BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTYLANE LYFT

    MDR report key: 11608037 · Received April 1, 2021

    Report

    Report Number
    MW5100517
    Event Type
    Injury
    Date Received
    April 1, 2021
    Date of Event
    December 29, 2020
    Report Date
    March 31, 2021
    Manufacturer
    GALDERMA LABORATORIES, L.P.
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Description of Event or Problem · 1

    PATIENT REPORT NODULE FORMATION FROM RESTYLANE LYFT INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501258 RESTYLANE LYFT IMPLANT, DERMAL, FOR AESTHETIC USE LMH GALDERMA LABORATORIES, L.P.

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other