BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIESSE INJECTABLE IMPLANT

    MDR report key: 14347807 · Received May 10, 2022

    Report

    Report Number
    3013840437-2022-00068
    Event Type
    Injury
    Date Received
    May 10, 2022
    Report Date
    May 10, 2022
    Manufacturer
    MERZ NORTH AMERICA, INC
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CASE WAS ASSESSED AS REPORTABLE TO THE FDA AS THE EVENT, TYNDALL EFFECT / BLUISH IN COLOR (INJECTION SITE DISCOLOURATION) WAS DEEMED TO MEET SERIOUS INJURY CRITERIA OF CAUSING PERMANENT DAMAGE. THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED AS THE LOT NUMBER WAS NOT REPORTED.

    Description of Event or Problem · 0

    THIS CONSUMER REPORT WAS RECEIVED FROM A US CONSUMER AND CONCERNS A FEMALE PATIENT. SHE WAS INJECTED WITH RADIESSE, INTO THE ZYGOMATIC ARCH (OFF LABEL USE OF DEVICE), IN (B)(6) 2020. ON THE SAME OCCASION, THE PATIENT WAS INJECTED WITH JUVEDERM. THE PATIENT WAS PREVIOUSLY INJECTED WITH HYALURONIC ACID AND FILLERS, AND THEY DID LAST FOR YEARS, IN DURATION. IN (B)(6) 2020, REPORTED AS TWO MONTHS AFTER THE RADIESSE INJECTION, THE PATIENT EXPERIENCED VEIN LIKE SWELLING, BLUISH IN COLOR. AS CORRECTIVE TREATMENT, THE HEALTH CARE PROFESSIONAL ADMINISTERED SODIUM THIOSULFATE (REPORTED AS STS) AND IT SHOWED LITTLE EFFECT. THE HEALTH CARE PROFESSIONAL DESCRIBED IT AS A TYNDALL EFFECT. THE PATIENT WAS NOT AWARE THAT THE RADIESSE WAS NOT DISSOLVABLE. AS REPORTED, ANOTHER CONSULT, RECOMMENDED THE PATIENT TO MELT RADIESSE THAT WAS VISIBLE ON MAGNETIC RESONANCE IMAGING (MRI). AT THE TIME OF THIS REPORT, THERE WAS A ROUND AREA, BLUISH IN COLOR TOWARDS THE TEMPLE OF THE ARCH. THE REPORTER WANTED TO KNOW ADDITIONAL INFORMATION REGARDING RADIESSE LONGEVITY. DUE TO THE PROVIDED INFORMATION, THE OUTCOME OF THE EVENT TYNDALL EFFECT / BLUISH IN COLOR, WAS CONSIDERED AS NOT RESOLVED. THE OUTCOME OF THE EVENT VEIN LIKE SWELLING WAS CONSIDERED AS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1791115 RADIESSE INJECTABLE IMPLANT IMPLANT, DERMAL, FOR AESTHETIC USE LMH MERZ NORTH AMERICA, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Disability JUVEDERM (HYALURONIC ACID) (GEL FOR THE INJECTION)