BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 1922846 · Received December 3, 2010

    Report

    Report Number
    2135225-2010-00089
    Event Type
    Other
    Date Received
    December 3, 2010
    Date of Event
    October 28, 2010
    Report Date
    November 4, 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
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DR (B)(6) INDICATED THAT THE PT WAS TREATED BY A DERMATOLOGIST NEAR THE PT'S HOME; DIAGNOSIS BY THE DERMATOLOGIST HAD NOT BEEN PROVIDED. THE PT WAS REPORTED AS HAVING NECROSIS AND WAS STILL IN THE MENDING PROCESS, AS OF (B)(6) 2010, THE PT WILL MOST LIKELY REQUIRE LASER TO TREAT THE PT'S PERSISTENT REDNESS. THE DEVICE HISTORY RECORDS FOR RADIESSE LOT 1021617 WERE REVIEWED; ALL REQUIRED TESTING SPECIFICATIONS WERE MET PRIOR TO RELEASE AND THERE WERE NO ABNORMALITIES NOTED FOR THIS LOT.

    Description of Event or Problem · 1

    DR (B)(6) INJECTED A PT WITH RADIESSE DERMAL FILLER IN THE CHEEKS, MARIONETTE LINES, AND A SMALL AMOUNT IN THE GLABELLA (ABOUT 0.1- 0.2CC). THE GLABELLA BLANCHED AND SURPRISED THE PHYSICIAN, SINCE THERE WAS ONLY A SMALL AMOUNT INJECTED. SHE DID NOT HAVE ANY NITROPASTE ON HAND. ON (B)(6) 2010, THE PT CALLED DR (B)(6) TO INFORM HER THAT SHE HAD DEVELOPED BLISTERS AND REDNESS AT THE GLABELLAR INJECTION AREA. THE PT LIVES ABOUT 300 MILES AWAY, SO THE PHYSICIAN HAD BEEN COMMUNICATING VIA PHONE. DR (B)(6) WAS UNSURE WHICH OF THESE THREE THINGS OCCURRED: (B)(6) (STAPH/ STREP INFECTION); (B)(6) INFECTION; ISCHEMIA WITH TISSUE NECROSIS. THE PT WAS SEEN BY A DERMATOLOGIST NEAR HER HOME (CONTACT NAME NOT PROVIDED) AND TREATED WITH MEDICATION TO REDUCE THE REDNESS.

    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.) 1021617

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention