| Lot Number CRSP016 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Swelling/ Edema (4577); Peripheral Edema (4578)
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| Event Date 09/01/2023 |
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Event Type
Injury
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Event Description
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Swelling is very exacerbated [injection site joint swelling] ([condition aggravated]).Unable to walk [unable to walk].Joint pain, worsening pain, pain is somewhat annoying/pulling pain in the back of the knee (popliteal fossa) [injection site joint pain] ([condition aggravated]).Unable to bend her knee at all, as a sequel, has experienced increased stiffness/stiffness in the knee was the most severe [stiff knees] ([condition aggravated], [joint range of motion decreased]).Did not felt improvement with any of the applications/it did not work for her/did not see any improvement at all with no reported adverse event [device ineffective].Received application of half a vial for each knee with no reported adverse event [incorrect dose administered].Received application of half a vial for each knee with no reported adverse event [wrong technique in device usage process].Case narrative: initial information received from mexico on (b)(6) 2023 regarding an unsolicited valid serious case received from a patient.This case is linked to case (b)(4).(multiple device suspect used for the same patient).This case involves an adult female patient who was unable to walk, swelling is very exacerbated, joint pain, worsening pain, pain is somewhat annoying/pulling pain in the back of the knee (popliteal fossa), unable to bend her knee at all, as a sequel, has experienced increased stiffness/stiffness in the knee was the most severe, did not felt improvement with any of the applications/it did not work for her/did not see any improvement at all and received application of half a vial for each knee with no reported adverse event, while being treated with medical device hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical treatment(s), vaccination(s) and family history were not provided.At the time of onset patient had ongoing: knee osteoarthritis, hypertension for 3 years, gastritis for 15 years, fibromyalgia for 10 years and arthritis for 33 years.Concomitant medications included methotrexate, chloroquine, folic acid and celecoxib.The patient purchased 5 devices of synvisc, and on (b)(6) 2023, the patient started treatment with synvisc for osteoarthritis of the knees, with a dosing regimen of 1 injection every week on each knee by medical indication.In (b)(6) 2023, the patient received the fifth injection of synvisc (hylan g-f 20, sodium hyaluronate) solution for injection (strength: 16mg/2ml) at a dose of 2ml weekly but received application of half a vial for each knee (incorrect dose administered and wrong technique in device usage process, onset date: (b)(6) 2023, latency: same day, intensity: mild) (batch number:crsp016, expiry date:15-sep-2025, with an unknown route) as treatment for knee osteoarthritis.The medication error occurred at the prescription stage, by her physical therapist, who prescribed this dosage regimen according to the damage on her knees.The patient mentioned that the medication error did not cause her any damage, however, she did not see any improvement at all (device ineffective, onset date: 2023, latency: unknown, intensity: mild).The patient did not felt improvement with any of the applications (device ineffective, onset date: 2023, latency: unknown, intensity: mild).Since (b)(6) 2023 (latency: unknown), the patient began to experience inability to walk (gait inability, intensity: moderate) and stiffness in the knee (joint stiffness, intensity: severe).The patient had not recovered from these adverse events, and as a sequel, has experienced increased stiffness (joint stiffness) (condition aggravated).She was unable to bend the knee that had more wear and tear (joint range of motion decreased, onset date: (b)(6) 2023, latency: unknown).The stiffness in the knee was the most severe, because at the beginning she could bend a little, but at the time of the report she could no longer do so.Since (b)(6) 2023 (latency: unknown), the patient began to experience joint pain, worsening pain, pain was somewhat annoying and now with pulling pain in the back of the knee (popliteal fossa) (injection site joint pain) (condition aggravated) (intensity: moderate).Since (b)(6) 2023 (latency: unknown), the patient started experiencing swelling which was very exacerbated (injection site joint swelling) (condition aggravated).Additionally, the patient reported that the product had a very high price and she made her best effort to buy it and it did not work for her, so she felt desperate.On (b)(6) 2023, the swelling decreased by half, due the patient administering an injection of betamethasone (hypack).The patient does not believe that the adverse events were caused by the treatment with synvisc.Action taken: not applicable for all events.Corrective treatment: performed physical therapies, applied heat packs, massage, ultrasound, laser, rehabilitation exercises and swimming for joint stiffness and gait inability; application of hot and cold compresses, as prescribed by physiotherapist and injection of betamethasone for injection site joint swelling; undergoing therapy and taking unspecified medications for injection site joint pain.At time of reporting, the outcome was recovering for injection site joint swelling and injection site joint pain, not recovered for gait inability and joint stiffness, unknown for rest of the events.A product technical complaint (ptc) was initiated on 05-sep-2023 for synvisc (lot/batch number: unknown) with global ptc number: (b)(4).The sample of the ptc was not available and the ptc stated preliminary assessment: based on the complaint from intake team, there is no quality related defect that would attribute to a malfunction a death or serious injury.Sanofi global pharmacovigilance and epidemiology continuously monitors adverse event reports with or without lot numbers, and assesses possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals.The defect class has been updated to ii - (dp 06sep23).Investigation (em 14sep2023) the product lot number was not provided.A batch record review is not possible.Based on the lack of information, no assessment is possible.It is the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result is identified and mitigated through the nonconforming material or product process.Sanofi will continue to monitor adverse events and perform trend analysis on a periodic basis to determine if a capa(corrective and preventive action) is required.The final investigation was completed on 18-sep-2023 with summarized conclusion as no assessment possible.Additional information was received on (b)(6) 2023 from patient along with live follow-up dated (b)(6) 2023 from quality department via other health care professional, both processed together with clock start date of (b)(6) 2023: based on the information received from patient, the case initially processed as non-serious was upgraded to a serious case.New events added: incorrect dose administered and wrong technique in device usage process.Joint range of motion and condition aggravated added as symptoms of joint stiffness.Event of arthralgia was updated to injection site joint pain with symptom condition aggravated.Event of joint swelling was updated to injection site joint swelling.Event of device use issue was deleted.As reported event verbatim, event onset date, and outcome for events injection site joint swelling, injection site joint pain, joint stiffness was updated.Concurrent conditions, concomitant medications and corrective treatment was added.Therapy start date, batch number, expiry date, strength and formulation updated for suspect.Ptc number and results were added.Clinical course was updated and text was amended.
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Event Description
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She cannot walk.[unable to walk].Started having pain, inflammation and stiffness/has increased [injection site joint inflammation] ([injection site joint pain], [stiff knees], [condition aggravated], [joint range of motion decreased]).Did not felt improvement with any of the applications/it did not work for her/did not see any improvement at all/had no effect and she did not improve or perceive any change/have not had any improvement, i feel worse with no ae [device ineffective].Received application of half a vial for each knee/patient applied the fifth and last synvi device: half dose on the right knee and half dose on the left knee with no reported adverse event [incorrect dose administered].Received application of half a vial for each knee/patient applied the fifth and last synvi device: half dose on the right knee and half dose on the left knee with no reported adverse event [wrong technique in device usage process].Medication error occurred at the prescription stage, by her physical therapist, who prescribed this dosage regimen according to the damage on her knees /five administrations of synvisc in the right knee with no reported adverse event [product prescribing error].Case narrative: initial information received from mexico on 05-sep-2023 regarding an unsolicited valid serious case received from a patient.This case is linked to case (b)(4).(multiple device suspect used for the same patient) and (b)(4) (duplicates).This case involves an 56 years old female patient who cannot walk, started having pain, inflammation and stiffness/has increased, did not felt improvement with any of the applications/it did not work for her/did not see any improvement at all/had no effect and she did not improve or perceive any change/have not had any improvement, feel worse/ don't see feel anything, on the contrary i feel worse with no ae(adverse event), received application of half a vial for each knee/patient applied the fifth and last synvisc device: half dose on the right knee and half dose on the left knee with no reported adverse event, and medication error occurred at the prescription stage, by her physical therapist, who prescribed this dosage regimen according to the damage on her knees/five administrations of synvisc in the right knee were prescribed as treatment for osteoarthritis and exacerbated pain caused by the underlying disease with no reported adverse event while being treated with medical device hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical treatment(s), vaccination(s) and family history were not provided.The patient's past medical treatment(s), vaccination(s) and family history were not provided.At the time of onset patient had ongoing: knee osteoarthritis, rheumatoid arthritis, hypertension since 3 years, gastritis since 15 years, fibromyalgia since 10 years and arthritis since 33 years the patient has not suffered from other relevant diseases in her medical history and has not undergone surgery.Concomitant medications included methotrexate, chloroquine, folic acid, celecoxib and betamethasone for joint swelling.The patient purchased 5 devices of synvisc.On (b)(6) 2023, the patient started treatment with synvisc (hylan g-f 20) 2 ml, by medical indication, due to cartilage wear, administering a full dose in the right knee.The patient received the second full dose of the medication fifteen days after the first administration.Then, she received subsequent administrations of synvisc every 8 days.All injections were administered by her physical therapist physician.On (b)(6) 2023, the patient started treatment with a complete dose of synvisc on the right knee.Fifteen days after, patient received the second full dose of synvisc on the right knee.Eight days after, patient received the third full dose of synvisc on the right knee.Eight days after, patient applied the fourth synvisc device: half dose on the right knee and half dose on the left knee.Since (b)(6) 2023, the patient began to experience inability to walk and stiffness in the knee, previously reported.As corrective treatment she performed physical therapies, applied heat packs, massage, ultrasound, laser, rehabilitation exercises and swimming.The patient has not recovered from these adverse events, and as a sequel, has experienced increased stiffness.She is unable to bend the knee that had more wear and tear and now with pulling pain in the back of the knee.Patient started experiencing swelling.As corrective treatment she performed application of hot and cold compresses, as prescribed by her physiotherapist.The swelling decreased by half, due the patient administering an injection of betamethasone (hypack).At the time of reporting, the patient was in recovery for this adverse event.As corrective treatment, she was undergoing therapy and taking unspecified medications.On 30-aug-2023, the patient received the fifth injection of synvisc (hylan g-f 20, sodium hyaluronate) solution for injection (strength: 16mg/2ml) at a dose of 2ml weekly but received application of half a vial for each knee(half dose on the right knee and half dose on the left knee) (incorrect dose administered and wrong technique in device usage process, onset date: (b)(6) 2023, latency: same day, intensity: mild) via intra-articular route (batch number:crsp016, expiry date:15-sep-2025) treatment for knee osteoarthritis.On (b)(6) 2023 the patient developed a non-serious event "cannot walk" (gait inability) (latency: 6 days; intensity: moderate) following the first dose intake of hylan g-f 20 and sodium hyaluronate.On (b)(6) 2023 the patient developed a non-serious event "started having pain, inflammation and stiffness/has increased" (injection site joint inflammation) (injection site joint pain) (joint stiffness) (condition aggravated) (latency: 6 days; intensity: moderate) following the first dose intake of hylan g-f 20 and sodium hyaluronate.In sep-2023 the patient developed a non-serious event "at the beginning she could bend a little, but at the time of the report she could no longer do so" (joint range of motion decreased) (few weeks: latency) following the first dose intake of hylan g-f 20 and sodium hyaluronate.In 2023 the patient developed a non-serious event "did not felt improvement with any of the applications/it did not work for her/did not see any improvement at all/had no effect and she did not improve or perceive any change/have not had any improvement, feel worse with no ae "(device ineffective) (few weeks: latency) following the first dose intake of hylan g-f 20 and sodium hyaluronate.In 2023 the patient developed a non-serious event "medication error occurred at the prescription stage, by her physical therapist, who prescribed this dosage regimen according to the damage on her knees/five administrations of synvisc in the right knee were prescribed as treatment for osteoarthritis and exacerbated pain caused by the underlying disease with no reported adverse event" (product prescribing error) (unknown latency) following the first dose intake of hylan g-f 20 and sodium hyaluronate.It was reported "the medication error occurred at the prescription stage, by her physical therapist, who prescribed this dosage regimen according to the damage on her knees.The patient mentioned that the medication error did not cause her any damage, however, she did not see any improvement at all, and the stiffness in the knee was the most severe, because at the beginning she could bend a little, but at the time of the report she could no longer do so.On (b)(6) 2023, patient applied the fifth and last synvi device: half dose on the right knee and half dose on the left knee.The patient used a total of 5 synvisc devices, all reported with lot number: crsp016, and expiration date: 15-sep-2023, as the patient purchased all the devices in a single exhibition.The five administrations of synvisc in the right knee were prescribed as treatment for osteoarthritis and exacerbated pain caused by the underlying disease.Because the left knee was beginning to bother and hurt, the drug was also applied to the left knee to counteract the problem.Patient reported that the inability to walk, joint pain in the knees, joint swelling in the knees and joint stiffness were experienced before treatment with synvisc, and she applied synvisc to relieve these symptoms, but had no effect and she did not improve or perceive any change with the treatment with synvisc.Patient have not had any improvement, patient feel worse.Patient need to know why patient don't see any improvement in myself, patient bought 5 vials and patient administer one every week in my knee, patient just finished my treatment and patient don't see feel anything, on the contrary patient feel worse.What could be happening, patient have osteoarthritis, as well as rheumatoid arthritis and fibromyalgia.The referenced number is contacted where the patient's niece answers who reports that two incomplete dose were administered in the left knee and the rest in the right knee, as well as three more complete doses in the right knee, last dose was administered on wednesday, 30 august 2023.Started having pain, inflammation and stiffness in both knees on tuesday, 5 september 2023 and it has increased, she cannot walk." action taken: not applicable for all events.Corrective treatment: not reported for all events.At time of reporting, the outcome was not recovered for gait inability and injection site joint inflammation; unknown for rest of the events.A product technical complaint (ptc) was initiated on 05-sep-2023 for synvisc (lot/batch number: unknown) with global ptc number: 100357655.The sample of the ptc was not available and the ptc stated.Preliminary assessment: based on the complaint from intake team, there is no quality related defect that would attribute to a malfunction a death or serious injury.Sanofi global pharma-covigilance and epidemiology continuously monitors adverse event reports with or without lot numbers, and assesses possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals.The defect class has been updated to ii - (dp 06sep23).Investigation (em 14sep2023) the product lot number was not provided.A batch record review is not possible.Based on the lack of information, no assessment is possible.It is the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result is identified and mitigated through the nonconforming material or product process.Sanofi will continue to monitor adverse events and perform trend analysis on a periodic basis to determine if a capa(corrective and preventive action) is required.The final investigation was completed on 18-sep-2023 with summarized conclusion as no assessment possible.Additional information was received on 17-sep-2023 from patient along with live follow-up dated 18-sep-2023 from quality department via other health care professional, both processed together with clock start date of 17-sep-2023: based on the information received from patient, the case initially processed as non serious was upgraded to a serious case.New events added: incorrect dose administered and wrong technique in device usage process.Joint range of motion and condition aggravated added as symptoms of joint stiffness.Event of arthralgia was updated to injection site joint pain with symptom condition aggravated.Event of joint swelling was updated to injection site joint swelling.Event of device use issue was deleted.As reported event verbatim, event onset date, and outcome for events injection site joint swelling, injection site joint pain, joint stiffness was updated.Concurrent conditions, concomitant medications and corrective treatment was added.Therapy start date, batch number, expiry date, strength and formulation updated for suspect.Ptc number and results were added.Clinical course was updated and text was amended.Additional information was received on 17-sep-2023 from patient (significant) with live followup on 20-sep-2023 from patient (significant) and on internal review on 23-sep-2023, the case (b)(4) (to be deleted) was identified to be duplicate of (b)(4) (to be retained).All the information from the case (b)(4) has been merged in the case (b)(4).Case (b)(4) with csd of 05-sep-2023, would be deleted: (processed together with csd 17-sep-2023): based on this information, the case initially considered as serious was downgraded to non-serious.As reported term of event device ineffective update; event of product prescribing error added.Age added; medical history added; route added; therapy start date added; as reported term of event device ineffective updated; onset date of all events updated; event of injection site joint inflammation, onset date of event incorrect dose administered updated; event of injection site joint swelling with symptom condition aggravated deleted; as reported term of event gait inability updated; as reported term of event joint stiffness updated; as reported term of event incorrect dose administered, wrong technique in device usage process updated; event of injection site joint pain, joint stiffness and condition aggravated was made as symptom to newly added event of injection site joint inflammation, related case ids added; clinical course was updated and text was amended.Local comments: *downgrade.*.
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Event Description
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Swelling is very exacerbated [injection site joint swelling] ([condition aggravated]) started having pain, inflammation and stiffness/has increased [injection site joint inflammation] ([injection site joint pain], [stiff knees], [condition aggravated], [unable to walk], [joint range of motion decreased]).Did not felt improvement with any of the applications/it did not work for her/did not see any improvement at all/had no effect and she did not improve or perceive any change/have not had any improvement, i feel worse with no ae [device ineffective].Received application of half a vial for each knee/patient applied the fifth and last synvi device: half dose on the right knee and half dose on the left knee with no reported adverse event [incorrect dose administered].Received application of half a vial for each knee/patient applied the fifth and last synvi device: half dose on the right knee and half dose on the left knee with no reported adverse event [wrong technique in device usage process].Five administrations of synvisc on right knee were prescribed as treatment for oa and exacerbated pain caused by underlying disease/error occurred at prescription stage by physical therapist prescribed dosage regimen due to damage on knees with no ae [product prescribing error].Case narrative: initial information received from mexico on 05-sep-2023 regarding an unsolicited valid serious case received from a patient.This case is linked to case: (b)(4) (multiple device suspect used for the same patient) and (b)(4) (duplicates).This case involves an 56 years old female patient who had product prescribing error (five administrations of synvisc on right knee were prescribed as treatment for oa and exacerbated pain caused by underlying disease/error occurred at prescription stage by physical therapist prescribed dosage regimen due to damage on knees with no ae), wrong technique in device usage process (received application of half a vial for each knee/patient applied the fifth and last synvisc device: half dose on the right knee and half dose on the left knee with no reported adverse event), device ineffective (have not had any improvement, feel worse, don't see any improvement, with any of the applications/it did not work for her/had no effect and she did not improve or perceive any change with the treatment with synvisc with no reported adverse event) and swelling was very exacerbated, started having pain, inflammation and stiffness/has increased while being treated with medical device hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical treatment(s), vaccination(s) and family history were not provided.The patient had knee osteoarthritis for 10 years since 2013, as well as rheumatoid arthritis, hypertension in 2020, gastritis (15 years ago) since 2008, arthritis for 33 years since 1990 and fibromyalgia for 10 years since 2013, inability to walk, joint pain in the knees/exacerbated pain caused by the underlying disease, joint swelling in the knees and joint stiffness.The patient has not suffered from other relevant diseases in her medical history and has not undergone surgery.Concomitant medications: metrotexate, chloroquine, folic acid, celecoxib.The patient purchased 5 devices of synvisc on (b)(6) 2023, the patient started treatment with synvisc (hylan g-f 20) 2 ml, by medical indication, due to cartilage wear, administering a full dose in the right knee.On (b)(6) 2023, the patient started treatment with a complete dose of synvisc on the right knee.Fifteen days after, patient received the second full dose of synvisc on the right knee.Eight days after, patient received the third full dose of synvisc on the right knee.Eight days after, patient applied the fourth synvisc device: half dose on the right knee and half dose on the left knee.All injections were administered by her physical therapist physician since on (b)(6) 2023, the patient began to experience inability to walk and stiffness in the knee, previously reported.As corrective treatment she performed physical therapies, applied heat packs, massage, ultrasound, laser, rehabilitation exercises and swimming.The patient has not recovered from these adverse events, and as a sequel, has experienced increased stiffness.She was unable to bend the knee that had more wear and tear and now with pulling pain in the back of the knee.Patient started experiencing swelling.As corrective treatment she performed application of hot and cold compresses, as prescribed by her physiotherapist.At the time of reporting, the patient was in recovery for this adverse event.As corrective treatment, she was undergoing therapy and taking unspecified medications.On (b)(6) 2023, the patient received the fifth injection of synvisc (hylan g-f 20, sodium hyaluronate) solution for injection (strength: 16mg/2ml) at a dose of 2ml weekly but received application of half a vial for each knee(half dose on the right knee and half dose on the left knee) (incorrect dose administered and wrong technique in device usage process, onset date: on (b)(6) 2023, latency: same day, intensity: mild) via intra-articular route (batch number: crsp016, expiry date: 30-sep-2025) treatment for knee osteoarthritis.The medication error occurred at the prescription stage, by her physical therapist, who prescribed this dosage regimen according to the damage on her knees.The five administrations of synvisc in the right knee were prescribed as treatment for osteoarthritis and exacerbated pain caused by the underlying disease (product prescribing error; onset date: 2023, latency: unknown).The patient mentioned that the medication error did not cause her any damage, however, she did not see any improvement at all (device ineffective, onset date: 2023, latency: unknown, intensity: mild).The patient did not felt improvement with any of the applications.Patient reported that the inability to walk, joint pain in the knees, joint swelling in the knees and joint stiffness were experienced before treatment with synvisc, and she applied synvisc to relieve these symptoms, but had no effect and she did not improve or perceive any change with the treatment with synvisc.Patient have not had any improvement, patient feel worse.Patient need to know why patient don't see any improvement.Patient just finished treatment and patient don't see feel anything, on the contrary patient feel worse.What could be happening, patient have osteoarthritis, as well as rheumatoid arthritis and fibromyalgia.The referenced number was contacted where the patient's niece answers who reports that two incomplete doses were administered in the left knee and the rest in the right knee, as well as three more complete doses in the right knee.The patient finished her treatment with synvisc on (b)(6) 2023, since on (b)(6) 2023 (latency: 6 days), started having pain/ worsening pain (injection site joint pain), inflammation (injection site joint inflammation), stiffness in both knees (joint stiffness) and unable to bend her knee (joint range of motion decreased) at all on (b)(6) 2023 and it has increased, she cannot walk (gait inability), leaving her unable to walk (condition aggravated).The patient reported that the swelling was very exacerbated (injection site joint swelling) (condition aggravated) (onset: on (b)(6) 2023; latency: few days) and the pain was somewhat annoying.Additionally, the patient reported that the product has a very high price and she made her best effort to buy it and it did not work for her so she feels desperate on (b)(6) 2023, the swelling decreased by half, due the patient administering an injection of betamethasone (hypack).At the time of reporting, the patient is in recovery for this adverse event.Action taken: not applicable for all events.Corrective treatment: application of hot and cold compresses, injection of betamethasone (hypack) for injection site joint swelling,physical therapies, applied heat packs, massage, ultrasound, laser, rehabilitation exercises and swimming, undergoing therapy and taking unspecified medications for injection site joint inflammation.At time of reporting, the outcome was recovering for injection site joint swelling and injection site joint inflammation; unknown for rest of the events.Reporter causality: not related for injection site joint swelling and injection site joint inflammation.A product technical complaint (ptc) was initiated on 05-sep-2023 for synvisc (lot/batch number: crsp016, expiry date: 30-sep-2025) with global ptc number: (b)(4).The sample of the ptc was not available and the ptc stated preliminary assessment: based on the complaint from intake team, there was no quality related defect that would attribute to a malfunction a death or serious injury.Sanofi global pharmacovigilance and epidemiology continuously monitors adverse event reports with or without lot numbers, and assesses possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals.The defect class has been updated to ii (dp on (b)(6) 2023) investigation (em on (b)(6) 2023).The product lot number was not provided.A batch record review is not possible.Based on the lack of information, no assessment is possible.It is the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result is identified and mitigated through the nonconforming material or product process.Sanofi will continue to monitor adverse events and perform trend analysis on a periodic basis to determine if a capa(corrective and preventive actions) is required.Reopened as per email and updated lot#: (dp 03oct2023) the production and quality control documentation for lot#: crsp016, expiration date (2025-09) was manufactured on 07oct2022 packaged (b)(4) singles were reviewed.The investigation showed that the product met specifications.No associated non-conformances were noted.Based on the lot#:, batch record review & lot#: frequency analysis for lot#: crsp016, no capa is required.As of 21sep2023, there are 5 complaints on file for lot#: crsp016 and all related sublots.5 complaints are on file for lot#: crsp016: (5) adverse event reports.Sanofi will continue to monitor complaints and trending as stated in "product event handling" to determine if a capa is required.The final investigation was completed on 03-oct-2023 with summarized conclusion as no assessment possible.Additional information was received on 17-sep-2023 from patient along with live follow-up dated 18-sep-2023 from quality department via other health care professional, both processed together with clock start date of 17-sep-2023: based on the information received from patient, the case initially processed as non serious was upgraded to a serious case.New events added: incorrect dose administered and wrong technique in device usage process.Joint range of motion and condition aggravated added as symptoms of joint stiffness.Event of arthralgia was updated to injection site joint pain with symptom condition aggravated.Event of joint swelling was updated to injection site joint swelling.Event of device use issue was deleted.As reported event verbatim, event onset date, and outcome for events injection site joint swelling, injection site joint pain, joint stiffness was updated.Concurrent conditions, concomitant medications and corrective treatment was added.Therapy start date, batch number, expiry date, strength and formulation updated for suspect.Ptc number and results were added.Clinical course was updated and text was amended.Additional information was received on 17-sep-2023 from patient (significant) with live followup on 20-sep-2023 from patient (significant) and on internal review on 23-sep-2023, the case: (b)(4) (to be deleted) was identified to be duplicate of (b)(4) (to be retained).All the information from the case: (b)(4) has been merged in the case: (b)(4).Case: (b)(4) with csd of 05-sep-2023, would be deleted: (processed together with csd 17-sep-2023): based on this information, the case initially considered as serious was downgraded to non-serious.As reported term of event device ineffective update; event of product prescribing error added.Age added; medical history added; route added; therapy start date added; as reported term of event device ineffective updated; onset date of all events updated; event of injection site joint inflammation, onset date of event incorrect dose administered updated; event of injection site joint swelling with symptom condition aggravated deleted; as reported term of event gait inability updated; as reported term of event joint stiffness updated; as reported term of event incorrect dose administered, wrong technique in device usage process updated; event of injection site joint pain, joint stiffness and condition aggravated was made as symptom to newly added event of injection site joint inflammation, related case ids added; clinical course was updated and text was amended.Additional information was received on 03-oct-2023 by quality department form other health care professional: ptc re-opened details added; expiry date updated from 15-sep-2025 to 30-sep-2025; upon internal view, the case initially considered as non-serious was updated to serious;event of injection site joint swelling added; as reported term of event injection site joint pain and gait inability updated; medical history added; treatment drug added; outcome of event injection site joint inflammation updated from not recovered to recovering; as reported term of event product prescribing error updated; clinical course was updated and text was amended.
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Event Description
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Swelling is very exacerbated [injection site joint swelling] ([condition aggravated]) started having pain, inflammation and stiffness/has increased [injection site joint inflammation] ([injection site joint discomfort], [injection site joint pain], [stiff knees], [condition aggravated], [unable to walk], [joint range of motion decreased]) did not felt improvement with any of the applications/it did not work for her/did not see any improvement at all/had no effect and she did not improve or perceive any change/have not had any improvement, i feel worse with no ae [device ineffective] five administrations of synvisc on right knee were prescribed as treatment for oa and exacerbated pain caused by underlying disease/error occurred at prescription stage by physical therapist prescribed dosage regimen due to damage on knees with no ae [product prescribing error] received application of half a vial for each knee/patient applied the fifth and last synvi device: half dose on the right knee and half dose on the left knee with no reported adverse event [incorrect dose administered] received application of half a vial for each knee/patient applied the fifth and last synvi device: half dose on the right knee and half dose on the left knee with no reported adverse event [wrong technique in device usage process] case narrative: initial information received from mexico on 05-sep-2023 regarding an unsolicited valid serious case received from a patient.This case is linked to case (b)(4) (multiple device suspect used for the same patient) and (b)(4) (duplicates).This case involves an 56 years old female patient who had product prescribing error (five administrations of synvisc on right knee were prescribed as treatment for oa and exacerbated pain caused by underlying disease/error occurred at prescription stage by physical therapist prescribed dosage regimen due to damage on knees with no ae), wrong technique in device usage process(received application of half a vial for each knee/patient applied the fifth and last synvisc device: half dose on the right knee and half dose on the left knee with no reported adverse event), device ineffective (have not had any improvement, feel worse, don't see any improvement, with any of the applications/it did not work for her/had no effect and she did not improve or perceive any change with the treatment with synvisc with no reported adverse event) and swelling was very exacerbated, started having pain, inflammation and stiffness/has increased and discomfort while being treated with medical device hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical treatment(s), vaccination(s) and family history were not provided.The patient had knee osteoarthritis for 10 years since 2013, as well as rheumatoid arthritis, hypertension in 2020, gastritis (15 years ago) since 2008, arthritis for 33 years since 1990 and fibromyalgia for 10 years since 2013, inability to walk, joint pain in the knees/exacerbated pain caused by the underlying disease, joint swelling in the knees and joint stiffness.The patient has not suffered from other relevant diseases in her medical history and has not undergone surgery.Concomitant medications: metrotexate, chloroquine, folic acid, celecoxib.The patient purchased 5 devices of synvisc.On (b)(6) 2023, the patient started treatment with synvisc (hylan g-f 20) 2 ml, by medical indication, due to cartilage wear, administering a full dose in the right knee.On (b)(6) 2023, the patient started treatment with a complete dose of synvisc on the right knee.Fifteen days after, patient received the second full dose of synvisc on the right knee.Eight days after, patient received the third full dose of synvisc on the right knee.Eight days after, patient applied the fourth synvisc device: half dose on the right knee and half dose on the left knee.All injections were administered by her physical therapist physician since (b)(6) 2023, the patient began to experience inability to walk and stiffness in the knee, previously reported.As corrective treatment she performed physical therapies, applied heat packs, massage, ultrasound, laser, rehabilitation exercises and swimming.The patient has not recovered from these adverse events, and as a sequel, has experienced increased stiffness.She was unable to bend the knee that had more wear and tear and now with pulling pain in the back of the knee.Patient started experiencing swelling.As corrective treatment she performed application of hot and cold compresses, as prescribed by her physiotherapist.At the time of reporting, the patient was in recovery for this adverse event.As corrective treatment, she was undergoing therapy and taking unspecified medications.On (b)(6) 2023, the patient received the fifth injection of synvisc (hylan g-f 20, sodium hyaluronate) solution for injection (strength: 16mg/2ml) at a dose of 2ml weekly but received application of half a vial for each knee(half dose on the right knee and half dose on the left knee) (incorrect dose administered and wrong technique in device usage process, onset date: (b)(6) 2023, latency: same day, intensity: mild) via intra-articular route (batch number:crsp016, expiry date:15-sep-2025) treatment for knee osteoarthritis.The medication error occurred at the prescription stage, by her physical therapist, who prescribed this dosage regimen according to the damage on her knees.The five administrations of synvisc in the right knee were prescribed as treatment for osteoarthritis and exacerbated pain caused by the underlying disease(product prescribing error; onset date: 2023, latency: unknown).The patient mentioned that the medication error did not cause her any damage, however, she did not see any improvement at all (device ineffective, onset date: 2023, latency: unknown, intensity: mild).The patient did not felt improvement with any of the applications.Patient reported that the inability to walk, joint pain in the knees, joint swelling in the knees and joint stiffness were experienced before treatment with synvisc, and she applied synvisc to relieve these symptoms, but had no effect and she did not improve or perceive any change with the treatment with synvisc.Patient have not had any improvement, patient feel worse.Patient need to know why patient don't see any improvement.Patient just finished treatment and patient don't see feel anything, on the contrary patient feel worse.What could be happening, patient have osteoarthritis, as well as rheumatoid arthritis and fibromyalgia.The referenced number was contacted where the patient's niece answers who reports that two incomplete doses were administered in the left knee and the rest in the right knee, as well as three more complete doses in the right knee.The patient finished her treatment with synvisc on (b)(6) 2023, since the unknown date of (b)(6) 2023 (latency: few days), started having pain/ worsening pain (injection site joint pain), inflammation (injection site joint inflammation), stiffness in both knees (joint stiffness), discomfort (injection site joint discomfort) as if there was a pull behind the knee as a consequence of the medication error and unable to bend her knee (joint range of motion decreased) at all and it has increased, she cannot walk (gait inability), leaving her unable to walk (condition aggravated).The patient reported that the swelling was very exacerbated (injection site joint swelling) (condition aggravated) (onset: (b)(6) 2023; latency: few days) and the pain was somewhat annoying.Additionally, the patient reported that the product has a very high price and she made her best effort to buy it and it did not work for her so she feels desperate.On (b)(6) 2023, the swelling decreased by half, due the patient administering an injection of betamethasone (hypack).At the time of reporting, it was stated that patient was having rehabilitation exercises, massage, application of compresses and application of heat for gait inability, injection site joint inflammation.Action taken: not applicable for all events.Corrective treatment: application of hot and cold compresses, injection of betamethasone (hypack) for injection site joint swelling, physical therapies, applied heat packs, massage, ultrasound, laser, rehabilitation exercises and swimming, undergoing therapy and taking unspecified medications for injection site joint inflammation; rehabilitation exercises, massage, application of compresses and application of heat for gait inability and injection site joint inflammation.At time of reporting, the outcome was recovering / resolving for injection site joint swelling and not recovered / not resolved for injection site joint inflammation; unknown for rest of the events.Reporter causality: not related for injection site joint swelling and injection site joint inflammation.A product technical complaint (ptc) was initiated on 05-sep-2023 for synvisc (lot/batch number: crsp016, expiry date: 30-sep-2025) with global ptc number: 100357655.The sample of the ptc was not available and the ptc stated preliminary assessment: based on the complaint from intake team, there was no quality related defect that would attribute to a malfunction a death or serious injury.Sanofi global pharmacovigilance and epidemiology continuously monitors adverse event reports with or without lot numbers, and assesses possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals.The defect class has been updated to ii - (dp 06sep23) investigation (em 14sep2023).The product lot number was not provided.A batch record review is not possible.Based on the lack of information, no assessment is possible.It is the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result is identified and mitigated through the nonconforming material or product process.Sanofi will continue to monitor adverse events and perform trend analysis on a periodic basis to determine if a capa(corrective and preventive actions) is required.Reopened as per email and updated lot# - (dp 03oct23) the production and quality control documentation for lot # crsp016 expiration date (2025-09) was manufactured on 07oct22 packaged (b)(4) singles were reviewed.The investigation showed that the product met specifications.No associated non-conformances were noted.Based on the lot # batch record review & lot # frequency analysis for lot # crsp016 no capa is required.As of 21sep2023 there are 5 complaints on file for lot# crsp016 and all related sublots.5 complaints are on file for lot# crsp016: (5) adverse event reports.Sanofi will continue to monitor complaints and trending as stated in "product event handling" to determine if a capa is required.The final investigation was completed on 03-oct-2023 with summarized conclusion as no assessment possible.Additional information was received on 17-sep-2023 from patient along with live follow-up dated 18-sep-2023 from quality department via other health care professional, both processed together with clock start date of 17-sep-2023: based on the information received from patient, the case initially processed as non serious was upgraded to a serious case.New events added: incorrect dose administered and wrong technique in device usage process.Joint range of motion and condition aggravated added as symptoms of joint stiffness.Event of arthralgia was updated to injection site joint pain with symptom condition aggravated.Event of joint swelling was updated to injection site joint swelling.Event of device use issue was deleted.As reported event verbatim, event onset date, and outcome for events injection site joint swelling, injection site joint pain, joint stiffness was updated.Concurrent conditions, concomitant medications and corrective treatment was added.Therapy start date, batch number, expiry date, strength and formulation updated for suspect.Ptc number and results were added.Clinical course was updated and text was amended.Additional information was received on 17-sep-2023 from patient (significant) with live followup on 20-sep-2023 from patient (significant) and on internal review on 23-sep-2023, the case 2023sa284656 (to be deleted) was identified to be duplicate of 2023sa272709 (to be retained).All the information from the case 2023sa284656 has been merged in the case 2023sa272709.Case 2023sa284656 with csd of 05-sep-2023, would be deleted: (processed together with csd 17-sep-2023): based on this information, the case initially considered as serious was downgraded to non-serious.As reported term of event device ineffective update; event of product prescribing error added.Age added; medical history added; route added; therapy start date added; as reported term of event device ineffective updated; onset date of all events updated; event of injection site joint inflammation, onset date of event incorrect dose administered updated; event of injection site joint swelling with symptom condition aggravated deleted; as reported term of event gait inability updated; as reported term of event joint stiffness updated; as reported term of event incorrect dose administered, wrong technique in device usage process updated; event of injection site joint pain, joint stiffness and condition aggravated was made as symptom to newly added event of injection site joint inflammation, related case ids added; clinical course was updated and text was amended.Additional information was received on 03-oct-2023 by quality department form other health care professional: ptc re-opened details added; expiry date updated from 15-sep-2025 to 30-sep-2025; upon internal view, the case initially considered as non-serious was updated to serious;event of injection site joint swelling added; as reported term of event injection site joint pain and gait inability updated; medical history added; treatment drug added; outcome of event injection site joint inflammation updated from not recovered to recovering; as reported term of event product prescribing error updated; clinical course was updated and text was amended.Additional information was received on 06-oct-2023 from the patient.Additional event of discomfort added.Expiry date updated.Start date of suspect updated.Clinical course updated and text amended accordingly.
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Event Description
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Swelling is very exacerbated/increased swelling at the injection [injection site joint swelling] ([condition aggravated]) started having pain, inflammation and stiffness/has increased [injection site joint inflammation] ([injection site joint discomfort], [injection site joint pain], [stiff knees], [condition aggravated], [unable to walk], [joint range of motion decreased]) did not felt improvement with any of the applications/it did not work for her/did not see any improvement at all/had no effect and she did not improve or perceive any change/have not had any improvement, i feel worse with no ae [device ineffective] five administrations of synvisc on right knee were prescribed as treatment for oa and exacerbated pain caused by underlying disease/error occurred at prescription stage by physical therapist prescribed dosage regimen due to damage on knees with no ae [product prescribing error] received application of half a vial for each knee/patient applied the fifth and last synvi device: half dose on the right knee and half dose on the left knee with no reported adverse event [incorrect dose administered] received application of half a vial for each knee/patient applied the fifth and last synvi device: half dose on the right knee and half dose on the left knee with no reported adverse event [wrong technique in device usage process] case narrative: initial information received from mexico on 05-sep-2023 regarding an unsolicited valid serious case received from a patient.This case is linked to case (b)(4) (multiple device suspect used for the same patient) and (b)(4) (duplicates) this case involves an 56 years old female patient who had product prescribing error (five administrations of synvisc on right knee were prescribed as treatment for oa and exacerbated pain caused by underlying disease/error occurred at prescription stage by physical therapist prescribed dosage regimen due to damage on knees with no ae), wrong technique in device usage process(received application of half a vial for each knee/patient applied the fifth and last synvisc device: half dose on the right knee and half dose on the left knee with no reported adverse event), device ineffective (have not had any improvement, feel worse, don't see any improvement, with any of the applications/it did not work for her/had no effect and she did not improve or perceive any change with the treatment with synvisc with no reported adverse event) and swelling is very exacerbated/increased swelling at the injection, started having pain/ presents pain in the back of the knee, like a strong pulling sensation, inflammation and stiffness/has increased/increased stiffness at the injection site and discomfort while being treated with medical device hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical treatment(s), vaccination(s) and family history were not provided.The patient had knee osteoarthritis for 10 years since 2013, as well as rheumatoid arthritis, hypertension in 2020, gastritis (15 years ago) since 2008, arthritis for 33 years since 1990 and fibromyalgia for 10 years since 2013, inability to walk, joint pain in the knees/exacerbated pain caused by the underlying disease, joint swelling in the knees and joint stiffness.The patient has not suffered from other relevant diseases in her medical history and has not undergone surgery.Concomitant medications: metrotexate, chloroquine, folic acid, celecoxib.The patient purchased 5 devices of synvisc on (b)(6) 2023, the patient started treatment with synvisc (hylan g-f 20) 2 ml, by medical indication, due to cartilage wear, administering a full dose in the right knee.On (b)(6) 2023, the patient started treatment with a complete dose of synvisc on the right knee.Fifteen days after, patient received the second full dose of synvisc on the right knee.Eight days after, patient received the third full dose of synvisc on the right knee.Eight days after, patient applied the fourth synvisc device: half dose on the right knee and half dose on the left knee.All injections were administered by her physical therapist physician since (b)(6) 2023, the patient began to experience inability to walk and stiffness in the knee, previously reported.As corrective treatment she performed physical therapies, applied heat packs, massage, ultrasound, laser, rehabilitation exercises and swimming.The patient has not recovered from these adverse events, and as a sequel, has experienced increased stiffness.She was unable to bend the knee that had more wear and tear and now with pulling pain in the back of the knee.Patient started experiencing swelling.As corrective treatment she performed application of hot and cold compresses, as prescribed by her physiotherapist.At the time of reporting, the patient was in recovery for this adverse event.As corrective treatment, she was undergoing therapy and taking unspecified medications.On (b)(6) 2023, the patient received the fifth injection of synvisc (hylan g-f 20, sodium hyaluronate) solution for injection (strength: 16mg/2ml) at a dose of 2ml weekly but received application of half a vial for each knee(half dose on the right knee and half dose on the left knee) (incorrect dose administered and wrong technique in device usage process, onset date: (b)(6) 2023, latency: same day, intensity: mild) via intra-articular route (batch number:crsp016, expiry date:15-sep-2025) treatment for knee osteoarthritis.The medication error occurred at the prescription stage, by her physical therapist, who prescribed this dosage regimen according to the damage on her knees.The five administrations of synvisc in the right knee were prescribed as treatment for osteoarthritis and exacerbated pain caused by the underlying disease(product prescribing error; onset date: 2023, latency: unknown).The patient mentioned that the medication error did not cause her any damage, however, she did not see any improvement at all (device ineffective, onset date: 2023, latency: unknown, intensity: mild).The patient did not felt improvement with any of the applications.Patient reported that the inability to walk, joint pain in the knees, joint swelling in the knees and joint stiffness were experienced before treatment with synvisc, and she applied synvisc to relieve these symptoms, but had no effect and she did not improve or perceive any change with the treatment with synvisc.Patient have not had any improvement, patient feel worse.Patient need to know why patient don't see any improvement.Patient just finished treatment and patient don't see feel anything, on the contrary patient feel worse.What could be happening, patient have osteoarthritis, as well as rheumatoid arthritis and fibromyalgia.The referenced number was contacted where the patient's niece answers who reports that two incomplete doses were administered in the left knee and the rest in the right knee, as well as three more complete doses in the right knee.The patient finished her treatment with synvisc on (b)(6) 2023, since the unknown date of sep-2023(latency: few days), started having pain/ worsening pain (injection site joint pain), inflammation (injection site joint inflammation), stiffness in both knees (joint stiffness), discomfort (injection site joint discomfort) as if there was a pull behind the knee as a consequence of the medication error and unable to bend her knee (joint range of motion decreased) at all and it has increased, she cannot walk (gait inability), leaving her unable to walk (condition aggravated).The patient reported that the swelling was very exacerbated (injection site joint swelling) (condition aggravated) (onset: sep-2023; latency: few days) and the pain was somewhat annoying.Additionally, the patient reported that the product has a very high price and she made her best effort to buy it and it did not work for her so she feels desperate on (b)(6) 2023, the swelling decreased by half, due the patient administering an injection of betamethasone (hypack).At the time of reporting, it was stated that patient was having rehabilitation exercises, massage, application of compresses and application of heat for gait inability, injection site joint inflammation.Further, patient presented pain in the back of the knee, like a strong pulling sensation, increased stiffness at the injection site (condition aggravated - intensity: moderate, seriousness: non-serious) and increased swelling at the injection site (condition aggravated - intensity: moderate, seriousness: non-serious).At the time of reporting, the patient has not recovered from the event of inability to walk.Action taken: not applicable for all events.Corrective treatment: application of hot and cold compresses, injection of betamethasone (hypack) for injection site joint swelling, physical therapies, applied heat packs, massage, ultrasound, laser, rehabilitation exercises and swimming, undergoing therapy and taking unspecified medications for injection site joint inflammation; rehabilitation exercises, massage, application of compresses and application of heat for gait inability and injection site joint inflammation.At time of reporting, the outcome was recovering / resolving for injection site joint swelling and not recovered / not resolved for injection site joint inflammation, gait inability; unknown for rest of the events.Reporter causality: not related for injection site joint swelling and injection site joint inflammation a product technical complaint (ptc) was initiated on 05-sep-2023 for synvisc (lot/batch number: crsp016, expiry date: 30-sep-2025) with global ptc number: (b)(4).The sample of the ptc was not available and the ptc stated preliminary assessment: based on the complaint from intake team, there was no quality related defect that would attribute to a malfunction a death or serious injury.Sanofi global pharmacovigilance and epidemiology continuously monitors adverse event reports with or without lot numbers, and assesses possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals.The defect class has been updated to ii - (dp (b)(6) 2023) investigation (em (b)(6) 2023).The product lot number was not provided.A batch record review is not possible.Based on the lack of information, no assessment is possible.It is the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result is identified and mitigated through the nonconforming material or product process.Sanofi will continue to monitor adverse events and perform trend analysis on a periodic basis to determine if a capa(corrective and preventive actions) is required.Reopened as per email and updated lot# - (dp (b)(6) 2023) the production and quality control documentation for lot # crsp016 expiration date (2025-09) was manufactured on 07oct22 packaged (b)(4) singles were reviewed.The investigation showed that the product met specifications.No associated non-conformances were noted.Based on the lot # batch record review & lot # frequency analysis for lot # crsp016 no capa is required.As of 21sep2023 there are 5 complaints on file for lot# crsp016 and all related sublots.5 complaints are on file for lot# crsp016: (5) adverse event reports.Sanofi will continue to monitor complaints and trending as stated in "product event handling" to determine if a capa is required.The final investigation was completed on 03-oct-2023 with summarized conclusion as no assessment possible.Additional information was received on 17-sep-2023 from patient along with live follow-up dated 18-sep-2023 from quality department via other health care professional, both processed together with clock start date of 17-sep-2023: based on the information received from patient, the case initially processed as non serious was upgraded to a serious case.New events added: incorrect dose administered and wrong technique in device usage process.Joint range of motion and condition aggravated added as symptoms of joint stiffness.Event of arthralgia was updated to injection site joint pain with symptom condition aggravated.Event of joint swelling was updated to injection site joint swelling.Event of device use issue was deleted.As reported event verbatim, event onset date, and outcome for events injection site joint swelling, injection site joint pain, joint stiffness was updated.Concurrent conditions, concomitant medications and corrective treatment was added.Therapy start date, batch number, expiry date, strength and formulation updated for suspect.Ptc number and results were added.Clinical course was updated and text was amended.Additional information was received on 17-sep-2023 from patient (significant) with live followup on 20-sep-2023 from patient (significant) and on internal review on 23-sep-2023, the case (b)(4) (to be deleted) was identified to be duplicate of (b)(4) (to be retained).All the information from the case (b)(4) has been merged in the case (b)(4).Case (b)(4) with csd of 05-sep-2023, would be deleted: (processed together with csd (b)(6) 2023): based on this information, the case initially considered as serious was downgraded to non-serious.As reported term of event device ineffective update; event of product prescribing error added.Age added; medical history added; route added; therapy start date added; as reported term of event device ineffective updated; onset date of all events updated; event of injection site joint inflammation, onset date of event incorrect dose administered updated; event of injection site joint swelling with symptom condition aggravated deleted; as reported term of event gait inability updated; as reported term of event joint stiffness updated; as reported term of event incorrect dose administered, wrong technique in device usage process updated; event of injection site joint pain, joint stiffness and condition aggravated was made as symptom to newly added event of injection site joint inflammation, related case ids added; clinical course was updated and text was amended.Additional information was received on 03-oct-2023 by quality department form other health care professional: ptc re-opened details added; expiry date updated from 15-sep-2025 to 30-sep-2025; upon internal view, the case initially considered as non-serious was updated to serious;event of injection site joint swelling added; as reported term of event injection site joint pain and gait inability updated; medical history added; treatment drug added; outcome of event injection site joint inflammation updated from not recovered to recovering; as reported term of event product prescribing error updated; clinical course was updated and text was amended.Additional information was received on 06-oct-2023 from the patient.Additional event of discomfort added.Expiry date updated.Start date of suspect updated.Clinical course updated and text amended accordingly.Additional information was received on 20-oct-2023 from patient: as reported term of event injection site joint pain, joint stiffness, injection site joint swelling updated; clinical course updated and text amended accordingly.
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