BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 2035786 · Received March 22, 2011

    Report

    Report Number
    2135225-2011-00020
    Event Type
    Other
    Date Received
    March 22, 2011
    Date of Event
    February 1, 2011
    Report Date
    March 7, 2011
    Manufacturer
    MERZ AESTHETICS, INC.
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT HAD REPORTED TO THE INJECTOR (OVER THE PHONE) THAT HER SKIN IS FINE AND THAT SHE IS HAVING NO OTHER ISSUES WITH THE AREAS INJECTED. THE DEVICE HISTORY RECORDS FOR RADIESSE LOT 1023186 WERE REVIEWED; ALL REQUIRED TESTING SPECIFICATIONS WERE MET PRIOR TO RELEASE, THERE WERE NO ABNORMALITIES NOTED.

    Description of Event or Problem · 1

    A PATIENT WAS INJECTED WITH RADIESSE DERMAL FILLER ON (B)(6) 2011. AT TWO WEEKS POST INJECTION, THE PATIENT NOTICED AN AREA OF REDNESS AND ITCHINESS ALONG THE RIGHT SIDE NASO LABIAL FOLD. THE PATIENT WAS ADVISED (OVER THE PHONE) TO USE HYDROCORTISONE CREAM. ON (B)(6) 2011, THE PATIENT AS SEEN BY DR (B)(6) , WHO DIAGNOSED "PAPULAR RASH" AND TREATED WITH BACTRIM DS (ORAL) BID FOR 10 DAYS. THE PATIENT WAS ALSO ADVISED TO USE HIBICLENS (ANTISEPTIC ANTIMICROBIAL SKIN CLEANSER) AND BACTRIBAN CREAM TWICE EACH DAY. THE PATIENT CALLED OVER THE WEEKEND, SAYING THE RASH SEEMS TO BE SPREADING TO THE OTHER SIDE AND THAT IT IS VERY ITCHY AND BOTHERSOME. THE PATIENT DID NOT RETURN FOR A FOLLOW-UP, BUT REPORTED ON (B)(6) 2011, THAT HER SKIN IS FINE AND IS HAVING NO PROBLEMS WITH THE AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIESSE DERMAL FILLER INJECTABLE IMPLANT LMH MERZ AESTHETICS, INC. 1023186

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention RADIESSE WAS MIXED WITH 0.2CC OF LIDOCAINE