BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIESSE(+)

    MDR report key: 23300049 · Received October 15, 2025

    Report

    Report Number
    3013840437-2025-00135
    Event Type
    Injury
    Date Received
    October 15, 2025
    Date of Event
    September 22, 2025
    Report Date
    October 14, 2025
    Manufacturer
    MERZ NORTH AMERICA, INC (FRANKSVILLE)
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ASSESSMENT BY MERZ: THE EVENTS OCCURRED IN COMPATIBLE TEMPORAL RELATIONSHIP. BOTH EVENTS IN A VICINITY AWAY FROM THE INJECTION SITE, WHICH IS POSSIBLE. INJECTION SITE ISCHAEMIA (SERIOUS) I AND PUSTULE (NON-SERIOUS) ARE EXPECTED BASED ON THE CURRENT VALID RUSSIAN INSTRUCTIONS FOR USE (IFU) LEAFLET OF RADIESSE AND CAN OCCUR AFTER TREATMENT WITH RADIESSE. THE REPORTED SWELLING, BRUISING, REDNESS AND VASCULAR REACTION ARE CONSIDERED TO BE SYMPTOMS OF THE ISCHAEMIA AND THE REPORTED EROSIVE LESIONS ARE CONSIDERED TO BE SYMPTOMS OF THE PUSTULE. OFF LABEL USE IS ONLY CODED FOR FORMAL REASONS. AN INJECTION INTO THE ABDOMEN IS NO APPROVED INDICATION FOR RADIESSE IN RUSSIA. THE IFU OF RADIESSE WARNS THAT SPECIAL ATTENTION HAS TO BE TAKEN IN ORDER TO AVOID THAT THE IMPLANT IS INJECTED INTO THE VASCULATURE WHICH MAY LEAD TO EMBOLIZATION, OCCLUSION, ISCHEMIA OR INFARCTION AND TO TAKE EXTRA CARE WHEN INJECTING AND APPLY THE LEAST AMOUNT OF PRESSURE NECESSARY. ACCORDING TO THE IFU, RARE EVENTS ASSOCIATED WITH INTRAVASCULAR INJECTION OF SOFT TISSUE FILLERS INTO THE FACE INCLUDE TEMPORARY OR PERMANENT VISION IMPAIRMENT, BLINDNESS, CEREBRAL ISCHEMIA OR CEREBRAL HAEMORRHAGE, LEADING TO STROKE, SKIN NECROSIS, AND DAMAGE TO UNDERLYING TISSUES. THE IFU RECOMMENDS TO IMMEDIATELY STOP THE INJECTION IF A PATIENT EXHIBITS ANY OF THE FOLLOWING SYMPTOMS, INCLUDING CHANGES IN VISION, SIGNS OF A STROKE, BLANCHING OF THE SKIN OR UNUSUAL PAIN DURING OR SHORTLY AFTER THE PROCEDURE AND PATIENTS SHOULD RECEIVE PROMPT MEDICAL ATTENTION. NEVERTHELESS, DURING INJECTION OF FILLERS IT CAN OCCUR THAT A SMALL BLOOD VESSEL IS OCCLUDED BY TWO DIFFERENT MECHANISMS: DIRECTLY BY ACCIDENTALLY INJECTING THE PRODUCT INTO THE LUMEN OR INDIRECTLY WHEN THE PRODUCT IS PLACED NEXT TO A VESSEL AND COMPRESSES IT FROM OUTSIDE. THE CLINICAL FINDINGS CAN DIFFER FROM ONLY DISCOLORATION OF THE CONCERNED AREA DUE TO CONGESTION OF THE BLOCKED VESSELS CALLED LIVEDO RETICULARIS WITHOUT TISSUE SLOUGH UP TO SKIN NECROSIS WITH TISSUE BREAKDOWN. IN THIS CASE, ISCHEMIA WITH PUSTULES EROSIVE LESIONS WERE REPORTED AND THE PATIENT RECEIVED COMPREHENSIVE TREATMENT WITH AN UNRESOLVED OUTCOME OF THE EVENTS. CAUSALITY FOR THE EVENTS IS ASSESSED AS POSSIBLY RELATED TO THE TREATMENT WITH RADIESSE BASED ON COMPATIBLE TEMPORAL AND POSSIBLE LOCAL RELATIONSHIP. THIS CASE IS CONSIDERED AS SERIOUS WITH THE SERIOUS EVENT INJECTION SITE ISCHAEMIA BECAUSE TREATMENT WAS DEEMED NECESSARY TO PREVENT A PERMANENT DAMAGE. MERZ CAUSALITY RE-ASSESSMENT DUE TO FOLLOW-UP INFORMATION RECEIVED ON 07-OCT-2025: THE SUSPECT PRODUCT WAS RECODED FROM RADIESSE TO RADIESSE(+). THE EVENTS OCCURRED IN COMPATIBLE TEMPORAL AND LOCAL RELATIONSHIP. INJECTION SITE ISCHAEMIA (SERIOUS) AND PUSTULE (NON-SERIOUS) ARE EXPECTED BASED ON THE CURRENT VALID RUSSIAN INSTRUCTIONS FOR USE (IFU) LEAFLET OF RADIESSE(+) AND CAN OCCUR AFTER TREATMENT WITH RADIESSE(+). THE REPORTED SWELLING, BRUISING, REDNESS AND VASCULAR REACTION/ VASCULAR COMPRESSION ARE CONSIDERED TO BE SYMPTOMS OF THE ISCHAEMIA AND THE REPORTED EROSIVE LESIONS ARE CONSIDERED TO BE SYMPTOMS OF THE PUSTULE. OFF LABEL USE IS ONLY CODED FOR FORMAL REASONS. AN INJECTION INTO CHIN IS NO APPROVED INDICATIONS FOR RADIESSE(+) IN RUSSIA. THE IFU OF RADIESSE(+) WARNS THAT SPECIAL ATTENTION HAS TO BE TAKEN IN ORDER TO AVOID THAT THE IMPLANT IS INJECTED INTO THE VASCULATURE WHICH MAY LEAD TO EMBOLIZATION, OCCLUSION, ISCHEMIA OR INFARCTION AND TO TAKE EXTRA CARE WHEN INJECTING AND APPLY THE LEAST AMOUNT OF PRESSURE NECESSARY. ACCORDING TO THE IFU, RARE EVENTS ASSOCIATED WITH INTRAVASCULAR INJECTION OF SOFT TISSUE FILLERS INTO THE FACE INCLUDE TEMPORARY OR PERMANENT VISION IMPAIRMENT, BLINDNESS, CEREBRAL ISCHEMIA OR CEREBRAL HAEMORRHAGE, LEADING TO STROKE, SKIN NECROSIS, AND DAMAGE TO UNDERLYING TISSUES. THE IFU RECOMMENDS TO IMMEDIATELY STOP THE INJECTION IF A PATIENT EXHIBITS ANY OF THE FOLLOWING SYMPTOMS, INCLUDING CHANGES IN VISION, SIGNS OF A STROKE, BLANCHING OF THE SKIN OR UNUSUAL PAIN DURING OR SHORTLY AFTER THE PROCEDURE AND PATIENTS SHOULD RECEIVE PROMPT MEDICAL ATTENTION. NEVERTHELESS, DURING INJECTION OF FILLERS IT CAN OCCUR THAT A SMALL BLOOD VESSEL IS OCCLUDED BY TWO DIFFERENT MECHANISMS: DIRECTLY BY ACCIDENTALLY INJECTING THE PRODUCT INTO THE LUMEN OR INDIRECTLY WHEN THE PRODUCT IS PLACED NEXT TO A VESSEL AND COMPRESSES IT FROM OUTSIDE. THE CLINICAL FINDINGS CAN DIFFER FROM ONLY DISCOLORATION OF THE CONCERNED AREA DUE TO CONGESTION OF THE BLOCKED VESSELS CALLED LIVEDO RETICULARIS WITHOUT TISSUE SLOUGH UP TO SKIN NECROSIS WITH TISSUE BREAKDOWN. IN THIS CASE, ISCHEMIA WITH PUSTULES EROSIVE LESIONS WERE REPORTED AND THE PATIENT RECEIVED COMPREHENSIVE TREATMENT WITH AN UNRESOLVED OUTCOME OF THE EVENTS. IN THE OPINION OF THE REPORTER, TREATMENT WAS NECESSARY BECAUSE TISSUE ISCHEMIA OCCURRED, WITHOUT TREATMENT, TISSUE NECROSIS, OR SCARRING WERE ABLE TO DEVELOP. CAUSALITY FOR THE EVENTS IS ASSESSED AS POSSIBLY RELATED TO THE TREATMENT WITH RADIESSE(+) BASED ON COMPATIBLE TEMPORAL AND LOCAL RELATIONSHIP. THIS CASE REMAINS AS SERIOUS WITH THE SERIOUS EVENT INJECTION SITE ISCHAEMIA BECAUSE TREATMENT WAS DEEMED NECESSARY TO PREVENT A PERMANENT DAMAGE.

    Description of Event or Problem · 0

    CASE DESCRIPTION: THIS SPONTANEOUS REPORT WAS RECEIVED FROM A RUSSIAN PHYSICIAN AND CONCERNS A 47-YEAR-OLD FEMALE PATIENT. THE PATIENT WAS INJECTED WITH A TOTAL OF 1.5 ML OF RADIESSE INTO THE ABDOMEN (OFF LABEL USE OF DEVICE), ON (B)(6) 2025. RADIESSE WAS INJECTED USING A 22 G CANNULA. SHE WAS PREVIOUSLY INJECTED WITH RADIESSE IN VECTOR TECHNIQUE, WHICH WAS WELL TOLERATED. THE PATIENT WAS CLASSIFIED AS TYPE II ON GLOGAU CLASSIFICATION. HER ALLERGIES, INTAKE OF INTERFERON OR OMALIZUMAB, SURGICAL INTERVENTIONS, AND CONCOMITANT MEDICATIONS WERE REPORTED AS NONE. ON (B)(6) 2025, IMMEDIATELY AFTER THE RADIESSE INJECTION, THE PATIENT EXPERIENCED ISCHEMIA, A BRUISE IN THE CENTER, SWELLING, IN THE CHIN AREA, AND SUBJECTIVELY MILD PAIN. ON THE THIRD OR FOURTH DAY, THERE WAS REDNESS ON THE NECK, AND ON THE FOURTH OR THE FIFTH DAY THERE WAS INCREASED INFILTRATION AND PUSTULES. ON THE FIFTH DAY, EROSIVE LESIONS APPEARED ON THE NECK, AND A VASCULAR REACTION DEVELOPED UNDER THE LOWER LIP. SYSTEMIC ANTIBIOTICS WERE PRESCRIBED. FROM THE FIRST DAY, THE PATIENT USED LYOTON GEL. ON THE FIFTH DAY, THE PATIENT RECEIVED LONGIDAZA 3000 UNITS AND 1000 UNITS, LOW-DENSITY MICROWAVES (REPORTED AS LDM) IN PHONOPHORESIS MODE ON LYOTON GEL, DEXAMETHASONE 8 MG, PENTOXIFYLLINE, ACTOVEGIN, AND SILDENAFIL. THE PATIENT TOOK AMOXICLAV 1000 MG TWICE DAILY, VALTREX 1000 MG, AND FUROSEMIDE. THE PATIENT ALSO UNDERWENT HIGH-INTENSITY LASER THERAPY (REPORTED AS HILT THERAPY), WHICH IMPROVED LYMPHATIC CIRCULATION IN THE BACKGROUND, AND TREATMENT WITH THE BIO-THERAPEUTIC LIMITED DEVICE (REPORTED AS BTL). THE OUTCOME OF THE EVENTS WAS REPORTED AS NOT RESOLVED. IN THE OPINION OF THE REPORTER, THE EVENTS WAS OF SEVERE INTENSITY, WAS NOT LIFE-THREATENING, DID NOT REQUIRE HOSPITALIZATION FOR MORE THAN 24 HOURS, WAS NOT CONSIDERED TO BE PERMANENT, A CAUSAL RELATIONSHIP TO THE FILLER INJECTION WAS SUSPECTED, AND A CAUSAL RELATIONSHIP TO INCORPORATED LOCAL ANESTHETIC IN THE PRODUCT WAS NOT SUSPECTED. FOLLOW-UP INFORMATION WAS RECEIVED ON 07-OCT-2025: THE SUSPECT PRODUCT WAS RECODED FROM RADIESSE TO RADIESSE(+). THE PATIENT WAS INJECTED WITH RADIESSE(+) FOR THE CORRECTION OF THE INSUFFICIENT CHIN VOLUME (OFF LABEL USE OF DEVICE). THE PATIENT WAS MEDICALLY HEALTHY AFTER THE EXAMINATION. AT THE TIME OF THIS REPORT, THE PATIENT UNDERWENT TREATMENT, AS THE EFFECTS OF THE VESSEL COMPRESSION DID NOT RESOLVE. THE THERAPY SHOWED POSITIVE DYNAMICS. THERE WERE NO DEVICE DEFECTS. THE OUTCOME OF THE EVENTS REMAINED UNCHANGED. IN THE OPINION OF THE REPORTER, TREATMENT WAS NECESSARY BECAUSE TISSUE ISCHEMIA OCCURRED, WITHOUT TREATMENT, TISSUE NECROSIS, OR SCARRING WERE ABLE TO DEVELOP, AND THE CAUSE-AND-EFFECT RELATIONSHIP WAS THE ADMINISTRATION OF A LARGE VOLUME OF THE DRUG, DISPROPORTIONATE TO THE TISSUE CAPACITY, AND THE INJECTION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2020260 RADIESSE(+) IMPLANT, DERMAL, FOR AESTHETIC USE LMH MERZ NORTH AMERICA, INC (FRANKSVILLE)

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Unknown Required Intervention| O