BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 3370364 · Received September 13, 2013

    Report

    Report Number
    2135225-2013-00090
    Event Type
    Other
    Date Received
    September 13, 2013
    Date of Event
    August 20, 2013
    Report Date
    August 22, 2013
    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

    THE DEVICE HISTORY RECORDS FOR RADIESSE LOT WERE NOT REVIEWED AS THE LOT NUMBER WAS UNK.

    Description of Event or Problem · 1

    PT'S ADVERSE EVENT WAS FORWARDED TO MERZ NORTH AMERICA INC, FROM (B)(6). CLINIC MGR AT (B)(6) REPORTED PT'S ADVERSE EVENT POST RADIESSE INJECTION. A FEMALE PT WAS INJECTED WITH 0.8 CC RADIESSE INTO HER NOSE ON (B)(6) 2013 INJECTOR ORDERED ORAL, TOPICAL, AND PARENTERAL ANTIBIOTICS TREATMENT FOR THE PT. PT'S RIGHT EYE FELT MILDLY UNCOMFORTABLE. ON (B)(6) 2013, CLINIC MGR NOTIFIED (B)(6) THAT PT DEVELOPED VASCULAR COMPROMISE/OCCLUSION. THE CLINIC STARTED HYPERBARIC OXYGEN TREATMENT ON THE SAME DAY. THE INJECTOR ALSO ORDERED ORAL ANTI-VIRUS AND STEROID FOR PT'S TREATMENT. UPDATE ON THE PT'S RECOVERY STATUS WAS REQUESTED; INFO WAS RECEIVED FROM (B)(6) THAT THERE IS NO UPDATE FROM THE INJECTING CLINIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462256 RADIESSE DERMAL FILLER RADIESSE INJECTABLE IMPLANT LMH MERZ NORTH AMERICA INC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention