BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 1855808 · Received October 1, 2010

    Report

    Report Number
    2135225-2010-00055
    Event Type
    Injury
    Date Received
    October 1, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 27, 2010
    Manufacturer
    MERZ AESTHETICS, INC. (FORMERLY BIOFORM MEDICAL, INC.)
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS FOR RADIESSE LOT 1016320 WERE REVIEWED; ALL REQUIRED TESTING SPECIFICATIONS WERE MET PRIOR TO RELEASE AND THERE WERE NO ABNORMALITIES NOTED FOR THIS LOT.

    Description of Event or Problem · 1

    PHYSICIAN REPORTED A PT WAS INJECTED WITH 0.8 CC RADIESSE INJECTABLE IMPLANT IN THE NASOLABIAL FOLDS AND GLABELLA, AND ABOUT 48 HOURS POST-INJECTION DEVELOPED INFLAMMATION MANIFESTED BY REDNESS, SWELLING AND BRUISING TO THE GLABELLA INJECTION SITE; A MICRO-EMBOLI TO THE GLABELLA WAS SUSPECTED AND THE PT WAS TREATED WITH ORAL DEXAMETHASONE. THE PT FURTHER DEVELOPED A MILD NECROSIS; EPIDERMOLYSIS AND BLISTERING TO THE LEFT GLABELLA ONLY. SHE HAD A MILD SLOUGH, WHICH HAS GONE ON TO FULL CLOSURE AND HEALED UP. SHE WAS LEFT WITH RESIDUAL ERYTHEMA THAT IS BEING TREATED WITH PULSED DYE LASER, AND SHE IS RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIESSE DERMAL FILLER RADIESSE INJECTABLE IMPLANT LMH MERZ AESTHETICS, INC. (FORMERLY BIOFORM MEDICAL, INC.) 1016320

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention