BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 1969211 · Received January 18, 2011

    Report

    Report Number
    2135225-2011-00002
    Event Type
    Injury
    Date Received
    January 18, 2011
    Date of Event
    December 15, 2010
    Report Date
    December 21, 2010
    Manufacturer
    MERZ AESTHETICS, INC. (FORMERLY BIOFORM MEDICAL, INC)
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FIVE DAYS POST-INJECTION, THE PT WENT TO THE ER AND WAS TREATED WITH IV ANTIBIOTICS AND RELEASED AFTER FOUR HOURS. SHE WAS DIAGNOSED WITH NECROSIS IN THE GLABELLAR REGION. THE PT IS NOW RECEIVING TREATMENT WITH SILVADENE, NITRO PATCHES AND DMSO FROM A PLASTIC SURGEON. IT IS BELIEVED THE PT WAS INADVERTENTLY INJECTED INTO AN ARTERY CAUSING TISSUE NECROSIS. DURING FOLLOW-UP, THE TREATING PHYSICIAN REPORTED THE PT IS SHOWING IMPROVEMENT HOWEVER, MAY NEED RECONSTRUCTIVE SURGERY TO REPAIR THE GLABELLA REGION. A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THE REPORTED LOT #1022641 MET ALL SPECIFICATIONS PRIOR TO RELEASE.

    Description of Event or Problem · 1

    OFFICE MANAGER AT (B)(6) IN (B)(6) REPORTED A PT WHO WAS INJECTED WITH RADIESSE DERMAL FILLER IN THE GLABELLAR REGION BY A PHYSICIAN IN (B)(6). THE PT WAS DIAGNOSED WITH AN ALLERGIC REACTION AND PRESCRIBED ANTIBIOTIC, CIPRO AND INJECTED WITH CEFTRIAXONE. FIVE DAYS LATER, AFTER SHOWING NO IMPROVEMENT THE PT WENT TO THE ER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIESSE DERMAL FILLER INJECTABLE IMPLANT LMH MERZ AESTHETICS, INC. (FORMERLY BIOFORM MEDICAL, INC) 1022641

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention