but, she had not obtained any results until (b)(6) 2020, for more than 2 full months.The patient when requested to send the numbers referring to the batches of products, she sent promptly, thereafter she received no further feedback.She sent emails, with no answers.The attendants claimed that in addition to the lot number seals, they would have to send a sample of the used syringes, which were discarded at the clinic where the procedures were performed.This information did not appear on the package inserts and on the websites that inform about the product.The patient had already been doing these procedures for more than 4 years (successfully) and this was the first time that the doctor provided the lot number stamps.If there was a possibility of a failure in the result of viscosupplementation with hylan g-f 20, sodium hyaluronate, it should be stated at least in the package insert that these items, batch number and product residue, should be kept until the result of the procedure, expected after 30 days.It was an expensive product that promised positive results, minor or major but she had a substantial expense with the procedures, with a negative result.She bought the medicine at a private clinic, where she took the money from the pocket itself, there were 4 injections where it left the loss.She mentioned that users should be warned to keep batch numbers and especially the syringe with residues of the product used.Patient was suspicious of the quality of the hylan g-f 20, sodium hyaluronate, always made the use of this product and this time did not feel the expected effect that always had.Action taken: not applicable for all the events with hylan g-f 20, sodium hyaluronate; not applicable for device ineffective, off label use, off label use of device and suspected counterfeit product; unknown for vitamin d3 (hydroxy 25) was 110 which is above the desirable one that is up to 100 (reference value) and drug withdrawn for rest of the events with prednisone corrective treatment: losartan potassium (corus) pressure increased/high blood pressure; not reported for rest of the events outcome: not recovered for stomach pain, felt a pressure in her head and pressure increased/high blood pressure; unknown for vitamin d3 (hydroxy 25) was 110 which is above the desirable one that is up to 100 (reference value and this was because of the corticosteroid, that she must have some allergy to her; not applicable for off label use, device ineffective, off label use of device and suspected counterfeit product; recovered for other events a product technical complaint (ptc) was initiated on 01-sep-2020 for synvisc one for unknown batch number and global ptc number: (b)(4).The product lot number was not provided; therefore, a batch record review was not possible.It was the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result was identified and mitigated through the ncr (non-conformances report) process.Adverse event reports with or without lot numbers were continuously monitored, and possible associations with their corresponding product lot are assessed, as part of routine safety surveillance effort to detect safety signals.This review had not indicated any safety issue.Sanofi would continue to monitor adverse events to determine if a capa (corrective and preventive action) was required.Investigation completion date: (b)(6) 2020 additional information was received on (b)(6) 2020 from healthcare professional.Global ptc number and its results were added.Text amended accordingly.Additional information was received on (b)(6) 2020 from patient.Events of this was because of the corticosteroid, that she must have some allergy to her; distrusts the product, thinks that the original drug was not applied this time were added.Symptoms and their details updated.Verbatim of did not obtain expected result/ lack of result/ had zero results updated.Reporter causality updated for the cushing syndrome and its symptoms to not related for synvisc one.Clinical course updated.Text amended accordingly.Additional information received on (b)(6) 2020 from patient.Verbatim of received the application on the left hip updated to received the application on the left hip via im route and its linking also updated.Verbatim of did not obtain the expected result/ lack of result/ had zero results updated to did not obtain the expected result/ lack of result/ had zero results/negative result/ no effect/didn't get any results.Indication and batch number of suspect added.Patient demographics updated.Concomitant medication added.Clinical course updated.Text amended accordingly.
|
| |
|
Search Alerts/Recalls
|
|
