BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 2424873 · Received January 13, 2012

    Report

    Report Number
    2135225-2012-00003
    Event Type
    Other
    Date Received
    January 13, 2012
    Date of Event
    December 8, 2011
    Report Date
    December 22, 2011
    Manufacturer
    MERZ AESTHETICS, INC.
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS WERE NOT REVIEWED. A LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    THIS REPORT WAS FORWARDED TO MERZ AESTHETICS BY (B)(4) AT MERZ PHARMA (B)(4). A FEMALE, PT, WAS INJECTED WITH TWO 0.8 CC RADIESSE SYRINGES INTO CHEEKBONES ON (B)(6) 2011, AND ON (B)(6) 2011, DEVELOPED BILATERAL INFLAMMATORY EDEMA (CHEEKBONES) WITHOUT PAIN, TREATED WITH ANTIBIOTICS PER "OS" PLUS CORTICOSTEROIDS (SOLUPRED). ON (B)(6) 2012, DR. (B)(6) MERZ (B)(6)FORWARDED AN UPDATE TO MERZ AESTHETICS. DR. (B)(6) REPORTED THE EVENT AS "2 INFLAMMATORY CHEEKBONES" FOLLOWING THE RADIESSE INJECTION MANIFESTED AS EDEMA AND REDNESS; MODERATE INTENSITY AND ONGOING. SINCE (B)(6) 2012, THE PT WAS TREATED WITH DIPROSONE CREAM, 2 TIMES DAILY FOR 6 DAYS LEADING TO TRANSIENT IMPROVEMENT; SOLUPRED (PREDNISOLONE) AND ORBENINE (CLOXACILLIN) FOR 6 DAYS. NO LIDOCAINE WAS ADDED TO THE RADIESSE SYRINGES. INDICATION FOR RADIESSE INJECTIONS WAS LISTED AS "INCREASING VOLUME OF CHEEKBONES." CAUSALITY RELATIONSHIP LISTED AS "PROBABLY." THE PT HAD PREVIOUS RADIESSE INJECTION "SINCE (B)(6) 2010, 8 VIALS." DR. (B)(6) STATED THE EVENT IS NOT SERIOUS, HOWEVER, HE ADDED THAT THE CONDITION REQUIRED MEDICAL/SURGICAL INTERVENTION AND THE INCIDENT IS CONSIDERED MEDICALLY IMPORTANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIESSE DERMAL FILLER RADIESSE INJECTABLE IMPLANT LMH MERZ AESTHETICS, INC. UNK X 2

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other