BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTYLANE

    MDR report key: 10096142 · Received May 27, 2020

    Report

    Report Number
    MW5094713
    Event Type
    Malfunction
    Date Received
    May 27, 2020
    Date of Event
    May 22, 2020
    Report Date
    May 25, 2020
    Manufacturer
    GALDERMA LABORATORIES L.P/ Q-MED AB
    Product Code
    LMH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I WENT TO (B)(6) SPA IN MY NEIGHBORHOOD. I TOLD A WOMAN NAMED (B)(6) THAT I NEEDED MY UPPER LIP TO BE FILLED WITH BOTOX OR FILLERS. SHE PROMISED SHE WOULD DO THAT; TODAY IS THE 25TH, AND I DO BELIEVE I HAVE BEEN SWINDLED. I WHAT PAID FOR, I DID NOT GET. MY LIPS LOOK AS I HAD NO PROCEDURE DONE. REASON FOR USE: TO PUMP LIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554464 RESTYLANE IMPLANT, DERMAL, FOR AESTHETIC USE LMH GALDERMA LABORATORIES L.P/ Q-MED AB

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR