BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 1486642 · Received September 24, 2009

    Report

    Report Number
    2135225-2009-00046
    Event Type
    Injury
    Date Received
    September 24, 2009
    Date of Event
    August 12, 2009
    Report Date
    September 1, 2009
    Manufacturer
    BIOFORM MEDICAL, INC.
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS TREATED WITH THE ANTIBIOTIC, AUGMENTIN AND WITHIN THREE DAYS WAS REPORTED TO BE DOING MUCH BETTER. THE PATIENT HAD A ROOT CANAL PROCEDURE PERFORMED THE WEEK PRIOR TO THE RADIESSE INJECTIONS, AND THE PHYSICIAN FEELS THIS MAY HAVE PLAYED A ROLE IN THE INFECTION. THE PHYSICIAN STATED THE PATIENT RETURNED TO HER HOME, AND DID NOT SEEK FURTHER MEDICAL TREATMENT. ADD'L CATALOGUE# 8069M0K1, LOT# 1013305, EXPIRATION DATE: 03/2011. ADDITIONAL DEVICE MANUFACTURE DATE: 03/2009.

    Description of Event or Problem · 1

    PATIENT INJECTED WITH RADIESSE DERMAL FILLER IN THE MID-FACE AND NASOLABIAL FOLDS DEVELOPED PITTING EDEMA WITH A RED, WARM AREA AND ONE EYE SWELLING SHUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIESSE DERMAL FILLER INJECTABLE IMPLANT LMH BIOFORM MEDICAL, INC. 1014106

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention