BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 3628080 · Received February 7, 2014

    Report

    Report Number
    2135225-2014-00002
    Event Type
    Other
    Date Received
    February 7, 2014
    Date of Event
    January 9, 2014
    Report Date
    January 10, 2014
    Manufacturer
    MERZ NORTH AMERICAL, INC.
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6) SPOKE TO A (B)(6) PHYSICIAN, DR. (B)(4). DR. (B)(4) STATED THAT THIS IS A CASE OF VASCULAR COMPROMISE. THE DEVICE HISTORY RECORD FOR REPORTED RADIESSE LOT WAS REVIEWED. ALL REQUIRED TESTING SPECIFICATIONS FOR THIS LOT WERE MET PRIOR TO RELEASE. NO NON-CONFORMANCES WERE DISCOVERED THAT WOULD HAVE CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    ON (B)(6) 2014, (B)(6) CALLED (B)(4) TO REPORT THAT SHE INJECTED A FEMALE PATIENT ON (B)(6) 2014. (B)(6) INJECTED 0.1CC RADIESSE INTO THE GLABELLA AND 0.1CC INJECTED INTO THE PERIOSTEAL AREA. INJECTED AREA WAS GREEN. INJECTOR THOUGHT SHE GOT A VESSEL. SHE USED PRESSURE AND RUBBED AROUND. THE AREA WAS GREEN WHEN THE PATIENT LEFT. (B)(6) THOUGHT THAT THE PATIENT WOULD END UP WITH A BRUISE. THE PATIENT CALLED (B)(6) AT 7AM ON (B)(6) 2014, (B)(6) INSTRUCTED THE PATIENT TO GO TO THE ER. (B)(6) PROVIDED A NOTE FOR THE PATIENT TO TAKE TO THE ER ABOUT USING WARM COMPRESS, ETC. A CT SCAN WAS PERFORMED. THERE WAS PRODUCT IN A VESSEL. THE PATIENT'S VISION WAS CHECKED AND PER THE PATIENT HER VISION IS OK. THERE WAS NO BLANCHING AT THE TIME OF THE INJECTION. THERE IS NO TISSUE DEATH AND IT HAS BEEN OVER 12 HOURS SINCE THE INJECTION. (B)(6) HAS INVOLVED HER MEDICAL DIRECTOR WHO IS A P.S. THEY ARE GOING TO TRY TO GET THE PATIENT TO COME BACK IN ON EITHER (B)(6) 2014 OR (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80971 RADIESSE DERMAL FILLER INJECTABLE IMPLANT LMH MERZ NORTH AMERICAL, INC. 100068836

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention