BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTYLANE CONTOUR

    MDR report key: 18961866 · Received March 22, 2024

    Report

    Report Number
    9710154-2024-00017
    Event Type
    Injury
    Date Received
    March 22, 2024
    Date of Event
    February 1, 2024
    Report Date
    March 22, 2024
    Manufacturer
    Q-MED
    Product Code
    LMH
    PMA / PMN Number
    P140029 S045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPANY COMMENT: THE SERIOUS EVENT OF VASCULAR OCCLUSION AND THE NON-SERIOUS EVENTS OF PALLOR AT IMPLANT SITE, LIVEDO RETICULARIS AND POOR PERIPHERAL CIRCULATION WERE CONSIDERED EXPECTED AND POSSIBLY RELATED TO THE TREATMENT. SERIOUSNESS CRITERIA INCLUDES THE NEED FOR MULTIPLE MEDICAL INTERVENTIONS TO PREVENT PERMANENT DAMAGE. THE LIKELY ROOT CAUSE INCLUDES INTRAVASCULAR FILLER INJECTION LEADING TO VASCULAR OCCLUSION AND ITS MANIFESTATIONS. POTENTIAL CONTRIBUTORY FACTOR INCLUDES INJECTION TECHNIQUE. THE CASE MEETS THE CRITERIA FOR EXPEDITED REPORTING TO THE REGULATORY AUTHORITIES. EVALUATION TEXT: ROUTINE INVESTIGATIONS HAVE BEEN PERFORMED AND PROVIDE SUFFICIENT INFORMATION TO ASSESS THE POTENTIAL ROOT CAUSE AND INDICATE A POSSIBLE ASSOCIATION TO THE TREATMENT PROCEDURE. THE REPORTED LOT NUMBER WAS VALID AND VERIFIED THE REPORTED PRODUCT. THE INFORMATION IN THIS CASE DOES NOT INDICATE A NON-CONFORMING PRODUCT OR MALFUNCTION. THE PERFORMED INVESTIGATIONS ARE THEREFORE CONSIDERED ADEQUATE, AND NO ADDITIONAL INVESTIGATIONS WILL BE CONDUCTED. CAPA COMMENT: NO CORRECTIVE OR PREVENTIVE ACTIONS ARE DEEMED NECESSARY BASED ON THE OUTCOME OF THE PERFORMED INVESTIGATIONS.

    Description of Event or Problem · 0

    CASE REFERENCE NUMBER (B)(4) IS A SPONTANEOUS REPORT SENT ON 26-FEB-2024 BY A REGISTERED NURSE, WHICH REFERS TO A 21-YEAR-OLD FEMALE PATIENT. THE MEDICAL HISTORY OF THE PATIENT INCLUDED MICROGENIA. SHE WAS HEALTHY AND HAD NO KNOWN ALLERGIES. NO INFORMATION ABOUT CONCOMITANT MEDICATION OR PREVIOUS FILLER TREATMENTS HAS BEEN PROVIDED. ON (B)(6) 2021, THE PATIENT RECEIVED HER FIRST DOSE OF UNSPECIFIED COVID-19 VACCINE AND SECOND DOSE ON (B)(6) 2021. ON (B)(6) 2024, THE PATIENT RECEIVED TREATMENT WITH UNKNOWN AMOUNT OF RESTYLANE VOLYME (LOT 21203-1) TO CHIN USING 27G NEEDLE IN THE SUPRAPERIOSTEAL PLANE WITH MICRO BOLUSES INJECTION TECHNIQUE. THE PATIENT HAD NO CONTRAINDICATIONS TO FILLER INJECTIONS. ALL INJECTIONS WERE PERFORMED IN MIDLINE AND NEGATIVE ASPIRATION WAS NOTED PRIOR TO EACH INJECTION. ALMOST IMMEDIATELY AFTER THE FIRST COUPLE OF MICRO BOLUSES, THE PATIENT EXPERIENCED BLANCHING (IMPLANT SITE PALLOR) AND MOTTLING/RETICULATION (LIVEDO RETICULARIS) AND SHE WAS DIAGNOSED WITH VASCULAR OCCLUSION (VASCULAR OCCLUSION) IN THE CHIN. IMMEDIATELY, THE HCP BEGAN HIGH DOSE HYALURONIDASE [HYALURONIDASE] PROTOCOL. THE HCP ASPIRATED BLOOD IN MIDLINE WHILE DISSOLVING THE FILLER WITH HYALURONIDASE BECAUSE THE PATIENT LIKELY HAD A MIDLINE DEVIATION OF SUBMENTAL ARTERY. THE HCP NOTED SLUGGISH CAPILLARY REFILL (POOR PERIPHERAL CIRCULATION). THEREAFTER, THE REPORTING HCP CONSULTED THE DISSOLVING SPECIALIST WHO RECOMMENDED HBOT TREATMENTS TO PREVENT SKIN NECROSIS. THE PATIENT WENT TO THE FIRST SESSION OF HBOT TREATMENT 12 HOURS POST VASCULAR OCCLUSION. THE HCP DISSOLVED THE FILLER WITH 1 ML OF HYALURONIDASE FROM (B)(6) 2024 AFTER HBOT TREATMENTS UNTIL THERE WAS SATISFACTORY CAPILLARY REFILL AND PERFUSION. THE PATIENT ALSO RECEIVED TREATMENT WITH 500 MG OF KEFLEX [CEFALEXIN] FOUR TIMES DAILY FROM (B)(6) 2024 AND 2% MUPIROCIN [MUPIROCIN] THREE TIMES A DAY FROM (B)(6) 2024. THE PATIENT ALSO HAD SMALL AMOUNT OF SOFT PALATE INVOLVEMENT UNDER HER TONGUE ON THE LEFT SIDE WHICH WAS TREATED WITH 0.15% OF TANTUM [BENZYDAMINE HYDROCHLORIDE] ORAL RINSE 3-4 TIME DAILY FROM (B)(6) 2024. THE PATIENT WAS COMPLETELY HEALED WITHIN 2 WEEKS. OUTCOME AT THE TIME OF THE REPORT: VASCULAR OCCLUSION WAS RECOVERED/RESOLVED. BLANCHING WAS RECOVERED/RESOLVED. MOTTLING/RETICULATION WAS RECOVERED/RESOLVED. SLUGGISH CAPILLARY REFILL WAS RECOVERED/RESOLVED. TRACKING LIST: V.0 INITIAL V.1 FU RECEIVED ON 13-MAR-2024 FROM THE SAME REPORTER: CASE WAS UPGRADED TO SERIOUS. EVENTS (IMPLANT SITE PALLOR, LIVEDO RETICULARIS AND POOR PERIPHERAL CIRCULATION) ADDED. SUSPECT DEVICE UPDATED TO RESTYLANE VOLYME. PATIENT DEMOGRAPHICS, MEDICAL HISTORY, VACCINE HISTORY, SUSPECT DEVICE IMPLANT DATE, LOT NUMBER, NEEDLE TYPE, INJECTION TECHNIQUE, SEVERITY AND REPORTER CAUSALITY OF EVENT VASCULAR OCCLUSION AND CORRECTIVE TREATMENT DETAILS WERE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    893142 RESTYLANE CONTOUR IMPLANT, DERMAL, FOR AESTHETIC USE LMH Q-MED 21203-1

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Female Required Intervention