BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCULPTRA

    MDR report key: 18074437 · Received November 3, 2023

    Report

    Report Number
    MW5147781
    Event Type
    Injury
    Date Received
    November 3, 2023
    Report Date
    October 31, 2023
    Manufacturer
    GALDERMA LABORATORIES, L.P.
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    PATIENT EXPERIENCING SUDDEN ONSET OF SEVERE RIGHT UPPER EXTREMITY LYMPHEDEMA, STARTING TWO WEEKS AFTER RECEIVING SCULPTRA FILLER TO THE RIGHT CHEST WALL, JUST ABOVE THE RIGHT BREAST. PATIENT HAS A HISTORY OF RIGHT BREAST CANCER TREATED WITH RIGHT MODIFIED MASTECTOMY, HOWEVER, PATIENT HAS ONLY EXPERIENCED MILD LYMPHEDEMA ABOUT ONCE A YEAR SINCE THIS SURGERY 17 YEARS AGO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350711 SCULPTRA IMPLANT, DERMAL, FOR AESTHETIC USE LMH GALDERMA LABORATORIES, L.P.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other