BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCULPTRA

    MDR report key: 18302870 · Received December 8, 2023

    Report

    Report Number
    MW5149084
    Event Type
    Injury
    Date Received
    December 8, 2023
    Date of Event
    July 1, 2023
    Report Date
    December 6, 2023
    Manufacturer
    GALDERMA LABORATORIES, L.P.
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE FDA RECENTLY APPROVED THE USE OF SCULPTRA FOR CHEEK WRINKLES. MY MEDICAL PROFESSIONAL HAD JUST TAKEN A WORKSHOP ON THIS APPROACH AND SHE INJECTED THE SCULPTRA JUST UNDER MY SKIN. IT HAS BEEN 5 MONTHS AND I STILL HAVE DISCOLORATION ON BOTH CHEEKS. I THOUGHT IT WAS BRUISING BUT SINCE IT HAS NOT GONE AWAY I THINK THERE IS SOMETHING WRONG WITH THIS METHOD OF USING THE PRODUCT. ANOTHER DOCTOR THOUGHT IT WAS THE FILLER SHOWING THROUGH MY SKIN, OR THE TYNDALL EFFECT. THERE IS REALLY NOTHING TO BE DONE FOR THIS NOW AND I AM NOT SURE WHEN OR IF IT WILL GO AWAY. I THINK THERE SHOULD BE SOME DISCLAIMER OR CAUTION WITH THIS APPROACH TO SCULPTRA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1830880 SCULPTRA IMPLANT, DERMAL, FOR AESTHETIC USE LMH GALDERMA LABORATORIES, L.P.

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female