BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 3082810 · Received April 24, 2013

    Report

    Report Number
    2135225-2013-00042
    Event Type
    Other
    Date Received
    April 24, 2013
    Date of Event
    March 19, 2013
    Report Date
    April 1, 2013
    Manufacturer
    BIOFORM MEDICAL, 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

    PT WAS ADMITTED TO HOSPITAL OVERNIGHT AND TREATED WITH IV ANTIBIOTIC, VANCOMYCIN AND IV STEROIDS. SHE WAS RELEASED THE FOLLOWING DAY WITH A HOME IV OF CYCLOSPORIN AND MEDROL DOSE PACK. DURING LATER F/U, THE PHYSICIAN REPORTED THE SWELLING HAS DECREASED AND THE PAIN IS GONE. ALL OF THE SYMPTOMS ARE RESOLVING AT THIS TIME. THE DEVICE HISTORY RECORD FOR RADIESSE LOT 100061410 WAS REVIEWED. ALL REQUIRED INCOMING, IN PROCESS, AND FINAL RELEASE TESTING SPECS 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

    PHYSICIAN WHO IS THE PT REPORTED BEING INJECTED WITH RADIESSE DERMAL FILLER BY A MERZ FIELD CLINICAL SPECIALIST IN THE MID-FACE AND NASOLABIAL FOLD AREAS. SHE LATER DEVELOPED SWELLING, TENDERNESS AND ITCHINESS ESPECIALLY IN THE RIGHT EYE AREA. SHE BEGAN TAKING BACTRUM WITH THE SWELLING AND TENDERNESS INCREASING. SHE BELIEVED THAT SHE HAD DEVELOPED CELLULITIS AND WENT TO THE HOSPITAL WERE SHE WAS ADMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175852 RADIESSE DERMAL FILLER INJECTABLE IMPLANT LMH BIOFORM MEDICAL, INC. 100061410

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization 0.26CC OF 2% LIDOCAINE| SYRINGE MIXED WITH