BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIESSE INJECTABLE IMPLANT

    MDR report key: 16429327 · Received February 23, 2023

    Report

    Report Number
    3013840437-2023-00015
    Event Type
    Injury
    Date Received
    February 23, 2023
    Date of Event
    October 4, 2022
    Report Date
    February 23, 2023
    Manufacturer
    MERZ NORTH AMERICA, INC
    Product Code
    LMH
    UDI-DI
    M2138071M0K22
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CASE WAS ASSESSED AS REPORTABLE TO THE FDA AS THE EVENT TORTUOUS BLOOD VESSELS/VARICOSITIES (VARICOSITY) WAS DEEMED TO MEET SERIOUS INJURY CRITERIA OF DISABILITY OR PERMANENT DAMAGE. THE DEVICE HISTORY RECORD OF RADIESSE INJECTABLE IMPLANT, LOT NUMBER A00053290, WAS REVIEWED. A LOT SEARCH WAS CONDUCTED ON THE REPORTED LOT AND NO SIMILAR EVENTS WERE NOTED. NO NONCONFORMANCES WAS RELATED TO THIS LOT.

    Description of Event or Problem · 0

    THIS MDR IS RELATED TO MDR 3013840437-2023-00016 REFERRING TO THE SAME PATIENT. THIS SPONTANEOUS REPORT WAS RECEIVED FROM AN US NURSE AND CONCERNS A PATIENT. THE PATIENT WAS INJECTED WITH RADIESSE. THE BATCH NUMBER WAS REPORTED AS A00053290 (EXPIRY DATE: 03/2025). THE BATCH RECORD REVIEW WAS RECEIVED AND THE LOT NUMBER FOR RADIESSE WAS CONFIRMED AS A00053290 (EXPIRY DATE: 03/2025). A LOT SEARCH IN THE GLOBAL SAFETY DATABASE WAS CONDUCTED. MORE THAN 3 MONTHS AFTER THE RADIESSE INJECTION, THE PATIENT EXPERIENCED A SOFT LUMP IN THE NECK. THE PATIENT BELIEVED THAT THE AESTHETIC INJECTION WAS THE CAUSE. ABOUT 3 MONTHS AFTER THE RADIESSE INJECTION, THE PATIENT DEVELOPED TORTUOUS BLOOD VESSELS/VARICOSITIES. THE OUTCOME OF THE EVENTS WAS UNKNOWN. FOLLOW-UP INFORMATION WAS RECEIVED ON 13-FEB-2023: THIS CASE WAS UPGRADED TO SERIOUS. THE EVENT TERM SOFT LUMP IN NECK WAS AMENDED TO SOFT LUMP IN NECK/ HYPODENSE RIGHT THYROID NODULE, CODING REMAINS UNCHANGED. EXPECTEDNESS FOR THE EVENT TORTUOUS BLOOD VESSELS/VARICOSITIES WAS REASSESSED. THE PATIENTS INITIALS, DATE OF BIRTH, AGE AND WEIGHT (58.9 KG) WERE PROVIDED. THE PATIENT WAS 51 YEARS OLD AT THE TIME OF THE EVENTS. THE PATIENT WAS INJECTED WITH RADIESSE, INTO THE NECK AND SUBMENTAL (OFF LABEL USE OF DEVICE), ON (B)(6) 2022. A TOTAL OF 1.5 ML WAS HYPERDILUTED 1:3, WITH 1.2 ML VOLUME DILUTED IN EACH AREA. THE PATIENT HAD NO KNOWN MEDICAL HISTORY OR PRIOR FILLERS. NO CONCOMITANT MEDICATIONS WERE NOTED. ON (B)(6) 2022, 85 DAYS AFTER THE RADIESSE INJECTION, THE PATIENT EXPERIENCED THE EVENTS. ON (B)(6) 2022, A COMPUTERISED TOMOGRAM (CT SCAN) DONE AND SHOWED THAT ON THE INFRAHYOID THERE WERE CURVILINEAR HYPODENSITIES IN THE SUBCUTANEOUS TISSUES OF THE LEFT ANTERIOR NECK AT THE LEVEL OF THE THYROID CARTILAGE DEEP TO THE FIDUCIAL MARKER, FAVORED TO REFLECT ASYMMETRICALLY PROMINENT AND TORTUOUS BLOOD VESSELS. THERE WERE MULTIPLE CURVILINEAR HYPERDENSITIES IN THE SUBCUTANEOUS ISSUES OF THE CHIN IN THE SUBMENTAL REGION, THAT MAY REFLECT POOLING OF THE CONTRAST WITHIN PROMINENT VESSELS VERSUS CALCIFIED PHLEBOLITHS. THERE WAS A SUB-CENTIMETER HYPODENSE RIGHT THYROID NODULE. THE LYMPH NODES WERE NOT PATHOLOGICALLY ENLARGED (FOR THE PATIENTS AGE) OR NECROTIC APPEARING LYMPH NODES. ON THE UPPER CHEST AND MEDIASTINUM (MEDIATINUM) THE IMAGED PORTION WAS UNREMARKABLE. ON THE MUSCULOSKELETAL THERE WAS NO AGGRESSIVE OSSEOUS LESIONS OR ACUTE OSSEOUS ABNORMALITY. THE CONCLUSION WAS THAT THERE WAS ASYMMETRICALLY PROMINENT AND TORTUOUS BLOOD VESSELS IN THE SUBCUTANEOUS TISSUES OF THE LEFT ANTERIOR NECK IN THE REGION OF PALPABLE CONCERN. THIS WAS NON-SPECIFIC AND POSSIBLY REFLECTED VARICOSITIES VERSUS A VASCULAR MALFORMATION. COSMETIC INJECTIONS POSSIBLY ALSO PRODUCED THIS IMAGING APPEARANCE OF THERE WAS CORRELATIVE HISTORY. RELEVANT LABORATORY TESTS ONLY INCLUDED THE COMPUTERISED TOMOGRAM. THE PATIENT WAS ALSO SEEN BY AN EAR, NOSE, AND THROAT SPECIALIST (ENT). NO TREATMENT MEASURES WERE GIVEN OR PRESCRIBED. AT THE TIME OF THIS REPORT, THERE WAS NO RESOLUTION YET. THE REPORTER SPOKE TO A PHYSICIAN REGARDING THE INCIDENT AND WAS GOING TO REFER THE PATIENT TO ANOTHER COLLEAGUE BUT DID NOT HEAR BACK. DUE TO THE PROVIDED INFORMATION, THE OUTCOME OF THE EVENTS WAS CONSIDERED AS NOT RESOLVED (CHANGED FROM UNKNOWN). IN THE OPINION OF THE REPORTER, THE EVENTS WERE PERMANENT, AND IT WAS UNKNOWN IF THEY WERE RELATED TO RADIESSE. THE REPORTERS CAUSALITY WAS THEREFORE CHANGED FROM REASONABLE POSSIBILITY TO NOT ASSESSABLE. TO THE REPORTERS KNOWLEDGE, NO TREATMENT WAS NECESSARY TO PREVENT A PERMANENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449443 RADIESSE INJECTABLE IMPLANT IMPLANT, DERMAL, FOR AESTHETIC USE LMH MERZ NORTH AMERICA, INC A00053290 M2138071M0K22

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Unknown Disability CONCOMITANT DRUG NOT AVAILABLE.