The patient was managed by a specialist in adverse event management in (b)(6), where the patient stayed 15 days to follow a protocol.First the patient got warm gauze to facilitate vasodilatation.Then the patient was prescribed: baycip 500 1-0-1 10 días.Pulcral sol ioox spray: 1-0-1.Aquaphor eucerin 1-1-1-1.Adiro 100 1-0-0.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.Literature data: 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.
|
The event occured outside of the us, in (b)(6).According to the received information, the patient was injected with teosyal rha 4: 1 ml in the cheek and jaw line of the right side on (b)(6) 2020.1 ml in the cheek and jaw line of the left side on (b)(6) 2020.2 ml in the cheek of the right side on (b)(6) 2020.On (b)(6) 2020, the patient presented an hematoma of severe intensity on the cheek of the right side and erythema and vascular compromise on the glabella.The injector that the area where the vascular compromise occurred could leave a little scar.Manufacturer (teoxane) was aware of the vent on (b)(6) 2020.The patient was managed by a specialist in adverse event management in (b)(6), where the patient stayed 15 days to follow a protocol.On (b)(6) 2020, the spanish affiliate informed us that the symptoms had resolved.
|