BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIESSE

    MDR report key: 22330432 · Received June 25, 2025

    Report

    Report Number
    3013840437-2025-00080
    Event Type
    Injury
    Date Received
    June 25, 2025
    Date of Event
    January 1, 2011
    Report Date
    June 13, 2025
    Manufacturer
    MERZ NORTH AMERICA, INC (FRANKSVILLE)
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE BATCH RECORD REVIEW FOR RADIESSE, LOT: 1020401, WAS NORMAL, NO NONCONFORMANCE REPORTS, CORRECTIVE/PREVENTIVE ACTIONS RELATED TO THIS LOT. A LOT SEARCH IN THE GLOBAL SAFETY DATABASE WAS CONDUCTED ON THE REPORTED LOT (BATCH: 1020401) AND NO SIMILAR EVENTS WERE NOTED. ASSESSMENT BY MERZ: THE EVENT OCCURRED IN A COMPATIBLE LOCAL RELATIONSHIP. EVENT ONSET WAS A FEW MONTHS FOLLOWING TREATMENT, WHICH IS LONG LATENCY BUT POSSIBLE. INJECTION SITE NODULE (SERIOUS) IS EXPECTED BASED ON THE CURRENTLY VALID EUROPEAN INSTRUCTIONS FOR USE (IFU) LEAFLET OF RADIESSE, AND CAN OCCUR AFTER THE TREATMENT WITH RADIESSE. OFF LABEL USE OF DEVICE AND PRODUCT PREPARATION ISSUE ARE CODED FOR FORMAL REASONS ONLY. A DILUTION OF RADIESSE WITH LIDOCAINE IS NO APPROVED INDICATION FOR RADIESSE IN THE EU. POSSIBLE CONFOUNDING FACTOR INCLUDES PREVIOUS INJECTIONS WITH VARIOUS ALLERGAN HYALURONIC ACID FILLERS IN ADDITION TO THE PREVIOUS TREATMENT WITH RADIESSE ON (B)(6) 2010. NEVERTHELESS, A CONTRIBUTORY ROLE OF THE TREATMENT WITH RADIESSE CANNOT BE EXCLUDED WITH CERTAINTY. CAUSALITY FOR THE EVENT IS ASSESSED AS POSSIBLY RELATED TO THE TREATMENT WITH RADIESSE BASED ON COMPATIBLE LOCAL AND POSSIBLE TEMPORAL RELATIONSHIP. THE CASE IS CONSIDERED AS SERIOUS WITH THE SERIOUS EVENT INJECTION SITE NODULE DUE TO PERMANENT DAMAGE.

    Description of Event or Problem · 0

    CASE DESCRIPTION: THIS CASE WAS LINKED WITH (B)(4), REFERRING TO THE SAME PATIENT. THIS SPONTANEOUS REPORT WAS RECEIVED FROM A SPANISH PHYSICIAN AND CONCERNS A 69-YEAR-OLD FEMALE PATIENT (WEIGHT: 65 KG, HEIGHT: 169 CM). SHE WAS INJECTED WITH RADIESSE 1.5 ML, INTO THE RIGHT AND LEFT MALAR AREAS FOR MALAR HYPOPLASIA, ON (B)(6) 2010. BATCH NUMBER WAS REPORTED AS 1020401 (EXPIRY DATE: 05/2012). THE BATCH RECORD REVIEW WAS RECEIVED AND THE LOT NUMBER FOR RADIESSE 1.5 ML WAS CONFIRMED AS 1020401 (EXPIRY DATE: 05/2012). A LOT SEARCH IN THE GLOBAL SAFETY DATABASE WAS CONDUCTED. RADIESSE 1.5 ML WAS DILUTED WITH LIDOCAINE (PRODUCT PREPARATION ISSUE, OFF LABEL USE OF DEVICE). SHE WAS PREVIOUSLY INJECTED WITH RADIESSE 1.5 ML INTO THE RIGHT AND LEFT MALAR AREAS TO TREAT HYPOPLASIA, ON (B)(6) 2010. BATCH NUMBER WAS REPORTED AS 1015132. RADIESSE 1.5 ML WAS DILUTED WITH 0.3 ML OF 2% LIDOCAINE. SHE WAS PREVIOUSLY INJECTED WITH VARIOUS ALLERGAN HYALURONIC ACID FILLERS WITH NO REMARKABLE INCIDENCES, BETWEEN 2007 AND 2009. IN 2011, A FEW MONTHS AFTER THE RADIESSE 1.5 ML INJECTION, THE PATIENT EXPERIENCED A BEASTLY NODULE (ALSO REPORTED AS A GRANULOMA) IN THE LEFT MALAR REGION. THIS GRANULOMA PRESENTED INTERMITTENT REACTIVATION (APPROXIMATELY TWICE A YEAR) DURING A PERIOD OF 5 YEARS. IT WAS CONTROLLED EACH TIME WITH ORAL CORTICOSTEROIDS (URBASON 4 MG IN A DESCENDING REGIMEN), WITHOUT THE NEED FOR INTRALESIONAL TREATMENT OR OTHER INVASIVE INTERVENTIONS. FOR YEARS SHE DID NOT VISIT THE CLINIC, UNTIL ON (B)(6) 2025, WHEN SHE CONTACTED AGAIN DUE TO THE PERSISTENCE OF THE NODULE, ALTHOUGH AT THE TIME OF THE REVIEW IT WAS NOT CLINICALLY ACTIVE. ON (B)(6) 2025, THE PATIENT REPORTED THE GRANULOMA CONTINUED TO PRESENT SPORADIC ACTIVATIONS. ON PALPATION THERE WAS EVIDENCE OF A NODULAR FORMATION IN THE LEFT MALAR REGION, COMPATIBLE WITH THE ALREADY DIAGNOSED GRANULOMA. THERE WERE NO CLINICAL SIGNS OF ACTIVE INFLAMMATION AT THE TIME OF THE REPORT. SHE WAS SCHEDULED TO UNDERGO A SURGICAL FACIAL LIFTING PROCEDURE. THE PHYSICIAN SUGGESTED TO THE ATTENDING SURGEON TO CONSIDER EXCISION OF THE GRANULOMA DURING THE SAME SURGICAL PROCEDURE, PROVIDED THAT THE ANATOMICAL AND TECHNICAL CONDITIONS ALLOWED FOR IT. IT WAS NOTED THAT THIS WAS A LONG-STANDING GRANULOMA, SECONDARY TO PRIOR INFILTRATION WITH RADIESSE 1.5 ML, WHICH DID NOT RESPOND DEFINITIVELY TO CONSERVATIVE TREATMENT AND WAS ABLE TO BENEFIT FROM DIRECT SURGICAL REMOVAL. THE GRANULOMA WAS NOT HISTOLOGICALLY CONFIRMED. DUE TO THE PROVIDED INFORMATION, THE OUTCOME OF THE EVENT WAS CONSIDERED AS NOT RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2290804 RADIESSE IMPLANT, DERMAL, FOR AESTHETIC USE LMH MERZ NORTH AMERICA, INC (FRANKSVILLE) 1020401

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Unknown Other| S