| Catalog Number 6301182010 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Host-Tissue Reaction (1297); Autoimmune Disorder (1732); Contusion (1787); Pain (1994); Tingling (2171); Arthralgia (2355); Joint Swelling (2356); Paraplegia (2448)
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| Event Date 01/01/2017 |
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Event Type
Injury
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Event Description
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Frozen arms (paralysis in the arms) [monoplegia], developed a terrible systemic immune reaction to euflexxa [immune system disorder], tingling in the legs [paraesthesia], right ankle is bruised [contusion], crippling pain in the right knee/ pain in the left knee [arthralgia], right knee was hot [arthralgia], right knee was swollen [joint swelling], wrist started to swell [joint swelling], pain in her wrist [arthralgia], her arms were hurting so bad it was difficult to put her jacket on [pain in extremity], pain in her hand [pain in extremity].This serious complaint, spontaneous report was received from a consumer in united states.This report concerns a (b)(6) female who experienced frozen arms (paralysis in the arms), developed a terrible systemic immune reaction to euflexxa, tingling in the legs, right ankle is bruised, crippling pain in the right knee/ pain in the left knee, right knee was hot, right knee was swollen, wrist started to swell, pain in her wrist, her arms were hurting so bad it was difficult to put her jacket on, and pain in her hand during treatment with intra-articular euflexxa (sodium hyaluronate) solution for injection 20 mg/ml, 20 mg/ml, weekly for 3 weeks (3 shots in both knees), for osteoarthritis from (b)(6) 2017.The patient stated that after the first injection, she had crippling pain in the right knee.The knee was hot and swollen.She experienced pain in the left knee as well but that was getting better and it was not as bad as the right knee.She also experienced tingling in the legs.On (b)(6) 2017, her wrist started to swell and she was experiencing pain in her wrist.Her arms were hurting so bad it was difficult to put her jacket on.The patient further explained the frozen arms as paralysis in the arms.Her physician prescribed her physical therapy to help gain movement back in her arms.The physician also gave her a cortisone injection to help with the symptoms.She was able to go to a couple physical therapy appointments, but due to lack of insurance she was no longer seeing her therapist.The patient reported that she was doing her own therapy at home in the swimming pool.Due to her therapy, she was now starting to get movement back in her arms.The patient stated that she was frustrated with everything going on so she was referred to a rheumatologist.The rheumatologist felt that she was experiencing an immune reaction to euflexxa.The patient also stated that her right ankle was bruised and she was experiencing pain in her hand that had improved since her injections.All of her symptoms were getting better as time had gone on.The frozen arms (paralysis in the arms) was medically significant.The systemic immune reaction was medically significant action taken with euflexxa was dose not changed.On an unknown date, the outcome of wrist started to swell, pain in her wrist, frozen arms (paralysis in the arms), developed a terrible systemic immune reaction to euflexxa, tingling in the legs, right ankle is bruised, crippling pain in the right knee/ pain in the left knee, right knee was hot, right knee was swollen, arms were hurting so bad it was difficult to put her jacket on, and pain in her hand was recovering/resolving.The patient's medical history was significant for sprained ankle 20 years ago (from 1997 to unknown stop date) and has twin girls (from unknown start date to unknown stop date) and allergy to sulfa (from unknown start date to unknown stop date) and broke her right wrist (from 1998 to unknown stop date).Concomitant medication was not reported.The following laboratory values were relevant: (b)(6).At the time of reporting the case outcome was recovering/resolving.This ae occurred in the 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 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.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: related.Other case numbers: (b)(4).
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Event Description
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Developed a terrible systemic immune reaction to euflexxa [immune system disorder], right ankle is bruised [contusion], tingling in the legs [paraesthesia], crippling pain in the right knee/ pain in the left knee [arthralgia], right knee was hot [arthralgia], right knee was swollen [joint swelling], wrist started to swell [joint swelling], pain in her wrist [arthralgia], her arms were hurting so bad it was difficult to put her jacket on [pain in extremity], pain in her hand [pain in extremity].Case (b)(4) is a serious, complaint, spontaneous case received from a consumer in united states.Follow up was received on 25-aug-2017 from the patient's physician.This report concerns a 57 year-old female who suffered a total autoimmune response to euflexxa (defined as experienced frozen arms (paralysis in the arms and terrible pain and inflammation)), right ankle is bruised, painful swelling in her feet, tingling in the legs,crippling pain in the right knee/ pain in the left knee, right knee was hot, right knee was swollen, wrist started to swell, pain in her wrist, her arms were hurting so bad it was difficult to put her jacket on, pain in her hand, and painful swelling in her ankles during treatment with intra-articular euflexxa (sodium hyaluronate) solution for injection 20 mg/ml, 20 mg/ml, weekly for 3 weeks (3 shots in both knees), for osteoarthritis from (b)(6) 2017.The patient stated that after the first injection, she had crippling pain in the right knee.The knee was hot and swollen.She experienced pain in the left knee as well but that was getting better and it was not as bad as the right knee.The physician reported that the patient had a mild knee effusion/swelling noted on exam prior to euflexxa.Upon exam of the knees one week after injection, mild swelling with no warmth was noted.The patient's physician stated the pain and swelling were mostly improved with diclofenac oral.She also experienced tingling in the legs.On (b)(6) 2017, her wrist started to swell and she was experiencing pain in her wrist.Her arms were hurting so bad it was difficult to put her jacket on.The patient further explained the frozen arms as paralysis in the arms that began on an unspecified date in (b)(6) 2017.Her physician prescribed her physical therapy to help gain movement back in her arms.The physician also gave her an unspecified steroid injection to the right knee in april to help with the symptoms.Physical therapy was done on (b)(6) 2017, but due to lack of insurance she was no longer seeing her therapist.The patient reported that she was doing her own therapy at home in the swimming pool.Due to her therapy, she was now starting to get movement back in her arms but still experienced weakness.The patient stated that she was frustrated with everything going on so she was referred to a rheumatologist.The rheumatologist felt that she was experiencing an immune reaction to euflexxa.The patient also stated that her right ankle was bruised and she was experiencing pain in her hand that had improved since her injections.All of her symptoms were getting better as time had gone on.The physician reported that the patient noted the systemic immune reaction started in april.The physician reported they saw her in april and notes from the visit do not reference the immune reaction but the patient had stated her arms were starting to bother her.The physician reported that the remaining events occurred after they saw her last.The physician reported the causality of frozen arms, bruising of the right ankle, wrist swelling and pain, arms were starting to hurt so bad it was difficult to put her jacket on, and pain in her hand as unlikely related to euflexxa.Causality of crippling pain in the right knee and pain in the left knee was reported as possible temporary reaction related to euflexxa.The systemic immune reaction to euflexxa was medically significant.Action taken with euflexxa was dose not changed.At the time of this report, the outcome of right knee was swollen, right ankle is bruised, developed a terrible systemic immune reaction to euflexxa, tingling in the legs, and right knee was hot was recovering/resolving.The outcome of pain in her hand was recovered.In (b)(6) 2017, the outcome of crippling pain in the right knee/ pain in the left knee was recovered.In (b)(6) 2017, the outcome of her arms were hurting so bad it was difficult to put her jacket, wrist started to swell, and pain in her wrist was recovered.The patient`s medical history was significant for sprained ankle 20 years ago (from 1997 to unknown stop date), physical therapy scope surgery (from 1990 to 1990), knee scope surgery (from 1980 to 1980), has twin girls, allergy to sulfa, broke her right wrist (from 1998 to unknown stop date).The patient`s past drug therapy was significant for corticosteroid (from (b)(6) 2016 to unknown stop date).The patient`s procedures included bilateral knee x-ray (from (b)(6) 2017) and physical examination ofknee (from unknown start date to unknown stop date).History of chronic pain, alcohol use, and rheumatoid arthritis were reported as unknown.No history of obesity.History of physical activity was reported as pool exercise and home program.The following concomitant medication was reported: diclofenac (from (b)(6) 2017 to an unknown stop date).Relevant laboratory values included: c-reactive protein: 39.5ni (no assessment), (b)(6) 2017.C-reactive protein: 61ni (no assessment), 2017.Red blood cell sedimentation rate: 63ni (no assessment), (b)(6) 2017.Red blood cell sedimentation rate: 18ni (no assessment), 2017.The events frozen arms (paralysis in the arms), developed a terrible systemic immune reaction to euflexxa were reported as serious.The events right ankle is bruised, tingling in the legs, crippling pain in the right knee/ pain in the left knee, right knee was hot, right knee was swollen, wrist started to swell, pain in her wrist, her arms were hurting so bad it was difficult to put her jacketon, pain in her hand were reported as non-serious.At the time of reporting the case outcome was recovering/resolving.This ae occurred in the 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 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.Additional information was received on 25-aug-2017 from the patient's physician: follow up 01- case became medically confirmed.Medical history, past drug therapy, procedures updated.Euflexxa start and stop dates added, concomitant medication added.Event onset date, end dates, and outcomes updated.Narrative updated.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: related.Other case numbers: case number, others = (b)(4).Case number, complaint = (b)(4).Mw 3500a mfr.Rpt.# = 3000164-2017-00025.Case number, complaint = (b)(4).Argus number: (b)(4).
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Event Description
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Developed a terrible systemic immune reaction to euflexxa [immune system disorder], right ankle is bruised [contusion], tingling in the legs [paraesthesia], crippling pain in the right knee/ pain in the left knee [arthralgia], right knee was hot [arthralgia], right knee was swollen [joint swelling], wrist started to swell [joint swelling], pain in her wrist [arthralgia], her arms were hurting so bad it was difficult to put her jacket on [pain in extremity], pain in her hand [pain in extremity], case (b)(4) is a serious, complaint, spontaneous case received from a consumer in united states.Follow up was received on 25-aug-2017 from the patient's physician.This report concerns a 57 year-old female who suffered a total autoimmune response to euflexxa (defined as experienced frozen arms (paralysis in the arms and terrible pain and inflammation)), right ankle is bruised, painful swelling in her feet, tingling in the legs,crippling pain in the right knee/ pain in the left knee, right knee was hot, right knee was swollen, wrist started to swell, pain in her wrist, her arms were hurting so bad it was difficult to put her jacket on, pain in her hand, and painful swelling in her ankles during treatment with intra-articular euflexxa (sodium hyaluronate) solution for injection 20 mg/ml, 20 mg/ml, weekly for 3 weeks (3 shots in both knees), for osteoarthritis from (b)(6) 2017.The patient stated that after the first injection, she had crippling pain in the right knee.The knee was hot and swollen.She experienced pain in the left knee as well but that was getting better and it was not as bad as the right knee.The physician reported that the patient had a mild knee effusion/swelling noted on exam prior to euflexxa.Upon exam of the knees one week after injection, mild swelling with no warmth was noted.The patient's physician stated the pain and swelling were mostly improved with diclofenac oral.She also experienced tingling in the legs.On (b)(6) 2017, her wrist started to swell and she was experiencing pain in her wrist.Her arms were hurting so bad it was difficult to put her jacket on.The patient further explained the frozen arms as paralysis in the arms that began on an unspecified date in (b)(6) 2017.Her physician prescribed her physical therapy to help gain movement back in her arms.The physician also gave her an unspecified steroid injection to the right knee in april to help with the symptoms.Physical therapy was done on (b)(6) 2017, but due to lack of insurance she was no longer seeing her therapist.The patient reported that she was doing her own therapy at home in the swimming pool.Due to her therapy, she was now starting to get movement back in her arms but still experienced weakness.The patient stated that she was frustrated with everything going on so she was referred to a rheumatologist.The rheumatologist felt that she was experiencing an immune reaction to euflexxa.The patient also stated that her right ankle was bruised and she was experiencing pain in her hand that had improved since her injections.All of her symptoms were getting better as time had gone on.The physician reported that the patient noted the systemic immune reaction started in april.The physician reported they saw her in april and notes from the visit do not reference the immune reaction but the patient had stated her arms were starting to bother her.The physician reported that the remaining events occurred after they saw her last.The physician reported the causality of frozen arms, bruising of the right ankle, wrist swelling and pain, arms were starting to hurt so bad it was difficult to put her jacket on, and pain in her hand as unlikely related to euflexxa.Causality of crippling pain in the right knee and pain in the left knee was reported as possible temporary reaction related to euflexxa.The systemic immune reaction to euflexxa was medically significant.Action taken with euflexxa was dose not changed.At the time of this report, the outcome of right knee was swollen, right ankle is bruised, developed a terrible systemic immune reaction to euflexxa, tingling in the legs, and right knee was hot was recovering/resolving.The outcome of pain in her hand was recovered.In (b)(6) 2017, the outcome of crippling pain in the right knee/ pain in the left knee was recovered.In (b)(6) 2017, the outcome of her arms were hurting so bad it was difficult to put her jacket, wrist started to swell, and pain in her wrist was recovered.The patient`s medical history was significant for sprained ankle 20 years ago (from 1997 to unknown stop date), physical therapy scope surgery (from 1990 to 1990), knee scope surgery (from 1980 to 1980), has twin girls, allergy to sulfa, broke her right wrist (from 1998 to unknown stop date).The patient`s past drug therapy was significant for corticosteroid (from (b)(6) 2016 to unknown stop date).The patient`s procedures included bilateral knee x-ray (from (b)(6) 2017) and physical examination ofknee (from unknown start date to unknown stop date).History of chronic pain, alcohol use, and rheumatoid arthritis were reported as unknown.No history of obesity.History of physical activity was reported as pool exercise and home program.The following concomitant medications were reported: diclofenac (from (b)(6) 2017 to an unknown stop date), turmeric, apple cider vinegar.Relevant laboratory values included: c-reactive protein: 39.5ni (no assessment), (b)(6) 2017.C-reactive protein: 61ni (no assessment), 2017.Red blood cell sedimentation rate: 63ni (no assessment), (b)(6) 2017.Red blood cell sedimentation rate: 18ni (no assessment), 2017.The events frozen arms (paralysis in the arms), developed a terrible systemic immune reaction to euflexxa were reported as serious.The events right ankle is bruised, tingling in the legs, crippling pain in the right knee/ pain in the left knee, right knee was hot, right knee was swollen, wrist started to swell, pain in her wrist, her arms were hurting so bad it was difficult to put her jacketon, pain in her hand were reported as non-serious.At the time of reporting the case outcome was recovering/resolving.This ae occurred in the 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 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.Additional information was received on 25-aug-2017 from the patient's physician: follow up 01- case became medically confirmed.Medical history, past drug therapy, procedures updated.Euflexxa start and stop dates added, concomitant medication added.Event onset date, end dates, and outcomes updated.Narrative updated.Additional information was received on 30-oct-2017 from the patient via regulatory authority: follow up 02- lab data added.Concomitant medication added.Serious event of immune system disorder updated to autoimmune disorder.Additonal events of painful swelling of the feet and ankles was added.Inflammation was subsumed under autoimmune disorder.Narrative updated.This case was submitted with the following mfr duplicate numbers: initial: mfr 3000164186-2017-00025 submitted on 25-jul-2017.Follow-up #1: mfr 3000164-2017-00025-1 submitted on 18-sep-2017.Follow-up #2: mfr3000164186-2017-00033-1 submitted on 10-nov-2017.Follow-up #1 correction to mfr# resubmitted on 17-aug-2020: mfr# 3000164186-2017-00025.Follow-up #2 correction to mfr# resubmitted on 18-aug-2020: mfr# 3000164186-2017-00025.Narrative updated.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: related.Other case numbers: case number, others = (b)(4).Case number, complaint = (b)(4).Mw 3500a mfr.Rpt.# = 3000164-2017-00025.Case number, complaint = (b)(4).Argus number: (b)(4).
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