| Lot Number 9RSL017 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Abdominal Pain (1685); Hypersensitivity/Allergic reaction (1907); High Blood Pressure/ Hypertension (1908); 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 a cushing's syndrome [cushing's syndrome, steroid-induced], ([swelling of face], [acne steroid-induced], [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 have effect [device ineffective].Case narrative: initial information from (b)(6) received on 01-sep-2020 regarding an unsolicited valid serious case received from the patient.This case is linked to cases (b)(4) (same patient).This case involves an unknown age female patient who experienced a reaction that could be the onset of a cushing's syndrome, stomach pain and vitamin d3 (hydroxy 25) was 110 which is above the desirable one that is up to 100 (reference value) while she was treated with prednisone and hylan g-f 20, sodium hyaluronate (synvisc one) which did not have effect (device ineffective).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On (b)(6) 2020, the patient received hylan g-f 20, sodium hyaluronate at unknown dosage via unknown (with an unknown batch number) for unknown indication in left knee.Information regarding batch number has been requested.Patient reported that she did not have effect with hylan g-f 20, sodium hyaluronate (device ineffective) after the product administration.As corrective treatment the lack of result of the application of hylan g-f 20, sodium hyaluronate the patient was prescribed a corticosteroid and an anti-inflammatory, which were meticortem (prednisone) and profenid (ketoprofen).On an unknown date patient started using prednisone (form, route, frequency, dose and batch number: unknown) for device ineffective.Patient informed that after the use of the medication she turned into a monster because she presented all possible side effects that included her face and body being swelled absurdly, she got an absurd jowl and also presented an allergy in the middle of the face.Due to this allergy, the patient had to go to general practitioner, who reported that this allergy was a type of acne typically caused by corticosteroids and could be the onset of a cushing's syndrome (cushing's syndrome; onset: 2020; latency: few days).Patient also reported that she had stomach pain (abdominal pain; onset: 2020; latency: few days) and the pressure increased (blood pressure increased; onset: 2020; latency: few days).Doctor instructed her 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.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 then return to rheumatologist.She was currently locked and in pain.Action taken: not applicable for all events with hylan g-f 20, sodium hyaluronate; not applicable for did not have effect and drug withdrawn for rest of the events with prednisone and unknown for vitamin d increased with prednisone.Corrective treatment: not reported for all events.The patient outcome is reported as not applicable for did not have effect without adverse event; unknown for vitamin d increased; recovering for rest of the events.A product technical complaint was initiated and the results for the same were pending.Reporter causality: related with prednisone for could be the onset of a cushing's syndrome (the patient related the events presented to the use of corticosteroids, because when she weaned the events began to improve visibly).
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Event Description
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Could be the onset of a cushing's syndrome [cushing's syndrome, steroid-induced] ([swelling of face], [acne steroid-induced], [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 have effect [device ineffective].Case narrative: initial information from brazil received on 01-sep-2020 regarding an unsolicited valid serious case received from the patient.This case is linked to cases (b)(4).This case involves an unknown age female patient who experienced a reaction that could be the onset of a cushing's syndrome, stomach pain and vitamin d3 (hydroxy 25) was 110 which is above the desirable one that is up to 100 (reference value) while she was treated with prednisone and hylan g-f 20, sodium hyaluronate (synvisc one) which did not have effect (device ineffective).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On (b)(6) 2020, the patient received hylan g-f 20, sodium hyaluronate at unknown dosage via unknown (with an unknown batch number) for unknown indication in left knee.Information regarding batch number has been requested.Patient reported that she did not have effect with hylan g-f 20, sodium hyaluronate (device ineffective) after the product administration.As corrective treatment the lack of result of the application of hylan g-f 20, sodium hyaluronate the patient was prescribed a corticosteroid and an anti-inflammatory, which were meticortem (prednisone) and profenid (ketoprofen).On an unknown date patient started using prednisone (form, route, frequency, dose and batch number: unknown) for device ineffective.Patient informed that after the use of the medication she turned into a monster because she presented all possible side effects that included her face and body being swelled absurdly, she got an absurd jowl and also presented an allergy in the middle of the face.Due to this allergy, the patient had to go to general practitioner, who reported that this allergy was a type of acne typically caused by corticosteroids and could be the onset of a cushing's syndrome (cushing's syndrome; onset: 2020; latency: few days).Patient also reported that she had stomach pain (abdominal pain; onset: 2020; latency: few days) and the pressure increased (blood pressure increased; onset: 2020; latency: few days).Doctor instructed her 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.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 then return to rheumatologist.She was currently locked and in pain action taken: not applicable for all events with hylan g-f 20, sodium hyaluronate; not applicable for did not have effect and drug withdrawn for rest of the events with prednisone and unknown for vitamin d increased with prednisone.Corrective treatment: not reported for all events.The patient outcome is reported as not applicable for did not have effect without adverse event; unknown for vitamin d increased; recovering for rest of the events.Reporter causality: related with prednisone for could be the onset of a cushing's syndrome (the patient related the events presented to the use of corticosteroids, because when she weaned the events began to improve visibly) a product technical complaint (ptc) was initiated on (b)(6) 2020 for synvisc one.Batch number: unknown; global ptc number: (b)(4).The product lot number was not provided; therefore, a batch record review is not possible.Based on lack of information provided, no capa was required.It was the requirement to review all finished batch records for specification conformation prior to release.Any out of specification result is identified and mitigated through the ncr process.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 surveillance effort to detect safety signals.This review did not indicate any safety issue.Sanofi would continue to monitor adverse events to determine if a capa was required.Investigation complete date: (b)(6) 2020.Additional information was received on 22-sep-2020 from other healthcare professional (genzyme event management group).Global ptc number and its results were added.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)] ([cushing's syndrome, steroid-induced], [swelling of face], [acne steroid-induced], [heart racing], [eye discomfort], [head discomfort], [blood pressure high], [swelling]) 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 have effect/zero results [device ineffective] distrusts the product, thinks that the original drug was not applied this time [suspected counterfeit product] case narrative: initial information from brazil received on 01-sep-2020 regarding an unsolicited valid serious case received from the patient.This case is linked to cases 2020sa230681, 2020sa230857, 2020sa230860, 2020sa238465, 2020sa238481 (multiple devices for same patient) and 2020sa238490 (same patient).This case involves an unknown age female patient who was treated with prednisone 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 have effect/zero results and distrusts the product, thinks that the original drug was not applied this time.The patient's past vaccination(s) and family history were not provided.Patient previously had treatment with hylan g-f 20, sodium hyaluronate in both shoulders 2 years ago and had quick results.The past medical history included shoulder pain.It was reported that during the consultation with the doctor 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.On (b)(6)2020, the patient received hylan g-f 20, sodium hyaluronate at unknown dosage via unknown (with an unknown batch number) for unknown indication in left knee.Information regarding batch number has been requested.Patient reported that she did not have effect with hylan g-f 20, sodium hyaluronate (device ineffective) after the product administration.As corrective treatment the lack of result of the application of hylan g-f 20, sodium hyaluronate the patient was prescribed a corticosteroid and an anti-inflammatory, which were prednisone (meticortem) and ketoprofen (profenid).On an unknown date patient started using prednisone (form, route, frequency, dose and batch number: unknown) for device ineffective.Patient informed that after the use of the medication she turned into a monster because she presented all possible side effects that included her face and body being swelled absurdly (swelling), she got an absurd jowl (swelling face) and also presented an allergy in the middle of the face (acne).Due to this allergy, the patient had to go to general practitioner, who reported that this allergy was a type of acne typically caused by corticosteroids 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.Patient also reported that she had stomach pain (abdominal pain; onset: 2020; latency: unknown) and the pressure increased (hypertension).Doctor instructed her 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 the events presented to the use of corticosteroids, because when she weaned the events began to improve visibly and believed that this had nothing to do with hylan g-f 20, sodium hyaluronate.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 then return to rheumatologist.She was currently locked and 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.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 had 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 was 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 (did not have effect/zero results, 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 did not have effect/zero results, suspected counterfeit product; unknown for vitamin d increased, and drug hypersensitivity; not recovered for head discomfort and abdominal pain upper, 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.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 complete date: (b)(6)2020 additional information was received on 22-sep-2020 from other healthcare professional (genzyme event management group).Global ptc number and its results were added.Clinical course updated.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 have effect updated to did not have effect/zero results.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)] ([cushing's syndrome, steroid-induced], [swelling of face], [acne steroid-induced], [heart racing], [eye discomfort], [head pressure], [blood pressure high], [swelling]) 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] there was no effect/not having result/not working/ did not obtain the expected result/ had zero results /negative result [device ineffective] distrusts the product, thinks that the original drug was not applied this time [suspected counterfeit product] synvisc one was given by intramuscular route (right knee) [off label use of device] case narrative: initial information from brazil received on (b)(6) 2020 regarding an unsolicited valid serious case received from the patient.This case is linked to cases (b)(4) (multiple devices for same patient) and (b)(4) (same patient).This case involves 68 years old female patient (165 cm and 60 kg) who was treated with prednisone 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), there was no effect/not having result/not working/ did not obtain the expected result/ had zero results /negative result, synvisc one was given by intramuscular route (right knee) and distrusts the product, thinks that the original drug was not applied this time.The patient's past vaccination(s) and family history were not provided.Patient previously had treatment with hylan g-f 20, sodium hyaluronate in both shoulders 2 years ago and had quick results.The past medical history included shoulder pain.Concomitant medication included calcium collagen as a vitamin.It was reported that during the consultation with the doctor 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.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 knee via im (intramuscular) route (off label use of device) for viscosupplementation for joints and knee pain.Information regarding batch number has been requested.Patient reported that she did not have effect with hylan g-f 20, sodium hyaluronate (device ineffective) after the product administration.As corrective treatment the lack of result of the application of hylan g-f 20, sodium hyaluronate the patient was prescribed a corticosteroid and an anti-inflammatory, which were prednisone (meticortem) and ketoprofen (profenid).On an unknown date patient started using prednisone (form, route, frequency, dose and batch number: unknown) for device ineffective.Patient informed that after the use of the medication she turned into a monster because she presented all possible side effects that included her face and body being swelled absurdly (swelling), she got an absurd jowl (swelling face) and also presented an allergy in the middle of the face (acne).Due to this allergy, the patient consulted her general practitioner, who reported that this allergy was a type of acne typically caused by corticosteroids 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.Patient also reported that she had stomach pain (abdominal pain; onset: 2020; latency: unknown) and the pressure increased (hypertension).Doctor instructed her 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, 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 the events presented to the use of corticosteroids, because when she weaned the events began to improve visibly and believed that this had nothing to do with hylan g-f 20, sodium hyaluronate.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 then return to rheumatologist.She was currently locked and 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.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 had 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 was not as good as hylan g-f 20, sodium hyaluronate, because she was already with shoulder pain, did not help anything.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 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 hypertension; 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 and abdominal pain upper, 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.Batch number: unknown; 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 complete date: (b)(6) 2020 additional information was received on (b)(6) 2020 from other healthcare professional (b)(6).Global ptc number and its results were added.Clinical course updated.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 have effect updated to did not have effect/zero results.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 event device ineffective updated.Event of synvisc one was given by intramuscular route (right knee) added.Indication and batch number of suspect added.Patient demographics updated.Concomitant medication added.Clinical course updated.Text amended accordingl.
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