|
Has not been able to go to work [impaired work ability].Did not have full range of motion [joint range of motion decreased].Could not sleep [insomnia].Pain in his leg, from mid thigh to foot [pain in extremity].Device use in unapproved indication [device use issue].Off label use of device [off label use of device].Case (b)(4) is a serious, spontaneous case received from a consumer in united states.This report concerns a (b)(6) male who has not been able to go to work, did not have full range of motion, could not sleep, experienced pain in his leg from mid thigh to foot and off label use of device during treatment with euflexxa (sodium hyaluronate) solution for injection unknown concentration and dose amount, weekly for 3 weeks, for arthralgia from (b)(6) 2018.The patient reported he had arthroscopic knee surgery on his left knee on (b)(6) 2018 for a small meniscus tear and went through physical therapy.After six weeks of physical therapy the patient could not achieve full range of motion without pain, so the doctor prescribed euflexxa (off label use).The patient received his first injection of euflexxa on (b)(6) 2018, his second injection on (b)(6) 2018 and his third injection on (b)(6) 2018.The patient reported that after the second injection, given by the physician's assistant, he experienced pain in his leg.The patient reported it was not pain at first, just did not have full range of motion, then it became painful.After the third shot, the pain became excruciating from mid-thigh to his foot.He followed up with his doctor and they tried cortisone, steroids, and he was still experiencing pain and he reported that it became a life changing event for him.The patient further described that it was life changing because he could not sleep, had not been able to go to work and was still feeling constant pain.The patient reported he was taking meloxicam, an arthritis type pain medication, for the pain.He reported that he still felt a dull ache, not in the knee, but throughout his leg.The patient's physician sent him to another surgeon in practice, who gave him an emg test, he thought (patient described test as nerve test where they put needle in knee or muscles).At the time of the reporting the patient was taking medications, using cold compresses and a follow up visit for scheduled.The event of patient has not been able to go to work was deemed serious due to disability.Action taken with euflexxa was dose not changed.At the time of this report, the outcome of has not been able to go to work was not recovered, the outcome of could not sleep was not recovered, the outcome of did not have full range of motion was not recovered, the outcome of pain in his leg, from mid thigh to foot was not recovered, the outcome of unapproved indication/off label use was not recovered.The patient`s medical history was significant for slightly high blood pressure (from unknown start date to unknown stop date) and meniscus tear (from unknown start date to unknown stop date) and physical therapy (from unknown start date to unknown stop date) and surgery on wrist (from 2009 to 2009).The patient`s procedures included arthroscopic knee surgery (from (b)(6) 2018).The following concomitant medications were reported: losartan, metoprolol tartrate, ibuprofen and baby aspirin.The event has not been able to go to work was reported as serious.The events did not have full range of motion, could not sleep, pain in his leg, from mid thigh to foot and use for unapproved indication/off label use 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: related.Other case numbers: internal # - others = (b)(4).These aes occurred in united sated and concerns the medical device euflexxa.Please report to your local health authority if required by local law.These aes were not reportable in eu because they 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 regulator.
|
