BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 1307268 · Received February 5, 2009

    Report

    Report Number
    2135225-2009-00001
    Event Type
    Injury
    Date Received
    February 5, 2009
    Date of Event
    January 17, 2009
    Report Date
    February 3, 2009
    Manufacturer
    BIOFORM MEDICAL, INC.
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING A FOLLOW-UP WITH THE CLINIC, IT WAS REPORTED THAT THE PATIENT HAD MOVED OUT OF STATE AND HAS NOT RETURNED TO THE CLINIC FOR EVALUATION. BASED ON VERBAL COMMUNICATION, THE PATIENT REPORTED THAT THE SYMPTOMS HAVE RESOLVED. THE DEVICE HISTORY RECORDS FOR RADIESSE LOT 1011899 WERE REVIEWED; THIS LOT MET ALL TESTING SPECIFICATIONS.

    Description of Event or Problem · 1

    PATIENT WAS INJECTED WITH RADIESSE DERMAL FILLER IN THE NASO LABIAL FOLDS. THE PATIENT DEVELOPED TENDERNESS, SWELLING, INFLAMMATION NEAR THE NOSTRIL AND ERYTHEMA ALONG THE RIGHT SIDE NL FOLD. THE PATIENT WAS SEEN BY AN ER PHYSICIAN AND TREATED WITH BROAD SPECTRUM ANTIBIOTIC. THE ER PHYSICIAN FEELS THIS EVENT WAS DUE TO PATIENT'S PREVIOUS CHEMOTHERAPY TREATMENTS IN 2003 AND THAT SHE SHOULD NOT HAVE BEEN INJECTED WITH ANY DERMAL FILLER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIESSE DERMAL FILLER INJECTABLE IMPLANT LMH BIOFORM MEDICAL, INC. 1011899

    Patients

    Seq Age Sex Outcome Treatment
    1 Other