| Lot Number 9RSL017 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Hypersensitivity/Allergic reaction (1907); Swelling (2091); Therapeutic Response, Decreased (2271); No Code Available (3191)
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| Event Date 01/01/2020 |
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Event Type
Injury
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Event Description
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Could be the onset of cushing's syndrome [cushing's syndrome, steroid-induced], ([acne steroid-induced], [swelling face], [swelling], [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 nos], did not obtain the expected result/ lack of result with no adverse event [device ineffective], received the application on the right hip [product administered at inappropriate site].Case narrative: this case is linked to cases (b)(4) (multiple devices) (same patient).Initial information received on (b)(6) 2020 from (b)(6) regarding an unsolicited valid serious case received from patient.This case involves female patient (age at the time of event onset not reported) who would be experiencing the onset of cushing's syndrome, had stomach pain, vitamin d3 (hydroxy 25) was 110 which is above the desirable one that is up to 100, did not obtain the expected result/ lack of result and received the application on the right hip with no adverse event with medical device hylan g-f 20, sodium hyaluronate (synvisc one) and prednisone (meticorten).Her past medical treatment included on hylan g-f 20, sodium hyaluronate received on (b)(6) 2020 which she received her right knee.Her past medical history, vaccination(s) and family history were not provided.On (b)(6) 2020, the patient received hylan g-f 20, sodium hyaluronate application on the right hip (frequency: once) (formulation, dosage, batch number, indication: unknown) (product administered at inappropriate site).On the unknown date of 2020, after 1 and a half months of taking of the product, patient reported that she did not obtain the expected result (device ineffective).No adverse events were reported that time.Due to lack of result of application of hylan g-f 20, sodium hyaluronate, the patient was prescribed with prednisone and ketoprofen as corrective treatment.On the unknown date in 2020, patient started prednisone (formulation, strength, dosage, indication, frequency: unknown) and profenid.On the unknown date in 2020, after unknown latency, patient's face and body swelled absurdly, got an absurd jowl (swelling) (swelling face) and also presented an allergy in the middle of face.Due to allergy, patient visited general practitioner, who mentioned 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) (seriousness: medically significant).In addition to these events, the patient also reported stomach pain (abdominal pain upper) and the pressure increased (blood pressure increased).Patient was instructed by the doctor to wean the corticosteroid and continue the use of profenid.The patient related these events to the use of corticosteroids, because when she weaned corticosteroids, the events began to improve visibly but reported that profenid was very weak as her pains returned.It was also reported that the fan and rheumatoic factor tests were negative, but vitamin d3 (hydroxy 25) was 110 which is above the desirable one that is up to 100 (reference value) (vitamin d increased nos).Patient was waiting for a period to retake vitamin d and would return to rheumatologist and informed that she was currently locked and still in pain.Action taken: not applicable for all the events with hylan g-f 20, sodium hyaluronate; unknown for vitamin d3 (hydroxy 25) was 110 which is above the desirable one that is up to 100 with prednisone; not applicable for did not obtain the expected result/ lack of result and received the application on the right hip with no adverse event with prednisone; drug withdrawn for rest of the events with prednisone corrective treatment: not reported.Outcome: recovering from 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; not applicable for rest of the two events.A product technical compliant was initiated and results were pending for same.
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Event Description
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Could be the onset of cushing's syndrome [cushing's syndrome, steroid-induced] ([acne steroid-induced], [swelling face], [swelling], [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 nos] , did not obtain the expected result/ lack of result [device ineffective], and received the application on the right hip [product administered at inappropriate site].Case narrative: initial information received on 01-sep-2020 from brazil regarding an unsolicited valid serious case received from patient.This case is linked to cases (b)(4) (multiple devices) and (b)(4) (same patient).This case involves female patient (age at the time of event onset not reported) who experienced the onset of cushing's syndrome, had stomach pain, vitamin d3 (hydroxy 25) was 110 which is above the desirable one that is up to 100, did not obtain the expected result/ lack of result and received the application on the right hip with medical device hylan g-f 20, sodium hyaluronate (synvisc one) and prednisone (meticorten).Her past medical treatment included on hylan g-f 20, sodium hyaluronate received on 13-jul-2020 which she received her right knee.Her past medical history, vaccination(s) and family history were not provided.On (b)(6) 2020, the patient received hylan g-f 20, sodium hyaluronate application on the right hip (frequency: once) (formulation, dosage, batch number, indication: unknown) (product administered at inappropriate site).On the unknown date of 2020, after 1 and a half months of taking of the product, patient reported that she did not obtain the expected result (device ineffective).No adverse events were reported that time.Due to lack of result of application of hylan g-f 20, sodium hyaluronate, the patient was prescribed with prednisone and ketoprofen as corrective treatment.On the unknown date in 2020, patient started prednisone (formulation, strength, dosage, indication, frequency: unknown) and profenid.On the unknown date in 2020, after unknown latency, patient's face and body swelled absurdly, got an absurd jowl (swelling) (swelling face) and also presented an allergy in the middle of face.Due to allergy, patient visited general practitioner, who mentioned 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) (seriousness: medically significant).In addition to these events, the patient also reported stomach pain (abdominal pain upper) and the pressure increased (blood pressure increased) (onset, latency: unknown).Patient was instructed by the doctor to wean the corticosteroid and continue the use of profenid.The patient related these events to the use of corticosteroids, because when she weaned corticosteroids, the events began to improve visibly but reported that profenid was very weak as her pains returned.It was also reported that the fan and rheumatoic factor tests were negative, but vitamin d3 (hydroxy 25) was 110 which is above the desirable one that is up to 100 (reference value) (vitamin d increased nos).Patient was waiting for a period to retake vitamin d and would return to rheumatologist and informed that she was currently locked and still in pain.Action taken: not applicable for all the events with hylan g-f 20, sodium hyaluronate; unknown for vitamin d3 (hydroxy 25) was 110 which is above the desirable one that is up to 100 with prednisone; not applicable for did not obtain the expected result/ lack of result and received the application on the right hip with no adverse event with prednisone; drug withdrawn for rest of the events with prednisone corrective treatment: not reported for all events.Outcome: recovering from 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; not applicable for rest of the two events.A product technical complaint (ptc) was initiated on 02-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 are 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 has 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.
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Event Description
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Experienced this was because of the corticosteroid, that she must have some allergy to her [specific allergy (drug)] ([swelling], [blood pressure high], [acne steroid-induced], [eye discomfort], [swelling face], [heart racing], [head discomfort], [cushing's syndrome, 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 nos] did not obtain the expected result/ lack of result/zero results/no effect [device ineffective] received the application on the right hip [product administered at inappropriate site] distrusts the product, thinks that the original drug was not applied this time [suspected counterfeit product] case narrative: initial information received on 01-sep-2020 from brazil regarding an unsolicited valid serious case received from patient.This case is linked to cases (b)(4) (same patient).This case involves female patient (age at the time of event onset not reported) who was treated with prednisone (meticorten) and hylan g-f 20, sodium hyaluronate (synvisc one) and experienced this was because of the corticosteroid, that she must have some allergy to her, stomach pain, vitamin d3 (hydroxy 25) was 110 which is above the desirable one that is up to 100 (reference value), did not obtain the expected result/ lack of result/zero results/no effect, received the application on the right hip and distrusts the product, thinks that the original drug was not applied this time.The patient's past medical treatment(s), vaccination(s) and family history were not provided.The patient has past history of shoulder pain.On (b)(6) 2020, the patient received hylan g-f 20, sodium hyaluronate application on the right hip (frequency: once) (formulation, dosage, batch number, indication: unknown) (product administered at inappropriate site).On the unknown date of 2020, after 1 and a half months of taking of the product, patient reported that she did not obtain the expected result (device ineffective).Due to lack of result of application of hylan g-f 20, sodium hyaluronate, the patient was prescribed with prednisone and ketoprofen (profenid) as corrective treatment.On the unknown date in 2020, patient started prednisone (formulation, strength, dosage, indication, frequency: unknown) and ketoprofen.On the unknown date in 2020, after unknown latency, patient's face and body swelled absurdly, got an absurd jowl (swelling) (swelling face) and also presented an allergy in the middle of face.Due to allergy, patient visited general practitioner, who mentioned 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) and as per the doctor the symptoms were sure to be a reaction to corticosteroids, that she must have some allergy to her (drug hypersensitivity; onset: 2020; latency: unknown, event assessed as medically significant).She said that most people there's something about this corticosteroid, but that's never as sharp as it was for the patient.In addition to these events, the patient also reported stomach pain (abdominal pain upper) and the pressure increased (hypertension) (onset, latency: unknown).Patient was instructed by the doctor to wean the corticosteroid and continue the use of ketoprofen.The patient said her heart was racing (palpitations), high blood pressure (hypertension), something she never had.It upset the patient.She discontinued the medicine on her own.She called the doctor who had done hylan g-f 20, sodium hyaluronate's application and prescribed the drug and said she would no longer take the corticosteroid.Patient said she recovered from all the symptoms, she swelled, she's no longer with any sign she's had before.Before, her eye wouldn't even open (ocular discomfort).The patient related these events to the use of corticosteroids, because when she weaned corticosteroids, the events began to improve visibly but reported that ketoprofen was very weak as her pains returned.It was also reported that the fan and rheumatoic factor tests were negative, but vitamin d3 (hydroxy 25) was 110 which is above the desirable one that is up to 100 (reference value) (vitamin d increased).Patient was waiting for a period to retake vitamin d and would return to rheumatologist and informed that she was currently locked and still in pain.Patient reported that the only thing she still had was that her pressure still fluctuates.Before the drug, her blood pressure was low, 110mmhgx80mmhg, 120mmhgx70mmhg, rarely reached 120mmhgx80mmhg.After the drug, her blood pressure reached 21 (as reported).She still has it sometimes, gets a snap to her head (head discomfort).The general practitioner prescribed her the drug losartan potassium (corus) as a treatment and told her to only take this medicine when she had any symptoms.So, when she saw she's high on blood pressure, she took a tablet.Patient did not understand why the doctor prescribed these drugs prednisone and ketoprofen.She said that the other times she used hylan g-f 20, sodium hyaluronate with other doctors, the doctor had not passed anything, nor anti-inflammatory.You told her to take dipyrone only if she had pain.The other times the applications were very fast.This time, it was time consuming, she applied a corticosteroid together and an anesthetic.She said it wasn't until she did the application on her shoulders that the doctor had given her anesthesia before hylan g-f 20, sodium hyaluronate.It was reported that during the consultation with the doctor now on (b)(6) 2020, she said she had only one hylan g-f 20, sodium hyaluronate in the clinic and she would ask for more over the internet.The first application was on (b)(6) 2020, in which she applied what she had in the clinic and on (b)(6) 2020 she made the next application, when more medicines arrived.She said this doctor passed the lot numbers to her and it was the first time a doctor passed the lot on to her.He said the four products had the same batch, even though the doctor bought some of the products later.The other times she used it; it had a very fast effect and good result, 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, 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 has doubts about the origin of hylan g-f 20, sodium hyaluronate of this application.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; onset: 2020; latency: unknown).She was just passing ointment on her arm, took miorrelax and novalgina because she was throbbing her shoulders and knees.She said she was going to do hylan g-f 20, sodium hyaluronate application 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 this product is not as good as hylan g-f 20, sodium hyaluronate, because she was already with shoulder pain, did not help anything.Action taken: not applicable for all events with hylan g-f 20, sodium hyaluronate; not applicable for device ineffective, suspected counterfeit product; unknown for vitamin d increased, and drug withdrawn for rest of the events with prednisone.Corrective treatment: losartan potassium for drug hypersensitivity; ketoprofen and prednisone for device ineffective; not reported for rest of the events outcome: not applicable for device ineffective, suspected counterfeit product; unknown for vitamin d increased, and drug hypersensitivity, not recovered for head discomfort, hypertension; recovered for rest of the events reporter causality: not related for drug hypersensitivity with hylan g-f 20, sodium hyaluronate; related for drug hypersensitivity with prednisone a product technical complaint (ptc) was initiated on 02-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 are 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 has 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 event did not obtain the expected result/ lack of result updated to did not obtain the expected result/ lack of result/zero results/no effect.Reporter causality updated for the cushing syndrome and its symptoms to not related for synvisc one.Clinical course updated.Text amended accordingly.
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Event Description
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This was because of the corticosteroid, that she must have some allergy to her [specific allergy (drug)] ([swelling], [blood pressure high], [acne steroid-induced], [eye discomfort], [swelling face], [heart racing], [head pressure], [cushing's syndrome, 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 nos] did not obtain the expected result/ lack of result/zero results/no effect/negative result/didn't get any results [device ineffective] received the application on the left hip via im route [off label use of device] distrusts the product, thinks that the original drug was not applied this time [suspected counterfeit product] case narrative: initial information received on (b)(6) 2020 from brazil regarding an unsolicited valid serious case received from patient.This case is linked to cases (b)(4), (multiple devices) and (b)(4) (same patient).This case involves 69 year old female patient (height: 165 cm, weight: 60 kg) who was treated with prednisone (meticorten) and hylan g-f 20, sodium hyaluronate (synvisc one) and experienced this was because of the corticosteroid, that she must have some allergy to her, stomach pain, vitamin d3 (hydroxy 25) was 110 which is above the desirable one that is up to 100 (reference value), did not obtain the expected result/ lack of result/zero results/no effect/negative result/didn't get any results, received the application on the left hip via im route and distrusts the product, thinks that the original drug was not applied this time.The patient's past medical treatment(s), history and family history were not provided.The patient had ongoing shoulder pain.Concomitant medications included calcium collagen.On (b)(6) 2020, the patient received hylan g-f 20, sodium hyaluronate injection (strength: 6 ml) application on the left hip once at unknown dose (batch number: 9rsl017) via intramuscular (im) route for viscosupplementation (off label use of device as injection given in hip via intramuscular route).The application was made by a physician and a reputable clinic.The hip procedure was guided by ultrasound and everything went well.On the unknown date of 2020, after 1 and a half months of taking of the product, patient reported that she did not obtain the expected result (device ineffective).Due to lack of result of application of hylan g-f 20, sodium hyaluronate, the patient was prescribed with prednisone and ketoprofen (profenid) as corrective treatment.On the unknown date in 2020, patient started prednisone (formulation, strength, dosage, indication, frequency: unknown) and ketoprofen.On the unknown date in 2020, after unknown latency, patient's face and body swelled absurdly, got an absurd jowl (swelling) (swelling face) and also presented an allergy in the middle of face.Due to allergy, patient consulted with a general practitioner, who mentioned 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) and as per the doctor the symptoms were sure to be a reaction to corticosteroids, that she must have some allergy to her (drug hypersensitivity; onset: 2020; latency: unknown, event assessed as medically significant).She said that some people presented reactions with this corticosteroid, but that's never as sharp as it was for the patient.In addition to these events, the patient also reported stomach pain (abdominal pain upper) and the pressure increased (hypertension) (onset, latency: unknown).Patient was instructed by the doctor to wean the corticosteroid and continue the use of ketoprofen.The patient said her heart was racing (palpitations), high blood pressure (hypertension), something she never had.It upset the patient.She discontinued the medicine on her own.She called the doctor who had done hylan g-f 20, sodium hyaluronate's application and prescribed the drug and said she would no longer take the corticosteroid.Patient said she recovered from all the symptoms, and the swelling reduced, she's no longer with any sign she's had before.Before, her eye wouldn't even open (ocular discomfort).The patient related these events to the use of corticosteroids, because when she weaned corticosteroids, the events began to improve visibly but reported that ketoprofen was very weak as her pains returned.It was also reported that the fan (expanded form not available) and rheumatoic factor tests were negative, but vitamin d3 (hydroxy 25) was 110 which is above the desirable one that is up to 100 (reference value) (vitamin d increased).Patient was waiting for a period to retake vitamin d and would return to rheumatologist and informed that she was currently locked and still in pain.Patient reported that the only thing she still had was that her pressure still fluctuates.Before the drug, her blood pressure was low, 110mmhgx80mmhg, 120mmhgx70mmhg, rarely reached 120mmhgx80mmhg.After the drug, her blood pressure reached 21 (as reported).She still has it sometimes, felt a pressure in her head (head discomfort).The general practitioner prescribed her the drug losartan potassium (corus) as a treatment and told her to only take this medicine when she had any symptoms.So, when she saw she's high on blood pressure, she took a tablet.Patient did not understand why the doctor prescribed these drugs prednisone and ketoprofen.She said that the other times she used hylan g-f 20, sodium hyaluronate with other doctors, the doctor had not passed anything, nor anti-inflammatory.The physician told her to take dipyrone only if she had pain.The other times the applications were very fast.This time, it was time consuming, she applied a corticosteroid together and an anesthetic.She said it was only when she did the application on her shoulders that the doctor had given her anesthesia before hylan g-f 20, sodium hyaluronate.It was reported that during the consultation with the doctor now on (b)(6) 2020, she said she had only one hylan g-f 20, sodium hyaluronate in the clinic and she would ask for more over the internet.The first application was on (b)(6) 2020, in which she applied what she had in the clinic and on (b)(6) 2020 she made the next application, when more medicines arrived.She said this doctor passed the lot numbers to her and it was the first time a doctor passed the lot on to her.He said the four products had the same batch, even though the doctor bought some of the products later.The other times she used it; it had a very fast effect and good result, 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, 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).It was reported that result according to site and bull, would be for after a month, which did not occur and patient didn't get any results.The patient has doubts about the origin of hylan g-f 20, sodium hyaluronate of this application and was suspicious of the quality of the drug as she always made the use of the product and this time did not feel the expected effect that always has.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; onset: 2020; latency: unknown).She was just passing ointment on her arm, took miorrelax and novalgina because she was throbbing her shoulders and knees.She said she was going to do hylan g-f 20, sodium hyaluronate application 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 this product is not as good as hylan g-f 20, sodium hyaluronate, because she was already with shoulder pain, did not help anything.Patient was requested the numbers regarding the batches of products, which she sent promptly, after a call on the cell phone, from then i received no further return.Patient sent emails, no answers and now was in via chat.The attendants claimed that in addition to the seals of the lot numbers, patient would have to send sample of the syringes used, which were discarded in the clinic itself where the procedures were performed.This information was not listed in the label and on the websites that inform you about the product.Patient had done these procedures for over 4 years (successfully) and this was the first time the doctor provided the stamps of the batch numbers.Patient said that if there was a possibility of a failure in the viscosupplementation result with hylan g-f 20, sodium hyaluronate, it should be included at least in the label, that these items, lot number and product residue, should be stored until the result of the procedure, provided after 30 days.It was an expensive product that promises positive results, smaller or greater, patient had a substantial expense with the procedures, with negative result.Patient said that users should be warned to store batch numbers and especially the syringe with residues of the product used.It was mentioned that same buys the drug in a private clinic, where he takes the money out of his own pocket, were 4 injections where it came out in the damage.It was reported that patient followed the guidelines of the post but have not obtained any results until today (reported on (b)(6) 2020), for more than 2 full months.Action taken: not applicable for all events with hylan g-f 20, sodium hyaluronate; not applicable for device ineffective, off label use of device, suspected counterfeit product; unknown for vitamin d increased, and drug withdrawn for rest of the events with prednisone.Corrective treatment: losartan potassium for drug hypersensitivity; ketoprofen and prednisone for device ineffective; not reported for rest of the events outcome: not applicable for device ineffective, off label use of device, suspected counterfeit product; unknown for vitamin d increased, and drug hypersensitivity, not recovered for head discomfort, hypertension; recovered for rest of the events reporter causality: not related for drug hypersensitivity with hylan g-f 20, sodium hyaluronate; related for drug hypersensitivity with prednisone a product technical complaint (ptc) was initiated on (b)(6) 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 are 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 has 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 event did not obtain the expected result/ lack of result updated to did not obtain the expected result/ lack of result/zero results/no effect.Reporter causality updated for the cushing syndrome and its symptoms to not related for synvisc one.Clinical course updated.Text amended accordingly.Additional information was received on 10-nov-2020 from patient via social media.Verbatim of event received the application on the right hip updated to received the application on the left hip via im route and for event did not obtain the expected result/ lack of result/zero results/no effect to did not obtain the expected result/ lack of result/zero results/no effect/negative result/didn't get any results.Batch number and route of administration added for the suspect.Patient demographics updated.Clinical course updated.Text amended accordingly.
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