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Increased heart rate [heart rate increased].
Shortness of breath [dyspnoea].
Pain in knee [arthralgia].
Swelling of the knee [joint swelling].
Case (b)(4) is a serious spontaneous case received from a nurse via a company representative in the united states.
This report concerns a (b)(6) male who experienced increased heart rate, shortness of breath, pain in knee and swelling of the knee during treatment with intra-articular euflexxa (sodium hyaluronate) solution for injection 2 ml, 2 ml, weekly, for osteoarthritis from (b)(6) 2018 to (b)(6) 2018.
The reporter stated that the patient had his first euflexxa injection on (b)(6) 2018 and within 24 hours, he went to the emergency room (er) due to pain and swelling of the knee.
The patient also had an increased heart rate and shortness of breath.
He returned to his prescribing physician's office on (b)(6) 2018 although stated that he did not want the second euflexxa injection due to pain, swelling, increased heart rate, and shortness of breath.
The patient was still being treated by his primary care physician for shortness of breath and higher heart rate and was taking benadryl and an inhaler.
The reporter stated that the prescribing physician did not believe the shortness of breath and higher heart rate were due to euflexxa, although the patient's primary care physician called inquiring about events and euflexxa.
The lot number was reported as n16424a with an expiration date of 21-aug-2019.
The shortness of breath was medically significant.
The increased heart rate was medically significant.
Action taken to euflexxa was dose withdrawn.
At the time of this report, the outcome of increased heart rate was not recovered, the outcome of shortness of breath was not recovered, the outcome of pain in knee was not recovered, and the outcome of swelling of the knee was not recovered.
Concomitant medication and medical history were reported as unknown.
The events increased heart rate, shortness of breath were reported as serious.
The events pain in knee, swelling of the knee 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: case number, others
=
(b)(4).
This ae occurred in the us 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 manufacture.
No corrective action was done by the manufacturer or requested by regulators.
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