BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTYLANE KYSSE

    MDR report key: 21445128 · Received February 24, 2025

    Report

    Report Number
    9710154-2025-00004
    Event Type
    Injury
    Date Received
    February 24, 2025
    Date of Event
    November 7, 2024
    Report Date
    February 24, 2025
    Manufacturer
    Q-MED AB
    Product Code
    LMH
    PMA / PMN Number
    P140028/S021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SERIOUS EVENT OF VASCULAR OCCLUSION AND THE NON-SERIOUS EVENT OF SWELLING 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 INCLUDES THE INTRAVASCULAR FILLER INJECTION LEADING TO VASCULAR OCCLUSION AND ITS MANIFESTATIONS. THE CASE MEETS THE CRITERIA FOR EXPEDITED REPORTING TO THE REGULATORY AUTHORITIES.

    Description of Event or Problem · 0

    CASE REFERENCE NUMBER (B)(4) IS A SPONTANEOUS REPORT SENT ON 28-JAN-2025 BY A PHYSICIAN CONCERNING A 47-YEAR-OLD FEMALE PATIENT. THE MEDICAL HISTORY OF THE PATIENT INCLUDED ALLERGY TO VOLTAREN AND BRUFEN. THE PATIENT WAS NOT PREGNANT. NO INFORMATION ABOUT CONCOMITANT MEDICATION OR PREVIOUS FILLER TREATMENTS HAS BEEN PROVIDED. ON (B)(6) 2024, THE PATIENT RECEIVED TREATMENT WITH 1 ML OF RESTYLANE KYSSE (LOT 22379-1), WITH 0.5 ML TO BOTH THE UPPER AND LOWER LIPS USING A 30G NEEDLE WITH AN UNKNOWN INJECTION TECHNIQUE FOR LIP AUGMENTATION. ON THE SAME DAY, THE PATIENT EXPERIENCED MILD VASCULAR OCCLUSION (VASCULAR OCCLUSION) IN THE RIGHT SIDE OF THE LOWER LIP. SUBSEQUENTLY, THE PATIENT WAS TREATED WITH 0.3 ML OF HYALURONIDASE [HYALURONIDASE] UNTIL (B)(6) 2024, 75 MG OF ASPIRIN [ACETYLSALICYLIC ACID] EVERY 6 HOURS, AND 20 MG OF CORTISONE [CORTISONE] TWICE DAILY FROM (B)(6) 2024, FOR 7 DAYS, RESULTING IN AN IMPROVEMENT IN HER CONDITION. ON (B)(6) 2024, THE PATIENT EXPERIENCED SWELLING (IMPLANT SITE SWELLING) IN THE LOWER LIP. IN (B)(6) 2024, THE PATIENT ALSO RECEIVED CORRECTIVE TREATMENTS WITH FOLLOWING CREAMS: REPARIL [DIETHYLAMINE SALICYLATE, ESCIN] CREAM, 0.2% OF GLYCERYL TRINITRATE [GLYCERYL TRINITRATE], AND HIRUDOID [MUCOPOLYSACCHARIDE POLYSULFURIC ACID ESTER] CREAM. BY (B)(6) 2024, THE PATIENT HAD RECOVERED FROM THE VASCULAR OCCLUSION. THE REPORTING PHYSICIAN ASSESSED THE CAUSALITY OF THE VASCULAR OCCLUSION AS POSSIBLY RELATED TO THE TREATMENT. OUTCOME AT THE TIME OF THE REPORT: VASCULAR OCCLUSION WAS RECOVERED/RESOLVED. SWELLING WAS RECOVERED/RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403873 RESTYLANE KYSSE IMPLANT, DERMAL, FOR AESTHETIC USE LMH Q-MED AB 22379-1

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Required Intervention