BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 2670830 · Received July 20, 2012

    Report

    Report Number
    2135225-2012-00080
    Event Type
    Other
    Date Received
    July 20, 2012
    Date of Event
    June 19, 2012
    Report Date
    July 19, 2012
    Manufacturer
    MERZ AESTHETICS, INC.
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RADIESSE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED, A LOT NUMBER WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THIS EVENT WAS FORWARDED TO MERZ AESTHETICS, INC. FROM MERZ (B)(4). THE REPORTER STATED THERE IS VASCULAR COMPRESS THAT LET TO NOSE NECROSIS. ON (B)(6) 2012, A FEMALE PATIENT WAS INJECTED WITH 0.7CC OF RADIESSE IN THE NOSE. ON (B)(6), THE INJECTOR, REPORTED THAT THIS PATIENT DEVELOPED BLEEDING, BRUISING AND SHARP PAIN. DR. (B)(6) ORDERED ORAL ANTIBIOTICS, OINTMENT, WARM COMPRESSES AND MASSAGE. THE PATIENT WAS TRANSFERRED TO THE HOSPITAL FOR HYPERBARIC TREATMENT SCHEDULED FOR (B)(6) 2012. AS OF TO DATE, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention