BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIESSE(+)

    MDR report key: 22531168 · Received July 17, 2025

    Report

    Report Number
    3013840437-2025-00099
    Event Type
    Injury
    Date Received
    July 17, 2025
    Date of Event
    May 1, 2025
    Report Date
    July 17, 2025
    Manufacturer
    MERZ NORTH AMERICA, INC (FRANKSVILLE)
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CASE WAS ASSESSED BY MERZ NORTH AMERICA AS NON-SERIOUS. THE EVENT OF INJECTION SITE REACTION 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-JUL-2025: THIS CASE WAS UPGRADED TO SERIOUS. THE SUSPECT PRODUCT WAS RECODED FROM RADIESSE TO RADIESSE (+). THE EVENT NECK ISSUES WAS DELETED. THE EVENTS NECROSIS AND ITCHY WERE ADDED. THIS CASE WAS ASSESSED BY MERZ NORTH AMERICA AS SERIOUS. THE EVENTS OF INJECTION SITE NECROSIS AND INJECTION SITE PRURITUS WERE ASSESSED AS EXPECTED BASED ON THE CURRENTLY VALID US INSTRUCTIONS FOR USE LEAFLET OF RADIESSE (+) AND POSSIBLY RELATED TO THE TREATMENT WITH RADIESSE (+). THE REPORTED HYPOPIGMENTED HYPERTROPIC SCAR WAS CONSIDERED TO BE CONSEQUENCE OF INJECTION SITE NECROSIS AND THEREFORE WAS NOT CODED. OFF LABEL USE OF DEVICE AND PRODUCT PREPARATION ISSUE WERE CODED ONLY FOR FORMAL REASONS. INJECTION INTO THE NECK IS NO APPROVED INDICATION FOR RADIESSE (+) IN US. DILUTION OF RADIESSE (+) FOR INJECTIONS INTO THE LOWER FACE AND NECK IS NOT APPROVED BASED ON THE CURRENTLY VALID US INSTRUCTIONS FOR USE LEAFLET OF RADIESSE (+). BASED ON THE INFORMATION PROVIDED, THIS CASE WAS ASSESSED AS REPORTABLE TO THE FDA AS THE EVENT OF INJECTION SITE NECROSIS 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 PHYSICIAN AND CONCERNS A PATIENT. THE PATIENT WAS INJECTED WITH RADIESSE. RADIESSE WAS HYPERDILUTED. AFTER THE RADIESSE INJECTION, THE PATIENT EXPERIENCED A NECK ISSUES. THE OUTCOME OF THE EVENT WAS UNKNOWN. FOLLOW-UP INFORMATION WAS RECEIVED ON 09-JUL-2025: THIS CASE WAS UPGRADED TO SERIOUS. THE SUSPECT PRODUCT WAS RECODED FROM RADIESSE TO RADIESSE (+). THE EVENT NECK ISSUES WAS DELETED. THE EVENTS NECROSIS AND ITCHY WERE ADDED. THE PATIENTS GENDER (FEMALE) WAS PROVIDED. SHE WAS INJECTED WITH RADIESSE (+) INTO THE LOWER FACE AND NECK (OFF LABEL USE OF DEVICE), ON (B)(6) 2025. BATCH NUMBER AND EXPIRY DATE WERE REPORTED AS UNKNOWN. RADIESSE (+) WAS HYPERDILUTED AT A 1:3 RATIO (PRODUCT PREPARATION ISSUE, OFF LABEL USE OF DEVICE). ON (B)(6) 2025, 2 DAYS AFTER THE RADIESSE (+) INJECTION, THE PATIENT EXPERIENCED A SIGNIFICANT TISSUE NECROSIS AT THE ENTRY POINTS ON THE LEFT SIDE OF THE FACE. THE PATIENT REPORTED IT WAS ITCHY. ON (B)(6) 2025, THE HEALTH CARE PROFESSIONAL BROUGHT PATIENT BACK AND DEBRIDED THE ENTRY POINTS AND APPLIED WOUND DRESSING. THE PHYSICIAN REPORTED THEY WERE 100% RESOLVED WITHIN 2 WEEKS. AT THE TIME OF THE REPORT, ONE SITE HAD A BIT OF HYPOPIGMENTED HYPERTROPIC SCAR, BUT PATIENT WAS OTHERWISE FINE. THE OUTCOME OF THE EVENTS WAS REPORTED AS RESOLVED, IN (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    964007 RADIESSE(+) IMPLANT, DERMAL, FOR AESTHETIC USE LMH MERZ NORTH AMERICA, INC (FRANKSVILLE)

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| O