BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIESSE INJECTABLE IMPLANT

    MDR report key: 6129033 · Received November 28, 2016

    Report

    Report Number
    2135225-2016-00035
    Event Type
    Injury
    Date Received
    November 28, 2016
    Date of Event
    November 21, 2016
    Report Date
    November 23, 2016
    Manufacturer
    MERZ NORTH AMERICA, INC.
    Product Code
    LMH
    UDI-DI
    M2138071M0K15
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CASE WAS ASSESSED AS REPORTABLE TO THE FDA AS THE EVENT, 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 FOR RADIESSE DERMAL FILLER LOT 100093271 WAS REVIEWED. NO NONCONFORMANCES WERE NOTED THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. A LOT SEARCH WAS CONDUCTED ON THE REPORTED LOT AND NO SIMILAR EVENTS WERE NOTED.

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED THAT A (B)(6) FEMALE PATIENT WAS INJECTED WITH RADIESSE. MEDICAL HISTORY AND CONCOMITANT MEDICATIONS NOT REPORTED. ON (B)(6) 2016, THE PATIENT WAS INJECTED WITH 0.4 CC OF RADIESSE TO THE GLABELLA. ON (B)(6) 2016, THE PATIENT REPORTED ERYTHEMA, TENDERNESS, AND "BLACK AREA ON THE SKIN" NEAR THE BRIDGE OF THE NOSE. ON 22-NOV-2016, FOLLOW UP INFORMATION WAS RECEIVED FROM THE PHYSICIAN. PATIENT'S MEDICAL HISTORY AND CONCOMITANT MEDICATIONS CLARIFIED AS NONE. ON (B)(6) 2016, THE PATIENT PRESENTED FOR A FOLLOW UP APPOINTMENT WITH THE PHYSICIAN AND WAS DIAGNOSED WITH A VASCULAR OCCLUSION. TREATMENT REPORTED AS 0.4 ML OF HYALURONIDASE, NITROPASTE, KEFLEX, VALTREX, ASPIRIN, AND A MEDROL DOSE PACK. PATIENT WAS INSTRUCTED TO PERFORM MASSAGE AND APPLY WARM COMPRESSES EVERY HOUR. SHE WAS REFERRED TO A PLASTIC SURGEON, WHO NOTED THE PATIENT'S SKIN WAS "ISCHEMIC ALREADY, THE SKIN WAS GOING TO DIE" AND ADVISED "NORMAL WOUND CARE." CAUSALITY REPORTED AS RELATED. OUTCOME REPORTED AS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779966 RADIESSE INJECTABLE IMPLANT IMPLANT, DERMAL, FOR AESTHETIC USE LMH MERZ NORTH AMERICA, INC. 100093271 M2138071M0K15

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention