On (b)(6) 2018, patient had pdo threads implanted on (b)(6) 2019, hcp reported an issue on the right lateral cheek (insertion point) with inflammation/papule.On (b)(6) 2019, - first follow up visit, patient had soft tissue infection vs granuloma.There was no discharge.On (b)(6) 2019, - second follow up visit, patient snipped the end of the thread which improved the situation but recurred prior to her visit.Practitioner informed inflammation continues but no threads were palpable at the time.On (b)(6) 2019, - third follow up visit, patient still concerned with redness.Erythema returned on (b)(6) 2019.03/01/2019, medical director explained this most likely happened due to inadequate trimming of the thread upon insertion and recommended thread removal if found.Otherwise, oral antibiotics were suggested.Hcp didn't provide additional information or patient status.
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