BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 1864685 · Received October 1, 2010

    Report

    Report Number
    2135225-2010-00056
    Event Type
    Injury
    Date Received
    October 1, 2010
    Date of Event
    September 2, 2010
    Report Date
    September 3, 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

    ON (B)(6) 2010, THE (B)(6) FIELD CLINICAL SPECIALIST WAS AT THE PHYSICIAN'S OFFICE AND NOTED THAT THE PT DID HAVE EDEMA AND REDNESS MORE IN THE INFRAORBITAL AREA BILATERALLY. THE PT HAS A HISTORY OF ASTHMA AND ALLERGIES AND HAD BEEN TREATED DURING THE SUMMER FOR BOTH THESE CONDITIONS. THE PHYSICIAN DID A 3MM PUNCH BIOPSY ON LOWER LEFT JAWLINE, SENT FOR PATHOLOGY. THE PHYSICIAN INJECTED THE SWOLLEN AREAS WITH TAC3 (TRIAMCINOLONE). A TINY DROPLET OF TAC, AMOUNT UNK. THE PHYSICIAN PRESCRIBED PREDNISONE 120 TABS, DOSE: 60 TABS FIRST WEEK, 40 THE SECOND, 20 THE THIRD WEEK. THE PT WAS ALSO PRESCRIBED BIAXIN, DOSE. DURATION UNK. ON (B)(6)2010, THE PHYSICIAN PROVIDED THE FOLLOWING INFORMATION: APPROXIMATELY TWO WEEKS AGO, A BIOPSY WAS TAKEN FROM AN AREA WHERE THERE WAS A GRANULOMAS INFLAMMATION; RESULT OF THE BIOPSY WAS NOT PROVIDED. THE PT WAS ON PREDNISONE AND BIOXIN 60MG/DAY. THE PT IS A FEMALE THAT IS (B)(6) LBS. SHE HAD AN UPSET STOMACH FROM THE MEDICATION AND WAS PRESCRIBED AMBIEN (DOSE & DURATION NOT PROVIDED). THE PT STOPPED TAKING THE PREDNISONE FOUR DAYS AGO ((B)(6) 2010). THE PHYSICIAN SAW THE PT ON (B)(6) 2010 AND PUT THE PT ON A LOWER DOSE OF PREDNISONE 20MG/DAY AND CONTINUED THE BIOXIN.

    Description of Event or Problem · 1

    DURING A TRAINING AT THE PHYSICIAN'S OFFICE ON (B)(6) 2010, THE PT WAS INJECTED MID-FACE TO EFFACE NLF, MARIONETTE LIKES, PRE-JOWL SULCUS. TWO 1.5 CC RADIESSE SYRINGES FROM LOT 1016957 WERE USED. THE PT'S LEFT SIDE OF FACE WAS INJECTED BY THE PHYSICIAN AND THERE ARE NO PROBLEMS ON THAT SIDE. THE RIGHT SIDE OF THE FACE WAS INJECTED BY A (B)(6) FIELD CLINICAL SPECIALIST (FCS). THE PT PRESENTED ONE MONTH LATER (IN (B)(6) 2010), LOVED THE RESULTS AND HAD NO PROBLEMS. THE PT PRESENTED ON (B)(6) 2010 WITH FIRMNESS, SWELLING AND REDNESS TO RIGHT SIDE OF THE FACE AT THE INJECTED AREAS. THERE WAS HARDNESS IN THE RIGHT CHEEK. THE PT HAS HAD INJECTIONS OF HYALURONIC ACIDS (HAS) IN THE PAST WITH NO PROBLEMS. THE PT WAS INJECTED WITH JUVEDERM TO LIPS SAME DAY AFTER THE RADIESSE INJECTIONS. THE PHYSICIAN DID NOT DO A DENTAL BLOCK FOR THIS INJECTION. THERE WAS NO PROBLEMS IN THE LIPS. THE PT WAS INJECTED ON (B)(6) 2010 WITH CORTISONE AND KENALOG BY THE PHYSICIAN. THE PT HAS NO FEVER.

    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.) 1016957

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention