BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIESSE(+)

    MDR report key: 24767118 · Received April 2, 2026

    Report

    Report Number
    3013840437-2026-00036
    Event Type
    Injury
    Date Received
    April 2, 2026
    Date of Event
    March 12, 2026
    Report Date
    April 1, 2026
    Manufacturer
    MERZ NORTH AMERICA, INC (FRANKSVILLE)
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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 PATIENT DISSATISFACTION WITH TREATMENT 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 CODED ONLY FOR FORMAL REASONS. INJECTION INTO THE CHEEKS IS NO APPROVED INDICATION FOR RADIESSE(+) IN US. 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 20-MAR-2026: THIS CASE WAS UPGRADED TO SERIOUS. THE REPORTED EVENT CONCERNS WAS CHANGED TO INFRAORBITAL ARTERY OCCLUSION/COMPRESSION AND WAS RECODED FROM PATIENT DISSATISFACTION WITH TREATMENT TO VASCULAR OCCLUSION. THE OUTCOME OF THE EVENT WAS REPORTED AS RESOLVING. THIS CASE WAS ASSESSED BY MERZ NORTH AMERICA AS SERIOUS. THE EVENT OF VASCULAR OCCLUSION WAS 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 HEMATOMA IS CONSIDERED TO BE A CONSEQUENCE OF VASCULAR OCCLUSION AND THEREFORE WAS NOT CODED. OFF LABEL USE OF DEVICE WAS CODED ONLY FOR FORMAL REASONS. INJECTION INTO THE CHEEKS 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 OCCLUSION WAS DEEMED TO MEET THE SERIOUS INJURY CRITERIA OF REQUIRED INTERVENTION TO PREVENT PERMANENT DAMAGE.

    Description of Event or Problem · 0

    CASE DESCRIPTION: THIS CASE WAS LINKED TO CASE (B)(4), REFERRING TO THE SAME PATIENT. THIS SPONTANEOUS REPORT WAS RECEIVED FROM A US PHYSICIAN AND CONCERNS A PATIENT. THE PATIENT WAS INJECTED WITH A TOTAL OF 1.5 ML OF RADIESSE(+) INTO THE CHEEKS (OFF LABEL USE OF DEVICE), ON (B)(6) 2026. RADIESSE(+) WAS INJECTED AT DEEP SUBCUTANEOUS AND PERIOSTEUM, 1.2 ML ON THE LEFT SIDE, AND 0.3 ML ON THE RIGHT SIDE. ON (B)(6) 2026, ON THE SAME NIGHT, AFTER THE RADIESSE(+) INJECTION, THE PATIENT EXPERIENCED CONCERNS. ON (B)(6) 2026, THE PHYSICIAN FLUSHED THE LEFT SIDE. IT WAS REPORTED THAT THE PATIENT WAS HEADED TO THE HYPERBARIC CHAMBER. THE OUTCOME OF THE EVENT WAS UNKNOWN. FOLLOW-UP INFORMATION WAS RECEIVED ON 20-MAR-2026: THIS CASE WAS UPGRADED TO SERIOUS. THE LINKING SENTENCE WAS ADDED. THE REPORTED EVENT CONCERNS WAS CHANGED TO INFRAORBITAL ARTERY OCCLUSION/COMPRESSION AND WAS RECODED FROM PATIENT DISSATISFACTION WITH TREATMENT TO VASCULAR OCCLUSION. PATIENT INITIALS, DATE OF BIRTH, AGE, GENDER (FEMALE) AND WEIGHT (53 KG) WERE PROVIDED. SHE WAS 44-YEAR-OLD AT THE TIME OF THE REPORT. SHE WAS INJECTED WITH RADIESSE(+) IN A RETROGRADE FASHION. BATCH NUMBER WAS REPORTED AS A00105280 (EXPIRY DATE: 24-APR-2026). LOT SEARCH AND BRR CANNOT BE PERFORMED DUE TO INCORRECT LOT NUMBER. SHE WAS PREVIOUSLY INJECTED WITH 3 ML OF RADIESSE INTO THE HIGH LATERAL CHEEK ON (B)(6) 2024 AND WITH 1.5 ML OF RADIESSE INTO THE HIGH LATERAL CHEEK ON (B)(6) 2024. THE PATIENT WAS ALLERGIC TO HAIR DYE. OTHER MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE REPORTED AS NONE. THE PATIENT DID NOT HAVE ANY MEDICAL NOR DENTAL PROCEDURES, ILLNESS OR VACCINATIONS SINCE THE INJECTION WITH RADIESSE(+). ON (B)(6) 2026, THE SAME DAY AFTER THE RADIESSE(+) INJECTION, THE PATIENT EXPERIENCED AN INFRAORBITAL ARTERY OCCLUSION/COMPRESSION. SHE EXPERIENCED A VASCULAR OCCLUSION/COMPRESSION OCCLUSION WITH HEMATOMA. SHE WAS IMMEDIATELY TREATED WITH 325 MG OF ACETYLSALICYLIC ACID (ASA), A MEDROL DOSE PACK, ELIQUIS (2.5 MG, TWICE DAILY), MINOCYCLINE, PREDNISONE 10 MG, TADAFIL (20 MG, DAILY) AND VIAGRA. CORRECTIVE TREATMENT ALSO INCLUDED A WARM COMPRESS AND MASSAGE, A HYPERBARIC OXYGEN CHAMBER DAILY, RED LIGHT THERAPY, DIMETHYL SULFOXIDE (DMSO) CREAM, 6 ML OF SALINE AND 750 UNITS OF HYALURONIDASE. TREATMENT WAS NECESSARY TO ACCELERATE RECOVERY AND TO PREVENT PERMANENT DAMAGE. NO RELEVANT LABORATORY TESTS WERE PERFORMED. THE PATIENT WAS NOT HOSPITALIZED. THE OUTCOME OF THE EVENT WAS REPORTED AS RESOLVING (CHANGED FROM UNKNOWN). IN THE OPINION OF THE REPORTER, THE EVENTS WERE RELATED (CHANGED FROM REASONABLE POSSIBLE) TO THE USE OF RADIESSE AS THAT WAS THE ONLY PRODUCT USED, AND IT WAS BAD LUCK AS SHE HAD 20 YEARS OF EXPERIENCE INJECTING RADIESSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    827058 RADIESSE(+) IMPLANT, DERMAL, FOR AESTHETIC USE LMH MERZ NORTH AMERICA, INC (FRANKSVILLE)

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Required Intervention| O