BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIESSE

    MDR report key: 1010441 · Received February 5, 2008

    Report

    Report Number
    1010441
    Event Type
    Malfunction
    Date Received
    February 5, 2008
    Date of Event
    January 17, 2008
    Report Date
    February 5, 2008
    Manufacturer
    BIOFORM MEDICAL
    Product Code
    LYC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING AN ATTEMPTED RADIESSE VOCAL CORD INJECTION THE 25 GAUGE NEEDLE FROM THE TIP OF THE RIGID INJECTION NEEDLE CAME OFF AND COULD NOT BE FOUND. A BRONCHOSCOPY WAS PERFORMED AND SOFT TISSUE X-RAY OF NECK AND CHEST X-RAY WERE COMPLETED, BUT TIP OF NEEDLE WAS NOT FOUND. PATIENT HAS BEEN INFORMED, BUT HAS NOT EXPERIENCED DISCOMFORT OR APPARENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIESSE RIGID INJECTION NEEDLE, STRAIGHT WITH SUPPORT CANNULA LYC BIOFORM MEDICAL * 1005588

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR