BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTYLANE

    MDR report key: 15715256 · Received November 1, 2022

    Report

    Report Number
    MW5113005
    Event Type
    Malfunction
    Date Received
    November 1, 2022
    Date of Event
    October 20, 2022
    Report Date
    October 28, 2022
    Manufacturer
    GALDERMA LABORATORIES, L.P.
    Product Code
    LMH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    WENT IN TO (B)(6) FOR LIP FILLER AND BOTOX, AFTER LIP FILLER MIGRATED CAUSING DEEP HORIZONTAL LINE AROUND MY MOUTH, BOTOX WAS WATERED DOWN CAUSING NO AFFECT BUT A HEADACHE FOR 2 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2949007 RESTYLANE IMPLANT, DERMAL, FOR AESTHETIC USE LMH GALDERMA LABORATORIES, L.P.
    2949008 BOTOX INJECTION NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE LMH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Other