BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 1050156 · Received May 21, 2008

    Report

    Report Number
    2135225-2008-00031
    Event Type
    Injury
    Date Received
    May 21, 2008
    Date of Event
    March 23, 2007
    Report Date
    May 19, 2008
    Manufacturer
    BIOFORM MEDICAL
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING A FOLLOW UP WITH NURSE PRACTITIONER, IT WAS REPORTED BOTH A TOPICAL AND INTRA-MUSCULAR ANTIBIOTIC WERE USED FOR TREATMENT OF THE AREA. PATIENT WAS HEALING AND HAS NO PERMANENT SCARRING. A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT THE REPORTED LOT #1004992, MET ALL SPECIFICATIONS. RADIESSE DERMAL FILLER INJECTIONS OF THE CHEEKS ARE CONSIDERED AN OFF-LABEL USE. THE MEDICAL DEVICE REPORT DECISION TREES WERE COMPLETED FOR THE FDA, WHEN THE COMPLAINT WAS FIRST RECEIVED AND AT THE TIME IT WAS DETERMINED FILING WAS NOT REQUIRED. HOWEVER, IN DOING A SECOND REVIEW OF THE COMPLAINT AND MDR DECISION TREES, AN MDR WILL BE FILED WITH THE FDA DUE TO PROCESS IMPROVEMENTS AND SERIOUSNESS OF THE INFECTION (REQUIRED AN INTRA-MUSCULAR ANTIBIOTIC). WE REGRET THE DELAY IN THE FILING OF THIS REPORT.

    Description of Event or Problem · 1

    NURSE PRACTITIONER REPORTED PATIENT INJECTED IN NASAL LABIAL FOLDS AND CHEEKS HAS NOW DEVELOPED AN INFECTION, SLOUGHING OFF OF SKIN AND GRAYING AREA WITH POSSIBLE NECROSIS ON RIGHT SIDE ONLY. IT WAS ALSO INDICATED THAT THE LIDOCAINE ANESTHESIA ON THE RIGHT SIDE WAS NOT AS EFFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIESSE DERMAL FILLER INJECTABLE IMPLANT LMH BIOFORM MEDICAL 1004992

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention