This incident occurred outside of the usa, in (b)(6).According to information received as of (b)(6) 2022, a patient was injected on (b)(6) 2022, with 0.4 ml of teosyal rha 3 (tp27l-213715c0) into the forehead depression and glabellar lines.One-day post-injection on (b)(6) 2022, the patient presented with erythema, accompanied by inflammation, and slight tenderness on the right glabellar lines.On (b)(6) 2022, the patient was reviewed by the practitioner who sent the spanish subsidiary photos of the patient demonstrating the appearance of vesicles on the affected area.As a remedial action, the practitioner prescribed an anti-inflammatory agent (glucocorticoid; prednisone).Following this initial report, a local medical expert was put in contact with the physician to advise on this case.The latter, diagnosed the adverse event as vascular compromise, and recommended injection of hyaluronidase (500 iu) along with a topical antibiotic (mupirocin ointment) and acid acetylsalicylic for seven 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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