BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCULPTRA

    MDR report key: 19520479 · Received June 12, 2024

    Report

    Report Number
    MW5156166
    Event Type
    Injury
    Date Received
    June 12, 2024
    Date of Event
    April 22, 2024
    Report Date
    June 10, 2024
    Manufacturer
    GALDERMA LABORATORIES, L.P.
    Product Code
    LMH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    HI, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I HAD MICRONEEDLING DONE AT A DERMATOLOGIST OFFICE AND THEY USED TOPICAL SCULPTRA, A PRODUCT MADE BY GALDERMA. I WAS NOT INFORMED OF SIDE EFFECTS BEFORE SIGNING A CONSENT FORM. THE PRODUCT HAS CREATED NUMEROUS SKIN LESIONS AND A LARGE LUMP UNDER MY EYE AS WELL AS SCARS ALL OVER MY FACE. I AM 65 YEARS OLD AND AM TOLD THAT THERE IS NO WAY TO CORRECT THE PROBLEM. I HAVE SINCE DOWNLOADED THE MANUFACTURE'S LITERATURE AND THE PRODUCT IS NOT APPROVED BY THE FDA OR THE MANUFACTURER FOR TOPICAL USE. THE FDA NEEDS TO PROHIBIT THE USE OF THE TOPICAL APPLICATION OF SCULPTRA. I HAVE EMOTIONAL PROBLEMS INCLUDE SUICIDAL THOUGHTS ASSOCIATED WITH THE CHANGES TO MY FACE CAUSED BY THE INAPPROPRIATE USE OF THE PRODUCT WHICH THE FDA APPROVED. I HAVE NO ISSUE WITH FDA APPROVING THE PRODUCT FOR USE PER THE MANUFACTURE'S REQUIREMENTS BUT THE FDA SHOULD PROHIBIT THE USE OF THE PRODUCT UNLESS THE PROVIDER FOLLOWS THE MANUFACTURER'S INSTRUCTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161219 SCULPTRA IMPLANT, DERMAL, FOR AESTHETIC USE LMH GALDERMA LABORATORIES, L.P.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| S| O MULTI VITAMINS