BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE

    MDR report key: 906082 · Received October 26, 2004

    Report

    Report Number
    2135225-2004-00018
    Event Type
    Other
    Date Received
    October 26, 2004
    Date of Event
    August 17, 2004
    Report Date
    September 24, 2004
    Manufacturer
    BIOFORM MEDICAL, INC.
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF DEVICE HISTORY RECORDS INDICATES THAT PRODUCT TESTED FROM THE INDICATED LOT MEETS ALL REQUIRED SPECIFICATIONS PRIOR TO RELEASE. THERE ARE NO SIGNIFICANT ISSUES ASSOCIATED WITH THE MANUFACTURE OF THIS LOT. BIOFORM MEDICAL, INC. IS USING PERIODIC CONTACT WITH DR.'S OFFICE AS A METHOD OF EVALUATION. DR. IS TREATING THIS PATIENT AT THE TIME OF THIS REPORT. THE PATIENT VISITED DR. IN 2004, AT WHICH TIME IT WAS REPORTED THAT THE PATIENT WAS DOING FINE. A MEDRAL DOSE PACK HAD BEEN PREVIOUSLY ADMINISTERED.

    Description of Event or Problem · 1

    PATIENT WAS INJECTED WITH RADIESSE IN HER LIPS. THE PATIENT IS EXPERIENCING SWELLING AT THE INJECTION SITE. THE OFFICE MANAGER AT DR.'S OFFICE DESCRIBED THIS EVENT AS A POSSIBLE ALLERGIC REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIESSE INJECTABLE IMPLANT LMH BIOFORM MEDICAL, INC. 8044M0 1000190

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other