Additional mfr narrative: skin infections are well known and described adverse reactions following dermal filler injections.They can happen after an injection with an improper technique, inducing a lack of asepsis of the injection environment, which in some case may result in sepsis.External factors, such as the use of makeup immediately after the injection, can also increase the risk of skin infection.Adequate treatment with antibiotics leads to a complete resolution of the symptoms without sequelae.Additionally, the risk of such adverse events is mentioned in the instructions for use of teosyal products.
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According to the received information, the patient was injected with an unknown amount of rha 3 in the nasolabial folds and three syringes of rha 4 in the cheeks on (b)(6) 2021.At the beginning of (b)(6), the patient experienced unilateral under eye swelling which progressively became worse, the full medial and lateral cheek of the right side became swollen, red, and tender, showing signs of infection.No symptoms occured in the nasolabial folds so only rha 4 product was considered.In the last week of (b)(6) 2022, the patient underwent a ct scan which showed chronic sinus infection and sinus polyps.A biopsy was scheduled on (b)(6) 2022 but it is unknown at the time of this report if the procedure was done.In an unknown date in (b)(6) 2022, the patient was prescribed antibiotics.The events were ongoing at the time of this report.No additional information could be retrieved.
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