Patient relayed deformation to the doctor about 2 weeks after bellafill injection, but will not allow the doctor to examine to determine cause or diagnosis.Patient states they require surgery to correct.Timeline: on (b)(6) 2020: the patient was injected with bellafill dermal filler in the "marionette lines, jowls, and parenthesis lines".On (b)(6) 2020: the patient reported the deformation to the doctor.The actual onset date is unknown.The area(s) of "deformation" is unknown.On (b)(6) 2020: date the issue was reported to (b)(6).Known patient medical history per the reporting account: patient states no known medical conditions.No known drug allergies.Currently takes no medications.No other fillers or facial treatments per the injector's knowledge.The lot used in the patient's bellafill procedure (lot f191096) was reviewed.No issues were noted with manufacturing records, the lot met all acceptance criteria upon release.Review of the retained lot samples for lot f191096 found the lot continues to meet release criteria.The patient has refused to come back to the injector for examination as of the date of this submission.The cause of the reported deformation is unknown.The patient was injected with bellafill dermal filler in the "marionette lines, jowls, and parenthesis lines".The area(s) of "deformation" is unknown.Bellafill dermal filler is indicated for the correction of nasolabial folds and moderate to severe, atrophic, distensible facial acne scars on the cheek in patients over the age of 21 years.Bellafill syringes are single use devices and are typically discarded after use.Per the bellafill ifu: "the syringe and any unused material should be discarded after a single treatment visit.".
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