BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 1211603 · Received October 23, 2008

    Report

    Report Number
    2135225-2008-00063
    Event Type
    Injury
    Date Received
    October 23, 2008
    Date of Event
    October 11, 2008
    Report Date
    October 22, 2008
    Manufacturer
    BIOFORM MEDICAL
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WAS INJECTED IN THE NOSE WITH RADIESSE DERMAL FILLER; THREE DAYS POST INJECTION, SHE DEVELOPED A NECROSIS ON THE TIP OF HER NOSE. SHE WAS TREATED WITH TETRACYCLINE (ANTIBIOTIC).

    Description of Event or Problem · 1

    PATIENT WAS INJECTED IN THE NOSE WITH RADIESSE DERMAL FILLER; THREE DAYS POST INJECTION, SHE DEVELOPED A NECROSIS OF THE TIP OF HER NOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIESSE DERMAL FILLER INJECTABLE IMPLANT LMH BIOFORM MEDICAL 8046M0 1009485

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention