BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 1150542 · Received September 3, 2008

    Report

    Report Number
    2135225-2008-00049
    Event Type
    Injury
    Date Received
    September 3, 2008
    Date of Event
    July 2, 2008
    Report Date
    September 2, 2008
    Manufacturer
    BIOFORM MEDICAL, INC.
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WAS INJECTED WITH RADIESSE DERMAL FILLER IN THE NL FOLDS AND MALAR REGIONS. ONE DAY AFTER THE INJECTION, THE PATIENT DEVELOPED SWELLING AND THE SKIN TURNED A PURPLISH COLOR WITH SIGNS OF TISSUE BREAK DOWN, INDICATING NECROSIS. PHYSICIAN TREATED THE PATIENT WITH NITRO-PASTE AND AN ANTIBIOTIC OINTMENT. THE PATIENT IS ALSO USING WARM COMPRESSES 3X'S DAILY AND THE AREA IS NOW HEALING. DURING FURTHER REVIEW OF THIS COMPLAINT; THE MEDICAL DEVICE REPORT DECISION TREES WERE RE-EVALUATED. THE DECISION WAS MADE TO FILE AN MDR WITH THE FDA DUE TO THE SERIOUSNESS OF THE ADVERSE EVENT, REQUIRING THE NITRO-PASTE. WE REGRET THE DELAY IN THE FILING OF THIS COMPLAINT.

    Description of Event or Problem · 1

    PHYSICIAN REPORTED A PATIENT INJECTED WITH RADIESSE DERMAL FILLER IN THE NL FOLDS AND MALAR REGIONS. THE PATIENT IS NOW EXPERIENCING PURPLISH SKIN DISCOLORATION WITH POSSIBLE NECROSIS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention