BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 1921471 · Received December 3, 2010

    Report

    Report Number
    2135225-2010-00085
    Event Type
    Injury
    Date Received
    December 3, 2010
    Date of Event
    November 4, 2010
    Report Date
    November 8, 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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS FOR RADIESSE LOT 1021743 WERE REVIEWED; ALL REQUIRED TESTING SPECIFICATIONS WERE MET PRIOR TO RELEASE AND THERE WERE NO ABNORMALITIES NOTED FOR THESE LOTS.

    Description of Event or Problem · 1

    PHYSICIAN REPORTED THAT A PATIENT WAS INJECTED WITH 1.6CC RADIESSE INJECTABLE IMPLANT IN THE NASOLABIAL FOLDS AND UPPER LIP ON (B)(6) 2010. A 0.02 CC OF 2% LIDOCAINE WAS USED FOR EACH 0.8 CC SYRINGE OF RADIESSE. THE PT EXPERIENCED AN IMMEDIATE PAIN AND BRUISING AT THE LEFT NASOLABIAL FOLD; AND FOUR DAYS POST INJECTION, EXPERIENCED ERYTHEMA, BLISTERING AND LESIONS AT THE LEFT NASOLABIAL FOLD AND UPPER LIP, DIAGNOSED AS HERPETIC OUTBREAK OR SHINGLES. THE PATIENT WAS INITIALLY TREATED WITH ICE TO AREA AND ORAL HYDROCODONE PRESCRIBED BY A FAMILY DOCTOR; DOSE AND FREQUENCY WERE NOT PROVIDED. ADD'L TREATMENT INCLUDES ORAL KEFLEX AND DARVOCET, DOSE AND FREQUENCY NOT PROVIDED; AND ORAL VALTREX, 500 MG TWICE A DAY. THE PT ALSO HAD ONE IM RICEFIN, DOSE NOT PROVIDED. THE PT'S MEDICAL HISTORY INCLUDES CHICKEN POX AT AGE (B)(6) AND ADD'L RADIESSE INJECTIONS, 3.0 CC INTO CHEEKS (1.5 CC PER CHEEK) BY THE SAME INJECTOR ON (B)(6) 2010, WITH NO ADVERSE EVENTS NOTED. DURING A LATER F/U OF (B)(6) CONSULTING PHYSICIAN ON (B)(6) 2010, WITH THE INJECTING PHYSICIAN, IT WAS DETERMINED THAT THIS EVENT REPRESENTS AN INTRAVASCULAR INJECTION INTO A BRANCH OF THE ANGULAR ARTERY AND IT IS NOT A HERPETIC INFECTION. FROM THE PT PHOTO, THERE APPEARS TO BE AT LEAST PARTIAL THICKNESS SKIN LOSS. DAILY IRRIGATION, AQUAPHOR OINTMENT TO KEEP AREA MOIST ALL THE TIME, CONTINUED KEFLEX, AND VALTREX (PROPHYLACTICALLY) WERE RECOMMENDED. ON (B)(6) 2010, AS A F/U, DR (B)(6) STATED THE PATIENT IS A "LOT BETTER, SHE IS RECOVERING NICELY", FOLLOWING THE TREATMENT OUTLINED DURING CONSULTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIESSE DERMAL FILLER RADIESSE INJECTABLE IMPLANT LMH MERZ AESTHETICS, INC. (FORMERLY BIOFORM MEDICAL, INC.) 1021743

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention