BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIESSE(+)

    MDR report key: 22005703 · Received May 12, 2025

    Report

    Report Number
    3013840437-2025-00061
    Event Type
    Injury
    Date Received
    May 12, 2025
    Report Date
    April 23, 2025
    Manufacturer
    MERZ NORTH AMERICA, INC (FRANKSVILLE)
    Product Code
    LMH
    UDI-DI
    00810235030327
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE BATCH RECORD REVIEW FOR RADIESSE(+), LOT: A00175530, 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: A00175530) AND NO SIMILAR EVENTS WERE NOTED. THIS CASE WAS ASSESSED BY MERZ NORTH AMERICA AS SERIOUS. THE EVENT OF VASCULAR COMPRESSION WAS ASSESSED AS EXPECTED BASED ON THE CURRENTLY VALID US INSTRUCTIONS FOR USE LEAFLET OF RADIESSE(+) AND POSSIBLY RELATED TO THE TREATMENT WITH RADIESSE(+). OFF LABEL USE OF DEVICE WAS ONLY CODED FOR FORMAL REASONS. INJECTION INTO THE RIGHT CHEEK IS NO APPROVED INDICATION FOR RADIESSE(+) IN US. BASED ON THE INFORMATION PROVIDED, THIS CASE WAS ASSESSED AS REPORTABLE TO THE FDA AS THE EVENT OF VASCULAR COMPRESSION 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 MALE PATIENT. THE PATIENT WAS INJECTED WITH RADIESSE(+) ON PERIOSTEUM INTO THE RIGHT CHEEK (OFF LABEL USE OF DEVICE). BATCH NUMBER WAS REPORTED AS A00175530 (EXPIRY DATE: 11/2026). THE BATCH RECORD REVIEW WAS RECEIVED AND THE LOT NUMBER FOR RADIESSE(+) WAS CONFIRMED AS A00175530 (EXPIRY DATE: 11/2026). A LOT SEARCH IN THE GLOBAL SAFETY DATABASE WAS CONDUCTED. AFTER THE RADIESSE(+) INJECTION, THE PATIENT EXPERIENCED SIGNS AND SYMPTOMS (REPORTED AS S/S) OF VASCULAR OCCLUSION, COMPRESSION. INTERVENTIONS WERE IMPLEMENTED TO INCREASE BLOOD FLOW TO THE AFFECTED AREA. THE PATIENT WAS TREATED WITH HYLANEX, PLAIN LIDOCAINE, STERILE WATER, WARM COMPRESSES, NITROGLYCERIN OINTMENT, AND ORALLY WITH ACETYLSALICYLIC ACID (ASA). CAPILLARY REFILL WAS LESS THAN 2 SECONDS AFTER INTERVENTIONS. THREE HOURS AFTER THE TREATMENT, THE HEALTH CARE PROFESSIONAL REPORTED A GOOD SKIN COLOR, DECREASED BRUISING, AND INFLAMMATION. DUE TO THE PROVIDED INFORMATION, THE OUTCOME OF THE EVENT WAS CONSIDERED AS RESOLVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389050 RADIESSE(+) IMPLANT, DERMAL, FOR AESTHETIC USE LMH MERZ NORTH AMERICA, INC (FRANKSVILLE) A00175530 00810235030327

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other| R