BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 3190101 · Received June 17, 2013

    Report

    Report Number
    2135225-2013-00074
    Event Type
    Other
    Date Received
    June 17, 2013
    Date of Event
    April 1, 2013
    Report Date
    May 20, 2013
    Manufacturer
    MERZ AESTHETICS, INC.
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL RADIESSE LOT USED: 8071M0K1, 100062240, EXPIRATION DATE: 01/2015. DATE OF MANUFACTURE: 01/2013. THE DEVICE HISTORY RECORDS FOR LOTS 100063141 AND 100062240 WERE REVIEWED. ALL REQUIRED TESTING SPECIFICATIONS FOR THESE LOTS WERE MET PRIOR TO RELEASE. NO NON-CONFORMANCES WERE DISCOVERED THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    DR (B)(6) INJECTED A FEMALE PATIENT WITH RADIESSE INTO NASOLABIAL FOLDS, MARIONETTE LINES, AND CHEEKS. SHE USED TWO 1.5CC SYRINGES AND PLACED THE PRODUCT SUBCUTANEOUSLY. THE PATIENT CAME IN THE OFFICE A FEW DAYS AFTER THE TREATMENT WITH BLISTERS INSIDE HER MOUTH AND NOSE AND REPORTING OF PAIN IN THE TREATED AREA. DR (B)(6) CULTURED THE BLISTERS AND THE CULTURES WERE NEGATIVE. THERE WERE NO ABSCESSES; BLISTERS WERE FIRM AND WERE NOT WARM TO THE TOUCH. DR (B)(6) TREATED THE PATIENT WITH PREDNISONE, KEFLEX, AND VALTREX, DOSE, FREQUENCY AND DURATION WERE NOT PROVIDED; AND THE BLISTERS RESOLVED WITHIN A FEW DAYS. THE PATIENT WAS TREATED A TOPICAL BLT TOPICAL ANESTHETIC PRIOR TO TREATMENT WHICH HAS SINCE BEEN THROWN OUT. ADDITIONAL INFORMATION WAS REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274539 RADIESSE DERMAL FILLER RADIESSE INJECTABLE IMPLANT LMH MERZ AESTHETICS, INC. 100063141

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention BLT TOPICAL ANESTHETIC