| Catalog Number 6301182010 |
| Device Problems
Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)
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| Patient Problems
Arthritis (1723); Therapeutic Response, Decreased (2271); Injury (2348); Arthralgia (2355); Joint Swelling (2356); Ambulation Difficulties (2544); Osteomyelitis (4533); Swelling/ Edema (4577); Peripheral Edema (4578)
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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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Bone infection [osteomyelitis].Condition worsened [condition aggravated].Bone marrow edema [bone marrow oedema].Right toe swelled up [peripheral swelling].Meniscus failing [meniscus injury].Couldn't put any weight on her leg (left) [weight bearing difficulty].Concerned there may be some type of contaminant, maybe fungus [occupational exposure to air contaminants].Knee swelled up [joint swelling].Knee was more painful [arthralgia].Right knee was mildly inflamed [arthritis].Euflexxa injected in patient's right toe [product administered at inappropriate site].Patient did not get normal response [therapeutic response decreased].Euflexxa injected for toe because of arthritis [drug use for unapproved indication].[product use in unapproved indication].Off label use [off label use].Case (b)(4) is a serious complaint, spontaneous case received from a physician in united states.This report concerns a (b)(6)-year-old female who experienced bone infection, condition worsened, bone marrow edema, right toe swelled up, meniscus failing, could not put any weight on her leg (left), concerned there may be some type of contaminant, maybe fungus, knee swelled up, knee was more painful, right knee was mildly inflamed, euflexxa injected in patient's right toe, patient did not get normal response, euflexxa injected for toe because of arthritis [drug use for unapproved indication] and off label use during treatment with euflexxa (sodium hyaluronate) solution for injection unknown concentration weekly for 3 weeks, for product used for unknown indication from (b)(6) 2020.The physician reported that he had administered euflexxa to a patient (once a year for the past three to four years with him) and experienced a reaction after her third injection on (b)(6) 2020.The doctor reported the patient received injections in both knees, although four days after the last injection, her left knee swelled up and was more painful, described as she did not get normal response.Her right knee was only mildly inflamed, but nothing like the left knee.Doctor reported that he also had a small amount left in his euflexxa vial from right knee, so he injected patient's right toe, because of arthritis.The patient's right toe swelled up as well.Doctor did run many cultures, and all were negative, he drained her left knee multiple times.Magnetic resonance imaging (mri) was done and showed bone infection.The reactions fluctuated, were bad, and then he used cortisone, and it was a little better, but cortisone really did not work, and then became bad again.He stated her condition worsened and she couldn't put any weight on her leg (left) and it was constantly inflamed.The patient went to surgeon and the surgeon stated it was due to her meniscus failing (from a previous allograft meniscus transplant) and she had knee surgery six weeks after euflexxa.The doctor reported that he did a repeat mri and it showed bone marrow edema (left knee).The surgeon stated that knee and right foot (toe) cultures are negative and synovial biopsy of left knee was also negative for infections.Doctor did report that patient had pseudosepsis reaction from another unknown knee medication in the past, although with another doctor.No further information was provided.The bone infection was medically significant.Action taken with euflexxa was not applicable.At the time of this report, the outcome of bone marrow edema was not recovered, the outcome of bone infection was not recovered, the outcome of condition worsened was not recovered, the outcome of right toe swelled up was not recovered, the outcome of meniscus failing was not recovered, the outcome of could not put any weight on her leg (left) was not recovered, the outcome of concerned there may be some type of contaminant, maybe fungus was unknown, the outcome of right knee was mildly inflamed was not recovered, the outcome of patient did not get normal response was not recovered, the outcome of knee swelled up was not recovered, the outcome of knee was more painful was not recovered.In (b)(6) 2020, the outcome of euflexxa injected in patient's right toe was recovered, the outcome of euflexxa injected for toe because of arthritis [drug use for unapproved indication] was recovered, the outcome of off label use was recovered.The patient's med hist/procedure was significant for drained knee (from 2020 to unknown stop date) and allograft meniscus transplant (from unknown start date to unknown stop date) and knee surgery (from 2020 to 2020) and pseudosepsis reaction (from unknown start date to unknown stop date) and arthritis (from unknown start date to unknown stop date).No concomitant medication was reported.The event bone infection was reported as serious.The events condition worsened, bone marrow edema, right toe swelled up, meniscus failing, could not put any weight on her leg (left), concerned there may be some type of contaminant, maybe fungus, knee swelled up, knee was more painful, right knee was mildly inflamed, euflexxa injected in patient's right toe, patient did not get normal response, euflexxa injected for toe because of arthritis [drug use for unapproved indication], off label use were reported as non-serious.At the time of reporting the case outcome was unknown.Sender comments: despite the temporal relationship between some of the reported events and euflexxa, events of 'bone marrow edema', 'bone infection', 'condition worsened', 'knee swelled', 'knee was more painful', 'could not put any weight on her leg (left)', 'patient did not get normal response' and 'right knee was mildly inflamed' are to be related to a pseudosepsis reaction from another unknown knee medication in the past as stated by the reporting physician.These events are also compatible with the already existing meniscus injury.Furthermore, cultures and synovial biopsy of left knee were negative for infections.Ferring gpv is waiting for the complaint's investigation's results.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: related.Other case numbers: (b)(4).This ae occurred in united states and concerns the medical device euflexxa.Please report to your local health authority if required by local law.This ae is not reportable in eu because it does not meet the definition of a medical device incident according to the requirements of the medical device directive/ because it did not occur in a eu + efta country and did not result in a corrective action by the manufacturer.No corrective action was done by the manufacturer or requested by regulators.
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Event Description
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Bone infection [osteomyelitis].Condition worsened [condition aggravated].Bone marrow edema [bone marrow oedema].Right toe swelled up [peripheral swelling].Meniscus failing [meniscus injury].Couldn't put any weight on her leg (left) [weight bearing difficulty].Concerned there may be some type of contaminant, maybe fungus [occupational exposure to air contaminants].Knee swelled up [joint swelling].Knee was more painful [arthralgia].Right knee was mildly inflammed [arthritis].Euflexxa injected in patient's right toe [product administered at inappropriate site].Patient did not get normal response [therapeutic response decreased].Euflexxa injected for toe because of arthritis [drug use for unapproved indication].[product use in unapproved indication].Off label use [off label use].(b)(4) is a serious complaint, spontaneous case received from a physician in united states.This report concerns a 62-year-old female who experienced bone infection, bone marrow edema, right toe swelled up, meniscus failing, couldn't put any weight on her leg (left), knee swelled up/ significant amount of swelling in her knees and getting worse, knee was more painful, right knee was mildly inflammed, during treatment with euflexxa (sodium hyaluronate) solution for injection, unknown concentration, weekly for 3 weeks, for osteoarthritis of the knee from (b)(6) 2020 to (b)(6) 2020.The physician reported that a patient who he has administered euflexxa to (once a year for the past three to four years with him) experienced a reaction after her third injection on (b)(6) 2020.The doctor reported the patient received injections in both knees, although four days after the last injection, her left knee swelled up and was more painful, described as the patient did not get normal response (therapeutic response changed).Her right knee was only mildly inflamed, but nothing like the left knee.Doctor reported that he also had a small amount left in his euflexxa vial from right knee, so he injected patient's right toe (product administered at inappropriate site, off label use), because of arthritis.The patient's right toe swelled up as well.The physician did run many cultures, and all were negative, she drained her left knee multiple times.Magnetic resonance imaging (mri) was done and showed bone infection.The reactions fluctuated, were bad, and then she used cortisone, and it was a little better, but cortisone really did not work, and then became bad again.She stated her condition worsened and she couldn't put any weight on her leg (left) and it was constantly inflamed.The patient went to surgeon and the surgeon stated it was due to her meniscus failing (from a previous allograft meniscus transplant) and she had knee surgery six weeks after euflexxa.The doctor reported that she did a repeat mri and it showed bone marrow edema (left knee).The surgeon stated that knee and right foot (toe) cultures are negative and synovial biopsy of left knee was also negative for infections.Doctor did report that patient had pseudosepsis reaction from another unknown knee medication in the past, although with another doctor.The physician was concerned there may be some type of contaminant, maybe fungus (product contamination).The physician would like to know if the reactions could be due to a product contaminant causing an immune response or a weird reaction that would not show up in normal cultures.No further information was provided.On 22-mar-2021, the medical assistant reported one of their patient's received a full series of euflexxa, bilaterally in (b)(6) 2020.After the series, she started having a significant amount of swelling in her knees.It started in the right knee and was now impacting both.The swelling had never gone down, and patient stated to her that it was getting worse.She had been seeing an orthopedic and rheumatoid specialist regularly.No further information provided.The bone infection was medically significant.Action taken with euflexxa was not applicable.At the time of this report, the outcome of bone infection, bone marrow edema, right toe swelled up, meniscus failing, couldn't put any weight on her leg (left), knee swelled up/ significant amount of swelling in her knees and getting worse, knee was more painful, right knee was mildly inflammed were not recovered.The patient's med hist/procedure was significant for drained knee (from 2020 to unknown stop date) and allograft meniscus transplant (from unknown start date to unknown stop date) and knee surgery (from 2020 to 2020) and pseudosepsis reaction (from unknown start date to unknown stop date) and arthritis (from unknown start date to unknown stop date).No concomitant medication was reported.The event bone infection was reported as serious.The events bone marrow edema, right toe swelled up, meniscus failing, couldn't put any weight on her leg (left), knee swelled up/ significant amount of swelling in her knees and getting worse, knee was more painful, right knee was mildly inflammed were reported as non-serious.At the time of reporting the case outcome was not recovered.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: not related: bone infection.Related: bone marrow edema, right toe swelled up, meniscus failing, couldn't put any weight on her leg (left), knee swelled up/ significant amount of swelling in her knees and getting worse, knee was more painful, right knee was mildly inflammed.Ferring sender comments: it is not suspected that the product was contaminated due the several negative test for infection.Company causality for bone infection is not related.Due to the patient's medical history of a pseudoseptic reaction it is considered more likely that the events are compatible with an immune reaction a la pseudosepsis.The events are complicated by the patients previous allograft meniscus transplant.However, due to the plausible temporal relationship a contributing factor of euflexxa cannot be excluded.Company causality for the events bone marrow edema, right toe swelled up, meniscus failing, couldn't put any weight on her leg (left), knee swelled up/ significant amount of swelling in her knees and getting worse, knee was more painful, right knee was mildly inflammed are related.Other case numbers: internal # - others = (b)(4).Internal # - affiliate = (b)(4).Internal # - complaint = (b)(4).Mw 3500a mfr.Rpt.# = 3000164186-2021-00006.E2b company number = (b)(4).Internal # - others = (b)(4).This ae occurred in united states and concerns the medical device euflexxa.Please report to your local health authority if required by local law.This ae is not reportable in eu because it does not meet the definition of a medical device incident according to the requirements of the medical device directive/ because it did not occur in a eu + efta country and did not result in a corrective action by the manufacturer.No corrective action was done by the manufacturer or requested by regulators.Qa investigations 16-mar-2021: since no complaint sample was received and the complaint description was poor in details, the investigation was limited to the described sections.The review of supporting data did not reveal any quality issues.The root cause for the patient's complaint is unknown.The investigation did not find any relevant potential root cause.Moreover, an infection can be caused during the injection procedure.Clarification regarding the doctors' report he had a small amount left in euflexxa vial from right knee, so he injected patients' right toe: it was very important to follow the instructions on the leaflet and to inject euflexxa only to the purpose it is designated for.Based on the investigation detailed above, this complaint was considered not confirmed and no further action will be taken at this time.Ferring will continue to monitor for this type of complaint.The investigation into this qr is now complete and considered closed.The nature of the complaint was such that it does not meet the criteria for a medical device reportable event.Additional information was received from physician on 22-mar-2020: reported the patient had significant amount of swelling in her knees and never gone down, and it was getting worse.The patient's height and weight were reported.Case fields and narrative updated accordingly.
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