BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 2860299 · Received November 7, 2012

    Report

    Report Number
    2135225-2012-00092
    Event Type
    Other
    Date Received
    November 7, 2012
    Date of Event
    October 7, 2012
    Report Date
    October 12, 2012
    Manufacturer
    MERZ AESTHETICS, INC.
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT WAS TREATED WITH TWO ANTIBIOTICS; MACROLIDE AND QUINOLONE SHOWING SIGNIFICANT IMPROVEMENT. THE PT RETURNED TO THE OFFICE ON (B)(6) 2012. SHE DID VERY WELL INITIALLY ON THE MEDROL DOSE PACK HOWEVER TWO DAYS AFTER COMPLETION SHE HAD REBOUND SWELLING AND INDURATION TO ONE CHEEK. THE COURSE OF PREDNISONE WAS EXTENDED, STARTING WITH 40 MG AND WILL TAPER DOWN TO 10 MG OVER 7-10 DAYS. THE PT CONTINUES TO BE ON TWO ANTIBIOTICS. THE PT IS DOING VERY WELL OVERALL. A REVIEW OF THE DEVICE HISTORY RECORDS INDICATED THE REPORTED LOTS #1034602 AND #1033998 MET ALL SPECIFICATIONS PRIOR TO RELEASE WITH NO ABNORMALITIES NOTED.

    Description of Event or Problem · 1

    THE PT WAS INJECTED IN THE MALAR REGIONS WITH 3.8 CC OF RADIESSE ON (B)(6) 2012. APPROXIMATELY 3-1/2 WEEKS POST INJECTION THE PT FLEW TO EUROPE ON VACATION. SHE REPORTED DEVELOPING INFLAMMATION, PAIN, SWELLING AND REDNESS WITH HARDENED AREAS THE EVENING SHE RETURNED HOME, (B)(60 2012. SHE REPORTED HER SYMPTOMS TO THE PHYSICIAN ON (B)(6) 2012. SHE RETURNED TO HIS OFFICE ON (B)(6)2012 AND WAS DIAGNOSED WITH INFECTION. SHE WAS TREATED WITH ANTIBIOTICS AND A MEDROL DOSE PACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIESSE DERMAL FILLER INJECTABLE IMPLANT LMH MERZ AESTHETICS, INC. 1034602, 1033998

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention