BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTYLANE KYSSE

    MDR report key: 20623676 · Received November 6, 2024

    Report

    Report Number
    9710154-2024-00067
    Event Type
    Injury
    Date Received
    November 6, 2024
    Date of Event
    October 9, 2024
    Report Date
    November 6, 2024
    Manufacturer
    Q-MED AB
    Product Code
    LMH
    PMA / PMN Number
    P140029 S050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPANY COMMENT: THE SERIOUS EVENT OF VASCULAR OCCLUSION AND THE NON-SERIOUS EVENT OF DISCOLOURATION AT IMPLANT SITE 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 IS INTRAVASCULAR FILLER INJECTION LEADING TO VASCULAR OCCLUSION AND ITS MANIFESTATIONS. 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 10-OCT-2024 BY A NURSE PRACTITIONER CONCERNING A 42-YEAR-OLD FEMALE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE SAME REPORTER ON 14-OCT-2024 AND 24-OCT-2024. THE PATIENT HAD NO KNOWN MEDICAL HISTORY OR ALLERGIES. NO INFORMATION ABOUT CONCOMITANT MEDICATION OR PREVIOUS FILLER TREATMENTS HAS BEEN PROVIDED. ON (B)(6)2024, THE PATIENT RECEIVED TREATMENT WITH 0.5ML OF RESTYLANE KYSSE (LOT 21181, EXPIRY DATE 30-NOV-2024), WITH 0.3 ML TO LOWER LIP AND 0.2 ML TO UPPER LIP USING AN UNKNOWN INJECTION TECHNIQUE AND NEEDLE TYPE. THE REPORTED STATED THAT THIS WAS THE PATIENT'S FIRST FILLER TREATMENT. ALMOST IMMEDIATELY AFTER INJECTION, ON (B)(6)2024, WHILE CHANGING THE LOCATION, THE PATIENT EXPERIENCED FLASH OF BLUE (IMPLANT SITE DISCOLOURATION) AND VASCULAR OCCLUSION (VASCULAR OCCLUSION) IN THE LIPS. THE HCP STOPPED INJECTION AND ADMINISTERED 2 VIALS OF HYLENEX [VORHYALURONIDASE ALFA] AFTER 30 MINUTES OF OBSERVATION. THE PATIENT WAS ALSO TREATED WITH PEPCID [FAMOTIDINE], ASPIRIN [ACETYLSALICYLIC ACID] AND DEXAMETHASONE [DEXAMETHASONE] WHILE IN THE OFFICE. SHE WAS GIVEN PREDNISONE [PREDNISONE], VALTREX [VALACICLOVIR HYDROCHLORIDE], DOXYCYCLINE [DOXYCYCLINE], AND CLARITIN [LORATADINE] TO TAKE AT HOME. THE HCP REPORTED THAT THE PATIENT DID NOT EXPERIENCE ANY OTHER SIGNS OR SYMPTOMS OF VASCULAR OCCLUSION. ON (B)(6)2024, THE PATIENT WAS TREATED WITH 4 VIALS OF HYLENEX, 2 VIALS TO THE FACIAL ARTERY AND 2 VIALS TO THE LIPS. ON (B)(6)2024, THE PATIENT AGAIN TREATED WITH 3 VIALS OF HYLENEX TO THE LIPS. ON (B)(6)2024, THE PATIENT WAS TREATED WITH A TOTAL OF 4 VIALS OF HYLENEX. ON AN UNKNOWN DATE IN (B)(6)2024, THE EVENTS WERE COMPLETELY RESOLVED. OUTCOME AT THE TIME OF THE REPORT: VASCULAR OCCLUSION WAS RECOVERED/RESOLVED. FLASH OF BLUE WAS RECOVERED/RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1991865 RESTYLANE KYSSE IMPLANT, DERMAL, FOR AESTHETIC USE LMH Q-MED AB 21181

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female Required Intervention