BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 2573177 · Received April 20, 2009

    Report

    Report Number
    2135225-2009-00018
    Event Type
    Injury
    Date Received
    April 20, 2009
    Date of Event
    January 1, 2008
    Report Date
    April 9, 2009
    Manufacturer
    BIOFORM MEDICAL, INC.
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S SYMPTOMS HAD RESOLVED AT THE TIME THIS ADVERSE EVENT HAD BEEN REPORTED TO BIOFORM MEDICAL, INC. SINCE THE INITIAL REPORTER WAS NOT THE PHYSICIAN WHO PERFORMED THE RADIESSE INJECTION, THE DATE OF INJECTION, LOT NUMBER, AMOUNT INJECTED AND ONSET OF SYMPTOMS WERE NOT REVEALED. THE RADIESSE LOT NUMBER WAS NOT PROVIDED; THEREFORE, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED.

    Description of Event or Problem · 1

    PATIENT WAS INJECTED WITH RADIESSE DERMAL FILLER IN AN UNIDENTIFIED FACIAL LOCATION, IN 2008. THE PATIENT DEVELOPED SWELLING, PAIN AND REDNESS, WHICH PERSISTED FOR SIX MONTHS. THE PATIENT WAS INITIALLY TREATED WITH ANTIHISTAMINES, ORAL STEROIDS AND STEROID INJECTIONS, WHICH REPORTEDLY MADE THE SYMPTOMS WORSE. THE PATIENT WAS THEN TREATED WITH A 30-DAY DOSE OF AUGMENTIN AND THE INFECTION HAS RESOLVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention