BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCULPTRA

    MDR report key: 14488372 · Received May 23, 2022

    Report

    Report Number
    MW5109855
    Event Type
    Malfunction
    Date Received
    May 23, 2022
    Date of Event
    May 19, 2021
    Report Date
    May 19, 2022
    Manufacturer
    GALDERMA LABORATORIES, L.P.
    Product Code
    LMH
    UDI-DI
    00299596104
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SD, US
    Reporter Occupation
    003
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    HEALTHCARE PROVIDER STATED WHEN THEY MIXED THE SCULPTRA KIT, IT WAS LUMPY AND UNUSABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150528 SCULPTRA IMPLANT, DERMAL, FOR AESTHETIC USE LMH GALDERMA LABORATORIES, L.P. 00299596104

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male