BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIESSE DERMAL FILLERS

    MDR report key: 18816981 · Received February 29, 2024

    Report

    Report Number
    MW5152234
    Event Type
    Injury
    Date Received
    February 29, 2024
    Report Date
    January 29, 2024
    Manufacturer
    MERZ NORTH AMERICA, INC.
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    MEDICAL SPA IS SELLING TONS OF FAKE FILLERS FROM BLACK MARKET. THREE OF US GOT SERIOUS BAD REACTIONS AND STILL DEALING WITH IT. THESE NURSES KEEP DOING IT TO MORE AND MORE PEOPLE JUST TO COLLECT MONEY. THEY NEED TO BE INVESTIGATED. (B)(6). REFERENCE REPORTS: MW5152232, MW5152233.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696345 RADIESSE DERMAL FILLERS IMPLANT, DERMAL, FOR AESTHETIC USE LMH MERZ NORTH AMERICA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown