BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 3787228 · Received April 25, 2014

    Report

    Report Number
    2135225-2014-00028
    Event Type
    Other
    Date Received
    April 25, 2014
    Date of Event
    March 24, 2014
    Report Date
    March 25, 2014
    Manufacturer
    MERZ NORTH AMERICA, INC
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS UNK IF THE INJECTOR IS A HEALTHCARE PROFESSIONAL OR WHAT THE INJECTOR'S TITLE IS. THE DEVICE HISTORY RECORD FOR THE INJECTED RADIESSE LOT WAS NOT REVIEWED AS THE LOT NUMBER WAS UNK. NO F/U INFO COULD BE OBTAINED AS THERE WAS NO CONTACT INFO PROVIDED FOR THE INJECTING OFFICE IN THE INTERNET POSTING. THE POSTING WAS THEN REMOVED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE MERZ (B)(4) OFFICE WAS INFORMED THAT DR (B)(6), A MERZ CUSTOMER HAD SEEN AN INTERNET POSTING THAT STATED THE FOLLOWING: THE PT WAS INJECTED WITH RADIESSE DERMAL FILLER IN NOSE AREA ON (B)(6) 2013 AND GOT SEVERE SWELLING IMMEDIATELY AFTER INJECTION. SHE GOT BRUISING AFTER GOING BACK HOME. SHE HAD SKIN NECROSIS IN NASAL ROOT AND GLABELLA AREAS ON (B)(6) 2013. A DOCTOR ORDERED LOCAL ANTIBIOTICS TO HER ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250397 RADIESSE DERMAL FILLER INJECTABLE IMPLANT LMH MERZ NORTH AMERICA, INC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention