BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 1559905 · Received December 8, 2009

    Report

    Report Number
    2135225-2009-00059
    Event Type
    Injury
    Date Received
    December 8, 2009
    Date of Event
    November 6, 2009
    Report Date
    December 7, 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 PHYSICIAN ADMINISTERED ANTIBIOTICS PRIOR TO SEEING THE PT. THE PHYSICIAN CONFIRMED UPON SEEING THE PT THAT THE PT HAD AN INFECTION. THE DEVICE HISTORY RECORDS FOR LOT FOR 1014108 AND 1014171 WERE REVIEWED. ALL REQUIRED TESTING MET SPECIFICATIONS AND THERE WERE NO DEVIATIONS NOTED. ADDITIONAL INFO: CATALOG# 8069M0K1; LOT# 1014171; EXPIRATION DATE: 05/01/2011.

    Description of Event or Problem · 1

    PT WAS INJECTED WITH RADIESSE DERMAL FILLER IN THE CHEEKS AND DEVELOPED A POSSIBLE INFECTION. THE PT'S SYMPTOMS WERE ERYTHEMA, RED BUMPS AND WHITE PUSTULES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIESSE DERMAL FILLER INJECTABLE IMPLANT LMH BIOFORM MEDICAL, INC. 1014108

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention