BEUDAMED
    FDA Adverse Event Other Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 2442903 · Received January 30, 2012

    Report

    Report Number
    2135225-2012-00017
    Event Type
    Other
    Date Received
    January 30, 2012
    Date of Event
    December 23, 2011
    Report Date
    January 30, 2012
    Manufacturer
    MERZ AESTHETICS INC
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEGREE OF BRUISING MAY BE A RESULT OF HER UNDERLYING AUTOIMMUNE DISEASE AND ASSOCIATED MEDICATIONS. BRUISING IS ESSENTIALLY RESOLVED TO DATE. THE DEVICE HISTORY RECORDS FOR THE REPORTED RADIESSE LOT WAS REVIEWED. ALL REQUIRED TESTING SPECS FOR THE LOT WERE MET PRIOR TO RELEASE, THERE WERE NO ABNORMALITIES NOTED.

    Description of Event or Problem · 1

    PT TREATMENT CONSISTED OF NLF AND CHEEK AUGMENTATION. A .2 - .3 CC BOLUSES WAS PLACED IN EACH CHEEK. THE RIGHT NLF STARTED TO SWELL SO PRESSURE WAS APPLIED ASSUMING NORMAL SWELLING. WITHIN 48 HOURS PT REPORTED INCREASED SWELLING AND REDNESS TO THE RIGHT NLF AND KEFLEX WAS INITIATED. PT WENT TO THE ER AND RECEIVED IV ANTIBIOTICS. THAT EVENING PT DEVELOPED A MIGRAINE HEADACHE WITH SEVERE VOMITING. SHE HAS A HISTORY OF INTENSE VOMITING AND VESSELS IN HER FACE RUPTURE. THE FOLLOWING DAY THE REDDENED AREAS BECAME PURPLE AND EVENTUALLY A BLACKISH DISCOLORATION THAT SPREAD TO HER ENTIRE UPPER LIP. THE AFFECTED AREAS WERE NOT PAINFUL, WEEPING OR WARM TO TOUCH. DR (B)(6) WAS CONCERNED ABOUT A POSSIBLE VASCULAR INJURY BUT THE PROGRESSION WAS SO SLOW, SHE NEVER EXPERIENCED PAIN NOR DID HER SKIN SLOUGH OR NECROSE. OVER THE COURSE OF 12 DAYS THE PURPURIC-TYPE BRUISING COMPLETELY RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIESSE DERMAL FILLER RADIESSE INJECTABLE IMPLANT LMH MERZ AESTHETICS INC 1030100

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization IMMUNE DEPRESSANT| PREDNISONE| VITAMIN B| FISH OIL