BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 2163750 · Received June 15, 2011

    Report

    Report Number
    2135225-2011-00050
    Event Type
    Injury
    Date Received
    June 15, 2011
    Date of Event
    May 25, 2010
    Report Date
    May 19, 2011
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT HAD NOT BEEN PREVIOUSLY REPORTED TO MERZ AESTHETICS BY THE PHYSICIAN OR THE PATIENT. MERZ AESTHETICS AWARENESS DATE WAS (B)(4) 2011 WHEN A COPY OF THE VOLUNTARY REPORT WAS RECEIVED ((B)(4)). NO FOLLOW-UP OR INVESTIGATION WAS ABLE TO BE CONDUCTED SINCE NO PHYSICIAN OR PATIENT INFORMATION WAS PROVIDED IN THE REPORT.

    Description of Event or Problem · 1

    A PATIENT REPORTED BEING INJECTED WITH RADIESSE DERMAL FILLER ALONG AND ABOVE THE ORBITAL BONE RESULTING IN LARGE RED BAGS UNDER EACH EYE. THE PATIENT RETURNED TO THE PHYSICIAN WHO WAS INSTRUCTED TO INJECT THE AREA WITH A PRODUCT TO DISSOLVE THE OTHER FILLERS. THE PATIENT WAS INJECTED AND DEVELOPED A SEVERE SINUS INFECTION AND NOSE BLEEDS WHICH HAVE PERSISTED OVER THE LAST YEAR. THE PATIENT LATER WENT TO A PLASTIC SURGEON WHO STATED, THE PRODUCT SHOULD NOT BE INJECTED IN THIS AREA AS IT IS PERMANENT AND WILL NOT BE ABSORBED BY THE BODY. THE PLASTIC SURGEON INDICATED TO THE PATIENT THAT THE ENTIRE AREA OF PRODUCT NEEDS TO BE REMOVED, THE BONE FILED DOWN AND THE SKIN DEFORMITY CUT AND LIFTED. THE PATIENT FEELS SHE IS LOSING HER VISION AND THE PRODUCT NEEDS TO BE REMOVED. THE PLASTIC SURGEON INFORMED THE PATIENT THAT THE PRODUCT SHOULD ONLY BE USED ON CANCER/HIV PATIENTS WHO SUFFER BONE LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIESSE DERMAL FILLER INJECTABLE IMPLANT LMH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention