BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 2086439 · Received May 2, 2011

    Report

    Report Number
    2135225-2011-00036
    Event Type
    Injury
    Date Received
    May 2, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 4, 2011
    Manufacturer
    MERZ AESTHETICS, INC
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT WAS TREATED WITH SOLUPRED (PREDNISOLONE) AND ANTIBIOTIC, AUGMENTIN. ADDITIONAL INFORMATION FROM THE PHYSICIAN REPORTS THE PT PRESENTED WITH TRANSIENT PARALYSIS DUE TO THE ANESTHESIA. THE VOMITING WAS RELATED TO OCULOMOTOR REFLEX DUE TO PERIORBITAL HEMATOMA. THE PT WAS KEPT UNDER OBSERVATION FOR 40 MINUTES. THE OPHTHALMOLOGIST REPORTED THERE WAS NO DIPLOPIA, NO NYSTAGMUS. A PRESENCE OF SMALL ECCHYMOSIS WITH MODERATE EDEMA WAS OBSERVED. SHE HAD NO BALANCE TROUBLE OR PARALYSIS AT THAT TIME. AN MRI WAS PERFORMED WITH NORMAL RESULTS. A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THE REPORTED LOT #1021755 MET ALL SPECIFICATIONS PRIOR TO RELEASE.

    Description of Event or Problem · 1

    PHYSICIAN REPORTED A PT INJECTED IN THE TEMPLES WITH RADIESSE DERMAL FILLER DEVELOPED INFRA-ORBITAL ECCHYMOSIS LEADING TO INFLAMMATION OF THE LEFT EYE, VISION TROUBLE, BALANCE PROBLEM, FEVER AND VOMITING. A VISIT TO OPHTHALMOLOGIST WAS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIESSE DERMAL FILLER INJECTABLE IMPLANT LMH MERZ AESTHETICS, INC 1021755

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention