BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCULPTRA

    MDR report key: 15249452 · Received August 17, 2022

    Report

    Report Number
    MW5111547
    Event Type
    Injury
    Date Received
    August 17, 2022
    Date of Event
    March 15, 2021
    Report Date
    August 14, 2022
    Manufacturer
    GALDERMA LABORATORIES, L.P.
    Product Code
    LMH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CI
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I RECEIVED AN SCULPTRA APPLICATION (A DILUTED VIAL) IN THE BUTTOCK AREA TO IMPROVE ATROPHIC ACNE SCARS ON (B)(6) 2020. THEN IN (B)(6) I FELT AN INFLAMED LUMP THAT APPEARED SPONTANEOUSLY, AND THAT LUMP REMAINED FOR MONTHS. AGAIN, IN (B)(6) THE LUMP SUDDENLY SWELLED DUE TO APPLYING INTRALESIONAL CORTICOSTEROIDS TO HELP REDUCE INFLAMMATION. UNTIL THIS DAY THE LUMP REMAINS AND HAS NOT GONE DOWN BY ITSELF. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2493349 SCULPTRA IMPLANT, DERMAL, FOR AESTHETIC USE LMH GALDERMA LABORATORIES, L.P.

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Male Required Intervention ISOTRETINOIN | SCULPTRA