BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 4102766 · Received September 9, 2014

    Report

    Report Number
    2135225-2014-00058
    Event Type
    Other
    Date Received
    September 9, 2014
    Date of Event
    August 1, 2014
    Report Date
    August 18, 2014
    Manufacturer
    MERZ NORTH AMERICA
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2014, (B)(6) STATED THE "PATIENT IS 100 PERCENT BETTER". THE PATIENT HAS A VERY SMALL DISCOLORATION "BUBBLE" ON THE SIDE OF HER NOSE THAT'S HEALING WELL. THE DEVICE HISTORY RECORD FOR RADIESSE LOT 100071730 WAS REVIEW. ALL REQUIRED TESTING SPECIFICATIONS FOR THIS LOT WERE MET PRIOR TO RELEASE. NO NON-CONFORMANCES WERE DISCOVERED THAT WOULD HAVE CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT WAS RECEIVED FROM A PHYSICIAN VIA A COMPANY EMPLOYEE AND CONCERNS A (B)(6) FEMALE INJECTED WITH TWO 1.5 CC RADIESSE INTO NASOLABIAL FOLDS, INFRA-ORBITAL RIM AND PRE-JOWL ON (B)(6) 2014. THE PATIENT EXPERIENCED FACIAL SWELLING AND PAIN WITHIN 24 HOURS. SHE WAS SENT TO THE EMERGENCY ROOM (ER) ON AUGUST 7, 2014 AND TO AN INFECTIOUS DISEASES PHYSICIAN FOR A DIAGNOSIS OF INFECTION. THE PATIENT RECEIVED INTRAVENOUS ANTIBIOTICS, FROM EITHER ER PHYSICIAN OR THE INFECTIOUS DISEASES PHYSICIAN; NAME, DOSE, FREQUENCY AND DURATION WERE NOT REPORTED. ON (B)(6) 2014, DR. (B)(4) SPOKE WITH DR. (B)(6) REGARDING HIS PATIENT. THE PATIENT THAT DR. (B)(6) TREATED FOR (B)(6) HAS A CLEAR VASCULAR OCCLUSION. DURING THE FOLLOW-UP CONVERSATION, DR. (B)(6) WILL REVIEW THE WAY TO DIAGNOSE A VASCULAR OCCLUSION AND HOW TO TREAT IT. IN ADDITION, TECHNIQUES WILL BE DISCUSSED ON HOW TO AVOID SUCH AN EVENT IN THE FUTURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556391 RADIESSE DERMAL FILLER INJECTABLE IMPLANT LMH MERZ NORTH AMERICA 100071730

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR