|
Anaphylaxis/ massive systemic reaction [symptoms subsumed throat closing, hoarse voice, could not speak, itching, flushing, swelling of face, tongue swollen] [anaphylactic reaction] euflexxa indicated for hip joint trauma [product use in unapproved indication].This serious, spontaneous report was received from a consumer in united states.This report concerns a (b)(6) female who experienced anaphylaxis/ massive systemic reaction during treatment with intra-articular euflexxa (sodium hyaluronate) solution for injection of unknown dose, once/single, for joint injury from (b)(6) 2017 and the co-suspect drug cortisone (cortisone) injection of unknown dose and route of administration, for an unknown indication on unknown dates.The patient received a euflexxa injection, along with a cortisone injection, in her left hip on (b)(6) 2017.She woke up in the middle of the night on (b)(6) 2017 due to itching.She reported she could not speak, had flushing, and had purple on spots on her face and bottoms of feet.She reported experiencing anaphylaxis/massive systemic reaction on (b)(6) 2017 with symptoms of throat closing, hoarse voice, swelling of face, and tongue swollen.She also reported experiencing the feeling of being poisoned, mouth burning, tongue raw, visual disturbances, and foul smelling urine and feces.She went to the urgent care and was given injectable steroids and oral steroids (unspecified) as treatment for five days.She also reported she was taking oral antihistamines.It was reported that even with treatment her symptoms did not resolve and in fact new symptoms appeared each day.She reported that her allergist said the drug was too high in sodium and her toxicity was off the charts.On (b)(6) 2017, the patient's vision was blurred and her eyes could not focus.Her eyebrows were drooping.On (b)(6) 2017, she reported all of her symptoms were worse.She experienced shooting pain through all her joints on the (b)(6) 2017.Her face became even more swollen.The patient reported that she went to the emergency room and was given iv fluids.Her eye physician told her it damaged her vision neurologically (type of damage was unspecified).It was also reported that she experienced neurologic damage to her facial nerves, was experiencing vertigo, and balance issues.She also experienced unbearable pain in her hip joint.The patient received an mri (on an unknown date) and a cyst was found on the head of her femur that was not there before the euflexxa injection.She also reported fraying of the labrum that is new and joint effusion.It was reported that her mri results all point to joint degeneration from euflexxa.The patient was restricted to bed rest and crutches.She also reported swelling in a ligament in her groin that is worse, numbness in her leg and foot, and a burned mouth that gives her a horrible taste.She also reported that she is in agony, is crippled, unable to bear weight, and has joint degeneration.The patient was not on any medications prior to this injection.Action taken to euflexxa was dose withdrawn.Action taken with cortisone was unknown.At the time of this report, the outcome of all of the events was not recovered.The patient`s medical history was significant for "does not smoke"," life-long vegetarian", and "does not drink".The patient`s procedure was significant for mri (from unknown start date to unknown stop date).Concomitant medication use was reported as no previous medications prior to the euflexxa injection.At the time of reporting the case outcome was not recovered.Additional information was received on 15-may-2017 from regulatory authority: no new significant information provided.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: related.Other case numbers: case number, others = (b)(4), fda maude mw5069371.The aes occurred in 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.(b)(4).
|
