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Fluid extracted [from knee] contained blood [haemarthrosis], developed a knee infusion [effusion] [joint effusion], swelling [knee] [joint swelling], intense /constant pain [knee] [arthralgia].
This serious, spontaneous regulatory authority report was received from a consumer in united states.
This report concerns a patient of unknown age and gender who experienced fluid extracted [from knee] contained blood, developed a knee infusion [effusion], swelling [knee], and intense /constant pain [knee] during treatment with euflexxa (sodium hyaluronate) solution for injection (product concentration, dosing regimen, route of administration, indication for use, and start/stop dates of therapy not reported).
On (b)(6) 2016, within three days of receiving a euflexxa shot, the patient developed a knee effusion which resulted in an emergency room visit for knee aspiration treatment.
The following day, and for at least three weeks thereafter, according to the report, the swelling and intense, constant knee pain continued to return causing the patient to have fluid aspirated from her knee at least two more times.
On one occasion 105 cc of fluid was extracted which was cultured and assessed as negative for infection and on another occasion, the extracted fluid contained blood (culture results unknown).
The events of haemarthosis and joint effusion were assessed as serious due to medical significance.
The events of joint swelling and arthralgia were assessed as non-serious.
The outcome of the events of haemarthrosis and joint effusion was unknown.
The outcome of the events of joint swelling and arthralgia was not resolved at the time of the report.
Action taken with euflexxa was unknown.
Concomitant medications were not reported.
The following medical procedures were reported: knee aspirations (from an unknown date in (b)(6) 2016 to an unknown date in (b)(6) 2016).
Additional medical history was not reported.
At the time of reporting, the case outcome was unknown.
Ferring global pharmacovigilance added the narrative since no narrative was provided.
Overall listedness (core label) is unlisted.
Reporter causality: related.
Company causality: related.
Other case numbers: case number, others
=
mw5059778.
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 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 argus number: (b)(4).
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