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Impaired mobility [mobility decreased].Pain led to limping [gait disturbance].Intense pain in, around, below and in back of injected knee [arthralgia].Doctor suggested that the gel might have been injected in the wrong area as ultrasound had not been used [wrong technique in product usage process].Case narrative: case (b)(4) is a serious spontaneous case received from a consumer via regulatory authority in united states (fda).This report concerns a female of unknown age who experienced impaired mobility, pain led to limping, and intense pain in, around, below and in back of injected knee during treatment with euflexxa (sodium hyaluronate) solution for injection, concentration and dosing regimen unknown, for product used for unknown indication from an unknown start date and unknown if ongoing.Events on-set reported as (b)(6) 2019.The patient reported after the first injection of euflexxa, the patient began to experience intense pain in, around, below and in back of injected knee.Pain led to limping and impaired mobility and persist to present.During a follow up visit, the physician's assistant showed little interest in determining the cause of pain and only prescribed physical therapy.Another doctor suggested that the gel might have been injected in the wrong area as ultrasound had not been used (wrong injection technique).The impaired mobility was reported as disabling/permanent damage.Action taken with euflexxa was unknown.At the time of this report, the outcome of impaired mobility was not recovered, the outcome of pain led to limping was not recovered, the outcome of intense pain in back of injected knee was not recovered.The following concomitant medication was reported: armour thyroid (from an unknown start date to an unknown stop date), estrace (from an unknown start date to an unknown stop date), vitamin c (from an unknown start date to an unknown stop date), vitamin b (from an unknown start date to an unknown stop date), digestive enzymes probiotic (from an unknown start date to an unknown stop date), betaine (from an unknown start date to an unknown stop date), hydrochloride b1 (from an unknown start date to an unknown stop date), calcium (from an unknown start date to an unknown stop date), magnesium (from an unknown start date to an unknown stop date), potassium (from an unknown start date to an unknown stop date).The event impaired mobility was reported as serious.The events pain led to limping, intense pain in, around, below and in back of injected 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: internal # - others = mw5087711.This ae occurred in 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 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.
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