Case reference number (b)(4) is a spontaneous report sent on 19-oct-2020 by a physician which refers to a patient of a (b)(6) female patient.The patient's medical history included guillain-barre syndrome and allergy to pcn, sulfa, codeine, dilantin, tetanus.Concomitant treatments included progesterone [progesterone], prozac [prozac] and thyroid [thyroid].The patient had previously received treatment with juvederm to cheeks and nasolabial folds on an unknown date in another office.On (b)(6) 2020, the patient received treatment with 1 ml restylane lyft with lidocaine (lot 17328) to upper cheeks and 1 ml restylane defyne (lot 16757) to perioral area and chin with unknown needle type and injection technique.On an unknown date in (b)(6) 2020, the patient experienced delayed onset issue/foreign body giant cell reaction to filler material/granuloma.On 06-oct-2020, the excised specimen was received.The details of dermatopathology report of 07-oct-2020 were as follows.Specimen site was left inferior medial malar cheek.Gross description: received in formalin were 4 fragment of skin and yellow fatty tissue measuring 3.2x2x1 cm in aggregate.The surgical margins were inked blue.Representative section were submitted.1b.Bom/mtr microscopic description: slides examined.The specimen sent was diagnosed as foreign body giant cell reaction to filler material/granuloma (foreign body reaction), excised.No malignancy seen.On (b)(6) 2020, the patient was seen in hcp office and received treatment with 60 units of hyaluronidase [hyaluronidase] with good resolution.Outcome at the time of the report: scar was not recovered/not resolved.Delayed onset issue/foreign body giant cell reaction to filler material/granuloma was recovered/resolved with sequelae.Tracking list: v.0 initial.V.1 fu received on 27-oct-2020 from the same reporter: case upgraded to serious.Event scar added.Event coding updated to foreign body reaction from adverse event.Patient demographics, medical history, past filler, concomitant medication, suspect device implant location, event severity, location, outcome, reporter causality and corrective treatment details were updated.
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