BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 1374666 · Received May 4, 2009

    Report

    Report Number
    2135225-2009-00021
    Event Type
    Other
    Date Received
    May 4, 2009
    Date of Event
    March 6, 2009
    Report Date
    April 22, 2009
    Manufacturer
    BIOFORM MEDICAL, INC.
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS REPORTED TO BIOFORM MED, INC., SIX WEEKS POST ONSET OF THE INFECTION AND THE PT HAS FULLY RECOVERED. THE RADIESSE LOT NUMBER HAD NOT BEEN RECORDED IN THE PT FILE; THEREFORE, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED.

    Description of Event or Problem · 1

    A PT WHO HAD BEEN INJECTED WITH RADIESSE DERMAL FILLER IN THE NASO LABIAL FOLDS AND MARIONETTE LINES IN (B) (6) 2008. ON (B) (6) 2009, THE PT DEVELOPED SWELLING OF THE UPPER LIP, AND A LUMP IN THE MUCOSA OF HER LOWER LIP. THE LUMP WAS INJECTED WITH 2% PLAIN LIDOCAINE MIXED WITH 0.9% NACL AND THEN MASSAGED. THE FOLLOWING DAY, THE PT STATED THE SWELLING WORSENED; SHE WENT TO URGENT CARE, WHERE THEY PRESCRIBED ANTIBIOTICS AND STEROID. TWO DAYS LATER, ENT ADMITTED HER TO THE HOSPITAL TO DRAIN THE ABSCESS; AT THIS TIME, THE PT WAS DIAGNOSED WITH (B) (6) INFECTION AND REMAINED IN THE HOSPITAL OVERNIGHT WITH IV ANTIBIOTICS.

    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 Hospitalization