Case reference number (b)(4) is a spontaneous report sent on 13-jul-2022 by a nurse which refers to a 44-year-old female patient.The patient's medical history included raynauds.The patient had no allergies.The patient was not taking any concomitant medications.The patient had previously received treatment with unspecified fillers to lips in 2017 (5 years ago) twice elsewhere and juvederm in 2019 (3 years ago).On (b)(6) 2022, the patient received treatment with 0.6 ml restylane kysse (lot 20171-1), 0.4 ml to upper lip and 0.2 ml to lower lip using 30g needle with rct and fanning technique for fuller lips.While injecting the lower lip, the patient experienced white patch (implant site pallor) that became bigger.The hcp stopped injecting, checked capillary refill and massaged the area.The hcp checked capillary refill once more and there was poor vascular refill/capillary refill sluggish (poor peripheral circulation) and vascular occlusion (vascular occlusion).The injecting hcp sent video to a senior hcp and prescribing physician, who advised to dissolve the area.The hcp injected 1500 iu of hyalase [hyaluronidase] to lower lip using 27g needle and capillary refill was sluggish.The hcp again massaged the area and repeated the treatment with 1500 iu of hyalase with good effect and the perfusion returned to normal with bruising (implant site bruising).Outcome at the time of the report: vascular occlusion was recovering/resolving.Poor vascular refill/capillary refill sluggish was recovered/resolved.White patch was recovering/resolving.Bruising was unknown.Tracking list: v.0 initial.V.1 fu received on (b)(6) 2022 from the same reporter: case upgraded to serious.Events (vascular occlusion, white patch and bruising) added.Patient demographics, medical history, past filler treatment, suspect device implant date, volume, needle type, lot number, expiry date, verbatim of event poor peripheral circulation, onset date, outcome and corrective treatment details were updated.
|