BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIESSE DERMA FILLER

    MDR report key: 1592408 · Received January 26, 2010

    Report

    Report Number
    2135225-2010-00003
    Event Type
    Injury
    Date Received
    January 26, 2010
    Date of Event
    December 30, 2009
    Report Date
    January 8, 2010
    Manufacturer
    BIOFORM MEDICAL, INC.
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS FOR RADIESSE LOT 1014081 WAS REVIEWED. ALL REQUIRED TESTING SPECIFICATIONS WERE MET PRIOR TO RELEASE OF THE LOT. THERE WERE NO ABNORMALITIES NOTED; THERE ARE NO OTHER ADVERSE EVENTS REPORTED FOR THIS DEVICE LOT. DURING A FOLLOW-UP, IT WAS REPORTED THAT HIS SYMPTOMS WERE RESOLVING.

    Description of Event or Problem · 1

    A PATIENT (PHYSICIAN) INJECTED HIMSELF IN THE CHEEKS WITH RADIESSE DERMAL FILLER ON (B) (6) 2009. ONE DAY POST INJECTION, HE DEVELOPED AN INFECTION IN THE CHEEKS, WHICH HE TREATED WITH LEVAQUIN. HE DIAGNOSED HIMSELF WITH CELLULITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIESSE DERMA FILLER INJECTABLE IMPLANT LMH BIOFORM MEDICAL, INC. 1014081

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other