BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIESSE DERMAL FILLER

    MDR report key: 2084763 · Received April 29, 2011

    Report

    Report Number
    2135225-2011-00025
    Event Type
    Injury
    Date Received
    April 29, 2011
    Date of Event
    March 25, 2011
    Report Date
    April 4, 2011
    Manufacturer
    MERZ AESTHETICS, INC. (FORMERLY BIOFORM MEDICAL, INC)
    Product Code
    LMH
    PMA / PMN Number
    P050052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PHYSICIAN PRESCRIBED PREDNISONE, CLEOCIN, CIPRO, CEPHALEXIN, AND APPLIED NITRO PASTE TO THE AFFECTED AREA. THE PT EXPERIENCED VASCULAR COMPROMISE WITH NECROSIS AND TREATMENTS INCLUDING VINEGAR SOAKS AND OCCLUSIVE DRESSINGS WERE ALSO PROVIDED. THE PT RETURNED FOR EVALUATION ONE WEEK LATER WITH TENDERNESS AND REDNESS PERSISTING. SHE DID NOT REPORT THE RESULTS OF HER EYE APPOINTMENT TO THE INJECTING PHYSICIAN. THE RESULTS OF THE ER VISIT HAVE NOT BEEN PROVIDED. DURING LATER F/U, THE PHYSICIAN REPORTED THE PT IS DOING BETTER. SHE HAS SOME SCABBING ON THE RIGHT SIDE OF THE NOSE. THE AREA IS SLIGHTLY RED; HOWEVER, THE SKIN IS BEGINNING TO HEAL. HE IS UNSURE IF THERE WILL BE ANY SCARRING REMAINING. THE OPTION OF A PULSED DYE LASER TREATMENT WAS DISCUSSED WITH THE PT BUT SHE REMAINS UNDECIDED AT THIS TIME. A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THE REPORTED LOT #1021366 MET ALL SPECIFICATIONS PRIOR TO RELEASE.

    Description of Event or Problem · 1

    PHYSICIAN REPORTED A PT INJECTED WITH RADIESSE IN THE DORSUM AND TIP OF THE NOSE DEVELOPED PAIN SEVERAL HOURS POST-INJECTION. SHE LATER EXPERIENCED RED STREAKS TRAVELING UP TO THE GLABELLA WITH PUSTULES, BLACKENED SKIN WITH TISSUE SLOUGHING AT RIGHT CHEEK, EYE AREA AND NOSE. SHE ALSO REPORTED SOME VISION IRREGULARITIES. THE PT LATER WENT TO AN EYE DOCTOR AND TO THE ER.

    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) 1021366

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention