This case occurred outside of the usa, in spain.According to the information received as of june 16, 2022.A patient was injected with 3 ml of teosyal rha 4 (tpul-213925c0) on (b)(6) 2022 into the bilateral oral commissures, cheeks, chin and the tear trough areas (object of this complaint), and with 1 ml of teosyal rha 2 (tp30l-213427b0) into the bilateral nasolabial folds, and the lips (object of the complaint (b)(4)).Approximately 4 months post-injection, on (b)(6) 2022 the patient presented with a granulomatous reaction described as indurated (firm consistency) on the chin and bilateral marionette lines, accompanied by erythema, pain, and difficulty moving the lips.As a corrective action the patient received the following treatment: on (b)(6) 2022 an anti-inflammatory treatment (glucocorticoid; dezacort 30 mg, 1 time per day for a total of 7 days), accompanied by antibiotic (ciprofloxacine 500 mg, 2 times per days for a total of 10 days).On (b)(6) 2022 dezacort 30 mg; 2 times per days for a total 7 days.On (b)(6) 2022 dezacort 30 mg; 1 time per day for a total of 7 days.Following this initial report, a local medical expert was put in contact with the practitioner, who advised to add another antibiotic (clarithromycin) , and to inject hyaluronidase 72 hours after the start of the antibiotic treatment, and to continue the injection of hyaluronidase every 3 days.Situation of the patient and symptoms evolution are monitored.No additional information is available at the time of this report.
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