BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCULPTRA (POLY-L-LACTIC ACID)

    MDR report key: 11655317 · Received April 12, 2021

    Report

    Report Number
    MW5100718
    Event Type
    Malfunction
    Date Received
    April 12, 2021
    Date of Event
    April 5, 2021
    Report Date
    April 8, 2021
    Manufacturer
    GALDERMA LABORATORIES, L.P.
    Product Code
    LMH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I WENT TO (B)(6) WHERE (B)(6), MD INJECTED SCULPTRA (INJECTABLE POLY-L-LACTIC ACID) ALSO KNOWN AS A DERMAL FILLER INTO MY BUTTOCKS. HE INJECTED 4 VIALS AND GAVE ME ONE OF THE EMPTY VIALS AS A "SOUVENIR" HE THEN LEFT THE ROOM AND I NOTICED THE VIAL EXPIRED OCTOBER OF 2020. THAT'S 6 MONTHS OLD AND I DID RESEARCH ONLINE, AND THAT COULD ACTUALLY BE DANGEROUS AND NOT GIVE ME PROPER RESULTS BECAUSE IT'S EXPIRED. I PAID A LOT OF MONEY FOR SOMETHING THAT WAS EXPIRED, AND POTENTIALLY HAZARDOUS. I TOOK PICTURES OF EVERYTHING BEFORE I LEFT, THE SETUP, THE VIALS, MY PAPERWORK. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551582 SCULPTRA (POLY-L-LACTIC ACID) IMPLANT, DERMAL, FOR AESTHETIC USE LMH GALDERMA LABORATORIES, L.P. A7125

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR