BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 1344992 · Received March 16, 2009

    Report

    Report Number
    2135225-2009-00013
    Event Type
    Injury
    Date Received
    March 16, 2009
    Date of Event
    February 11, 2009
    Report Date
    March 16, 2009
    Manufacturer
    BIOFORM MEDICAL, INC.
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DURING A F/U WITH THE NURSE INJECTOR, IT WAS REPORTED THAT THE ANTIBIOTIC DOSAGE HAS BEEN COMPLETED AND THE PT'S INFECTION HAS RESOLVED. THE PT WAS ALSO TREATED WITH IPL TO PROMOTE CIRCULATION. PER THE IFU FOR RADIESSE DERMAL FILLER: NO STUDIES OF INTERACTIONS OF RADIESSE WITH IMPLANTS HAVE BEEN CONDUCTED. THE DEVICE HISTORY RECORDS FOR RADIESSE LOTS 1012130 AND 1011607 WERE REVIEWED; THESE TWO LOTS MET ALL TESTING SPECIFICATIONS.

    Description of Event or Problem · 1

    PT WAS INJECTED WITH RADIESSE DERMAL FILLER IN THE CHEEKS AND NASO LABIAL FOLDS. THE PT HAS PERMANENT CHEEK IMPLANTS AND THE RADIESSE WAS INJECTED INTO TISSUE PLANE SUPERIOR TO THE IMPLANTS. TWO DAYS POST RADIESSE INJECTION, THE PT DEVELOPED AN INFECTION AND WAS TREATED WITH ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIESSE DERMAL FILLER INJECTABLE IMPLANT LMH BIOFORM MEDICAL, INC. 1011607 & 1012130

    Patients

    Seq Age Sex Outcome Treatment
    1 Other