BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIESSE

    MDR report key: 14376521 · Received May 11, 2022

    Report

    Report Number
    MW5109659
    Event Type
    Injury
    Date Received
    May 11, 2022
    Date of Event
    April 28, 2022
    Report Date
    May 9, 2022
    Manufacturer
    MERZ NORTH AMERICA, INC.
    Product Code
    PKY
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    INFLAMMATORY REACTION POST DERMAL FILLER. ONE (1) SYRINGE OF RADIESSE FILLER TO THE DORSUM OF EACH HAND. EACH SYRINGE WAS MIXED / DILUTED WITH 1CC OF LIDOCAINE; 7 DAYS LATER, THE PT REPORTED REDNESS AND ITCHING. EXAM SHOWED INFLAMMATION, AND ACCUMULATION OF PURULENT FLUID WHICH REQUIRED I+D.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2504718 RADIESSE IMPLANT, DERMAL, FOR AESTHETIC USE IN THE HANDS PKY MERZ NORTH AMERICA, INC. A000449930
    2504719 RADIESSE IMPLANT, DERMAL, FOR AESTHETIC USE IN THE HANDS PKY MERZ NORTH AMERICA, INC. A000449930

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Other 1% LIDOCAINE WITH | EPINEPHRINE XYLOCAINE| FRESENIUS KABI