BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTYLANE LYFT

    MDR report key: 19560062 · Received June 17, 2024

    Report

    Report Number
    MW5156367
    Event Type
    Injury
    Date Received
    June 17, 2024
    Date of Event
    May 25, 2024
    Report Date
    June 13, 2024
    Manufacturer
    GALDERMA LABORATORIES, L.P.
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ERYTHEMATOUS NODULE ON CHEEK STARTING THREE DAYS AFTER DENTAL CLEANING, THAT THEN PROGRESSED INTO FOUR BUMPS ON THE SAME CHEEK AND TWO BUMPS ON THE OTHER CHEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1511871 RESTYLANE LYFT IMPLANT, DERMAL, FOR AESTHETIC USE LMH GALDERMA LABORATORIES, L.P.

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Female RESTYLANE REFYNE. THERAPY START DATE AND END DATE: