BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIESSE

    MDR report key: 828277 · Received March 13, 2007

    Report

    Report Number
    2135225-2007-00004
    Event Type
    Injury
    Date Received
    March 13, 2007
    Date of Event
    September 27, 2006
    Report Date
    March 12, 2007
    Manufacturer
    BIOFORM MEDICAL, INC.
    Product Code
    LYC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING A FOLLOW-UP WITH THE RADIESSE INJECTING PHYSICIAN, IT WAS REPORTED THAT THE PT WAS RELEASED FROM THE HOSPITAL WITH ALL SYMPTOMS RESOLVED. THERE WAS NO PERMANENT DAMAGE OR DETERIORATION IN HEALTH REPORTED. THE TEST RESULTS FROM THE ALLERGY TESTING WERE NOT PROVIDED TO BIOFORM MEDICAL. A REVIEW OF THE DEVICE HISTORY RECORDS FOR RADIESSE LOT NUMBER 1003241, INDICATES THERE IS NOTHING THAT WOULD HAVE CONTRIBUTE TO THIS REPORTED EVENT.

    Description of Event or Problem · 1

    A PT WAS INJECTED IN THE NASO LABIAL FOLDS WITH RADIESSE AT A TRAINING WORKSHOP IN ANOTHER COUNTRY. WITHIN ONE HOUR, THE PT DEVELOPED SWELLING. THE SWELLING INCREASED OVERNIGHT, AND THE NEXT DAY, THE PT WAS ADMITTED TO THE HOSPITAL. THE TREATING PHYSICIAN AT THE HOSPITAL RAN A SERIES OF ALLERGY TESTS AND PRESCRIBED SEVERAL MEDICATIONS TO REDUCE THE SWELLING AND REDNESS. THE INJECTABLE IMPLANT IS APPROVED FOR FACIAL AUGMENTATION IN ANOTHER COUNTRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIESSE INJECTABLE IMPLANT LYC BIOFORM MEDICAL, INC. * 1003241

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization