BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 2090104 · Received May 6, 2011

    Report

    Report Number
    2135225-2011-00039
    Event Type
    Injury
    Date Received
    May 6, 2011
    Date of Event
    March 25, 2011
    Report Date
    April 11, 2011
    Manufacturer
    MERZ AESTHETICS, INC.
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DR (B)(4) INDICATED THAT THE PT HAS SLIGHT IMPROVEMENT, BUT THAT IT MAY TAKE 3-6 MONTHS FOR COMPLETE RESOLUTION. THE DEVICE HISTORY RECORDS FOR RADIESSE LOT 1024255 WERE REVIEWED. ALL REQUIRED TESTING SPECIFICATIONS WERE MET PRIOR TO RELEASE; THERE WERE NO ABNORMALITIES NOTED.

    Description of Event or Problem · 1

    DR. MICHAEL LAFKAS INJECTED A PT WITH RADIESSE DERMAL FILLER ON (B)(6) 2011, IN THE NL FOLDS AND ALONG ZYGOMA. AT THREE DAYS POST, THE PT INDICATED SHE LOVED THE RESULTS. AT SIX DAYS POST ((B)(6) 2011), THE PT AWOKE TO FULL FACIAL CRANIAL BELL'S PALSY, AFFECTING ALL 5 BRANCHES. THE PT ALSO REPORTED INNER LEFT EAR PAIN. NO FEVER DETECTED. DR. LAFKAS REFERRED THE PT TO HER PRIMARY CARE PHYSICIAN AND/OR ER. PT WENT TO ER, WHERE A SERIES OF TESTS AND BLOOD WORK WERE RUN. PT PRESCRIBED ACYCLOVIR WITH STEROIDS AND ER PHYSICIAN CONFIRMED DIAGNOSIS AS BELL'S PALSY. THIS RADIESSE INJECTION WAS THE FIRST DERMAL FILLER THAT THE PT HAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIESSE DERMAL FILLER INJECTABLE IMPLANT LMH MERZ AESTHETICS, INC. 1024255

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Disability RADIESSE WAS MIXED WITH 0.5CC OF 2% LIDOCAINE.