Pharmaco-vigilance comments: the serious events of foreign body reaction, and scar were considered expected, and related to the treatment with restylane lyft with lidocaine.Serious criteria include the need for surgical intervention and permanent damage.The serious expected event of foreign body reaction was considered related to the treatment with restylane defyne and the serious, expected event of scar was considered unrelated to the treatment with restylane defyne as no excision was performed in that treatment area.The case meets the criteria for expedited reporting to the regulatory authorities.Engineering evaluation: the information in this single case does not suggest involvement of a nonconforming product or quality problem, and will not initiate a corrective or preventive action.Manufacturing narrative: the reported lot number was valid.
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Case reference number: (b)(4) is a spontaneous report sent on (b)(6) 2020, by a physician, which refers to a patient of a (b)(6)-year-old 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 (b)(6) 2020, the excised specimen was received.The details of dermatopathology report of (b)(6) 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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