This serious spontaneous report was received from laboratories genevrier (ref.Nr.(b)(4) on (b)(6) 2020 describes the occurrence of hypoesthesia, malaise and erythema, in a unknown patient who was prescribed sinovial (hyaluronate sodium 0.8 %), injection, 2 ml for unknown indication.Description: (b)(6) 2019: right knee infiltration around 2 p.M.A month before, the patient had been infiltrated in the left knee with the same products, it was the 3rd infiltration.1 hour later the patient presented with a feeling of malaise, with significant heat, redness of the face without urticarial flare the next day.While washing she found hypoesthesia of the right hemiface, all over territory of v, without paralysis of the facial nerve vii, having lasted approximately 48 hours.Assessment in emergency room and neuro intensive care without particularity, with an mri scanner, normal biology eliminating a stroke or tumor pathology.Possible assessment for infiltration, but neither likely nor certain.The declaration was made due to the potential severity of the neurological reaction and the lack of reporting of this side effect with this product.The patient was not taking any concomitant medication.The case is considered serious for hospitalization.The patient recovered without sequalae.Ibsa comment: serious, unlisted, possible reaction to infiltration due to lack of alternative explanation.However this could be also a concomitant spontaneous event.On (b)(6) 2020 follow up was received from laboratories genevrier: it is not very clear whether all the symptoms lasted 48 hours or only the hypoesthesia.The case was reported by the crpv (regional center of pv) of toulouse.Ibsa comment: follow up information doesn't change the assessment, serious case, possible, unlisted.
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