Vascular complications are rare serious side effects, although widely known and documented in the context of filler injections.They are related to the accidental injection of the product inside or close to a blood vessel, leading to its occlusion or compression, blocking the blood flow.If treated on time with an appropriate treatment, symptoms can be fully resolved without sequalae.If the vascular complication is not detected/diagnosed and treated timely, it can lead to a skin necrosis.The risk of such adverse reactions is mentioned in the instructions for use of teosyal products.
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This event happened outside of the us, in (b)(6).According to information received as of 2 june 2021, the patient was injected with 1 ml of teosyal rha 3 (tp27l-201011b1) in the chin, nasion and glabella areas on (b)(6) 2021.A few hours after injection, the patient developed a superficial skin infection in the chin area.There was also pain in the nasion and anterior nasal spine without signs of infection.On (b)(6) 2021, the patient received the following treatment: antibiotic therapy (augmentine 875 mg 3 times per day during 2 weeks), and topical ointment mupirocin (every 8 hours during 2 weeks).The (b)(6) subsidiary contacted a local medical expert to monitor the situation and provide treatment advice.According to the expert, the event is a vascular compromise due to the involvement of the left mental artery.The medical expert recommended a curettage treatment to remove the necrotic tissue and also a topical antibiotic to avoid further infection.On 03.06.2021, we were informed that the patient received a curettage treatment.According to the latest information on (b)(6) 2021, the patient's symptom is resolving properly, however the patient still presents some scar on the chin area.
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