BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 1444618 · Received August 17, 2009

    Report

    Report Number
    2135225-2009-00037
    Event Type
    Injury
    Date Received
    August 17, 2009
    Date of Event
    July 1, 2009
    Report Date
    July 30, 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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DURING A F/U WITH THE CLINIC, IT WAS REPORTED THAT THE PT WAS PRESCRIBED CLINDAMYCIN (ANTIBIOTIC) FOR TREATMENT OF THE CELLULITIS BY THE PRIMARY PHYSICIAN. THE PT WAS NOT SEEN BY THE INJECTING CLINIC FOR TREATMENT OF THE CELLULITIS. THE DEVICE HISTORY RECORDS FOR RADIESSE DERMAL FILLER LOT 1012283 WERE REVIEWED; ALL REQUIRED TESTING MET SPECS, AND THERE WERE NO DEVIATIONS NOTED.

    Description of Event or Problem · 1

    A PT WAS INJECTED IN THE CHEEKS AND TEAR TROUGH WITH RADIESSE DERMAL FILLER; A FEW DAYS LATER, THE PT WAS DIAGNOSED WITH A SOFT TISSUE INJURY CAUSING POSSIBLE CELLULITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIESSE DERMAL FILLER INJECTABLE IMPLANT LMH BIOFORM MEDICAL, INC. 1012283

    Patients

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