BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIESSE INJECTABLE IMPLANT

    MDR report key: 6190995 · Received December 20, 2016

    Report

    Report Number
    2135225-2016-00038
    Event Type
    Injury
    Date Received
    December 20, 2016
    Date of Event
    August 15, 2016
    Report Date
    December 20, 2016
    Manufacturer
    MERZ NORTH AMERICA, INC.
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CASE WAS ASSESSED AS REPORTABLE TO THE FDA AS THE EVENT, OCCLUSION OF ARTERY, 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 OF RADIESSE INJECTABLE IMPLANT COULD NOT BE REVIEWED AS THE LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT WAS RECEIVED FROM A (B)(6) PHYSICIAN AND CONCERNS A FEMALE PATIENT WHO WAS INJECTED WITH RADIESSE. THE PATIENT EXPERIENCED A NOT FURTHER SPECIFIED ADVERSE EVENT AFTER THE INJECTION. NO INFORMATION RELATED TO THE PROCEDURE OR TREATMENT AREAS COULD BE OBTAINED. CORRECTIVE TREATMENT INCLUDED RADIO FREQUENCY. FOLLOW UP INFORMATION WAS RECEIVED ON 12-SEP-2016: THE PATIENT INITIALS, DATE OF BIRTH AND AGE WERE REPORTED. THIS CASE CONCERNS A (B)(6) FEMALE PATIENT ((B)(6)). ON (B)(6) 2016, THE PATIENT WAS INJECTED SUBCUTANEOUSLY WITH A TOTAL OF 1.5 ML OF RADIESSE (0.75 ML IN 2 INJECTION POINTS ON EACH SIDE) INTO NASOLABIAL FOLDS. NEEDLE USED FOR INJECTION WAS 22 G. THE PATIENT WAS PREVIOUSLY INJECTED WITH BOTOX INTO GLABELLA AND FOREHEAD IN (B)(6) 2016. THE PATIENT'S MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE REPORTED AS NONE. IT WAS REPORTED THAT NO NECROSIS OCCURRED, BUT NO OTHER ADVERSE EVENT WAS REPORTED INSTEAD. CORRECTIVE TREATMENT INCLUDED ORAL ANTIBIOTICS, CORTISONE 50 MG, VIAGRA 100 MG, ACETYLSALICYLIC ACID 100 MG, SEVERAL INJECTIONS WITH NACL 0.9%, INJECTION OF HYLASE AT THE EVENT SITE, HEAT AND MASSAGE. THE PATIENT WAS NOT HOSPITALIZED. IN THE OPINION OF THE REPORTER, THE EVENT WAS OF SEVERE INTENSITY, NOT PERMANENT, NOR LIFE-THREATENING. FOLLOW-UP INFORMATION WAS RECEIVED ON 24-NOV-2016: THE PHYSICIAN DIAGNOSED "SUSPECTED NECROSIS CAUSED BY PARTIAL OCCLUSION OF THE ARTERY AFTER TREATMENT WITH RADIESSE." THE PHYSICIAN REPORTED THAT DUE TO THE COMPREHENSIVE CORRECTIVE TREATMENT THE PATIENT UNDERWENT, A NECROSIS COULD BE AVOIDED. THE SYMPTOMS DEVELOPED A FEW HOURS AFTER THE TREATMENT AND RESOLVED COMPLETELY, AND THEY WERE DEFINITELY RELATED TO RADIESSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841136 RADIESSE INJECTABLE IMPLANT IMPLANT, DERMAL, FOR AESTHETIC USE LMH MERZ NORTH AMERICA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention