BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIESSE(+)

    MDR report key: 23803280 · Received December 15, 2025

    Report

    Report Number
    3013840437-2025-00176
    Event Type
    Injury
    Date Received
    December 15, 2025
    Report Date
    December 15, 2025
    Manufacturer
    MERZ NORTH AMERICA, INC (FRANKSVILLE)
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CASE WAS ASSESSED BY MERZ NORTH AMERICA AS NON-SERIOUS. THE EVENT OF INJECTION SITE NODULE WAS ASSESSED AS EXPECTED BASED ON THE CURRENTLY VALID US INSTRUCTIONS FOR USE LEAFLET OF RADIESSE(+) AND POSSIBLY RELATED TO THE TREATMENT WITH RADIESSE(+). BASED ON THE INFORMATION PROVIDED, THERE WAS NO EVIDENCE OF A REPORTABLE DEATH, SERIOUS INJURY, OR MALFUNCTION. MERZ CAUSALITY RE-ASSESSMENT DUE TO FOLLOW-UP INFORMATION RECEIVED ON 09-DEC-2025: THE BATCH RECORD REVIEW FOR RADIESSE(+), LOT A00193260, WAS NORMAL, NO NONCONFORMANCE REPORTS, CORRECTIVE/PREVENTIVE ACTIONS RELATED TO THIS LOT. THE BATCH RECORD REVIEW FOR RADIESSE(+), LOT A00185520, CONTAINS NONCONFORMANCE REPORTS OR CORRECTIVE/PREVENTIVE ACTIONS RELATED TO THIS LOT, BUT NONE THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. A LOT SEARCH IN THE GLOBAL SAFETY DATABASE WAS CONDUCTED ON THE REPORTED LOT (BATCH A00193260 AND A00185520) AND NO SIMILAR EVENTS WERE NOTED. THIS CASE WAS UPGRADED TO SERIOUS. THE REPORTED EVENT NODULE WAS CHANGED TO NODULE/FOCAL COLLAGEN ACCUMULATION AND THE CODING REMAINED UNCHANGED. PRODUCT PREPARATION ISSUE AND OFF LABEL USE OF DEVICE WERE ADDED. IN THE OPINION OF THE REPORTER, THE EVENT WAS RELATED TO RADIESSE(+). THIS CASE WAS ASSESSED BY MERZ NORTH AMERICA AS SERIOUS. THE EVENT OF INJECTION SITE NODULE WAS ASSESSED AS EXPECTED BASED ON THE CURRENTLY VALID US INSTRUCTIONS FOR USE LEAFLET OF RADIESSE(+). PRODUCT PREPARATION ISSUE AND OFF LABEL USE OF DEVICE WERE CODED ONLY FOR FORMAL REASONS. DILUTION OF RADIESSE(+) FOR INJECTION INTO THE MIDFACE IS NOT APPROVED BASED ON THE CURRENTLY VALID US INSTRUCTIONS FOR USE LEAFLET OF RADIESSE(+). POSSIBLE CONFOUNDING FACTORS INCLUDE PATIENT EXTENSIVE HISTORY OF AESTHETIC INJECTIONS, AND THE REPORTED PRIOR AESTHETIC TREATMENTS APPLIED IN THE AREA TREATED WITH RADIESSE(+). HOWEVER, INFORMATION PROVIDED WAS SPARSE, AND THE REPORTED EVENT CAN OCCUR AFTER THE TREATMENT WITH RADIESSE(+). CAUSALITY FOR THE REPORTED EVENT IS THEREFORE ASSESSED AS POSSIBLY RELATED TO THE TREATMENT WITH RADIESSE(+). BASED ON THE INFORMATION PROVIDED, THIS CASE WAS ASSESSED AS REPORTABLE TO THE FDA AS THE EVENT OF INJECTION SITE NODULE WAS DEEMED TO MEET THE SERIOUS INJURY CRITERIA OF REQUIRED INTERVENTION TO PREVENT PERMANENT DAMAGE.

    Description of Event or Problem · 0

    CASE DESCRIPTION: THIS SPONTANEOUS REPORT WAS RECEIVED FROM A US HEALTH CARE PROFESSIONAL AND CONCERNS A PATIENT. THE PATIENT WAS INJECTED WITH RADIESSE(+) INTO THE MIDFACE, FOR VOLUME LOSS, IN (B)(6) 2025. IT WAS REPORTED THAT 2 RADIESSE(+) WAS INJECTED. IN 2025, AFTER THE RADIESSE(+) INJECTION, THE PATIENT EXPERIENCED A NODULE. THE OUTCOME OF THE EVENT WAS UNKNOWN. FOLLOW-UP INFORMATION WAS RECEIVED 09-DEC-2025 THIS CASE WAS UPGRADED TO SERIOUS. THE REPORTED EVENT NODULE WAS CHANGED TO NODULE/FOCAL COLLAGEN ACCUMULATION AND THE CODING REMAINED UNCHANGED. THE PATIENTS INITIALS, GENDER, AND WEIGHT (AMBIGUOUSLY REPORTED AS 110) WERE PROVIDED. SHE WAS INJECTED SUBCUTANEOUSLY WITH RADIESSE(+), IN 2024 DURING A TRAINING. BATCH NUMBERS WERE REPORTED AS A00193260 (EXPIRY DATE: 09-DEC-2026) AND A00185520 (EXPIRY DATE: 03-DEC-2026). THE BATCH RECORD REVIEW WAS RECEIVED AND THE LOT NUMBERS FOR RADIESSE(+) WERE CONFIRMED AS A00193260 (EXPIRY DATE: 09-DEC-2026) AND A00185520 (EXPIRY DATE: 03-DEC-2026). A LOT SEARCH IN THE GLOBAL SAFETY DATABASE WAS CONDUCTED. RADIESSE(+) WAS DILUTED IN A 1:3 RATIO (PRODUCT PREPARATION ISSUE, OFF LABEL USE OF DEVICE) AND INJECTED WITH A 22G 50.8 MM CANNULA. NO TOXIN WAS PERFORMED. PREVIOUS AESTHETIC TREATMENTS IN THE AREAS WHERE RADIESSE(+) WAS INJECTED INCLUDED RADIESSE FULL STRENGTH AND HYPERDILUTED, RHA 2, 3 ,4, JEUVEAU, HYLENEX, JUVEDERM, SCULPTRA, AND PLATELET-RICH FIBRIN (PRF). MEDICAL HISTORY INCLUDED DEPRESSION, ASTHMA, ANXIETY. PAST MEDICAL HISTORY INCLUDED SEPSIS. SHE HAD NO KNOWN ALLERGIES. AFTER THE RADIESSE(+) INJECTION, THE PATIENT EXPERIENCED FOCAL COLLAGEN ACCUMULATION. NO RELEVANT LABORATORY TEST WERE PERFORMED. THE PATIENT WAS DELAYING HER CARE. IN THE OPINION OF THE PROVIDER, SHE NEEDED TO BE FLOODED WITH BACTERIOSTATIC NORMAL SALINE (BNS), PER RECOMMENDATION. THE PATIENT WAS MADE AWARE AND WAS EDUCATED BY THE PROVIDER THAT IF SHE DID NOT ALLOW TREATMENT, IT WAS GOING TO CONTINUE TO GROW AND COULD BECOME LARGER. SHE WANTED A SECOND OPINION AND MULTIPLE TEXTS WERE SENT. THE PATIENT DID NOT RESPOND. THE OUTCOME OF THE EVENT WAS REPORTED AS UNKNOWN. IN THE OPINION OF THE REPORTER, THE EVENT WAS RELATED TO RADIESSE(+), AND POSSIBLY THE TECHNIQUE OR THE FACT THAT RADIESSE(+) WAS WORKING. THEREFORE, THE CAUSALITY WAS CHANGED FROM REASONABLE POSSIBILITY/SUSPECTED TO RELATED. TREATMENT WAS NECESSARY TO PREVENT PERMANENT DAMAGE. THE PATIENT WAS NOT HOSPITALIZED, AND THE EVENT WAS NOT CONSIDERED TO BE PERMANENT BUT COULD BE IF THE PATIENT DID NOT ALLOW CORRECTIVE TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766340 RADIESSE(+) IMPLANT, DERMAL, FOR AESTHETIC USE LMH MERZ NORTH AMERICA, INC (FRANKSVILLE) A00193260, A00185520

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other| R