BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 1449351 · Received August 21, 2009

    Report

    Report Number
    2135225-2009-00036
    Event Type
    Injury
    Date Received
    August 21, 2009
    Date of Event
    July 20, 2009
    Report Date
    July 24, 2009
    Manufacturer
    BIOFORM MEDICAL, INC.
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING A FOLLOW-UP WITH THE CLINIC, IT WAS REPORTED THAT THE HARDENED AREAS MAY HAVE BEEN DUE TO INFECTION. THE PT WAS PLACED ON BIAXIN (ANTIBIOTIC) FOR TREATMENT. THE DEVICE HISTORY RECORDS FOR RADIESSE DERMAL FILLER LOT 1012118 WERE REVIEWED; ALL REQUIRED TESTING MET SPECIFICATIONS, AND THERE WERE NO DEVIATIONS NOTED.

    Description of Event or Problem · 1

    A PT WAS INJECTED IN THE CHEEKS AND NASO LABIAL FOLDS WITH RADIESSE DERMAL FILLER; TWO MONTHS POST INJECTION, THE PT DEVELOPED HARDENED AREAS IN THE CHEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIESSE DERMAL FILLER INJECTABLE IMPLANT LMH BIOFORM MEDICAL, INC. 1012118

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention RADIESSE DERMAL FILLER INJECTION.| AS ANESTHETIC