BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 2543126 · Received March 27, 2012

    Report

    Report Number
    2135225-2012-00030
    Event Type
    Other
    Date Received
    March 27, 2012
    Date of Event
    January 27, 2012
    Report Date
    March 26, 2012
    Manufacturer
    MERZ AESTHETICS, INC.
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT WAS TREATED WITH FAGRON COOLING LINIMENT TOGETHER WITH THE APPLICATION OF CHINOSOI-SOAKED BANDAGES AND AZITHROMYCIN AS A SYSTEMIC ANTIBIOTIC. AT THE TIME OF THE REPORT THE HEALING WAS NOT YET COMPLETE. NO BATCH NUMBERS WERE PROVIDED AND A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    PT WAS INJECTED IN THE NASOLABIAL FOLDS WITH RADIESSE DERMAL FILLER AND BELOTERO INTENSE IN THE GLABELLAR FROWN LINES DURING A WORKSHOP ON (B)(6) 2012. THE PT DEVELOPED INFLAMMATION AND SWELLING, UNEXPLAINED BLOOD AND SECRETION DISCHARGE FROM PORES ON LEFT SIDE OF THE NOSE AND TO A LESSER EXTENT ALONG TWO GLABELLAR FROWN LINES. NECROTIC AREAS, SOME CONFLUENT ARE LOCATED ON BOTH SIDES OF THE NASAL BRIDGE AND IN PATCHES ALONG THE LEFT SIDE OF THE NOSE. RESIDUAL NECROTIC CONDITIONS WITH SOME DEEPER SKIN INDENTATIONS EXIST AFTER 14 DAYS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention