BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTYLANE KYSSE

    MDR report key: 16214831 · Received January 19, 2023

    Report

    Report Number
    MW5114398
    Event Type
    Injury
    Date Received
    January 19, 2023
    Date of Event
    November 29, 2022
    Report Date
    January 17, 2023
    Manufacturer
    GALDERMA LABORATORIES, L.P.
    Product Code
    LMH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    HAD ONE SYRINGE OF RESTALYNE KYSSE INJECTED INTO MY TOP AND BOTTOM LIP. AS EXPECTED, I IMMEDIATELY EXPERIENCED SWELLING, STIFFNESS, AND PAIN IN THE INJECTION SITE. HOWEVER, THE PAIN, TENDERNESS, STIFFNESS, AND EVENTUALLY ITCHINESS PERSISTED. I'VE HAD LIP FILLER SEVERAL TIMES BEFORE AND WAS FAMILIAR WITH THE HEALING PROCESS, BUT THIS SITUATION WAS DIFFERENT. AS I WAS EXPERIENCING THESE ISSUES, I REMAINED IN CONTACT WITH THE OFFICE THAT HAD INJECTED ME. THEY ADVISED ME TO WAIT 2 WEEKS FOR FILLER TO SETTLE. HOWEVER, BECAUSE THE PAIN WAS SO INTENSE AND I WAS BEGINNING TO HAVE NERVE PAIN IN MY CHIN, I RETURNED AFTER 8 DAYS TO HAVE THE FILLER RESOLVED. THE INJECTOR AGREED THAT THE FILLER WAS NOT HEALING CORRECTLY. I WENT TWICE TO GET IT DISSOLVED WITH HYLENEX. ALTHOUGH THIS HELPED, IT WAS NOT FULLY SUFFICIENT - THE FILLER REMAINED. I'VE SINCE GONE TO A DIFFERENT CLINIC AND HAVE HAD THE FILLER DISSOLVED ONCE MORE. IT'S STILL NOT GONE AND MY LIPS ARE STILL ITCHY AND TENDER. I WILL HAVE TO CONTINUE UNDERGOING HYLENEX TREATMENTS UNTIL THE REST OF THIS FILLER IS GONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412949 RESTYLANE KYSSE IMPLANT, DERMAL, FOR AESTHETIC USE LMH GALDERMA LABORATORIES, L.P.

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Female Required Intervention TIROSINT 112 MCG, HYLENEX..