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Panniculitis [panniculitis].Pain in the injection site [injection site pain].Waited another two months before getting the 2nd injection [wrong schedule].Off label use [unapproved schedule according to core label] [off label use].Case (b)(4) is a serious spontaneous case received from a consumer via the fda in united states.This report concerns a female patient of unknown age, who experienced panniculitis and pain in the injection site during treatment with intra-articular euflexxa (sodium hyaluronate) solution for injection unknown concentration 5 injections, for arthritis from 2020 to 2020.The patient reported she had arthritis in her knees and was given a steroid injection for the pain and was later told by her doctor about euflexxa.The patient was told that she would be given three injections, once a week for three weeks.On an unspecified date in 2020, the patient received the first injection and reported that she experienced pain in the injection site and complained to her doctor about the pain and it was decided to wait for another week before getting the second injection.Due to this procedure happening during the covid lock down, the patient waited another two months before getting back to the doctor's office for her third injection.The patient was then told that she would have to start all over and stated that she had a total of five euflexxa injections.The patient reported that after taking these injections, she started to develop lumps in her right calf and a few days later the same lumps in her left leg.The patient visited her doctor and a biopsy was taken from her left leg and was diagnosed with panniculitis.The patient believed that the panniculitis was a result of the euflexxa injection and that she was reacting to the euflexxa gel.The panniculitis was medically significant.Action taken with euflexxa was not applicable.At the time of this report, the outcome of panniculitis was unknown, the outcome of pain in the injection site was unknown.Concomitant medication was not reported.The event panniculitis was reported as serious.The event pain in the injection site was reported as non-serious.At the time of reporting the case outcome was unknown.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: not related.Sender´s comment: due to the administration of euflexxa as intra-articular and the genesis of panniculitis is it considered very unlikely that the euflexxa caused the panniculitis, hence company causality as not related.Other case numbers: internal # - others = mw5097449.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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Panniculitis [panniculitis] pain in her right knee [arthralgia] pain in the injection site [injection site pain] waited another two months before getting the 2nd injection [wrong schedule] incomplete dose administered between feb-2020 and apr-2020 [incorrect dose administered] case (b)(4) is a serious complaint spontaneous case received from a consumer via the fda in united states.This report concerns a 64-year-old female patient who experienced panniculitis, pain in her right knee, pain in the injection site, waited another two months before getting the 2nd injection and incomplete dose administered between (b)(6) 2020 and (b)(6) 2020 during treatment with intra-articular euflexxa (sodium hyaluronate) solution for injection unknown concentration 2 injections, unknown frequency from (b)(6) 2020 to (b)(6) 2020 and received series of 3 injections, unknown route and frequency for osteoarthritis of the knee from (b)(6) 2020 to (b)(6) 2020.The patient reported she had arthritis in her knees and was given a steroid injection for the pain and was later told by her doctor about euflexxa.The patient reported that on unspecified dates, sometime between (b)(6) 2020 and (b)(6) 2020, she received two euflexxa injections, unknown time in between injections, to her right knee.Her third injection was not received due to covid-19.When she wanted to resume her euflexxa injections, she was told she would have to begin the series all over again.She received her complete three injection series of euflexxa, to her right knee, sometimes between (b)(6) 2020 and (b)(6) 2020.On an unspecified date in 2020, the patient received the first injection and reported that she experienced pain in the injection site and complained to her doctor about the pain and it was decided to wait for another week before getting the second injection.Due to this procedure happening during the covid lock down, the patient waited another two months before getting back to the doctor's office for her third injection.She experienced ongoing and at times, increased pain in her right knee, after each injection and ongoing.She iced her knee to help with the pain.The patient reported that after taking these injections, on an unspecified date over the summer of 2020, she began to experience large lumps behind her bilateral knees and calves, which had discolored, hardened areas of skin.The patient visited her doctor and a biopsy was taken from her left leg and was diagnosed with panniculitis.The patient believed that the panniculitis was a result of the euflexxa injection and that she was reacting to the euflexxa gel.The patient reported she underwent a biopsy of the lumps on an unspecified date between (b)(6) 2020 and (b)(6) 2020 and was informed the fatty tissue was infiltrated.No treatment was prescribed.Around the same time that she experienced the large bumps, she injured her left knee by bumping it with a crate, but her physician said this area of bruising had nothing to do with the large bumps.Also, around this time, on unspecified dates, the consumer was started on unspecified medication for blood thinning and for cholesterol, for unknown reasons.At the time of this report, the bilateral bumps with discolored and hardened skin have improved but not resolved.No further information provided.The panniculitis was medically significant.Action taken with euflexxa was not applicable.At the time of this report, the outcome of panniculitis was unknown, the outcome of pain in her right knee was not recovered, the outcome of pain in the injection site was unknown.In 2020, the outcome of waited another two months before getting the 2nd injection was recovered.In (b)(6) 2020, the outcome of incomplete dose administered between (b)(6) 2020 and (b)(6) 2020 was recovered.The patient's med hist/procedure was significant for cholesterol (from unknown start date to unknown stop date) and high blood pressure (from unknown start date to unknown stop date) and acid reflux (from unknown start date to unknown stop date) and bronchitis (from unknown start date to unknown stop date) and torn meniscus (from unknown start date to unknown stop date) and blood thinning (from unknown start date to unknown stop date).The patient's past drug therapy was significant for steroids (from unknown start date to unknown stop date).The patient received unknown concomitant medications for high blood pressure and acid reflux.The event panniculitis was reported as serious.The events pain in her right knee, pain in the injection site, waited another two months before getting the 2nd injection, incomplete dose administered between (b)(6) 2020 and (b)(6) 2020 were reported as non-serious.At the time of reporting the case outcome was unknown.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: related.Sender´s comment: due to the administration of euflexxa as intra-articular and the genesis of panniculitis is it considered very unlikely that euflexxa caused the panniculitis and its related symptoms.Other case numbers: internal # - others = mw5097449.Mw 3500a mfr.Rpt.# = 3000164186-2020-00015.E2b company number = us-ferringph-2020fe08000.Internal # - affiliate = ferr5974.Internal # - complaint = (b)(4).Internal # - others = us21-00283 additional information was received from consumer on 21-jan-2021: follow up 01: new events of pain in her right knee, pain in the injection site, waited another two months before getting the 2nd injection, incomplete dose administered between (b)(6) 2020 and (b)(6) 2020 were added.Euflexa indication was reported.The patient's medical history and concomitant medications (names unknown) were reported.The patient age, height and weight were reported.Case fields and narrative updated accordingly.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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