BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE

    MDR report key: 676532 · Received February 13, 2006

    Report

    Report Number
    2135225-2006-00002
    Event Type
    Other
    Date Received
    February 13, 2006
    Date of Event
    January 13, 2006
    Report Date
    February 10, 2006
    Manufacturer
    BIOFORM MEDICAL, INC.
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    BIOFORM MEDICAL PERFORMED A FOLLOW-UP WITH THE PATIENT OF 3/7/06. SHE REPORTED THAT SHE WENT TO A DERMATOLOGIST WHO DIAGNOSED HER WITH PERIORAL DERMATITIS. THE DERMATOLOGIST FEELS THAT THIS IS NOT RELATED TO RADIESSE. THE DERMATOLOGIST PROVIDED TREATMENT WHICH RESOLVED THE SYMPTOMS. THE PATIENT SUGGESTED WE CLOSE THE COMPLAINT.

    Description of Event or Problem · 1

    DR'S OFFICE REPORTED TO BIOFORM MEDICAL INC. IN 2006, THAT A PT INJECTED WITH RADIESSE DURING 2/2005 EXPERIENCED REDNESS AT THIS INJECTION SITE TWO WEEKS POST INJECTION. THIS REDNESS RESOLVED DURING THE NEXT THREE WEEKS. THE REDNESS PERIODICALLY RETURNED AND DISAPPEARED OVER THE NEXT SEVERAL MONTHS. OTHERS WERE INJECTED WITH RADIESSE ON THE SAME DAY WITH NO COMPLICATIONS. THESE PTS WERE INJECTED WITH DIFFERENT SYRINGES, EACH CONTAINING MATERIAL FROM THE SAME MFG LOT. THIS EVENT WAS REPORTED TO BIOFORM BECAUSE THIS PT RECENTLY DEVELOPED SMALL PIMPLES AT THE INJECTION SITE THAT APPEAR TO BE FILLED WITH FLUID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIESSE INJECTABLE IMPLANT LMH BIOFORM MEDICAL, INC. * 1000732

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other