BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIESSE INJECTABLE IMPLANT

    MDR report key: 8437644 · Received March 20, 2019

    Report

    Report Number
    2135225-2019-00019
    Event Type
    Injury
    Date Received
    March 20, 2019
    Date of Event
    February 28, 2019
    Report Date
    March 20, 2019
    Manufacturer
    MERZ NORTH AMERICA, INC.
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CASE WAS ASSESSED AS REPORTABLE TO THE FDA AS THE EVENT, POSSIBLE VASCULAR OCCLUSION, WAS DEEMED TO MEET SERIOUS INJURY CRITERIA OF NECESSITATING 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 · 1

    THIS SPONTANEOUS REPORT WAS RECEIVED FROM A NURSE AT A MEDICAL SPA AND CONCERNS A FEMALE PATIENT WHO WAS INJECTED WITH AN UNSPECIFIED AMOUNT OF RADIESSE TO THE NASOLABIAL FOLDS ON (B)(6) 2019. MEDICAL HISTORY AND CONCOMITANT MEDICATIONS NOT REPORTED. ON (B)(6) 2019, THE PATIENT REPORTED SEVERE PAIN AND BRUISING, POSSIBLE VASCULAR OCCLUSION. CAUSALITY, LOT, TREATMENT AND OUTCOME NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231142 RADIESSE INJECTABLE IMPLANT IMPLANT, DERMAL, FOR AESTHETIC USE LMH MERZ NORTH AMERICA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention