BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIESSE

    MDR report key: 965746 · Received December 15, 2007

    Report

    Report Number
    2135225-2007-00019
    Event Type
    Injury
    Date Received
    December 15, 2007
    Date of Event
    October 11, 2007
    Report Date
    December 13, 2007
    Manufacturer
    BIOFORM MEDICAL, INC.
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT RECEIVED RADIESSE AND BOTOX INJECTIONS IN THE GLABELLAR FOLDS AT ELASE MEDICAL SPA. PATIENT DEVELOPED NECROSIS-LIKE SYMPTOMS AND WENT TO AN URGENT CARE FACILITY. ER PHYSICIAN DIAGNOSED AREA AS CELLULITIS AND TREATED WITH ANTIBIOTIC. PATIENT WENT TO DERMATOLOGIST, WHO THEN DIAGNOSED AREA AS NECROSIS. TREATED PATIENT WITH ASPIRIN AND NITROPASTE. PATIENT RETURNED TO DR. STOLMAN, IS STILL MOISTURIZING BUT HEALING WELL. PATIENT TO RETURN AGAIN ONLY IF FURTHER TREATMENT REQUIRED. DURING FOLLOW-UP IN 2007 WITH ELASE MEDICAL, INJECTOR TREASURE MORGAN REPORTED PATIENT HAS SINCE RETURNED FOR BOTOX INJECTIONS. APPEARS TO HAVE NO SCARRING OR REDNESS REMAINING FROM INITIAL EVENT. WE REGRET THE DELAY IS THE FILLING OF THIS REPORT.

    Description of Event or Problem · 1

    BIOFORM MEDICAL TERRITORY MANAGER REPORTED PATIENT WITH COMPLICATION FROM GLABELLAR INJECTION RECEIVED AT ELASE MEDICAL SPA. PATIENT RECEIVED BOTOX AND RADIESSE INJECTIONS IN GLABELLAR FOLDS AND HAS DEVELOPED NECROSIS. INJECTOR: TREASURE MORGAN AT ELASE MEDICAL TREATING PHYSICIAN: DERMATOLOGIST.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention