BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIESSE (+) INJECTABLE IMPLANT

    MDR report key: 15419771 · Received September 14, 2022

    Report

    Report Number
    3013840437-2022-00110
    Event Type
    Injury
    Date Received
    September 14, 2022
    Report Date
    September 14, 2022
    Manufacturer
    MERZ NORTH AMERICA, INC
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CASE WAS ASSESSED AS REPORTABLE TO THE FDA AS THE EVENT, VASCULAR OCCLUSION (PT: VASCULAR OCCLUSION) WAS DEEMED TO MEET SERIOUS INJURY CRITERIA OF NECESSITATED MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE. THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED AS THE LOT NUMBER WAS NOT REPORTED.

    Description of Event or Problem · 0

    THIS SPONTANEOUS REPORT WAS RECEIVED FROM A US HEALTH CARE PROFESSIONAL AND CONCERNS A PATIENT. THE PATIENT WAS INJECTED WITH RADIESSE(+), INTO THE NASOLABIAL FOLDS (REPORTED AS NSL). AFTER THE RADIESSE(+) INJECTION, THE PATIENT EXPERIENCED A VASCULAR OCCLUSION (REPORTED AS VO). THE PATIENT HAD A LOT OF PAIN IN THE NOSE, WITH DARKENING, TURNING INTO BLANCHING. THE REPORTER WANTED TO KNOW HOW TO DILUTE RADIESSE(+). THE OUTCOME OF THE EVENT WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2644251 RADIESSE (+) INJECTABLE IMPLANT IMPLANT, DERMAL, FOR AESTHETIC USE LMH MERZ NORTH AMERICA, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention CONCOMITANT DRUG NOT AVAILABLE