BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 2670750 · Received July 20, 2012

    Report

    Report Number
    2135225-2012-00075
    Event Type
    Other
    Date Received
    July 20, 2012
    Date of Event
    June 1, 2012
    Report Date
    July 18, 2012
    Manufacturer
    MERZ AESTHETICS, INC.
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS WERE NOT REVIEWED AS THE LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    PT'S ADVERSE EVENT WAS FORWARDED TO MERZ AESTHETICS, INC. BY (B)(4), MERZ PHARMACEUTICALS (B)(4). THE INITIAL COMPLAINT CAME FROM (B)(4), MERZ (B)(4). DR. (B)(6) INJECTED A FEMALE PT WITH ABOUT 0.3 CC RADIESSE ON (B)(6) 2012 INTO NASAL DORSUM. PER THE REC'D INFO, "THE PT SUFFERED A PREVIOUS RHINOPLASTY (SOME YRS AGO). THE RHINOPLASTY WAS NOT CARRIED OUT IN THE CLINIC OF DR. (B)(6), BUT THE PT WAS INJECTED IN NASAL DORSUM IN 4 OCCASIONS IN THE LAST (B)(6) IN THIS CLINIC". THE PT STATED THAT SHE HAD DOUBLE VISION AND SUFFERED VAGAL SYMPTOMS THAT REQUIRED TRANSFER TO THE HOSPITAL WHERE SHE WAS STABILIZED. THE DIAGNOSIS WAS CAVERNOUS SINUS THROMBOSIS. THE PT WAS TREATED WITH ANTICOAGULANTS, CORTICOIDS AND EYE DROPS BECAUSE OF OBSERVED PARALYSIS OF ONE BRANCH OF THE TRIGEMINAL. THE PT WAS DISCHARGED FROM THE HOSPITAL AND WILL RECEIVE F/U CARE THROUGH THE EXTERNAL SERVICES. THE PT'S RECOVERY STATUS WAS REQUESTED AND NOT REC'D TO DATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization