BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCULPTRA

    MDR report key: 19864494 · Received July 29, 2024

    Report

    Report Number
    MW5157796
    Event Type
    Injury
    Date Received
    July 29, 2024
    Date of Event
    June 27, 2024
    Report Date
    July 29, 2024
    Manufacturer
    GALDERMA LABORATORIES, L.P.
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2024 REPORTER WENT TO A MEDICAL SPA THAT WAS HAVING AN EVENT. WHILE SHE WAS THERE SHE WAS ASKED TO BE A MODEL FOR SCULPTRA. LATER THAT EVENING HER LIPS STARTED TO SWELL AND BLEED. HER LIPS WERE ALSO CRACKED AND PEELING. SHE IS TAKING ZYRTEC TO HELP WITH THE SWELLING. REPORTER STATES IT MAY BE AN ALLERGIC REACTION BUT IT'S NOT CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281414 SCULPTRA IMPLANT, DERMAL, FOR AESTHETIC USE LMH GALDERMA LABORATORIES, L.P.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female