On (b)(6) 2020, the injector noticed a white area after injection and decided to injected 1 vial of hyaluronidase and informed the patient to keep an eye of it.2 days later, the patient reported that she has white spots on her nose.As the injector suspected a vascular occlusion, the patient came back immediately to the surgery.The injector used hyaluronidase 4 times more and prescribed antibiotics (flucloxacillin 500 mg) and an ointment (chloramphenicol).2 days after, symptoms were slowly subsiding but as the patient was worried, she went to the hospital where they gave her a drip.Kept her 2 days and then she was discharged.A full analysis of the related batch records of the products has being conducted to test for specification and sterility compliance.Results show that these products are compliant with the applicable specifications.No element allows us to identify a defect in the quality, sterility or safety of our products.Vascular compromises are serious adverse events that are well known and well-documented related to the injection of hyaluronic acid fillers.They are linked to an accidental injection in, or next to a vessel, triggering its compression or occlusion.If treated on time with an appropriate treatment, symptoms can be fully resolved, without sequalae.If not, they can worsen and develop into skin necrosis.Additionally, the risk of such adverse event is also mentioned in the instructions for use of our products.- de boulle k, heydenrych i.Patient factors influencing dermal filler complications: prevention, assessment, and treatment.Clin cosmet investig dermatol.2015;8:205-14 - signorini, m., et al.(2016)."global aesthetics consensus: avoidance and management of complications from hyaluronic acid fillers-evidence- and opinion-based review and consensus recommendations." plastic and reconstructive surgery 137(6):961e-971e - delorenzi, c.(2014)."complications of injectable fillers, part 2: vascular complications." aesthetic surgery journal / the american society for aesthetic plastic surgery 34(4): 584-600.
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The adverse event occurred outside of the us, in (b)(6).According to the received information, the patient was injected with teosyal rha 4 on (b)(6) 2020.The same day, the patient presented a purple coloration of the nose until the glabella.The injector suspected a vascular complication.The issue is now completely resolved.
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